Immune cells from pediatricians help uncover an antibody cocktail against RSV and hMPV

medicalxpress - Researchers in China recently published a study in Science Translational Medicine describing a new antibody cocktail for protection against two common viruses. The proposed preventative treatment consists of antibodies identified in pediatricians who have…

AI Summary: Researchers mined the blood of pediatricians — occupationally exposed to many childhood viruses — to isolate highly potent antibodies, then combined them into a cocktail that neutralizes respiratory syncytial virus (RSV) and human metapneumovirus (hMPV). Preclinical results show strong neutralization and protection, offering a promising prophylactic or therapeutic option for infants and at-risk adults.

FDA formalizes one pivotal trial policy via NEJM perspective

Zachary Brennan / endpoints - Top FDA officials said that a single pivotal trial requirement will be the “new default standard” for drug approvals, a move that goes beyond the agency’s prior discretion around not requiring two trials. In a ...

AI Summary: The FDA has moved to make a single pivotal trial the new default for drug approvals, abandoning the long-standing two-study standard to speed access and ease OTC transitions. The policy, outlined by agency leaders and discussed in a NEJM perspective, raises questions about evidence thresholds and downstream safety monitoring. Welcome to faster approvals — now let's hope that lone study behaves.

F.D.A. Reverses Decision and Agrees to Review Moderna’s Flu Vaccine

Christina Jewett and Rebecca Robbins / nytimes - Moderna said it had held further discussions with regulators and announced that the agency would accept the company’s application for approval of its flu vaccine that uses mRNA technology.

AI Summary: After renewed discussions with the company, the FDA reversed its earlier stance and agreed to accept Moderna’s amended application for an mRNA seasonal influenza vaccine. Regulators will now evaluate the submitted safety and efficacy data to determine whether the shot meets approval standards — a regulatory about-face that will keep flu-watchers and investors awake.

Ocular Therapeutix Eyes FDA Filing After Wet AMD Drug Tops Regeneron’s Eylea in Phase 3 Test

Frank Vinluan / medcitynews - In the first of two Phase 3 tests, Ocular Therapeutix’s Axpaxli met the main goal of helping maintain vision in patients with the wet form of age-related macular degeneration. The Ocular drug was compared to Eylea, a blockbuster wet AMD drug marketed by R…

AI Summary: Ocular Therapeutix’s investigational drug Axpaxli met its primary endpoint in a pivotal Phase 3 trial, showing superiority to Regeneron’s Eylea for wet age‑related macular degeneration. The company plans an FDA submission, positioning Axpaxli as a potential new first‑line therapy if regulators agree — a welcome development for patients tired of frequent injections.

Lilly appeals retatrutide classification ruling in case that could impact compounders

Alexis Kramer / endpoints - Eli Lilly is challenging a decision over how the FDA classified its experimental, next-gen obesity shot, in a case that could affect the ability of compounders to rival it. On Thursday, Lilly filed a notice ...

AI Summary: Eli Lilly is contesting a regulatory classification decision for its next‑generation obesity shot while simultaneously stockpiling doses ahead of potential U.S. approval. The dispute has broader implications for compounding pharmacies and has coincided with lawsuits accusing telehealth vendors and compounders of selling unapproved oral GLP‑1 alternatives — a messy intersection of commerce, regulation and patient safety.

HPV cancer vaccine slows tumor growth and extends survival in preclinical model

medicalxpress - Throughout the past decade, Northwestern University scientists have uncovered a striking principle of vaccine design: Performance depends not only on vaccine components but also on vaccine structure. After proving this concept across multiple studies, the…

AI Summary: A therapeutic HPV vaccine showed tumor shrinkage and longer survival in preclinical models of HPV‑driven oropharyngeal cancer, suggesting a possible adjunct to surgery and chemo‑radiation. Researchers say the approach could boost anti‑tumor immunity and inform next‑stage trials, though human efficacy and safety await clinical proof.

Studies test whether gene-editing can fix high cholesterol. For now, take your medicine

medicalxpress - Scientists are testing an entirely new way to fight heart disease: a gene-editing treatment that might offer a one-time fix for high cholesterol.

AI Summary: Researchers are testing gene‑editing approaches aimed at providing a single‑procedure solution for elevated LDL cholesterol. Early human studies probe safety and durability, but experts urge patients to continue proven lipid‑lowering therapies for now. The line between ambitious science and everyday clinical care remains prudently guarded.

Eli Lilly Expands Its In Vivo Ambitions, Acquiring Cell Therapy Startup Orna for up to $2.4B

Frank Vinluan / medcitynews - Orna Therapeutics brings Eli Lilly an in vivo cell therapy ready for Phase 1 testing as a potential treatment for autoimmune diseases. Lilly is now the latest pharma company to use M&A to enter this growing field, following deals made in the past year by …

AI Summary: Eli Lilly is acquiring Orna Therapeutics for up to $2.4 billion to secure in‑vivo cell‑therapy capabilities and jump‑start its presence in CAR‑T and immune‑resetting platforms. The deal signals big pharma’s move to couple traditional drug development muscle with next‑generation cell‑engineering, accelerating clinical testing and commercialization plans.

Sanofi's Paul Hudson out, with Belén Garijo to step in as new CEO

Reynald Castañeda / endpoints - Paul Hudson is stepping down from his post as CEO of Sanofi, and his last day will be Feb. 17. The French drugmaker's board decided not to renew Hudson's mandate on ...

AI Summary: Sanofi’s board has opted not to renew Paul Hudson’s tenure, installing Belén Garijo as the new chief executive amid mixed reactions. The leadership swap arrives as the French drugmaker faces pipeline pressures and investor impatience—expect strategic shuffles, belt‑tightening and plenty of corporate soul‑searching with a side of investor scrutiny.

