Biotech Breakthroughs, Pharma Power Moves & Health Shocks: News Roundup (Aug 18–19, 2025)

Biotech Sector – Big Deals, Funding, and FDA Drama

• Genentech cuts ties in $2B cancer pact: In a cost-cutting push, Genentech (Roche) is terminating its high-profile cell therapy collaboration with Adaptive Biotechnologies, originally a January 2019 deal worth up to $2 billion fiercebiotech.com. The partnership aimed to harness Adaptive’s T-cell receptor (TCR) technology for personalized cancer immunotherapies. Genentech says the decision “was not based on any emerging safety concerns,” emphasizing respect for Adaptive’s innovation fiercebiotech.com. (Adaptive got a $300 million upfront; the breakup echoes Genentech’s similar exit from a $3B Adaptimmune deal last year fiercebiotech.com.)
• Kriya Therapeutics scores $313M mega-fundraise: Gene therapy startup Kriya announced a whopping $313 million Series D financing, one of 2025’s largest biotech raises fiercebiotech.com. The SEC filing on Aug. 15 revealed the private U.S. company’s haul, surpassed this year only by Verdiva Bio’s $410M launch and a few others fiercebiotech.com. Kriya’s pipeline spans nine gene therapy programs (neurology, metabolic disease, ophthalmology), including two in clinical trials fiercebiotech.com. CEO Shankar Ramaswamy has said Kriya’s “ambitious goal [is] to advance gene therapies to highly prevalent diseases that affect millions” fiercebiotech.com, leveraging past acquisitions of Redpin and Tramontane to expand into epilepsy, neuralgia, and NASH/MASH programs fiercebiotech.com.
• ALS Trial Delays blamed on FDA staffing woes: Australia’s Neurizon, developing an ALS drug (NUZ-001, a repurposed sheep dewormer), revealed the FDA is delaying review of its clinical hold response until October due to agency staff shortages fiercebiotech.com fiercebiotech.com. “While this delay is extremely disappointing… we remain confident in the potential of NUZ-001 as a transformative therapy for ALS,” Neurizon CEO Michael Thurn said, noting they’re lobbying U.S. experts and advocates for faster review fiercebiotech.com. Neurizon’s IND had been on hold since January pending dosing and safety data; they answered FDA’s questions in July, but budget cuts at the FDA have extended the timeline beyond the standard 30 days fiercebiotech.com. This déjà vu follows Coya Therapeutics’ similar ALS trial delay last month, part of a “broader pattern” of extended review times amid FDA “resourcing challenges” fiercebiotech.com.
• Stealth BioTherapeutics makes 3rd try for rare disease drug: After two prior rejections, Stealth BioTherapeutics has resubmitted its FDA application for elamipretide in ultra-rare Barth syndrome fiercebiotech.com. The mitochondrial-targeted peptide had a complete response letter (CRL) in May despite a split advisory panel vote favoring approval fiercebiotech.com. Stealth’s new filing, as directed by FDA, contains no new efficacy data but confirms manufacturing fixes and minor safety updates fiercebiotech.com. FDA encouraged Stealth to seek accelerated approval using an intermediate endpoint (improved knee muscle strength) after the pivotal trial missed its walking-distance goal fiercebiotech.com. The company notes a >45% gain in knee extension strength correlated with better walk tests fiercebiotech.com. FDA will likely give this resubmission a Class 2 review (6-month clock), testing the agency’s openness to patient-backed Barth therapy despite earlier skepticism.
• Boehringer’s latest eye disease deal: Continuing its ophthalmology expansion, Boehringer Ingelheim inked a pact worth up to $327 million (€280M) with Palatin Technologies to co-develop first-in-class treatments for diabetic retinopathy fiercebiotech.com fiercebiotech.com. Palatin’s program targets the melanocortin receptor pathway – involved in inflammation and immune responses – to address retinal vascular damage in diabetes fiercebiotech.com fiercebiotech.com. Boehringer’s Remko Bakker, head of eye health R&D, said vision loss from diabetic eye disease robs millions of independence, and a melanocortin agonist “is a strategic fit… focusing on the three main drivers of retinal disease: inflammation, vascular dysfunction, and neurodegeneration” fiercebiotech.com. This “beyond borders” approach to eye disorders aligns with Boehringer’s recent string of retina deals (e.g. a $1B+ drug delivery tie-up fiercebiotech.com), as it bets on novel mechanisms to tackle blindness caused by diabetes.

