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.

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.

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.

#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.

Novo Nordisk vows legal action to protect Wegovy pill

medicalxpress - Novo Nordisk said Thursday it would take legal action against a US chain offering a copycat of the new pill version of its Wegovy weight-loss drug.

AI Summary: Novo Nordisk has vowed to take legal action after discovering that competitors – including Hims & Hers – plan to market a compounded, lower‐priced version of its new Wegovy weight‐loss pill. The company is mobilizing its legal team to protect its intellectual property amid fierce market competition.

Letters, Jan. 27, 2026: ‘A Team Canada must be assembled’ to help diversify trade

Jeffrey Morgan / calgarysun - Need to diversify I just watched a video detailing the prior commercial trading practices between Canada and the U.S. It makes me realize there is nothing more important than Canada diversifying its trade with other countries. By ‘nothing,’ I mean all pro…

AI Summary: Summit Therapeutics announced that the U.S. Food and Drug Administration has accepted its Biologics License Application for Ivonescimab—intended for patients with EGFR‑mutated non‑small cell lung cancer who have progressed after TKI therapy. The regulatory nod signals a promising step forward in targeted lung cancer treatment.

FDA lifts hold on one of two Phase 3 gene editing studies by Intellia

Lei Lei Wu / endpoints - The FDA has allowed Intellia Therapeutics to resume one of its two pivotal trials of a gene editing therapy for transthyretin amyloidosis, which is a disease caused by misfolded proteins. Intellia

AI Summary: U.S. regulators have just cleared Intellia Therapeutics’ Phase 3 study of a gene‐editing therapy intended to treat a genetic nerve disorder, effectively rescinding a clinical hold. This development opens the door to renewed patient enrolment and further evaluation of the treatment’s safety and effectiveness.

#JPM26: Day 3 at the JP Morgan Healthcare Conference

ENDPOINTS / endpoints - It’s Wednesday at the JP Morgan Healthcare Conference, and as the sessions wind down, we’ll be keeping an eye on presentations from WuXi AppTec and AbbVie. Yesterday afternoon, our Executive Editor Drew Armstrong spoke with ...

AI Summary: At the JP Morgan Healthcare Conference 2026, top industry leaders unveiled transformative developments—from embedding AI into EHR systems to discussions on GLP‐1 compounding innovations and strategic Q&A sessions with leading pharma CEOs. The event provided a broad overview of emerging trends in healthcare technology and innovation.

F.D.A. Decisions on Abortion Pill Were Based on Science, New Analysis Finds

Pam Belluck / nytimes - A study of more than 5,000 pages of agency documents on mifepristone over 12 years found that agency leaders almost always followed the evidence-based recommendations of scientists.

AI Summary: New in‑depth analyses of internal FDA documents reveal that regulatory decisions on the abortion pill mifepristone were firmly based on thorough evidence rather than political pressure, dispelling common misconceptions about politicized review processes.

FDA rejects cancer therapy for rare post-transplant disease

Ella Jeffries / beckershospitalreview - Atara Biotherapeutics received a second complete response letter from the FDA for its biologics license application for Ebvallo (tabelecleucel). The letter, received Jan. 9, said the FDA no longer considers the single-arm ALLELE trial adequate to support …

AI Summary: The FDA has again rejected Atara’s cell therapy aimed at treating rare post‐transplant complications linked to Epstein–Barr virus. Despite high hopes for this innovative approach, regulatory concerns remain over its safety and efficacy—clearly a “repeat performance” in the world of breakthrough therapies.

NVIDIA and Eli Lilly Launch $1B AI Co-Innovation Lab to Reinvent Drug Discovery

oncodaily - Dave Ricks, Chair, CEO at Eli Lilly and Company, shared Eli Lilly and Company‘s post on LinkedIn, adding: “Exciting news from the JPMorgan Healthcare Conference: Lilly and NVIDIA are joining […]

AI Summary: Eli Lilly and Nvidia have teamed up to invest up to $1 billion in a brand‑new AI lab aimed at reinventing drug discovery. This collaborative venture promises to streamline R&D with cutting‑edge artificial intelligence while hinting that pharma’s reliance on tech is evolving – and it’s not all sci‑fi smoke and mirrors.

Merck Could Strike 30 Billion Deal for Revolution Medicines

oncodaily - According to the Financial Times, Merck is in talks to acquire Revolution Medicines, a Redwood City, California-based cancer drug developer, in a deal that could value the company at roughly […]

AI Summary: Merck is reportedly in advanced talks to acquire Revolution Medicines—a Redwood City–based cancer drug developer—in a deal that could be worth around $30 billion. A separate report adds speculative color, reinforcing market buzz about this strategic move in oncology.