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Browse the latest news from BioSpace, and press releases from around the industry. Want to filter by date, keyword, and more? Search here.
TOP STORIES
Less than 24 hours after resigning his post as the FDA’s head drug regulator, George Tidmarsh is reportedly reconsidering his decision and vowing to fight for his name and credibility amid a probe into his “personal conduct” at the agency.
At the center of the licensing deal is an NLRP3 inhibitor that has shown “encouraging efficacy in acute inflammation models,” according to TransThera, indicating its potential in various metabolic and inflammatory diseases.
Follow along as BioSpace tracks job cuts and restructuring initiatives.
Manifold will use its tissue-targeting shuttle technology to help Roche develop new therapeutics for diseases of the central nervous system.
Industry leaders say uncertainty in funding, clinical development and manufacturing is driving companies to embrace digital transformation, streamlined operations and strategic partnerships to navigate a turbulent market and global tariff pressures.
A month after sparking optimism for patients with Huntington’s disease with highly positive data for AMT-130, uniQure revealed Monday that the FDA may be changing its tune on the evidence required for an approval application, a change of direction Stifel called “very challenging” for uniQure.
Pfizer has filed two separate lawsuits in an effort to stop Novo Nordisk’s unsolicited bid to acquire obesity biotech Metsera.
Vinay Prasad, chief of the FDA’s Center for Biologics Evaluation and Research, is planning to publish a paper this month to outline his office’s thinking on accelerating gene editing reviews.
Optimization Through Culture, Quality Control and Regulatory Standards
Novo Nordisk, under new CEO Maziar Mike Doustdar, has a new attitude. It’s making Pfizer livid.
Skyrizi and Rinvoq made nearly $7 billion combined, almost half of the company’s income for the quarter alone.
Otsuka Pharmaceuticals could shell out over $400 million in total for the Asia-Pacific rights to 4D-150, which combines a VEGF-C inhibitory RNAi with Regeneron’s Eylea into a single ocular injection.
PRESS RELEASES
- Preliminary results confirm earlier findings that inobrodib in combination with pomalidomide + dexamethasone (InoPd) for multiple myeloma has promising clinical activity and a tolerable safety profile in a heavily pretreated population - - The Company will host a live investor event on December 7, at 8:00 p.m. ET in Orlando following the poster presentation -
Pathologic Clearance: 100% Tumor Clearance (Complete Response) in One Patient, Greater than 90% (Near Complete Response) in Second Patient, Greater than 50% (Partial Response) in Third Patient Pathologic Results Assessed at Approximately 5 Weeks Safety Monitoring Committee Issues Favorable Review of Safety Data at the Maximum Dose
Uniphar announces U.S. expansion, integrating leading companies and appointing new senior leadership
- New integration aligns U.S. operations, unifying RRD BioPharma Development, Uniphar Clinical, Diligent Health Solutions and BESTMSLs under the Uniphar brand. - Mike Ebhardt is appointed President of Uniphar Pharma Services U.S., alongside Cindy Thompson as Vice President of Operations and Transformation.