Nyxoah Announces CE Mark Approval for Genio® 2.1

Nyxoah Announces CE Mark Approval for Genio 2.1

The next generation external activation chip leverages Nyxoah's scalable platform to continuously enhance patient comfort and therapy efficacy

Mont–Saint–Guibert, Belgium "" July 18, 2022, 10:30pm CET / 4:30pm ET "" Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)("Nyxoah" or the "Company"), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that the DEKRA Notified Body has approved the use of Nyxoah's next generation Genio 2.1 system for patients in Europe. As with the recent approval of Genio 2.1 by the U.S. FDA for use in the DREAM U.S. IDE pivotal study, this CE mark pertains entirely to the external components of the Genio system and will be available to all patients who have received Genio implants.

Genio 2.1 is designed to improve patient comfort and compliance with a new smartphone application and upgraded external activation chip. Genio 2.1 offers patients daily feedback on therapy usage and the autonomy to adjust stimulation amplitude within pre–defined boundaries. Physicians can fine–tune stimulation amplitude to determine the optimal level of comfort for patients without compromising therapy efficacy. Additional embedded sensors will allow physicians to further tailor therapy stimulation parameters based on patient position and throughout the night.

"Genio 2.1 embodies the patient–centric design and the scalability of the Genio platform with features that allow for greater customization of therapy to meet individual patient's needs," commented Olivier Taelman, Nyxoah's Chief Executive Officer. "Importantly, these additional features are made available without the need for a surgical procedure to replace the implantable component. We are excited to launch Genio 2.1 in Europe, strengthening our vision to address the needs of OSA patients with and without Complete Concentric Collapse (CCC) and further accelerating market share gains."

About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah's lead solution is the Genio system, a patient–centered, leadless and battery–free hypoglossal neurostimulation therapy for OSA, the world's most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors' therapy. Additionally, the Company is currently conducting the DREAM IDE pivotal study for FDA and US commercialization approval.

For more information, please visit http://www.nyxoah.com/.

Caution "" CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.

Contacts:
Nyxoah
Loic Moreau, Chief Financial Officer
corporate@nyxoah.com
+32 473 33 19 80

Jeremy Feffer, VP IR and Corporate Communications
jeremy.feffer@nyxoah.com
+1 917 749 1494

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Triller Calls for Immediate Ban of TikTok Dubbing it Greatest Existential Threat to the Fabric of America

LOS ANGELES, July 18, 2022 (GLOBE NEWSWIRE) — Triller calls on CFIUS, President Joe Biden, Congress the Department Of Defense to ban TikTok calling it the largest security threat to America today in open letter by CEO and Chairman of Triller Mahi De Silva.

As the CEO of a global company whose mission is to help creators take control of their destiny in the creator economy, leveraging transformative adaptive technology, I stand with a growing chorus of elected officials, regulators, intelligence officials, other global executives, and consumers who recognize the enormity of the devastating impact of TikTok on our society. The danger signs abound from the leaders of our intelligence community to the most versatile and connected technology journalists. Every American parent needs to ask what this social video app knows about their children and how those signals are used to get a deeper understanding of the location, preferences, and habits of their parents and the entire family. The petaflops of data sent from American TikTok users start with content preferences and location information that can quickly lead to the determination of home ownership, work, and vacation schedules and a host of much more granular data on every aspect of our American lives.

Today, we call for every American to remove TikTok from their devices immediately. Additionally, Triller calls on the U.S. government to take immediate action and ban TikTok and its Chinese–owned parent ByteDance. The stakes have never been higher.

Professor Scott Galloway's recent piece, TikTok: Trojan Stallion, illustrated this deftly:

"The Chinese government has the power to access the data of private– sector companies whenever it wants. A wide range of laws makes this possible, including the Law of Guarding State Secrets: If you're suspected of harboring sensitive state information, you must grant access. The state takes small ownership positions known as golden shares (that typically come with board seats) in businesses deemed strategic to the state. One of those golden share arrangements is with ByteDance. And though TikTok is not accessible to Chinese consumers, Chinese access to TikTok's data is not in dispute. In June, Buzzfeed obtained over 80 audio recordings of internal TikTok meetings, confirming that Chinese management at ByteDance had unfettered access to TikTok's data. A TikTok manager refers to an engineer in Beijing, known as the "Master Admin,' who "has access to everything."

This creates some meteoric concerns around TikTok in the United States.

The AI systems that drive the recommendation of short–form videos will be expanded to influence e–commerce and its associated supply chain, which, in turn, will shape and influence the future of American commerce. The Chinese–owned ByteDance and its agent in the United States, TikTok, already have the lion's share of digital attention, where Americans spend up to 90 minutes a day scrolling through AI– recommended content, far more than the time spent on platforms like Google, Facebook, or Amazon.

More importantly, our concerns as Americans should extend beyond our wallets to the very backbone of our society: representative democracy and free speech. The AI systems controlled by Chinese– owner ByteDance and delivered via TikTok are the penultimate tool to influence our youth by shaping content and perceptions favoring a pro–China agenda.

It is clear that in the lexicon of technology, the signal–to–noise ratio for TikTok and its Chinese–owned parent ByteDance is all signal. It has become unavoidable that TikTok's overweight position in the marketplace is not simply a threat within the creator ecosystem but a threat to our entire economy, because its Chinese owners don't have to abide by the same rules as other platforms in this space. These present and future dangers threaten the whole of the American innovation economy.

We understand that some may counter that Google, Facebook, and Triller also collect a myriad of digital grains of sand on users; however, like every other U.S. company, Triller operates under the laws of the United States. It also may seem convenient for a company to call for the ban of the biggest company in its space. But at our core, Triller is about giving creators complete control over their content and their fan data "" and ultimately " complete control of their destiny.

As Professor Galloway rightly concluded, we have, as a society, welcomed a foreign actor to seduce our children and dominate this market, and we have done so without objection.

Triller believes that must end.

As Triller has expanded to build the platform for creators and to lay the foundation for its first–of–its–kind Creator Platform, we have developed a far more profound understanding of the creator economy. Through our lens, which watches over 175 billion social media content items per quarter, covering over 2 million creators and 25,000 brands, we have witnessed that TikTok suppresses the content and contributions from Black creators, making that content invisible to its audiences. It is indisputable that the TikTok AI algorithm designed by ByteDance is the ultimate propaganda tool "" and it is why India has banned the app from its citizens. Another example is TikTok's role in the recent Philipino elections for Bong Bong Marcos, as detailed by Bloomberg. As the article expertly assigns culpability to TikTok's role in rewriting the history of the Philippines, it should also be a clarion call for each of us to understand that exact mechanism is in each of our homes.

There is no doubt that TikTok plays a central role in enabling surveillance networks inside and outside China. The avenues that these technologies can access our lives are almost unlimited. This is a clear and present danger and a national security issue.

Look at the breadth of data that TikTok has access to and understands. Then, marry it with the broader concerns that our political leaders, intelligence community, and business leaders are raising "" where there is smoke, there is fire.

Triller is pulling the fire alarm today.

We do not have time to waste.

Triller, the platform for creators by creators, has built a network of creator–first services and products. It has assembled a revolutionary ecosystem to serve the immediate and long–term needs of those who seek to share their passions with the world. While our focus is on the creator and the future of the creator economy, we believe the broader future of American innovation is at risk because of our continued indifference to this threat that is literally in our hands.

Join us today and take action. Join us and all clear–thinking, freedom– loving Americans who believe in free markets, creative freedom, innovation, and a future where we can direct our lives unhindered by dark forces.

Mahi de Silva
CEO
Triller, Inc.