Pharma & Drug Development – Approvals, Showdowns, and Safety Signals

• Wegovy Wins FDA OK for fatty liver disease: Novo Nordisk’s obesity drug Wegovy (semaglutide) just became the first GLP-1 therapy approved for MASH – metabolic dysfunction-associated steatohepatitis, a serious fatty liver disease biopharmadive.com. The FDA’s late-week clearance (announced Aug. 15) marks Wegovy’s third indication fiercepharma.com biospace.com, targeting ~22 million U.S. patients with moderate-to-advanced liver fibrosis due to MASH. In trials, the weekly injectable led to significant liver fat reduction and fibrosis improvement. Novo Nordisk hailed the approval as a breakthrough for an unmet condition often known as NASH, saying semaglutide’s metabolic benefits can now extend to slowing liver disease biopharmadive.com. (Wegovy remains indicated for weight management and was already used off-label in fatty liver; official FDA backing could spur broader insurance coverage.)
• Ozempic half-price deal targets uninsured: In a savvy marketing move amid booming demand (and copycat competition), Novo Nordisk unveiled a $499/month cash-pay option for its diabetes injection Ozempic fiercepharma.com fiercepharma.com. That’s roughly 50% off Ozempic’s ~$1,000 list price. Starting this week, U.S. patients with type 2 diabetes who lack adequate insurance can get Ozempic delivered via Novo’s NovoCare Pharmacy or at retail through GoodRx’s network fiercepharma.com fiercepharma.com. Novo’s diabetes marketing chief Kevin Donahoe said the goal is to reach “as many people as possible” who face high out-of-pocket costs fiercepharma.com fiercepharma.com. Ozempic already has “very high insurance coverage,” he noted, so the unmet need isn’t as large as for obesity drug Wegovy – whose similar $499 offer accounts for ~10% of Wegovy’s sales fiercepharma.com. Still, Novo sees the cash program as making popular GLP-1 drugs more accessible amid criticism of their price tags and the rise of off-brand compounded versions.
• Vanda’s “landmark” legal win vs. FDA: In a rare rebuke to the FDA, a U.S. appeals court sided with Vanda Pharmaceuticals in its 6-year battle to get Hetlioz approved for jet lag disorder fiercepharma.com fiercepharma.com. Vanda sued after the FDA stalled and ultimately refused to approve Hetlioz (already marketed for a sleep disorder in blind patients) for treating jet lag in travelers fiercepharma.com fiercepharma.com. A D.C. Circuit panel vacated the FDA’s denial, slamming the agency’s review as “cursory” and noting Vanda’s trials “showed statistically significant improvement” in jet lag symptoms fiercepharma.com. The court held FDA had violated the law by not granting Vanda a timely hearing on its appeal fiercepharma.com – the application had languished nearly 2,000 days. Now FDA must either approve the new indication or properly consider the evidence. Vanda hailed the decision as a “sweeping win” forcing FDA to “resolve the drug application or hold a hearing” after years of delay fiercepharma.com fiercepharma.com. This case may set precedent nudging FDA to adhere to timelines and give sponsors their day in court.
• Sarepta faces scrutiny on gene therapy safety: With its Duchenne muscular dystrophy gene therapy Elevidys under a cloud, Sarepta Therapeutics released detailed safety data after patient advocates petitioned the FDA to update warnings fiercepharma.com. As of July 22, eight DMD patients have died after receiving Elevidys, the company disclosed fiercepharma.com. However, except for two deaths from acute liver failure (a known risk of the viral vector), the other six fatalities were deemed unrelated to the therapy (caused by advanced disease progression or complications like collapsed lung, cardiac arrest, influenza, etc.) fiercepharma.com. Liver toxicity remains the key concern – 5.8% of ~1,000 Elevidys-treated patients worldwide have been hospitalized for acute liver injury, with non-ambulatory patients at higher risk (8.4% incidence) than those still walking (5.8%) fiercepharma.com. Sarepta emphasized that the “vast majority” of liver issues are mild and non-hospitalized, and ~94%+ of patients have avoided serious liver events fiercepharma.com. The transparency comes as a DMD patient group urges stronger safety labeling after three liver-related deaths (two on Elevidys and one on a similar investigational gene therapy) in the past months fiercepharma.com. Regulators and families will be watching how FDA responds as this cutting-edge treatment’s benefits are weighed against its risks.

