New regulatory decisions, manufacturing partnerships, and financing pressures are reshaping access, supply, and development pathways for emerging advanced therapies.
|Articles|July 1, 2011
- BioPharm International-07-01-2011
- Volume 24
- Issue 7
BioPharm International, July 2011 Issue (PDF)
Using Blow-Fill-Seal Technology
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Articles in this issue
over 15 years ago
Impact of cGMP on Supply Chainover 15 years ago
Legislation v. Litigationover 15 years ago
The Status of the DNA Vaccine Fieldover 15 years ago
Biotech Posts Strong Gainsover 15 years ago
Biopharmaceutical Manufacturing Using Blow–Fill–Seal Technologyover 15 years ago
Offsetting Budget Cutsover 15 years ago
FDA and Manufacturers Ponder Biosimilars PathwayAdvertisement
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Caribou is halting vispa-cel and CB-011, allogeneic CAR-T therapies that showed up to 92% response rates, citing a difficult financing environment.
Celltrion USA's Omlyclo, the first interchangeable biosimilar to Xolair, reaches the U.S. market across four allergic and inflammatory indications.
Alvotech turns to a CDMO's 40,000-liter Syracuse facility for biosimilar drug substance as it expands its manufacturing network.
AbbVie's c-Met ADC Temab-A showed a 15.6% response rate in late-line colorectal cancer ahead of its 2 new FDA breakthrough designations.
New data and partnerships are advancing brain-penetrant enzyme therapy, targeted antibodies, flexible obesity dosing, and frontline lymphoma treatment strategies.
Topline phase 3 data show epcoritamab plus R-CHOP reduced the risk of progression or death by 51% in newly diagnosed diffuse large B-cell lymphoma.
Part 2 of the VK2735 maintenance study tests whether daily or weekly oral tablets can hold weight loss first achieved with weekly subcutaneous injections.
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