About Triller:

Triller is the AI–powered open garden technology platform for creators. Pairing music culture with sports, fashion, entertainment, and influencers through a 360–degree view of content and technology, Triller encourages its influencers to post the content created on the app across different social media platforms and uses proprietary AI technology to push and track their content virally to affiliated and non–affiliated sites and networks, enabling them to reach millions of additional users. Triller additionally owns VERZUZ, the live–stream music platform launched by Swizz Beatz and Timbaland; Amplify.ai, a leading customer engagement platform; FITE, a premier global PPV, AVOD, and SVOD streaming site; and Thuzio, a leader in B2B premium influencer events and experiences. Triller recently filed for an IPO expected to occur later this year.

About TikTok:

TikTok is a Chinese communist party trojan horse weapon of war disguised as a short form app that 80 percent or American children have downloaded on their phone. It can read, download, watch, copy, track and control any and all aspects of the phone the information of the owner and those close to it and sends the information back to America's greatest enemy the China Communist Party. Make no mistake about it, TikTok is not a toy but one of the most advanced weapons of war to ever invade America.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ca8bb25e–7e18–4071–846d–6d75cf7bfbe9


Charles Lachaux Signs Exclusive Direct to Consumer Distribution Deal With Blockchain-Based Membership Wine Community Crurated

LONDON, July 18, 2022 (GLOBE NEWSWIRE) — Charles Lachaux, Burgundy's most forward–thinking winemaker, today announced an exclusive partnership with blockchain–based membership wine community Crurated. Under the terms of the deal, Lachaux's celebrated and award winning wines, that are small production and in high demand all over the globe, will be sold exclusively to Crurated members. More details on the offerings and on Crurated membership can be found at www.Crurated.com.

For members special offerings will be released in multiple phases throughout the year. The first offering includes 1 mixed case of six appellations:

  • Bourgogne Aligot, Les Champs d'Argent, 2021
  • Bourgogne Rouge, La Croix Blanche, 2021
  • Cte de Nuits Village, Aux Montagnes, 2021
  • Aloxe–Corton premier cru, Les Valozires, 2021
  • Nuits Saint Georges village, La Petite Charmotte, 2021
  • Nuits Saint Georges premier cru, Aux Argillas, 2021

Starting July 25th the wines will be offered to Crurated members through private sale.

"Innovation in winemaking is key to producing and distributing an exceptional bottle of wine," said Charles. "For decades wine has been distributed to discerning wine lovers without an eye for how the process can be improved. Crurated streamlines access to rare wines and their use of blockchain and NFT technology provides buyers with the authenticity and provenance much needed in this industry. They are the ideal partner for us as we embark on a new age of direct to consumer wine sales."

"Our team is fortunate to be working with the world's greatest wines and winemakers and Charles Lachaux is no exception," said Alfonso de Gaetano, Founder of Crurated. "Our blockchain–based technology platform has revolutionized the way rare wines are bought and sold. We are the first member–based wine community to offer full transparency and asset value protection. This model is already redefining the wine cellar far beyond the four walls."

Each bottle will be accompanied with an NFT. Recorded forever on the blockchain, the NFT will verify the authenticity of the bottle and provide other important details including ownership history, vintage, vineyard location, varietal, and other key details. The NFTs are easily accessible by tapping on an NFC or RFID enabled phone. The bottle history is also updated via a new blockchain recording anytime the wine is resold and the token moves from one client to another.

Although Charles Lachaux wines will be sold directly to consumers exclusively through the Crurated platform, B2B restaurant sales will still be handled by distributors.

About Charles Lachaux
Charles Lachaux has made revolutionary changes to the viticulture at Arnoux–Lachaux, pushing the boundaries of Burgundian winemaking today. Described by Jancis Robinson as "a bright new star", he embodies the new generation. In 2021 Charles was crowned "best young winemaker on the planet" at the Golden Vines Awards held in London. He is an advocate of high density planting, low yields and intensive vineyard work, which includes training his vines into long "arches' rather than pruning their shoots. Lachaux represents the 6th generation to care for the family estate located in Vosne–Romane (Cte–d'Or).

About Crurated
Launched in 2021 with an emphasis on France and Italy, Crurated is a membership–based wine community designed to connect connoisseurs directly with world–class producers. A team of specialists provides personalized services and authentic experiences, while Crurated's seamless logistics service guarantees quality and provenance thanks to secure wine cellar storage and innovative blockchain technology. For more on Crurated, visit crurated.com.

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/46bc59bd–f682–410f–94ff–03d5c0785b65

https://www.globenewswire.com/NewsRoom/AttachmentNg/c2c51c18–d26f–4042–bbd6–6eb2502e8f88


Entera Bio Announces Execution of Key Regulatory Milestones for EB613, the First Oral Anabolic Drug Proposed for the Treatment of Osteoporosis; Miranda Toledano Assumes CEO Position

JERUSALEM, July 18, 2022 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered peptides and therapeutic proteins, announced today the execution of the following key milestones:

  • The U.S. Food and Drug Administration (FDA) has granted Entera's request for a Type C Meeting based on the revised phase 3 registrational study for lead clinical asset, EB613 (oral formulation of PTH (1–34, teriparatide), as the first oral anabolic drug to treat post–menopausal women with osteoporosis. The meeting is expected in H2 2022
  • Following its End of Phase 2 Meeting with the FDA, Entera designed the pivotal study for EB613 as an 18 month double blind placebo–controlled study, followed by a 6–month open label transition to alendronate for all patients
  • The study's primary endpoint employs the Foundation for the National Institutes of Health Bone Quality Program (FNIH BQP) total hip Bone Mineral Density (BMD) as a surrogate endpoint to evaluate fracture risk. FDA re–confirmed that with a well–designed BMD study, EB613 approval would not require a fracture study
  • In line with her increased executive role since earlier this year, Ms. Miranda Toledano, Entera Board Member and industry veteran with over 20 years of experience succeeds Dr. Spiros Jamas as Chief Executive Officer

FDA Acceptance of Type C Meeting: Phase 3 Design of EB613 Under Review

During Entera's End of Phase 2 Meeting, FDA's Division of Endocrinology remarked on the FNIH BQP published meta–regression analysis which is based on patient–level BMD and fracture incidence data from more than 22 placebo–controlled fracture endpoint studies across all classes of osteoporosis drugs, including teriparatide. The FNIH BQP data indicate that changes in Total Hip BMD (in contrast to lumbar spine or femoral neck BMD measurements) provides a superior surrogate marker of an osteoporosis drug's effects on vertebral, nonvertebral and all site fracture risk. The FNIH BQP BMD data and Surrogate Threshold Effects (STEs) are in the process of qualification by the FDA to become the first surrogate endpoint for fracture risk reduction1.

FDA suggested that Entera explore the FNIH BQP STEs and the design of a placebo–controlled study as an alternative to the originally contemplated non–inferiority design versus Forteo. Entera has since submitted to the FDA, as part of its Type C briefing documents, a revised Phase 3 protocol. The study is expected to be an 18–month randomized, double–blind, multicenter study comparing the effects of oral PTH (1–34, teriparatide) EB613 vs. placebo on BMD in post–menopausal women with osteoporosis at high risk of fracture, followed by a 6–month open–label extension where all patients will be transitioned to alendronate, a standard of care anti–resorptive therapy.

1 Black DM et. al. The Lancet. Diabetes & Endocrinology 2020 Eastell R et. al. JBMR 2021
FDA Approves Biomarker Qualification Plan for the First Surrogate Endpoint in Anti–Osteoporosis Drug Trials, June 1st, 2022, https://www.fnih.org/news/announcements/fda–approves–biomarkers–qualification–plan–first–surrogate–endpoint–anti

Patients will be randomized in a 2:1 ratio to receive blinded treatments with either EB613 (N=400) 2.5mg dose of oral PTH or Placebo (N=200). The 6–month extension phase of the study is intended to provide information on the transition from EB613 to a standard anti–resorptive therapy which has been shown to maintain or augment the increases in BMD following injectable PTH therapies, to preserve blinding of the prior therapy and to ensure that patients randomized to the placebo arm also receive an osteoporosis treatment.

