Fierce Pharma2h
With biosimilar competition looming, Roche takes a hit with failure of high-dose Ocrevus
“These findings reaffirm that the current Ocrevus IV 600 mg is optimally dosed to significantly slow disability progression,” ...
Fierce Pharma2h
For struggling cell and gene therapy field, Peter Marks' FDA exit adds even more uncertainty
The sudden resignation of Peter Marks, M.D., Ph.D., from the FDA branch that regulates biological products for humans ...
Fierce Pharma6h
Amid uncertainty in the US, Boehringer Ingelheim projects 'slight' revenue increase for '25
Boehringer Ingelheim picked a challenging day to reveal its 2024 financial results and guidance for this year. | Boehringer ...
Fierce Pharma6h
Japan's Marubeni takes on Sumitomo's Asia pharma business to make new company in deal worth up to $480M
In the latest in a growing trend of pharma reshuffling moves in Asia, Marubeni Corporation is absorbing Sumitomo Pharma’s ...
Fierce Pharma6h
FDA taps insider Scott Steele to lead CBER on acting basis after Peter Marks departure
Amid a dramatic reshaping of the federal healthcare apparatus, the FDA has named an acting leader of its Center for Biologics Evaluation and Research. | Amid a dramatic reshaping of the federal ...
Fierce Pharma7h
Gene therapy CDMO Artis BioSolutions launches with acquisition of Landmark Bio
Out of the shadows, new CDMO Artis BioSolutions has decloaked on a mission to tackle the tricky production process for ...
Fierce Pharma8h
Cellares' cell therapy factory-in-a-box scores coveted advanced manufacturing technology tag from FDA
A little over a year after winning manufacturing certification for its cell therapy factory-in-a-box, South San Francisco’s ...