Medical & Clinical Updates – Guidelines and Safety Notices

• New U.S. blood pressure guidelines endorse renal denervation: For the first time, renal denervation – a catheter-based ablation of nerves to the kidney – earned a mention in updated hypertension treatment guidelines from the American Heart Association (AHA) and American College of Cardiology. The 2025 guidelines (the first overhaul since 2017) give renal denervation a Class IIb recommendation as an adjunct for resistant hypertension (systolic ≥140 mmHg despite multiple meds) fiercebiotech.com fiercebiotech.com. This “IIb” grade means the benefit may outweigh risks in some patients, supported by randomized sham-controlled trials, but evidence is not yet strong (lower weight than Class I or IIa) fiercebiotech.com. The guidelines, published jointly in Circulation, JACC, and Hypertension, caution that denervation is not a cure or replacement for medications given the lack of long-term outcomes data fiercebiotech.com. It should be considered only for tough cases alongside standard drug therapy and lifestyle changes fiercebiotech.com fiercebiotech.com. The inclusion – endorsed by multiple specialty societies – is a milestone for device-based hypertension treatment, coming after the FDA approved the first denervation systems in late 2023. Clinicians are advised that while promising, the procedure should be reserved for carefully selected patients until more evidence accrues.
• Hospital alert: Baxter pump recall expands: Baxter International and the FDA warned hospitals of additional software glitches in Baxter’s Novum IQ infusion pumps, which are used to deliver IV medications. In July, Baxter disclosed that its Novum IQ large-volume pump (LVP) could sometimes over- or under-infuse drugs – a flaw linked to 2 patient deaths and 79 injuries fiercebiotech.com fiercebiotech.com. Now new issues affect both the LVP and the Novum IQ syringe pump devices fiercebiotech.com. One bug can cause the pump’s display to go blank (“blank Run screen”), preventing dose adjustments during an infusion fiercebiotech.com. Another error triggers a false “motor movement” alarm on the syringe pump at low flow rates fiercebiotech.com. Baxter’s Aug. 4 field notice urged providers to consider alternative pumps if available, or to closely follow new instructions to ensure accurate delivery fiercebiotech.com. The blank-screen glitch, for example, won’t stop an infusion in progress, but nurses would have to power-cycle or re-load the syringe to regain control fiercebiotech.com. These expanding recalls and workarounds underscore growing concerns about medical device safety. The FDA has published detailed charts of affected models and fixes, and Baxter has paused new pump shipments as it works on software updates fiercebiotech.com fiercebiotech.com. Hospitals are on high alert, as infusion pump errors can pose serious risks to patients if not carefully mitigated.