The primary objective or endpoint of the phase 3 study will evaluate the effect of daily oral EB613 treatment on percent change in Total Hip BMD over 18 months versus placebo. Statistical methods will compare the observed treatment effect compared to pre–defined STEs associated with vertebral fracture, all site fracture and nonvertebral fracture risk reduction. The study will also look at secondary endpoints including changes in lumbar spine and femoral neck BMD and EB613's effects on biochemical markers of bone formation and resorption.

"In the past months, Entera has invested a considerable amount of time aligning our proposed Phase 3 study with FDA's EOP2 guidance, with the support of our clinical and statistical team, world–renowned scientific and clinical leaders in osteoporosis drug development, and representative institutional review boards. We are appreciative of FDA's inputs and believe that the current Phase 3 design is a much de–risked pivotal study pathway and enables us to continue to study a similar patient population, based on T–Score and other criteria, as in our Phase 2 dose ranging study which met its 3–month biomarker and 6–month BMD endpoints. We look forward to providing updates to you on the outcome of our conversation with FDA later this year," said Miranda Toledano, Entera's Chief Executive Officer.

CEO Transition

Entera's Board of Directors appointed Miranda Toledano as Chief Executive Officer (CEO) as of July 15th, 2022, succeeding Dr. Spiros Jamas.

Chairman of the Board Mr. Jerry Lieberman said, "The management transition reflects a strategic reorientation of Entera as we embark on pivotal clinical development and ongoing strategic discussions. I am thrilled to announce Miranda as our new CEO. Her fundamental understanding of Entera's pipeline and transaction–focused track record in the industry is aligned to the current stage of the Company. Her contributions as an independent board member for the last 4 years also demonstrate her passion and commitment to establishing Entera as a leading biopharmaceutical entity. On behalf of Entera's Board, we would like to recognize and thank Dr. Spiros Jamas for his contributions to Entera and advancement to success across our core programs."

Ms. Toledano stated, "We are laser focused on unlocking the value of Entera's oral delivery platform and core therapeutic assets. Both of our lead oral PTH drug candidates, EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism are highly differentiated with the potential to meaningfully change the treatment paradigm and the lives of patients in their respective indications. I am excited to take on the challenge of leading Entera at this critical time and help the Company forge forward which is why I first took more executive responsibility a few months ago. We believe that Entera's science has poised it as one of the leading entities in transforming the profile of therapeutic proteins to an oral route of administration. We further believe that this is especially valuable in chronically treated indications such as osteoporosis where most patients are under–treated because of the high cost and their reluctance to take injectable drugs. EB613 is positioned as a viable anabolic (bone formation) option to potentially lower the risk of fractures for a much wider population of post–menopausal osteoporotic women versus SC injected PTH drugs. We believe EB613 will deliver a tablet form (oral) PTH to fulfill the promise of this validated therapeutic class."

Dr. Jamas said, "I'm very proud of the significant progress we made advancing Entera's lead oral PTH asset, EB613 for the treatment of osteoporosis towards a pivotal Phase 3 study, including successfully completing the Phase 2 study. We demonstrated and presented data on the utility of Entera's oral delivery platform with other peptides, filed IP on a new and improved oral delivery platform and strengthened the management team. I support this transition and have full confidence that the team will realize Entera's full potential."

Ms. Toledano has served as a Member of the Board of Directors at Entera since 2018, and as Member of the Scientific Advisory Committee since February 2022. In May 2022, she also joined as Entera's Chief Business Officer and Chief Financial Officer. Previously, Miranda served as Chief Operating Officer, Chief Financial Officer, and Director of TRIGR Therapeutics, an oncology focused, clinical stage bispecific antibody company acquired by Compass Therapeutics (Nasdaq: CMPX) in June 2021 just 3 years after its establishment with her co–founder George Uy. At TRIGR, Miranda oversaw the clinical development of lead asset TR009 (now CTX–009) and led strategic execution, including a $117 million China License Transaction and acquisition by CMPX. Previously, Ms. Toledano served as Head of Healthcare Investment Banking at MLV & Co. (acquired by B. Riley FBR & Co.), where she completed biotech equity financings (IPOs, ATMs, and follow–ons) totaling over $4 billion in aggregate value. Earlier in her career, Ms. Toledano served as vice president in the investment group of Royalty Pharma. Ms. Toledano is also a member of the board of directors of Journey Medical (Nasdaq: DERM) and NEXGEL (Nasdaq: NXGL). Ms. Toledano holds a B.A. in Economics from Tufts University and an MBA in Finance and Entrepreneurship from the NYU Stern School of Business.

About EB613

Parathyroid hormone (PTH) is an 84–amino acid hormone and the primary regulator of calcium and phosphate metabolism in bone and kidney. EB613 is an oral formulation of synthetic hPTH (1–34), (teriparatide), a peptide consisting of the first 34 amino acids of PTH which represent the functional region. Subcutaneous Forteo (teriparatide injection) has been the leading anabolic treatment of osteoporosis since 2002. EB613 utilizes Entera's oral drug delivery platform which promotes enteric absorption and stabilizes teriparatide in the gastrointestinal tract. Entera's Oral PTH formulations have been administered collectively to a total of 225 subjects in two Phase 1 studies and 3 phase 2 studies (including 35 in 2 phase 2 hypoparathyroidism studies). The most recent study was a dose ranging Phase 2 study in postmenopausal women with low bone mass. This study met primary and key secondary endpoints and was presented in a late–breaker oral presentation at the ASBMR 2021 conference. For the primary efficacy endpoint: a statistically significant increase in P1NP (a bone formation marker) at 3 months was achieved. A significant dose response was observed for 0.5, 1.0, 1.5 and 2.5 mg oral PTH doses on P1NP, Osteocalcin and bone mineral density (BMD). Subjects receiving the 2.5 mg dose of EB613 showed significant increases in dose–related BMD at the lumbar spine, total hip, and femoral neck at 6 months. Subjects receiving the 2.5 mg dose of EB613 daily for 6 months had a significant placebo adjusted increase of 3.78% in lumbar spine BMD (p<0.008) which is similar to the 3.9% increase in lumbar spine BMD seen with Forteo in clinical studies reported in the literature2. Increases in total hip and femoral neck BMD were greater than those previously reported with Forteo . EB613 exhibited an excellent safety profile, with no drug related serious adverse events. The most common adverse events included mild nausea, moderate back pain, moderate headache, and moderate upper abdominal pain.

