News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Just days after the release of its Biosimilar Action Plan to encourage generic competition, the US FDA has approved another biosimilar product: Pfizer’s answer to Amgen’s Neupogen, ‘Nivestym’.
A report to the FDA of a serious adverse effect, during a clinical trial conducted by Mersana Therapeutics’, resulted in a partial hold.
China’s authorities’ condemnation of Changsheng Biotechnology, after it was found to have falsified data regarding a rabies virus, has caused public concern over the domestic vaccine market.
Roche has teamed up with PureTech to take advantage of its milk-derived exosome platform to potentially create oral formulations of antisense drugs.