News from Biogen Inc. and partner Eisai Co. Ltd. that U.S. regulators accepted the BLA related to aducanumab for Alzheimer’s disease (AD) – and assigned it priority review, no less – set Wall Street abuzz.
News from Biogen Inc. and partner Eisai Co. Ltd. that U.S. regulators accepted the BLA related to aducanumab for Alzheimer’s disease (AD) – and assigned it priority review, no less – set Wall Street abuzz, especially as the companies noted in their press release that the FDA “if possible, plans to act early” on the anti-amyloid beta (a-beta) monoclonal antibody. Regulators’ decision came about 30 days after they took receipt of the submission; they could have waited 60.
HONG KONG – Tokyo-headquartered Eisai Co. Ltd. is targeting new markets for its orexin receptor antagonist, Dayvigo, to treat insomnia. The company launched the drug in Japan on July 6, alongside a new fine granule formulation for its antiepileptic drug, Fycompa.
LONDON – Amphista Ltd. becomes the latest to join the growing band of proteolysis targeting chimera (Protac) specialists, arriving on the scene with a $7.5 million series A and what it says is a new approach to targeted protein degradation (TPD).
A lot of development dollars are shed when the FDA withdraws approval or requests that a drug be withdrawn from the market because new potential risks have come to light. And it’s not just the brand company that feels the loss.
It appears that the spirit of giving has come early, with leading biopharmaceutical companies providing investors with a surprise present of a significant jump in their share prices in October. The reversal in the sector's fortunes was catalyzed by an outpouring of positive news, including strong third-quarter financial results that has spilled over into early November.
Biogen Inc.'s decision to file for approval early next year of beta-amyloid-targeting aducanumab (adu) in Alzheimer's disease (AD) based on fresh analysis of a bigger phase III dataset juiced the stock and induced shock at the same time, as Wall Street pressed company officials for details on their rationale behind the move.