2 Leder BZ et.al. JCEM 2015

About Entera Bio

Entera is a leader in the development of orally delivered large molecule therapeutics for use in areas with significant unmet medical need where adoption of injectable therapies is limited due to cost, convenience and compliance challenges for patients. The Company's proprietary, oral drug delivery technology is designed to address the technical challenges of poor absorption, high variability, and the inability to deliver large molecules to the targeted location in the body through the use of a synthetic absorption enhancer to facilitate the absorption of large molecules, and protease inhibitors to prevent enzymatic degradation and support delivery to targeted tissues. The Company's most advanced product candidates, EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism are in clinical development. The Company recently completed the phase 2 study for EB613. Entera also licenses its technology to biopharmaceutical companies for use with their proprietary compounds and, to date, has established a collaboration with Amgen Inc. For more information on Entera Bio, visit www.enterabio.com.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are "forward–looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, "anticipate," "believe," "can," "could," "expect," "estimate," "design," "goal," "intend," "may," "might," "objective," "plan," "predict," "project," "target," "likely," "should," "will," and "would," or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera's forward–looking statements include, among others: changes in our interpretation of the 3–month biomarker data from the Phase 2 clinical trial of EB613, the timing of data readouts from the Phase 2 clinical trial of EB613, the full results of the Phase 2 clinical trial of EB613 and our analysis of those full results, the FDA's interpretation and review of our results from and analysis of our Phase 2 trial of EB613, unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains, loss of available workforce resources, either by Entera or its collaboration and laboratory partners, due to travel restrictions, lay–offs or forced closures or repurposing of hospital facilities; impacts to research and development or clinical activities that Entera is contractually obligated to provide, such as those pursuant to Entera's agreement with Amgen; overall regulatory timelines, if the FDA or other authorities are closed for prolonged periods, choose to allocate resources to review of COVID–19 related drugs or believe that the amount of Phase 2 clinical data collected are insufficient to initiate a Phase 3 trial, or a meaningful deterioration of the current political, legal and regulatory situation in Israel or the United States; the availability, quality and timing of the data from the Phase 2 clinical trial of EB613 in osteoporosis patients; the size and growth of the potential market for EB613 and Entera's other product candidates including any possible expansion of the market if an orally delivered option is available in addition to an injectable formulation; the scope, progress and costs of developing Entera's product candidates including EB612 and GLP–2; Entera's reliance on third parties to conduct its clinical trials; Entera's expectations regarding licensing, business transactions and strategic collaborations; Entera's operation as a development stage company with limited operating history; Entera's ability to continue as a going concern absent access to sources of liquidity; Entera's expectations regarding its expenses, revenue, cash resources, liquidity and financial condition; Entera's ability to raise additional capital; Entera's interpretation of FDA feedback and guidance and how such guidance may impact its clinical development plans; Entera's ability to obtain and maintain regulatory approval for any of its product candidates; Entera's ability to comply with Nasdaq's minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera's intellectual property position and its ability to protect its intellectual property; and other factors that are described in the "Cautionary Statement Regarding Forward–Looking Statements," "Risk Factors", "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Entera's more recent annual, quarterly and current report and other documents filed by Entera with the SEC and available free of charge on the SEC's website at http://www.sec.gov. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated in such forward–looking statements and estimates will be achieved. The information in this release is provided only as of the date of this release, and Entera undertakes no obligation, to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.


A New World Order is Dawning – But will it be Liberal or Illiberal?

Pinched between two antagonistic blocs, the United Nations was in a deadlock for decades. Credit: United Nations

By Marc Saxer
BERLIN, Jul 18 2022 – With the invasion of Ukraine, Russia effectively destroyed the European peace order. Now, Europe needs to find ways to contain its aggressive neighbour, while its traditional protector, the United States, continues its shift of focus to the Indo-Pacific.

This task, however, becomes impossible when China and Russia are driven into each other’s arms because, if anything, the key to end the war in Ukraine lies in Beijing. China hesitates to be dragged into this European war as bigger questions are at stake for the emerging superpower:

Will the silk road be wrecked by a new iron curtain? Shall it stick to its ‘limitless alliance’ with Russia? And what about the territorial integrity of sovereign states? In short: for China, it is about the world order.

The unipolar moment after the triumph of the West in the Cold War is over. The war in Ukraine clearly marks the end of the Pax Americana. Russia and China openly challenge American hegemony. Russia may have proven to be a giant with clay feet, and has inadvertently strengthened the unity of the West.

But the shift of the global balance of power to East Asia is far from over. In China, the United States has encountered a worthy rival for global predominance. But Moscow, Delhi, and Brussels also aspire to become power hubs in the coming multipolar order.

So, we are witnessing the end of the end of history. What comes next? To better understand how world orders emerge and erode, a quick look at history can be helpful.

What is on the menu?

Over the course of the long 19th century, a great power concert has provided stability in a multipolar world. Given the nascent state of international law and multilateral institutions, congresses were needed to carefully calibrate the balance between different spheres of interest.

The relative peace within Europe, of course, was dearly bought by the aggressive outward expansion of its colonial powers.

Marc Saxer

This order was shattered at the beginning of the World War I. What followed were three decades of disorder rocked by wars and revolutions. Not unlike today, the conflicting interests of great powers collided without any buffer, while the morbid domestic institutions could not mitigate the devastating social cost of the Great Transformation.

With the founding of the United Nations and the Universal Declaration of Human Rights, the foundations of a liberal order were laid after the end of World War II. However, with the onset of the Cold War, this experiment quickly ran into a quagmire.

Pinched between two antagonistic blocs, the United Nations was in a deadlock for decades. From the Hungarian Revolution over the Prague Spring to the Cuban missile crisis, peace between the nuclear powers was maintained through the recognition of exclusive zones of influence.

After the triumph of the West in the Cold War, American hyperpower quickly declared a new order for a now unipolar world. In this liberal world order, rule-breaking was sanctioned by the world’s policeman.

Proponents of the liberal world order pointed to the rapid diffusion of democracy and human rights around the globe. Critics see imperial motifs at work behind the humanitarian interventions. But even progressives place great hopes in the expansion of international law and multilateral cooperation.

Now that the West is mired in crises, global cooperation is again paralysed by systemic rivalry. From the war in Georgia over the annexation of Crimea to the crackdown in Hong Kong, the recognition of exclusive zones of influence is back in the toolbox of international politics.

After a short heyday, the liberal elements of the world order are jammed again. China has begun to lay the foundations of an illiberal multilateral architecture.

How will great power competition play out?

In the coming decade, the rivalries between great powers are likely to continue with undiminished vigour. The ultimate prize of this great power competition is a new world order. Five different scenarios are conceivable.

First, the liberal world order could survive the end of the unipolar American moment. Second, a series of wars and revolutions can lead to the total collapse of order. Third, a great power concert could bring relative stability in a multipolar world but fail to tackle the great challenges facing humanity.

Fourth, a new cold war may partly block the rule-based multilateral system, but still allow for limited cooperation in questions of common interest. And finally, an illiberal order with Chinese characteristics. Which scenario seems the most probable?

Many believe that democracy and human rights need to be promoted more assertively. However, after the fall of Kabul, even liberal centrists like Joe Biden und Emmanuel Macron have declared the era of humanitarian interventions to be over.

Should another isolationist nationalist like Trump or others of his ilk come to power in Washington, London, or Paris, the defence of the liberal world order would once and for all be off the agenda. Berlin is in danger of running out of allies for its new value-based foreign policy.

In all Western capitals, there are broad majorities across the ideological spectrum that seek to up the ante in the systemic rivalry with China and Russia. The global reaction to the Russian invasion shows, however, that the rest of the world has very little appetite for a new bloc confrontation between democracies and autocracies.

The support for Russia’s attack on the sovereignty and territorial integrity of Ukraine – values especially smaller countries unwaveringly adhere to – should not be read as sympathy for a Russian or Chinese-led order, but as deep frustration over the US empire.

Seen from the Global South, the not-so-liberal world order was merely a pretext for military interventions, structural adjustment programmes, and moral grandstanding. Now, the West comes to realise that in order to prevail geopolitically, it needs the cooperation of undemocratic powers from Turkey to the Gulf monarchies, from Singapore to Vietnam.

The high-minded rhetoric of the systemic rivalry between democracies against autocracies is prone to alienate these much-needed potential allies. But if even the West were to give up on universalism of democracy and human rights, what would be left of the liberal world order?

Are the great power rivalries that play out in the background of the war in Ukraine, the coups in Western Africa and the protests in Hong Kong only the beginning of a new period of wars, coups, and revolutions?

The ancient Greek philosopher Thucydides already knew that the competition between rising and declining great powers can beget great wars. So, are we entering a new period of disorder?

Not only in Moscow and Beijing, but also in Washington, there are thinkers that seek to mitigate these destructive dynamics of the multipolar world through a new concert of great powers. The coordination of great power interests in fora from the G7 to the G20 could be the starting point for this new form of club governance. The recognition of exclusive zones of influence can help to mitigate conflict.

However, there is reason for concern that democracy and human rights will be the first victims of such high-powered horse-trading. This form of minimal cooperation may also be inadequate to tackle the many challenges humankind is facing from climate change over pandemics to mass migration.

The European Union, an entity based on the rule of law and the permanent harmonisation of interests, may have a particularly hard time to thrive in such a dog-eat-dog world.

Not only in Moscow, some fantasize about a revival of imperialism that negates the right to self-determination of smaller nations. This dystopian mix of technologically supercharged surveillance state on the inside and never-ending proxy wars on the outside is eerily reminiscent of George Orwell’s 1984. One can only hope that this illiberal neo-imperialism is shattered in the war in Ukraine.

