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The FDA is undergoing a major transformation in its drug approval processes, regulatory oversight and transparency initiatives. This webinar explores the implications of these reforms and what they mean for innovation, compliance and strategy in the biopharma industry.
Pfizer and Novo Nordisk seem to want Metsera bad. Analysts are wondering, though: Is the obesity biotech really worth this much effort?
According to reporting from Reuters, reviewers at the agency pointed to an inability to differentiate from placebo to justify rejecting the drug, but an FDA office director approved the drug anyway.
Investors got to hear Novo Nordisk’s side of the Metsera bidding war drama for the first time on Wednesday, as the company reported third-quarter earnings. A rough quarter underscored the stakes for the Danish pharma.
Pfizer and Novo Nordisk continue to fight for ownership of obesity startup Metsera; CDER Director George Tidmarsh leaves his position amid an ongoing probe into his “personal conduct”; FDA reverses course on approval requirements for uniQure’s Huntington’s gene therapy; Sarepta’s exon-skipping Duchenne muscular dystrophy drugs fail confirmatory study.
Biohaven is proposing troriluzole for the treatment of spinocerebellar ataxia, a group of rare, genetic diseases that lead to the progressive loss of control over movement.
Arena launched with $500 million in early 2024 to fund basic biological research, from which it planned to spin out dedicated companies to focus on drug development.
Harmony Biosciences has paused a mid-stage trial of ZYN002 in 22q11.2 deletion syndrome after the THC-free cannabinoid drug failed to significantly improve social avoidance in a late-stage study in fragile X Syndrome.
Amgen remains confident in its obesity asset MariTide, for which it has launched a broad Phase III program.
Due to the litigation Pfizer filed Friday and Monday against Metsera, Novo Nordisk and the biotech’s lead shareholder, CEO Albert Bourla was limited in what he could say. But he said Pfizer was the best fit for Metsera.
Both companies have submitted revised bids, with Novo’s coming in $1.9 billion higher than Pfizer’s.
The potential approval of Vertex’s IgAN therapy povetacicept in 2026 comes amid launch headwinds for the company’s non-opioid pain medicine Journavx and gene therapy Casgevy.
PRESS RELEASES
Shareholders Must Recast Their Votes to be Counted
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.