Public Health & Policy – Vaccine Rift, Medicare Cuts, and Wellness Initiatives

• Vaccine recommendations split from U.S. government: In an unprecedented move, the American Academy of Pediatrics (AAP) broke ranks with federal health agencies on COVID-19 vaccination guidance statnews.com statnews.com. On Aug. 19, the AAP released its own immunization schedule for the upcoming respiratory virus season, pointedly recommending COVID-19 vaccines for all children 6–23 months old, and for older children at high risk statnews.com. This directly contradicts the FDA’s new stance (under the Trump administration) limiting future COVID boosters mainly to seniors and high-risk adults statnews.com statnews.com. AAP President Dr. Susan Kressly stressed the pediatricians’ group “will continue to provide recommendations for immunizations that are rooted in science and in the best interest of… infants, children and adolescents” statnews.com. The rift comes after HHS Secretary Robert F. Kennedy Jr. – a noted vaccine skeptic – ousted the CDC’s expert vaccine advisory panel in June and signaled a retreat from broad COVID vaccination campaigns statnews.com statnews.com. “We are severely disappointed,” said UCLA obstetrics professor Dr. Neil Silverman, calling the federal pullback on maternal COVID shots a “public health tragedy on a grand scale” floridaphoenix.com. State health officials and medical societies are now scrambling to issue their own guidance to fill the void and combat growing vaccine misinformation floridaphoenix.com floridaphoenix.com. The AAP’s defiance highlights a growing schism in vaccine policy, as medical groups insist on science-driven advice amid political interference: “The politicization of the vaccine process… is what concerns me the most,” warned Connecticut OB/GYN Dr. Yvette Martas floridaphoenix.com.
• Massive tax bill threatens Medicare funding: The non-partisan Congressional Budget Office (CBO) warned that the new Republican “One Big Beautiful Bill Act” – a sweeping tax cut package – could trigger $500 billion in Medicare cuts over the next decade fiercehealthcare.com fiercehealthcare.com. In a letter to Congress on Aug. 18, CBO analysts explained that under federal “PAYGO” law, deficit-increasing legislation leads to automatic spending sequesters in entitlement programs fiercehealthcare.com. Medicare’s slice would be capped at $45B per year (4% of its budget), but over 2027–2034 those yearly hits accumulate to $491B less in Medicare spending fiercehealthcare.com. The CBO projected that if the White House had to enforce the law, other programs would face impossibly deep cuts too – likely beyond their entire budgets – once Medicare’s max cut is taken fiercehealthcare.com. Such a scenario is usually averted by Congress (indeed, since 2010 lawmakers have routinely waived PAYGO to spare Medicare) fiercehealthcare.com. Nonetheless, the ominous estimate puts pressure on legislators to intervene. The controversial bill, which also slashes Medicaid and is predicted to add trillions to the debt, has healthcare industry groups sounding alarms. Hospital advocates warned it could hike uncompensated care costs by $42B in a single year if not corrected fiercehealthcare.com fiercehealthcare.com. The CBO analysis gives Democrats potent ammunition in the policy fight, as both parties acknowledge the need to prevent sudden Medicare sequester cuts that could destabilize the program.
• Uptick in U.S. COVID cases and precautions: Health officials note that COVID-19 activity is quietly rising as the country heads toward fall. CDC data for mid-August show virus levels climbing from “low” to “moderate” in wastewater surveillance, with the highest concentrations in the Western and Southern states cidrap.umn.edu cidrap.umn.edu. Likewise, test positivity nationwide jumped from 6.5% to 8.6% in one week cidrap.umn.edu, and emergency room visits for COVID are up 19% – a clear sign of increasing infections (though still far below prior waves) cidrap.umn.edu. Reported COVID hospitalizations remain modest, and weekly death counts have actually ticked down slightly cidrap.umn.edu. The CDC’s models suggest infections are “growing or likely growing” in most states cidrap.umn.edu. In response, some hospitals and schools are considering a return to indoor masking or ramping up booster shot awareness for high-risk groups. Experts are also tracking the emergence of new Omicron subvariants (e.g. FL.1.5.1 and others) that could drive a late-summer mini wave. For now, officials urge caution but not alarm: “We’re seeing a slow, steady rise – not a surge,” one CDC epidemiologist noted, emphasizing the continued importance of vaccination and testing as first lines of defense.