The Russian recognition of separatist provinces of a sovereign state have rung the alarm bells in Beijing. After all, what if Taiwan follows this model and declares its independence? At least rhetorically, Beijing has returned to its traditional line of supporting national sovereignty and condemning colonialist meddling in internal affairs.

There are debates in Beijing whether China should really side with a weakened pariah state and retreat behind a new iron curtain, or would benefit more from an open and rules-based global order.

So, what is this ‘Chinese Multilateralism’ promoted by the latter school of thought? On the one hand, a commitment to international law and cooperation to tackle the great challenges facing humankind, from climate change over securing trade routes to peacekeeping.

However, China is only willing to accept any framework for cooperation if it is on equal footing with the United States. This is why Beijing takes the United Nations Security Council seriously, but tries to replace the World Bank and the International Monetary Fund with its own institutions such as the Asian Infrastructure Investment Bank.

If Chinese calls for equal footing are rejected, Beijing can still form its own geopolitical bloc with allies across Eurasia, Africa, and Latin America. In such an illiberal order, there would still be rule-based cooperation, but no longer any institutional incentives for democracy and human rights.

Hard choices: what should we strive for?

Alas, with a view of containing an aggressive Russia, a rapprochement with China may have its merits. For many in the West, this would require an about-face. After all, the recently fired German admiral Schönbach was not the only one who wanted to enlist Russia as an ally for a new cold war with China.

Even if Americans and Chinese would bury the hatchet, a post-liberal world order would pose a predicament for Western societies.

Is the price for peace really the right to self-determination of peoples? Is cooperation to tackle the great challenges facing humankind contingent on the rebuttal of the universality of human rights? Or is there still a responsibility to protect, even when the atrocities are committed in the exclusive zone of influence of a great power rival?

These questions go right to the West’s normative foundation.

Which order will prevail in the end will be determined by fierce great power competition. However, who is willing to rally around the banner of each different model differs significantly. Only a narrow coalition of Western states and a handful of Indo-Pacific value partners will come to the defence of democracy and human rights.

If this Western-led alliance of democracies loses the power struggle against the so-called axis of autocracies, the outcome could well be an illiberal world order with Chinese characteristics.

At the same time, the defence of international law, especially the inviolability of borders and the right to self-defence, are generally in the interest of democratic and authoritarian powers alike. An alliance for multilateral cooperation with the United Nations at its core finds supports across the ideological spectrum.

Finally, there could be issue-based cooperation between different centres. If ideological differences are set aside, hybrid partners could cooperate, for instance, in the fight against climate change or piracy, but be fierce competitors in the race for high-tech or energy.

Thus, it would not be surprising if the United States were to replace their ‘alliance of democracies’ with a more inclusive coalition platform.

Politically, Germany can only survive within the framework of a united Europe. Economically, it can only prosper in open world markets. For both, a rules-based, multilateral order is indispensable. Given the intensity of today’s systemic rivalry, some may doubt its feasibility. However, it is worth remembering that even at the heyday of the Cold War, within the framework of a constrained multilateralism, cooperation based on common interests did occur.

From arms control over the ban of the ozone-killer CFC to the Helsinki Accords, the balance sheet of this limited multilateralism was not too bad. In view to the challenges facing humankind, from climate change over pandemics to famines, this limited multilateralism may just be the best among bad options. For what is at stake is the securing of the very foundations of peace, freedom, unity, and prosperity in Europe.

Marc Saxer coordinates the regional work of the Friedrich-Ebert-Stiftung (FES) in the Asia Pacific. Previously, he led the FES offices in India and Thailand and headed the FES Asia Pacific department.

Source: International Politics and Society published by the Global and European Policy Unit of the Friedrich-Ebert-Stiftung, Hiroshimastrasse 28, D-10785 Berlin.

IPS UN Bureau

 


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Abortion Decision Felt Worldwide

A half-century of reproduction rights upended by the Supreme Court. Credit: Greenpeace.

By Joseph Chamie
PORTLAND, USA, Jul 18 2022 – The 24 June decision of United States Supreme Court to overturn the country’s nearly 50-year constitutional right of a woman to an abortion is being felt worldwide.

In addition to the objections and protests to the court’s landmark decision within the United States, governments, world leaders, and others have expressed their concerns and dissatisfaction about the overturning a woman’s constitutional right to an abortion.

The court’s decision to overturn the constitutional right to an abortion established in 1973 is at odds with the views of a broad majority of the public. No less than two-thirds of U.S. adults did not want the court to overturn the 1973 decision

The European Union’s parliament overwhelmingly condemned the decision ending the constitutional protections of women for abortion in the United States. Fearing the expansion of anti-abortion movements in Europe, the parliament also called for safeguards to abortion rights be enshrined in the EU’s fundamental rights charter and protections be adopted across the EU.

The Director General of the World Health Organization was very disappointed with the decision and the United Nations High Commissioner for Human Rights called the court’s decision a major setback. Access to safe, legal, and effective abortion, the Commissioner stressed, is firmly rooted in international human rights law.

Objections to the decision came from many government leaders worldwide. The Prime Minister of the United Kingdom, for example, saw the decision as a big step backwards. Accusing the court of diminishing the rights of U.S. women, the President of France said that abortion is a fundamental right of all women.

The German Chancellor viewed the decision as a threat to the rights of women, as did New Zealand’s Prime Minister who saw it as a loss for women everywhere. The Belgian Prime Minister expressed concerns about the signal the decision sends to the rest of the world about a woman’s right to an abortion.

Fifty years ago, various U.S. states criminalized a woman having an abortion. In 1973 in the case Roe v. Wade, the Supreme Court’s majority of seven justices established a woman’s constitutional right to an abortion in all 50 states (Table 1).

 

The justices concluded that state statutes criminalizing abortion in most instances violated a woman’s constitutional right of privacy, which it found to be implicit in the liberty guarantee of the due process clause of the Fourteenth Amendment in the U.S. Constitution.

Thirty years ago, the Supreme Court revisited Roe v. Wade in the 1992 case of Planned Parenthood v. Casey. A majority of five justices reaffirmed a woman’s right to an abortion but imposed a new standard to determine the validity of laws restricting abortions.

The new standard asks whether a state abortion regulation has the purpose or effect of imposing an “undue burden”, which is defined as a substantial obstacle in the path of a woman seeking an abortion before the fetus attains viability.

In June 2022, in the case of Dobbs v. Jackson Women’s Health Organization a majority of six justices concluded that the 1973 and 1992 abortion decisions of a dozen former justices were egregiously wrong in their legal reasoning that led to erroneous decisions concerning the right to an abortion.

After nearly a half century of women having a constitutional right to an abortion enshrined in the 1973 decision and reaffirmed in the 1992 decision, six justices of the current Supreme Court concluded that there is no such constitutional right. In the dissenting opinion, the court’s remaining three justices wrote that the U.S. will become an international outlier after the decision.

The court’s decision to overturn the constitutional right to an abortion established in 1973 is at odds with the views of a broad majority of the public. No less than two-thirds of U.S. adults did not want the court to overturn the 1973 decision.

In addition, a majority of Americans, approximately 60 percent, and President Biden with the backing of many Democratic leaders support Congress passing a law establishing a nationwide right to abortion. Such a law would protect a woman’s right to choose whether or not to have an abortion.

In contrast, a comparatively small minority of Americans, 13 percent in 2022, are opposed to abortion, with some, including Republican leaders, considering a federal abortion ban for all fifty states. Since 1975, the annual proportion of Americans who say abortion should be illegal in all circumstances has varied from a low of 12 percent in 1990 to a high of 22 percent in 2002 (Figure 1).

 

Source: Gallup Polls.

