Data and Decisions in Advanced NSCLC at the 2026 TTLC Symposia – IASLC
oncodaily - International Association for the Study of Lung Cancer (IASLC) shared a post on LinkedIn: “2026 TTLC Symposia Event Data and Decisions in Advanced NSCLC The treatment landscape for advanced NSCLC is evolving […]
AI Summary: TTLC 2026 brought together lung cancer experts to present symposia on advanced NSCLC topics — from RAS inhibition to mechanisms of EGFR resistance — and unveiled new clinical data. The meeting, including LungCancerRx LIVE Season 2 sessions, fostered debate, rapid data exchange and collaborations likely to steer upcoming trials and treatment approaches.
A novel C. diff vaccine shows promise
Mariah Taylor / beckershospitalreview - Nashville, Tenn.-based Vanderbilt Health researchers have developed a promising novel vaccine to treat Clostridioides difficile infections. Previous vaccine strategies targeted the bacterium’s primary toxins, according to a Feb. 18 system news release. Th…
AI Summary: Researchers at Vanderbilt have reported a novel experimental vaccine that prevents Clostridioides difficile infection and reduces recurrence in early studies, demonstrating strong protective immune responses. The work offers a much‑needed alternative to antibiotics and recurrent‑infection management, though larger clinical trials will be required to confirm safety, durability and real‑world impact.
Novartis signs macrocyclic deal with Unnatural Products for $100M upfront
Kyle LaHucik / endpoints - Novartis will pay $100 million upfront to tap into a macrocyclic peptide platform from Unnatural Products, a deal that could lead to new cardiovascular disease medicines. The move allows the Swiss pharma giant to delve ...
AI Summary: Novartis has committed $100 million upfront to partner with Unnatural Products, acquiring access to a macrocyclic peptide platform designed to reach challenging protein targets. The deal accelerates Novartis’ efforts to expand into next‑generation peptide therapeutics and bolsters its early R&D pipeline with technology aimed at previously “undruggable” targets.
Disc Medicine Rare Disease Drug Picked for Faster Regulatory Review Is Rejected by the FDA
Frank Vinluan / medcitynews - The FDA asked for more data to determine whether Disc Medicine’s bitopertin is benefiting patients with erythropoietic protoporphyria, a rare blood disorder. Analysts say it’s a surprising delay considering bitopertin is one of the first drugs in a new FD…
AI Summary: The FDA has rejected Disc Medicine’s application for its rare-disease candidate even after granting an accelerated review pathway, concluding the submitted evidence did not demonstrate sufficient benefit. The setback stalls a high-profile regulatory push and requires the company to collect more robust clinical data before re‑seeking approval.
Walgreens to lay off hundreds of employees
Dani James / healthcaredive - The drugstore retailer said it was simplifying its organization to speed up decision-making in a move impacting at least 600 workers.
AI Summary: Walgreens is planning significant staff reductions—hundreds of roles eliminated—as part of a corporate reorganization intended to simplify decision‑making and reduce costs under new ownership. The layoffs are concentrated across multiple states and reflect broader retail pharmacy cost‑cutting pressures.
'Universal' nasal-spray vaccine protects against viruses, bacteria and allergens in mice
livescience - In an early animal test, a new nasal-spray vaccine has shown promise against a variety of germs and a common allergen, scientists report.
AI Summary: Scientists reported a nasal-spray vaccine that protected mice against a range of respiratory viruses, bacteria and even a common allergen, a tantalizing step toward a universal respiratory vaccine. The animal data look promising, but human trials are essential before anyone ditches annual shots for a single spritz and a prayer.
Your Cat May Share the Same Cancer Genes as You, and Offer Clues for Treatment
discovermagazine - Learn how cats and humans can share key cancer mutations — and why those similarities could guide future treatment research.
AI Summary: A comparative genomics study finds the household cat shares key cancer mutations with humans across several tumor types, offering a practical animal model for understanding tumor biology and testing therapies. Researchers suggest these feline-human parallels could accelerate translational oncology for both species, turning a once-dismissed pet anecdote into useful science.
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.