• “Food as medicine” gains traction: A major insurer is investing in nutrition to improve health outcomes. Elevance Health (formerly Anthem) announced an expansion of its Food as Medicine program into community health centers serving Medicaid populations fiercehealthcare.com fiercehealthcare.com. In partnership with the National Association of Community Health Centers, Elevance will train primary care teams to provide personalized nutrition support for patients at risk of diet-related chronic illnesses fiercehealthcare.com fiercehealthcare.com. “Incorporating food as medicine directly into primary care enables us to treat nutrition not just as a social driver of health, but as a clinical lever for improving outcomes,” said Dr. Shantanu Agrawal, Elevance’s chief health officer fiercehealthcare.com. The initiative includes medically tailored meal plans, dietary coaching, and referrals to services like produce delivery, often via telehealth for convenience fiercehealthcare.com fiercehealthcare.com. To scale the model, Elevance’s foundation is also funding a six-month grant for NACHC to develop a “Nutrition Center of Excellence” that can be replicated nationally fiercehealthcare.com fiercehealthcare.com. Healthcare leaders – and even Congress – are increasingly embracing “food is medicine” interventions as research links nutrition to outcomes in diabetes, heart disease, and more. (Earlier this year, Kaiser Permanente and Tufts launched a national Food is Medicine Research Network, with Elevance as a founding member fiercehealthcare.com.) By treating healthy food as a core part of care, these programs aim to reduce hospitalizations and disparities. As NACHC President Dr. Kyu Rhee put it, community clinics have long innovated in nutrition support and now can “identify and scale evidence-based nutrition care models to the communities that need them most” fiercehealthcare.com fiercehealthcare.com.
• Global health watch – Europe battles tropical disease outbreaks: Public health officials in Europe are grappling with unusual infectious disease surges. France, for example, is enduring its earliest and largest chikungunya outbreak on record, triggered by travelers from a massive epidemic in Réunion (an island territory) news-medical.net. By mid-July, France had 10 localized chikungunya clusters (27 cases across 5 regions), with the first local transmission in late May – the earliest ever for any mosquito-borne virus in France news-medical.net news-medical.net. The tiger mosquito (Aedes albopictus) has expanded its range into Europe, raising concern that typically tropical viruses like chikungunya, dengue, and West Nile will increasingly spark local epidemics in temperate areas. The French national health agency (Santé Publique) had to mobilize intensive door-to-door mosquito control and surveillance far earlier than its usual summer schedule news-medical.net news-medical.net. Meanwhile, polio remains in the spotlight after detections of poliovirus in wastewater from New York to London over the past year, and the WHO is monitoring resurgences in at least 3 countries where polio had been eliminated. Health authorities urge maintaining high vaccination rates to prevent old foes from regaining ground. These events underscore a global message: climate change and travel are erasing old disease boundaries, demanding stronger international preparedness for “tropical” diseases appearing in new locales. (As one epidemiologist quipped, “No disease is an island in our interconnected world.”)

Sources: Key news and expert quotes were gathered from Fierce Biotech fiercebiotech.com fiercebiotech.com, Fierce Pharma fiercepharma.com fiercepharma.com, Fierce Healthcare fiercehealthcare.com fiercehealthcare.com, STAT News statnews.com statnews.com, the Florida Phoenix floridaphoenix.com floridaphoenix.com, CIDRAP cidrap.umn.edu cidrap.umn.edu, and other authoritative sources as cited above. Each development is linked to its original reporting for further reading. The roundup covers events and announcements from August 18–19, 2025, providing a comprehensive digest of the latest in biotech, pharma, medical, and health news.