 

Following its decision to overturn the Roe v. Wade decision, confidence in the Supreme Court has reached historic lows. A majority of the U.S. public, 58 percent, have an unfavorable view of the Supreme Court. That level of disapproval is now on par with the public’s unfavorable view of Congress.

In addition, the United States has become a patchwork of abortion laws and given rise to a myriad of enforcement regulations, numerous court cases, and challenging legal questions. Abortion is now banned in at least nine states and more bans are expected in the near future. In some states, such as Alabama, Arkansas, Mississippi, Missouri, and South Dakota, abortion is banned with no exceptions for rape or incest.

Also, many state legislatures are considering ways of stopping or criminalizing out of state abortions. They are also proposing banning or tightly restricting the use of abortion medication, which was approved in 2000 by the U.S. Food and Drug Administration and accounted for an estimated 54 percent of the country’s abortions in 2020. In response, other states are advancing legislation and executive orders protecting patients and providers from legal risks outside their borders.

The Supreme Court’s recent decision finding no constitutional right to an abortion has raised concerns that other rights not enumerated in the U.S. Constitution are at risk of being overturned. Among those rights are same-sex marriage, same-sex relationships, and contraceptives.

In a concurring opinion to the recent abortion decision, for example, one of the court’s justices indicated that other precedents should be reconsidered. He also mentioned that future legal cases could curtail other rights not clearly addressed in the U.S. Constitution.

The court’s abortion decision may also embolden abortion opponents, influence policymakers, and affect reproductive health programs in other countries as well. The decision puts U.S. alongside several other countries, including Poland, El Salvador, and Nicaragua, that have backtracked on or restricted abortion policy in recent decades.

However, the court’s abortion decision runs counter to recent global liberalization trends on reproductive rights. During the past three decades about 60 countries have expanded laws and policies relating to reproductive rights, including legal access to abortion.

In sum, the recent decision of the U.S. Supreme Court has not only revoked the nearly 50-year constitutional right of a woman to an abortion, but it is also now out of sync with the increasing worldwide recognition of fundamental reproductive rights, including a woman’s right to an abortion.

Joseph Chamie is a consulting demographer, a former director of the United Nations Population Division and author of numerous publications on population issues, including his recent book, “Births, Deaths, Migrations and Other Important Population Matters.”

 

Immigrant Supports Other US Migrants Run the Gauntlet of Bureaucracy

Safe Passages arranges food distribution for 120 immigrant families. Families also receive immigration information, legal information, and referrals, such as rental assistance programs, COVID-19 vaccination details, and parenting resources. Credit: Safe Passages

Safe Passages arranges food distribution for 120 immigrant families. Families also receive immigration information, legal information, and referrals, such as rental assistance programs, COVID-19 vaccination details, and parenting resources. Credit: Safe Passages

By SeiMi Chu
Stanford, Jul 18 2022 – Veronica Vega’s husband was the first in the family to immigrate to Oakland, California. When 27 years ago Vega decided to join him, she was five months pregnant and walked across the Mexican border to come to the United States.

“It was a horrible experience. It was so sad to leave your country, your town, and your family behind. Everything was different – the country, the language, the community. That’s why I looked around to find somewhere I could belong,” Vega reflected.

She discovered Safe Passages, an organization that supports youth and families by providing enhanced services and community development through various programs. Vega no longer felt alone.

Now, Vega is the Community Development Manager at Safe Passages, and she assists other immigrants in getting the help they need to integrate into US society successfully.

Vega tells of a success story. She helped a family from Tijuana, Mexico, receive their acceptance to the renowned Deferred Action for Childhood Arrivals (DACA) program. DACA is an immigration policy that provides immigrants who came to the US as a child a work permit and a two-year period to reside in the country without facing deportation. After two years, immigrants need to submit a renewal application for DACA. US Citizenship and Immigration Services (USCIS) allows renewal subject to requirements.

The mother of two fled from Mexico to California because she faced domestic violence from her husband. She and her children contacted Safe Passages, where they met Vega.

Safe Passages serves about 5,000 families annually. One of their programs focuses on helping children who may face deportation due to their refugee status. Vega connected this family to one of their partners, East Bay Community Law Center (EBCLC).

A private lawyer through EBCLC helped them receive their permanent residencies, and the service they received was free.

“When I heard they were considered permanent residents of the United States, I was so happy. They never realized they would receive anything, and I was so happy,” Vega said.

Vega helps families who fear deportation. She aids about 1,500 families per year with immigration resources.

She wants to partner with more non-profit organizations to help immigrant families.

“I was accepted into this country, and I love to work in the community. I love to help people regardless of race, age, and status,” Vega explained.

Alicia Perez, Chief Operating Officer of Safe Passages, described how the different programs at Safe Passages interconnect.

Safe Passages aims to support families with children with a big focus on school-based programs. They have after-school and tutoring programs, family resources, and health centers. Safe Passages makes the information accessible by ensuring materials are in the migrants’ home languages – informing them about their civil rights.

The organization provides immigrant families with Red Cards created by the immigrant Legal Resource Center. The Red Card informs families about their rights under the US Constitution, whether they are immigrants or not. Safe Passages asks families to carry their Red Cards in case they are stopped by law enforcement or the police.

“We believe all children should have access to education, health care, and support. By doing so, they are most likely to live fulfilling lives and be successful, regardless of race, economic status, ethnicity, or gender,” Perez said.

Refugee Processing Center’s Refugee Admission Report releases data on the number of refugee arrivals. California had the highest refugee arrivals from October 1, 2021, through May 31, 2022, with 1,128 people arriving in the state.

Florencia Reyes Donohue, a senior paralegal in Kids in Need of Defense’s (KIND) San Francisco office, helps prepare and file forms for unaccompanied child clients seeking protection in the US.

KIND’s mission is to ensure that no child goes into immigration court without high-quality legal representation and that unaccompanied children have access to the protection they need and deserve. The organization partners with pro bono attorneys from more than 700 law firms and corporations to represent clients at no cost.

KIND worked with 29,000 children from 2009 to 2021. In addition to legal services, they provide holistic care through its social services program. KIND ensured that children would have an easier time adjusting to a country they were unfamiliar with by addressing their traumas. KIND offers counseling referrals, social-emotional support, health insurance assistance, school enrollment, and job placements, among other services.

Reyes Donohue said she admired the bravery the children she worked with had. “They do this journey alone; they are incredibly resilient.”

Fathers attend their kids’ soccer team practices and Safe Passages’ parenting workshops. Safe Passages provides immigration information, parenting workshops, and referrals during these practices. Credit: Safe Passages

IPS UN Bureau Report

 


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Xenophobia in Mandiba’s Land: Too Black…Or Just Too Poor?

UN Photo/Pernaca Sudhakaran

By Baher Kamal
MADRID, Jul 18 2022 – South Africa, the home land of the late giant fighter against Apartheid, racism and discrimination – Nelson Mandela “Mandiba”, is already ‘on the precipice of explosive xenophobic violence’ against migrants, refugees, asylum seekers – and even citizens perceived as outsiders.

Just three days ahead of this year’s Nelson Mandela International Day (18 July), a group of independent United Nations human rights experts condemned reports of escalating violence targeting foreign nationals in South Africa.

Today, the world honours a giant of our time; a leader of unparalleled courage and towering achievement; and a man of quiet dignity and deep humanity

António Guterres, UN Secretary-General

Known as Special Procedures of the UN Human Rights Council’s independent fact-finding and monitoring mechanisms that address either specific country situations or thematic issues in all parts of the world, the human rights experts warned that the ongoing xenophobic mobilisation is “broader and deeper,” and has become the central campaign strategy for some political parties in the country.

 

Operation Dudula

In a statement released on 15 July 2022, the United Nations independent human rights experts cited “Operation Dudula” as an example of the spreading hate speech.

Originally a social media campaign, Operation Dudula has become an umbrella for the mobilisation of “violent protests, vigilant eviolence, arson targeting migrant-owned homes and businesses, and even the murder of foreign nationals.”

