Cures, Cash & Controversy: Global Biotech & Health Roundup (Aug 14–15, 2025)

Breakthroughs in Biotech & Pharma

• First Immunotherapy for a Rare Disease: The FDA approved Papzimeos (zopapogene imadenovec), a novel adenoviral vector immunotherapy, as the first-ever treatment for recurrent respiratory papillomatosis (RRP) fda.gov. In trials of adult RRP patients who previously needed repeated airway surgeries, 51.4% achieved a complete response (no surgeries for 12 months) after four injections of Papzimeos fda.gov. “This approval has the potential to transform the treatment landscape for RRP,” noted Dr. Vijay Kumar of FDA’s biologics center, as patients may finally avoid the cycle of tumor regrowth and surgery fda.gov fda.gov. The therapy (from Precigen) received Priority Review, Orphan Drug and Breakthrough designations, underscoring its significance for this HPV-driven rare disease fda.gov.
• Autoimmune Breakthrough in China: In primary Sjögren’s syndrome, China’s RemeGen announced its biologic telitacicept (already approved there for lupus) hit the primary endpoint in a Phase 3 trial ts2.tech. The BLyS/APRIL-targeting antibody “sustainably and effectively” improved Sjögren’s symptoms over 24 weeks with a favorable safety profile ts2.tech. RemeGen plans to file for Chinese approval and present detailed data internationally, fueling hopes for a global therapy in a disease affecting ~4 million in the U.S. if results hold up ts2.tech. (In contrast, not all late-stage programs thrived: U.S.-based Prelude Therapeutics halted development of its lead SMARCA2 cancer drug after underwhelming Phase 1 results, and will only revive it with a partner’s help fiercebiotech.com fiercebiotech.com.)
• Weight-Loss Pill Shows Promise: Response Therapeutics reported a Phase 2 victory with RDX-002, a once-daily oral drug aimed at helping people maintain weight loss after stopping injectable GLP-1 therapies ts2.tech. In a trial of patients who had come off popular GLP-1 drugs like Wegovy, RDX-002 met its primary endpoint by significantly reducing post-meal blood fat levels and curbing weight regain compared to placebo ts2.tech. No serious side effects emerged. RDX-002’s mechanism (an MTP inhibitor) is “differentiated and complementary” to GLP-1s for extending patients’ hard-won health gains, said CMO Dr. William Sasiela ts2.tech. The company sees potential to use the pill alongside GLP-1 injections to prolong weight-control benefits.