Ama launches independent vaccine review after CDC criticism

medicalxpress - Two major medical groups will begin reviewing vaccine safety and effectiveness after major changes at the U.S. Centers for Disease Control and Prevention (CDC) have raised alarms among experts.

AI Summary: The American Medical Association announced an independent review of vaccine safety and effectiveness in response to recent CDC changes and criticism, partnering with external researchers to evaluate evidence and restore public trust. The panel aims to provide transparent, expert analysis free of political noise.

BridgeBio Stands Tall as Phase 3 Data Put Dwarfism Drug on Track for FDA Filing

Frank Vinluan / medcitynews - Infigratinib achieved statistically significant improvement in growth rate and body composition in a Phase 3 clinical trial that tested the BridgeBio Pharma drug in achondroplasia, the most common form of dwarfism. Regulatory submissions are planned for l…

AI Summary: BridgeBio reported statistically significant Phase 3 results for infigratinib in achondroplasia, showing improved growth rates and body composition, moving the program toward an FDA filing. The readout strengthens BridgeBio’s rare-disease momentum and sets the stage for regulatory discussions and potential market entry.

AbbVie sues over selection of Botox for IRA negotiations

Nicole DeFeudis / endpoints - AbbVie is suing CMS for picking Botox for the third round of Medicare negotiations, making it the first drugmaker to challenge the upcoming cycle in court. In a lawsuit filed Wednesday in Washington, DC, AbbVie ...

AI Summary: AbbVie has filed suit challenging the federal decision to include Botox in Medicare’s drug price negotiation program, arguing the selection process was flawed and that the move could imperil innovation and pricing strategies. The lawsuit seeks to block or alter implementation while the industry and regulators brace for legal precedent.

FDA refuses to review Moderna flu vaccine

Ella Jeffries / beckershospitalreview - Moderna has received a refusal-to-file letter from the FDA’s Center for Biologics Evaluation and Research for its biologics license application for mRNA-1010, its investigational seasonal influenza vaccine. The letter, signed by Vinayak Prasad, MD, chief …

AI Summary: Moderna’s mRNA flu vaccine application has been rejected by the FDA—Moderna received a refusal‐to‐file letter while accusing the agency of shifting its review standards. Multiple reports echo this regulatory setback, fueling industry concerns over consistent, transparent decision‐making.

AstraZeneca gets CRL for prefilled pen version of lupus drug Saphnelo

Anna Brown / endpoints - The FDA has handed AstraZeneca a complete response letter for the subcutaneous prefilled, self-injectable pen of Saphnelo for systemic lupus erythematosus (SLE), a month after the asset gained approval in Europe ...

AI Summary: AstraZeneca’s application to market its subcutaneous prefilled pen formulation of Saphnelo for treating lupus has hit a roadblock after the FDA issued a complete response letter. The decision delays the drug’s approval and raises questions about its future in the competitive immunotherapy market.

HHS to drop 340B rebate pilot after court rulings

Ella Jeffries / beckershospitalreview - HHS will drop its 340B rebate model pilot program following two federal court rulings that blocked its implementation. The program, announced in August 2025, was challenged by the American Hospital Association, the Maine Hospital Association and four safe…

AI Summary: In a twist that no one saw coming (except the federal courts), HHS has scrapped its controversial 340B rebate pilot after two judicial rulings blocked its implementation. Providers, relieved to avoid a potential cash flow nightmare, are quietly celebrating the decision as one less bureaucratic headache to manage.

#ISC26: Bayer’s asundexian reduced ischemic strokes by 26% in Phase 3 trial

Ayisha Sharma / endpoints - Bayer shared more details from its unexpected win in a Phase 3 study testing its next-generation blood thinner for secondary stroke prevention. The factor XIa inhibitor, named asundexian, reduced the occurrence of ischemic stroke by ...

AI Summary: Bayer’s latest Phase 3 study of asundexian has shown a 26% reduction in secondary ischemic stroke risk—without an increased bleeding risk. This compelling data bolsters the drug’s prospects as a blockbuster in stroke prevention and underscores Bayer’s commitment to advancing cardiovascular therapies.

Eikon Therapeutics Raises $381 M in IPO to Advance Live-Cell Imaging in Cancer Drug Discovery

oncodaily - Eikon Therapeutics has raised $381 million through its IPO, pricing at the top of its range in a strong sign of renewed investor appetite for biotech offerings. The South San […]

AI Summary: Eikon Therapeutics successfully raised $381 million in its IPO, reinforcing investor confidence in novel biotechnology approaches for cancer drug discovery. The fundraising milestone is expected to accelerate live‐cell imaging and other innovative oncology research initiatives.

HHS scraps 340B rebate pilot in win for hospitals

Emily Olsen / healthcaredive - The Trump administration agreed to drop a controversial pilot that would have allowed drugmakers to give post-sales rebates on some drugs instead of upfront discounts.

AI Summary: Federal health officials have reversed course on a highly controversial 340B rebate pilot program after federal courts blocked its implementation – a move hailed by providers as a long‐awaited relief from cash flow and administrative burdens.

Statin pills much safer than advertised, major review finds

bbc - The results, in The Lancet journal, come from trials involving more than 120,000 people comparing statins with a dummy drug or placebo.

AI Summary: Multiple large‐scale analyses have debunked the long‐held worries about statin side effects – it turns out that those pesky symptoms listed on package leaflets are no more common than when taking a placebo. In other words, patients can keep calm and lower cholesterol with confidence.