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Since its inception in 1992, the FDA’s accelerated approval pathway has helped shepherd nearly 300 new drugs to the market. However, recent years have seen a number of high-profile market withdrawals and failed confirmatory trials.
As companies roll out data showing the power and improved safety profile of antibodies that target two antigens, analysts say the class could overtake monoclonal antibody Keytruda as the “immunotherapy backbone” of solid tumor treatment.
Senator Elizabeth Warren told the Federal Trade Commission that the acquisition of contract manufacturer Catalent could increase Novo’s dominance over the hot GLP-1 market, reducing competition and increasing prices.
Turnstone is shifting resources to focus on clinical advancement of its selected tumor-infiltrating lymphocyte therapy as three C-suite members exit their roles.
Two biotechs set out for the public markets this week, with Upstream Bio raising $255 million for its inflammatory disease work, while CAMP4 Therapeutics picked up $75 million to develop RNA-targeting drugs.
Despite substantial variability in the presented data and no well-controlled trial, the FDA advisory committee voted in favor of Stealth BioTherapeutics’ Barth syndrome therapy elamipretide, citing the urgent unmet need.
With the regulatory approval for advanced breast cancer, Roche’s inavolisib is a potential challenger to Novartis’ PI3K inhibitor Piqray, which last year generated $505 million in revenue.
The U.S. Department of Justice alleged that Teva violated the Anti-Kickback Statute and the False Claims Act. The payment is in addition to the criminal penalty paid by Teva USA under its deferred prosecution agreement.
Oditrasertib, which blocks the inflammatory RIPK1 protein, earlier this year also failed a Phase II trial in amyotrophic lateral sclerosis, forcing the company to discontinue its development a few months later.
Vaccine biotech Gritstone bio is filing for bankruptcy while securing a stalking horse bid from an unnamed party, which the company hopes will save its clinical research in cancer and infectious disease.
Astellas is opening a second location of Universal Cells, its wholly owned subsidiary, at a research campus in Japan and transferring 12 roles from Universal’s Seattle location.
In the third episode of our mini series on artificial intelligence, Lori and guests continue their exploratory discussion on AI and the opportunity in patient lives.
PRESS RELEASES
Integration into McKesson’s Medical-Surgical Solutions marketplace serving a nationwide customer base
Phase I results provide platform-level validation supporting AdJane’s broader development programs in pandemic preparedness, respiratory infectious diseases and antimicrobial resistance
International experts from leading universities, global biopharmaceutical companies, and investment organizations will convene in Riyadh, Saudi Arabia, September 14–16, 2026, for the fourth edition of RGMBS.
Leinfelden, Germany. Recent infectious disease events—from hantavirus outbreaks and meningitis cases to recurring disease outbreaks in livestock farming—highlight the need for flexibly scalable vaccine manufacturing processes. To address this challenge, Stuttgart-based technology company KyooBe Tech has developed a platform designed to accelerate vaccine production. This technology is now also available to external users for studies at the Fraunhofer Institute for Cell Therapy and Immunology (IZI).
AmesNet’s Task-Conditioned Learning architecture outperforms FDA, MIT, Tencent, and the University of Sydney models in both sensitivity and balanced accuracy on out-of-domain chemical data on a public dataset; AmesNet is built on top of ChemPrint, the core and proprietary deep-learning engine of the GALILEO platform that powers the company’s drug pipeline.