Big Deals & Industry Moves

• Cardinal’s $1.9B Urology Bet: U.S. distributor Cardinal Health is acquiring Solaris Health – the nation’s largest urology practice network – for $1.9 billion in cash ts2.tech. Solaris will fold into Cardinal’s Specialty Solutions arm, expanding its reach in specialist care ts2.tech. Cardinal CEO Jason Hollar said the deal fits a strategy to grow in specialist medicine, calling urology “an attractive specialty for us” and highlighting the combined capabilities it will bring to community urologists ts2.tech. The acquisition is expected to close by year-end, with Solaris’ leadership staying on in advisory roles ts2.tech.
• Bayer’s KRAS Partnership: Germany’s Bayer struck a major collaboration with California biotech Kumquat Biosciences, committing up to $1.3 billion for rights to an experimental cancer therapy targeting the notoriously “undruggable” KRAS^G12D mutation ts2.tech. KRAS mutations (like G12D, present in ~38% of pancreatic cancers) long evaded drug efforts, but recent KRAS^G12C inhibitors have opened the field ts2.tech. Kumquat’s KRAS^G12D inhibitor just cleared FDA to begin human trials, and Bayer’s hefty upfront bet underscores the high stakes of this next wave in oncology R&D ts2.tech.
• Lilly’s $1.3B Obesity Deal: Expanding its metabolic pipeline, Eli Lilly signed a $1.3 billion pact with Boston-based startup Superluminal Medicines to develop new small-molecule drugs for cardiometabolic disease and obesity fiercebiotech.com. Superluminal will use its G protein-coupled receptor (GPCR) discovery platform to identify compounds, with Lilly getting exclusive global rights fiercebiotech.com. The biotech, which Lilly already backed as a seed investor, could receive upfront and milestone payments plus royalties totaling $1.3B fiercebiotech.com. “Our collaboration with Lilly is a defining moment for Superluminal, and a testament to the power of our platform to deliver high-quality candidates against historically intractable GPCR targets,” said CEO Cony D’Cruz fiercebiotech.com. The deal also boosts Lilly’s next-gen obesity portfolio after its own oral GLP-1 candidate recently underwhelmed in Phase 3 fiercebiotech.com.
• Sarepta Sells Stake to Raise Cash: Facing a hefty milestone payment, Sarepta Therapeutics sold 9.2 million shares of partner Arrowhead Pharmaceuticals in a block trade to raise about $174 million ts2.tech. Sarepta will use the cash to help fund a $100 million milestone it owes Arrowhead for their RNAi therapeutic partnership, and it transferred another $50 million in shares to partially satisfy that obligation ts2.tech. “The sale of our equity investment is a strategic decision to help fund this milestone but does not change our conviction in the utility of the siRNA approach or our confidence in [Arrowhead’s] work,” Sarepta CEO Doug Ingram said ts2.tech. The move comes as Sarepta navigates an expensive gene therapy rollout and over $1 billion in debt due by 2027 ts2.tech.
• VC Mega-Fund for Startups: North Carolina’s Hatteras Venture Partners closed over $200 million across two new funds to back early-stage life science startups ts2.tech. The raise – split between Hatteras’ seventh venture fund and its first “Opportunity Fund” – brings the firm’s total capital raised to ~$900 million over 25 years ts2.tech. Celebrating its 100th portfolio company, General Partner Clay Thorp reflected on “25 years [of] exhilarating wins… along with heartbreaking disappointments.” Most gratifying, he said, are “the relationships we have made with scholarly innovators, committed entrepreneurs, and resilient co-investors” that drive breakthrough healthcare ventures ts2.tech. The new funds will fuel seed and early-stage biotech, medtech, and healthtech startups “disrupting the status quo in healthcare.” ts2.tech
• Activist Pressure on a Supplier: Lab supplies and bioprocessing giant Avantor is under activist scrutiny after its stock plunged ~50% this year. Engine Capital, which disclosed a 3% stake, sent an open letter urging Avantor to cut costs, boost margins or even sell itself ts2.tech. The investor blasted Avantor’s “self-inflicted organizational dysfunction,” comparing it unfavorably to more disciplined peers ts2.tech. With Avantor’s board installing a new CEO (ex-Cytiva chief Emmanuel Ligner) to orchestrate a turnaround, Engine warned management to improve performance or explore strategic alternatives ts2.tech.

Regulatory & Health Policy Updates

• U.S. Revives Vaccine Safety Panel: The Department of Health and Human Services is relaunching a task force on childhood vaccine safety that was disbanded in the late 1990s fiercepharma.com. The Task Force on Safer Childhood Vaccines, chaired by NIH Director Dr. Jay Bhattacharya, will include FDA and CDC leaders and work with the existing vaccine injury compensation board fiercepharma.com. Its mandate: recommend ways to “refine” childhood vaccines to result in fewer adverse reactions while improving development and monitoring fiercepharma.com. The panel’s first report to Congress is due in two years, with periodic updates thereafter fiercepharma.com. The move aligns with HHS Secretary Robert F. Kennedy Jr.’s long-held goal of revisiting the vaccine schedule, prompting concern among experts that it could undermine vaccine confidence fiercepharma.com.
• FDA Delay for Transplant Drug: Omeros hit a regulatory speed bump as the FDA extended its review by 3 months for the biotech’s drug narsoplimab, aimed at a lethal complication of bone marrow transplants fiercebiotech.com fiercebiotech.com. The agency had faced a Sept. 25 deadline to decide on approving narsoplimab for transplant-associated thrombotic microangiopathy (TA-TMA), but after requesting additional analyses from Omeros, pushed the decision to Dec. 26 fiercebiotech.com. Omeros noted that “all analyses requested by FDA…provided statistically significant support of narsoplimab’s benefit” in the data resubmitted fiercebiotech.com. The delay adds to broader concerns that FDA approval timelines are slipping amid high workloads and staff shortages (a trend highlighted by multiple postponed drug decisions this year) fiercebiotech.com.
• Texas Sues Lilly over ‘Kickbacks’: In a new legal salvo, the Texas Attorney General filed a lawsuit accusing Eli Lilly of an illegal kickback scheme to boost sales of its popular diabetes and obesity drugs (such as Mounjaro) ts2.tech. The suit alleges Lilly provided Texas doctors with free support services (a “Free Nurse Program”) and other perks to induce them to prescribe Lilly’s medications, including to Medicaid patients – leading to millions in improper state claims ts2.tech. “Big Pharma compromised medical decision-making by engaging in an illegal kickback scheme,” Texas AG Ken Paxton said, vowing “I will not stand by while corporations unlawfully manipulate our healthcare system to line their own pockets.” ts2.tech Lilly denies wrongdoing and noted that similar whistleblower-driven claims were dismissed previously as meritless ts2.tech, setting the stage for a contentious court battle.

