Latest News
& Press Releases
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
A few short days after announcing an FDA pivot on a separate asset, REGENXBIO is planning to test the agency’s apparent newfound rare disease outlook on another late-stage gene therapy.
A new report from RBC Capital Markets lists Biotechnology Innovation Organization chief executive John Crowley and military physician Heidi Overton as potential candidates for the role of FDA commissioner—in addition to the agency’s current acting leader, top food regulator Kyle Diamantas.
The FDA has so far secured 600 new hires and is looking for 1,600 more as interim leadership at the agency aims to rebuild the workforce and morale after more than a year of intense attrition.
Novartis and Antares Therapeutics are shooting for the stars, launching a joint mission to develop small molecule oncology therapies.
Lilly has already spent more than $25 billion in potential business development commitments this year, including the $6.3 billion buyout of Centessa Pharmaceuticals that closed today.
AbbVie scooped up immunology player Apogee Therapeutics for nearly $11 billion in one of the year’s top deals to-date, while Sanofi made a big play to survive its upcoming Dupixent patent cliff; FDA uncertainty continues as the agency changes direction on gene therapies by uniQure and REGENXBIO; and Jef Akst and Annalee Armstrong report back from San Diego.
The combined business entity with Boundless Bio, which will carry Serapha Bio’s name and fold in Boundless Bio, will focus on the development of a gene editor for alpha-1 antitrypsin deficiency.
For the 2026 fiscal year, Takeda anticipates declines in revenue and profit, highlighting what CEO-elect Julie Kim says is the need for the company to “invest in future growth.”
Speaking to media on Tuesday, BIO CEO John Crowley complimented China’s rise as a biotech powerhouse but said U.S. policy needs to protect and maintain America’s lead.
With positive feedback on a Phase 3 trial design, Ollin Biosciences has collected a $330 million series B to advance its VEGF/Ang2 antibody, which bested Genentech’s therapy in a head-to-head study.
Controlling CEOs, manipulative middle managers and high-performing jerks can damage employees’ trust in employers and motivate them to hit the job market. Kaye/Bassman’s Michael Pietrack discusses the problematic behaviors executives must watch for in the workplace.
Even biopharma’s biggest players have been forced to take a hard look at their businesses and realign their cost structures to cope with the continued and compounding challenges plaguing the industry.
PRESS RELEASES
CardioMech Strengthens Leadership Team to Advance Development of its Catheter based Minimally Invasive Mitral Valve Repair Technology (TMVr)
CEO Daniel Haders, PhD, will highlight upcoming catalyst events for the company’s two lead assets: MDL-001, a first-in-class, universal, direct-acting therapeutic for influenza-like-illness (ILI) and chronic hepatitis, targeting the novel RdRp Thumb-1 site, and MDL-4102, a first-in-class therapeutic for various cancers and inflammatory diseases, targeting the epigenetic reader and master regulator of gene transcription, BRD4.
Nitto Denko Avecia begins first commercial-scale cGMP production of PH-762 drug substance Newly manufactured supply will support upcoming clinical trial in next development phase