According to the human rights experts, xenophobia is often explicitly racialised, targeting low-income Black migrants and refugees and, in some cases, South African citizens accused of being “too Black to be South Africans.”

 

Inequality

South Africa is one of the most unequal countries in the world, according to a recent World Bank’s report titled ‘Inequality in Southern Africa’.

The report highlighted how inequality is consistent as 10% of the population owns more than 80% of the wealth.

Out of its 60 million inhabitants, “an estimated 10 million people in South Africa live below the food poverty line, while the unemployment rate is at a record high of almost 40% amongst Black South Africans according to Statistics South Africa.”

Poverty, unemployment and crime are reportedly the greatest sources of contention as Operation Dudula and its members believe that illegal foreigners are the reason that South Africa’s public socioeconomic systems do not benefit its native Black majority.

Impoverished former European colonies –who also fall victims of deepening poverty and inequality–, South Africa’s neighbouring countries- Namibia, Botswana, Zimbabwe, Mozambique, and the enclaved Lesotho-, have been lastly a source of increasing migration.

 

Fueled by the Government

“Anti-migrant discourse from senior government officials has fanned the flames of violence, and government actors have failed to prevent further violence or hold perpetrators accountable,” say the UN human rights Special Rapporteurs.

According to the World Bank’s country review, the South African economy was already in a weak position when it entered the pandemic after a decade of low growth.

From 2021, the recovery is expected to continue in 2022, with Gross Domestic Product (GDP) growth expected at 2.1% and to average 1.7% over the medium term.

Commodity prices remain important for South Africa, a major net exporter of minerals and net importer of oil, however, strengthening investment, including foreign direct investment, will be critical to propelling growth and creating jobs.

The World Bank goes on explaining that South Africa has made considerable strides to improve the wellbeing of its citizens since its transition to democracy in the mid-1990s, but progress has stagnated in the last decade.

The percentage of the population below the upper-middle-income-country poverty line fell from 68% to 56% between 2005 and 2010 but has since trended slightly upwards to 57% in 2015 and is projected to have reached 60% in 2020.

Structural challenges and weak growth have undermined progress in reducing poverty, which have been heightened by the COVID-19 pandemic, adds the review.

“The achievement of progress in household welfare is severely constrained by rising unemployment, which reached an unprecedented 35.3% in the fourth quarter of 2021. The unemployment rate is highest among youths aged between 15 and 24, at around 66.5%.”

In her extensively documented, detailed article on IPS: Myths Fuel Xenophobic Sentiment in South Africa, Fawzia Moodley also reported from Johannesburg on a study by the World Bank: Mixed Migration, Forced Displacement and Job Outcomes in South Africa.

Debunking the myth that foreign nationals are ‘stealing’ jobs from locals or are better off than locals is the finding that “one immigrant worker generated approximately two jobs for local residents in South Africa between 1996 and 2011”.

 

Nelson Mandela

“Today, the world honours a giant of our time; a leader of unparalleled courage and towering achievement; and a man of quiet dignity and deep humanity,” said the UN secretary general, António Guterres, in his message on the occasion of the 2022 Nelson Mandela International Day.

“Our world today is marred by war; overwhelmed by emergencies; blighted by racism, discrimination, poverty, and inequalities; and threatened by climate disaster,” adds Guterres.

“Let us find hope in Nelson Mandela’s example and inspiration in his vision.”

Nelson Mandela devoted his life to the service of humanity — as a human rights lawyer, a prisoner of conscience, an international peacemaker and the first democratically elected president of a free South Africa. See Mandela’s life >>. See also: Mandela Rules >>

“It is easy to break down and destroy. The heroes are those who make peace and build.”- Nelson Mandela.

 

Any politicians listening over there?

 

Clean Energies Seek to Overcome Obstacles in Argentina

View of the solar park in the municipality of Escobar, located an hour's drive from Buenos Aires. Inaugurated this month, it is the first municipally financed and managed solar energy project, at a time when private investment has withdrawn from large clean energy projects in Argentina. CREDIT: Daniel Gutman/IPS - Clean energies experienced a boom in Argentina starting in 2016, thanks to the Renovar Program, which managed to attract domestic and foreign private investors

View of the solar park in the municipality of Escobar, located an hour’s drive from Buenos Aires. Inaugurated this month, it is the first municipally financed and managed solar energy project, at a time when private investment has withdrawn from large clean energy projects in Argentina. CREDIT: Daniel Gutman/IPS

By Daniel Gutman
ESCOBAR, Argentina, Jul 18 2022 – The multitude of solar panels stands out along a dirt road in an unpopulated area. Although located just an hour’s drive from Buenos Aires, the new solar park in the municipality of Escobar is in a place of silence and solitude, symbolic of the difficulties faced by renewable energies in making inroads in Argentina.

The Escobar plant, inaugurated this month, is the first solar energy park with municipal investment and management, at a time when private initiative has practically withdrawn from clean energy projects in this South American country of 47 million people, which has been in the grip of a deep economic and financial crisis for years.

“There are 3,700 photovoltaic solar panels that produce electricity to be sold to one of the electric cooperatives that distributes power in the area. With this plant, we seek to position ourselves as a sustainable municipality and access financing for new projects,” Victoria Bandín, director of Innovation in the Municipality of Escobar, told IPS during a tour of the grounds of the six-hectare park.

Located 50 kilometers from the Argentine capital, to which it is connected by a freeway, Escobar is a municipality on the northern edge of Greater Buenos Aires, a gigantic metropolitan area of 15 million inhabitants where the country’s greatest wealth and poverty live side by side.

Escobar’s extensive green areas have attracted thousands of families in recent years seeking to get away from the cement and noise of Buenos Aires, which has fuelled the construction of dozens of upscale high-security private housing developments.

Escobar is also home to a large community of Bolivian immigrants, who play a key role in the production of fruits and vegetables. In fact, the fresh food market that supplies the stores of several municipalities in the area bears the name “Bolivian Community”.

Next to the market, which is very close to the solar park, the white, inflated tarp of a biodigester, in which the market’s organic waste is processed, stands out.

Eliseo Acchura is about to send spoiled food discarded by stallholders to the biodigester at Escobar's fruit and vegetable market. The biodigester, operating since last year, produces biogas that is then converted into electricity used in the market. CREDIT: Daniel Gutman/IPS - Clean energies experienced a boom in Argentina starting in 2016, thanks to the Renovar Program, which managed to attract domestic and foreign private investors

Eliseo Acchura is about to send spoiled food discarded by stallholders to the biodigester at Escobar’s fruit and vegetable market. The biodigester, operating since last year, produces biogas that is then converted into electricity used in the market. CREDIT: Daniel Gutman/IPS

“I pick up almost a ton of fruit and vegetables per day that the stallholders discard, and after 40 to 60 days of decomposition in the biodigester, we have biogas,” Eliseo Acchura, who works on the project inaugurated last year with support from the United Nations Development Program (UNDP), told IPS.

The biogas is used to generate electricity to supply part of the market.

“We have rural areas and we seek to preserve ourselves as a green place on the edge of the great gray blob that is the greater metropolitan area,” Guillermo Bochatón, coordinator of the Sustainable Escobar program, which is carrying out several environmental initiatives, told IPS.

The rise and fall of renewables

Clean energies experienced a boom in Argentina starting in 2016, thanks to the Renovar Program, which managed to attract domestic and foreign private investors.

Through this program, the national government guaranteed the purchase of electricity for 20 years at a fixed rate in dollars and created a guaranty fund with the participation of international credit institutions to guarantee payment.

The share of renewable sources in the total electricity mix, almost non-existent in 2015, grew significantly since 2016, reaching a record high of 13 percent on average in 2021.

Today, Argentina’s electricity system has an installed capacity of almost 43,000 MW, of which 5,175 MW are renewable. The main source of generation is thermal (powered by natural gas and, to a lesser extent, oil) making up 59 percent of the total, followed by large hydroelectric projects, which make up 25 percent (only hydroelectric projects of less than 50 MW are considered renewable).