Public Health Developments

• Measles Resurgence in the Americas: Measles is surging across the Western Hemisphere, with 10 countries reporting 10,139 cases and 18 deaths so far in 2025 – a 34-fold increase over the same period last year paho.org paho.org. The Pan American Health Organization warned that low vaccination coverage is driving the outbreaks, as 71% of cases are in unvaccinated people paho.org. Regional MMR immunization rates (89% for one dose, ~79% for two) remain well below the 95% needed to prevent outbreaks paho.org. “Measles is preventable with two doses of a vaccine… To stop these outbreaks, countries must urgently strengthen routine immunization and conduct targeted campaigns in high-risk communities,” said Dr. Daniel Salas of PAHO paho.org. The largest outbreaks are in Canada (4,548 cases), Mexico (3,911), and the U.S. (1,356), including clusters among under-vaccinated communities paho.org.
• Tropical Virus Surge in China: A major chikungunya fever outbreak in southern China’s Guangdong province has swelled past 7,000 cases, prompting the U.S. CDC to issue a travel advisory ts2.tech. The mosquito-borne virus (which causes high fever and severe joint pain) spread rapidly after heavy monsoon rains and flooding created swarms of Aedes mosquitoes in the region ts2.tech. Chinese authorities have escalated mosquito control measures (intensive insecticide spraying and removal of standing water) to curb the outbreak ts2.tech. Travelers to affected areas are urged to use DEET repellent, wear long sleeves, and sleep under bed nets, and a vaccine is available for those headed into high-risk zones ts2.tech. Experts note that climate change is expanding the range of Aedes mosquitoes, with about 240,000 chikungunya cases globally in 2025 and new regions – including parts of East Asia – now at risk ts2.tech.

