Latest News
& Press Releases

Follow along as BioSpace tracks job cuts and restructuring initiatives.

Jubilant HollisterStier received a warning letter over problems that the FDA said necessitate an immediate and comprehensive assessment of the contract manufacturing organization’s global operations.

After 27 deaths were reported in a group receiving its blood cancer drug, ADC Therapeutics is downsizing, implementing layoffs for about 30 workers.

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.

• New patent application covers treatment-emergent immune signature related to ‘turning cold tumors hot’ and the activation of targeted cytotoxic cellular immune responses • Company to host conference call later in April 2026 to review new biomarker signature • Biomarker signature meets pharmacodynamic/response criteria established by FDA’s Biomarkers, EndpointS and other Tools (BEST) program for use as a surrogate clinical endpoint of 1-year event free survival and 2-year overall survival in OST-HER2’s Phase 2b trial in the prevention of delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma to support a BLA submission under FDA’s Accelerated Approval Program

Anticipated peptide reclassification could expand the addressable market for PharmaTher’s PharmaPatch™ product strategy and PatchPrint™ manufacturing platform, strengthening its position in next-generation peptide delivery

Proven Med Tech Leader with an Established Track Record of Commercial Success and Optimizing Shareholder Value Leading to over $3.4 Billion in Successful Exits

Model Medicines’ antiviral intellectual property portfolio encompasses 15 patent families covering novel compositions of matter, multi-scaffold Markush chemistry, formulations, and broad-spectrum methods of use across RNA and DNA viruses

· New XSeed Labs team at Servier’s Paris-Saclay campus brings together AI and immunology expertise to advance next-generation biologics.