Among renewables, the largest share last year came from wind (74 percent), followed by solar (13 percent), small hydro (7 percent) and bioenergies, according to official data

Of the 189 renewable energy projects in operation, 133 were commissioned over the last four years.

The biodigester at Escobar's wholesale fruit market was inaugurated last year and is part of the environmentally friendly initiatives launched in this municipality near the Argentine capital. CREDIT: Daniel Gutman/IPS - Clean energies experienced a boom in Argentina starting in 2016, thanks to the Renovar Program, which managed to attract domestic and foreign private investors

The biodigester at Escobar’s wholesale fruit market was inaugurated last year and is part of the environmentally friendly initiatives launched in this municipality near the Argentine capital. CREDIT: Daniel Gutman/IPS

Clean energies today face two major problems in this country, according to Marcelo Alvarez, a member of the board of directors of the Argentine Chamber of Renewable Energies (CADER).

One has to do with infrastructure due to the saturation of the electricity transmission networks that deliver electric power to large cities. Another is the lack of financing, as a result of the macroeconomic conditions in the country.

“Even private ventures in distributed generation today are practically reserved only for environmental activists, because the lack of financing and extremely low electricity rates make them unprofitable,” Alvarez explained.

He said that the way things are going, the country is not likely to meet the goal set by law in 2015, for 20 percent of the national electricity mix to come from domestic sources by 2025.

“From a technical point of view, Argentina’s potential for renewable energies is enormous, because it has the necessary natural resources. And economically too, because in the medium term the costs of electricity production will fall,” Gabriel Blanco, a specialist in renewable energies from the National University of the Center of the Province of Buenos Aires (UNICEN), told Ecoamericas.

“The main obstacle is that there is no political will, because the decision is to bet on the energy business of fossil fuels, large hydroelectric and nuclear power plants,” he added.

The Escobar solar park has an installed capacity of 2.3 MW and required an investment of some two million dollars, which will be recovered with the sale of electricity within seven years, said the mayor of Escobar, Ariel Sujarchuk. “Between 23 and 53 more years of useful life of pure profit will be left after that,” he added.

The inauguration was also attended by Environment Minister Juan Cabandié, who pledged more than 1.7 million dollars in government funds for the expansion of the solar park, which has a large piece of land available for the installation of more panels.

In his speech in Escobar, Cabandié criticized industrialized countries for failing to comply with the financing needed to transform the economies of developing countries, as pledged under the Paris Agreement on climate change, adopted in the French capital in 2015.

The minister said that “the sector responsible for damaging the planet is in the Northern, not the Southern, hemisphere,” and argued that it is the countries of the North that must assume “the responsibility of financing the transition to sustainability of the countries of the South.”

Most Suspended Ugandan NGOs Still in Limbo

Many NGOs suspended in 2021 remain in limbo. There have been allegations that the organisations’ suspension was because they were critical of President Yoweri Museveni’s government and policies. Graphic Credit: Cecilia Russell/IPS

Many NGOs suspended in 2021 remain in limbo. There have been allegations that the organisations’ suspension was because they were critical of President Yoweri Museveni’s government and policies. Graphic Credit: Cecilia Russell/IPS

By Issa Sikiti da Silva
Kampala, Jul 18 2022 – Nearly a year after the Ugandan government suspended 54 NGOs for allegedly operating illegally and failing to file accounts, most civil society organisations (CSOs) remain shut.

Analysts say this is because President Yoweri Museveni sees them as a threat to his 36-year regime.

Dickens Kamugisha, CEO of Africa Institute for Energy Governance (AFIEGO), told IPS: “The two court cases we filed against the NGO Bureau for illegal actions against AFIEGO are still ongoing in court. But we know that the NGO Bureau knows their actions toward the affected CSOs are wrong. This is why it has continued to make endless phone calls to AFIEGO and others for informal discussions. We have asked them to put their invitation in writing, but they haven’t done so perhaps to avoid implicating themselves.”

Before its suspension, AFIEGO was one of four Ugandan organisations involved in legal action to stop the $10 billion oil project by TotalEnergies and China National Offshore Oil Corporation (CNOOC). Its opposition is based on environmental concerns.

At a recent signing of the agreement between the government and the oil major, Museveni said that the “associations that criticise this project are people who don’t have a job. They have nothing to do, so let these idiots continue to wander aimlessly. They are only good at drinking tea and eating cookies”.

However, Kamugisha asked: “What’s wrong with fighting against anything that worsens the impacts of climate change, such as this risky oil project, the deforestation of the forests of Bugoma and Budongo, the safeguarding of Nile River and Lake Edward, of Murchison Falls and Queen Elizabeth NPs, and so on?”

Kamugisha said the government’s actions towards CSOs showed that the civic space in Uganda was not getting any better.

According to Amnesty International, in the run-up to the January 2021 elections, Museveni critics bore the brunt of the security forces.

“In 2020, dozens of people were killed in the context of electoral campaigning ahead of the January 2021 general election, most of them by police and other security forces…The rights to freedom of expression, peaceful assembly and association were severely restricted. The authorities targeted organisations working on human rights and shut down the internet,” the human rights organisation said.

Many observers believe Museveni deliberately targeted the organisations for challenging his policies and undermining his rule.

Justice climate activist Robert Agenonga told IPS from Germany that the government’s decision to suspend NGOs was retaliation for their critical role before, during, and after the elections.

“So many violations occurred during the electoral period, whereby people were detained, killed, and tortured. And organisations such as Chapter Four, for instance, provided legal support to opposition politicians, ordinary people and activists that were intimidated and prosecuted during and after the electoral period.”

Museveni believes NGOs act as agents of foreign governments and are supported by outsiders to undermine the government, Agenonga said, adding that this is done to reduce the capacity of CSOs and their ability to influence communities.

Another reason behind the suspension is that the Museveni administration has accused NGOs of replacing the state’s role by receiving money for state institutions.

“Over the years, donors were becoming increasingly unhappy with Museveni’s overstaying in power. So, they have resorted to channelling money they were giving to the state through NGOs. That’s what might have angered the government.”

Before the mass suspension of 54 NGOs, the government cracked down on the Democratic Governance Facility (DGF), a multi-million-dollar fund assisting local organisations that focus on democracy, human rights and good governance.

In 2019, the authorities banned the Citizens’ Coalition for Electoral Democracy in Uganda (CCEDU), an election monitoring coalition.

In January 2021, the authorities also banned the National Elections Watch – Uganda, a coalition of local organisations, from monitoring national elections.

Kamugisha categorically denied the government’s allegations that the suspended NGOs were operating illegally, stating that it was all about intimidating, harassing and instilling fear in the CSOs sector.

“You know that the Executive Director of Chapter Four spent weeks in prison, and later his case was dismissed due to lack of prosecution. The government lost interest in the case, and later the man left for the US apparently on study leave but heard on study leave, but his organisation is as good as closed,” he added.

“Even the AFIEGO issues with the police, the police do not have any evidence of criminal offences. We are legally registered, and the NGO Bureau knows it very well.”

Chapter Four Uganda applied to the High Court Civil Division to challenge its suspension.

In May 2022, High Court Judge Musa Ssekaana called the decision to indefinitely suspend Chapter Four “irregular”. This was because there was no timeframe for comprehensive investigations into the NGO’s operations to enable the bureau to determine whether or not to revoke its permit and cancel the registration.

In June, Chapter Four was allowed to resume operations.

Another affected the NGO Democratic Governance Facility (DGF), had its suspension lifted in late June. The NGO, funded by Denmark, Ireland, Austria, the UK, Sweden, Norway, and the European Union, was suspended in January 2021. It supports projects for poverty eradication, equitable growth, and the rule of law.

Gideon Chitanga, a political analyst with the Johannesburg-based Centre for Study of Democracy, told IPS that NGO suspensions were a  draconian violation of civil liberties and human rights by the Ugandan government.

IPS UN Bureau Report

 


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