Noteworthy Medical Research

• Brain Surgery Before Birth: In a world-first, surgeons have successfully treated a deadly fetal brain condition in utero. A Boston Children’s team reported in JAMA that they performed brain surgery on fetuses with Vein of Galen malformation (VOGM) – a critical vessel defect that causes massive blood flow issues at birth ts2.tech. Using ultrasound guidance, they catheterized and embolized the abnormal vein in 7 fetuses, repairing it before delivery ts2.tech. The early results are dramatic: historically, VOGM leads to ~90% newborn mortality with devastating brain damage ts2.tech. But treating it during pregnancy cut newborn mortality by more than half (to ~43%), and 3 of 5 treated babies so far have survived infancy without neurologic impairment ts2.tech. “These early results…strongly suggest the procedure is safe and effective,” said lead author Dr. Darren Orbach ts2.tech. A larger trial is underway to confirm if fixing this once-untreatable aneurysm before birth can consistently save lives and prevent brain injury ts2.tech.
• ‘Triple’ Weight-Loss Drug a “Home Run”?: An experimental obesity drug from Eli Lilly, called retatrutide, yielded unprecedented results in a Phase 2 trial – helping patients lose 24% of body weight over 48 weeks on the highest dose ts2.tech. By comparison, the current market-leading GLP-1 drug semaglutide (Wegovy) induces ~15% weight loss in similar timeframes ts2.tech. Retatrutide is a once-weekly injectable that activates three hormone pathways (GLP-1, GIP and glucagon) to turbocharge metabolism. An editorial in New England Journal of Medicine hailed the results as potentially a “home run” for obesity treatment ts2.tech. While large Phase 3 trials are ongoing, experts say if retatrutide’s impressive efficacy and safety hold up, it could become a game-changer in the booming weight-loss market ts2.tech – potentially the next major entrant alongside Wegovy and Lilly’s own Mounjaro (tirzepatide).
• AI Designs New Antibiotics: Scientists have harnessed generative AI to fight drug-resistant bacteria, using deep-learning models to design entirely new antibiotics from scratch fiercebiotech.com. In a study published in Cell (Aug 14), a model trained on 40,000 chemical structures created novel compounds that proved potent against two of the world’s most notorious superbugs fiercebiotech.com fiercebiotech.com. Two lead molecules, “NG1” and “DN1,” were able to kill multidrug-resistant gonorrhea, and DN1 also wiped out MRSA (methicillin-resistant Staph aureus) fiercebiotech.com. MRSA is “probably the most famous of the resistant pathogens,” noted Dr. James Collins of MIT, the study’s senior author fiercebiotech.com. Collins’ team had previously used AI to discover a new antibiotic (halicin) – now they’ve used it to invent candidates, a leap from screening to AI-driven molecular design fiercebiotech.com fiercebiotech.com. The new AI-designed antibiotics will be further developed through a nonprofit startup co-founded by Collins, with hopes of advancing them toward clinical trials fiercebiotech.com.

Healthcare Technology & Innovation

• Sleep Apnea Implant Approved (and Challenged): A new implantable device for obstructive sleep apnea is coming to the U.S., but it’s already sparking a patent fight. Nyxoah, a Belgium-based medtech, won FDA approval for its Genio system, a battery-free nerve stimulator implanted in the chin that keeps airways open during sleep fiercebiotech.com. In a pivotal trial, Genio reduced patients’ apnea episodes by ~71%, and an impressive 82% of users improved from severe to mild apnea (or better) after the implant fiercebiotech.com. “Today marks a defining moment for Nyxoah and for U.S. patients suffering from OSA,” said CEO Olivier Taelman on the approval fiercebiotech.com. The device – already available in Europe as an alternative to nightly CPAP masks – delivers small pulses to tongue-control nerves via an external patch and smartphone app fiercebiotech.com. However, U.S. launch plans hit a snag as rival Inspire Medical (maker of a competing implant) filed a patent infringement suit and even secured an import ban on certain Apple Watch-like controllers, alleging Nyxoah copied its pulse-oximetry tech reuters.com reuters.com. Nyxoah is navigating the legal roadblock but remains poised to roll out Genio to American patients seeking a cutting-edge solution for sleep apnea.
• Apple Watch’s Blood Oxygen Comeback: Apple is restoring a popular health feature to its U.S. smartwatches after a regulatory tussle. On Aug. 14, Apple announced a software update (iOS 18.6.1 / watchOS 11.6.1) that will bring back blood oxygen monitoring for Apple Watch Series 9, Series 10, and Ultra 2 models in the U.S. reuters.com. The feature – first introduced in 2020 – had been deactivated on newer watches due to a legal dispute with Masimo Corp. over pulse-oximetry patents reuters.com. Masimo accused Apple of stealing its tech and won a trade ruling to block imports of Apple Watches with SpO2 sensors, leading Apple to temporarily remove the capability reuters.com reuters.com. Now, after receiving clearance from U.S. Customs, Apple’s update uses a workaround: the Watch’s sensors collect oxygen data, but readings are calculated and displayed on the paired iPhone’s Health app, not on the Watch screen reuters.com reuters.com. This approach complies with the import ban while re-enabling the much-requested health metric. Apple’s resolution comes just ahead of its next product launch, and Masimo – which launched its own W1 health watch – continues to pursue its patent claims in court reuters.com.

Sources: Original news reports, press releases and scientific publications from Aug 14–15, 2025 fda.gov fiercebiotech.com fiercepharma.com paho.org fiercebiotech.com, as cited above. Each development is attributed to reputable sources including FDA announcements, company press statements, peer-reviewed journals, and expert commentary to ensure accuracy and context.