News
FEATURED STORIES
To drive true innovation in drug development, executives must not let excitement about the latest shiny object obscure ultimate outcomes.
Heading into the final quarter of a year that has seen dramatic upheaval at the FDA—from the exodus of numerous senior leaders to unclear policy changes and a safety saga that engulfed the gene therapy space—drug approvals appear roughly on par with recent years.
Therapies from industry leaders BioMarin and Ascendis Pharma supply a key hormone that promotes bone growth. In order to move the field forward, challengers are looking to address the underlying cause of the rare, genetic disease.
Job Trends
Companies are announcing significant investments in U.S. manufacturing in response to looming tariffs. An AstraZeneca executive and Eli Lilly and Novo Nordisk spokespeople discuss potential job and skill-building opportunities and where manufacturing might head in the future.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
BioSpace Senior Editor Annalee Armstrong reflects on the year that was, and what’s to come in 2025.
THE LATEST
Of the 25 companies receiving tax incentives in Massachusetts, 23 will add jobs outside of Boston and Cambridge. Medtronic, which is receiving the largest award, will create 220 roles in Billerica. Other recipients include AbbVie, Dyne Therapeutics and Viridian Therapeutics.
In three draft guidance documents, the FDA has laid out pointers to help companies craft better drug development programs and drug applications.
The discontinued CAR T therapy bbT369 came to Regeneron when the pharma bought all of 2seventy bio’s pipeline assets for $5 million upfront in January 2024.
Sales of Sanofi’s COVID-19 and flu vaccines fell 17% in the third quarter amid declining vaccination rates and pricing pressures in Europe.
The antibody-drug conjugate, withdrawn from the market by GSK in 2022 after failing a confirmatory study, was approved Thursday by the FDA for previously treated patients with multiple myeloma. This is despite a negative advisory committee vote in July.
Viking Therapeutics CEO Brian Lian is watching the growth of interest in MASH and obesity but prepared to go it alone.
Roche has already signed several high-ticket deals this year, including the $3.5 billion acquisition of 89bio and Genentech’s $2.1 billion molecular glue pact with Orionis Biosciences.
In this episode presented by Element Materials Technology, guests Dr. Jihye Jang-Lee and Dr. Khanh Courtney discuss how small biotechs face mounting pressure amid manufacturing uncertainties.
Despite showing no meaningful benefit on lung function, Arcturus’ mRNA therapy ARCT-032 reduced mucus volume in patients with cystic fibrosis—an outcome William Blair found “potentially promising.”
With Avadel under its fold, Alkermes expects to accelerate its expansion into the sleep market, laying the foundation for its late-stage narcolepsy asset alixorexton.