Zacks.com on MSN2d
Biogen Stock Down on Regulatory Update in the EU for Alzheimer's Drug
The EC requests CHMP to reassess new safety data that emerged after the positive opinion recommending the approval of ...
Zacks.com on MSN2d
MRK Gets Positive CHMP Nod for 21-Valent Pneumococcal Jab Capvaxive
The Committee for Medicinal Products for Human Use recommends approval for Merck's pneumococcal 21-valent conjugate vaccine, ...
BioArctic stock sinks on EU regulatory concerns
Despite the regulatory setback, BioArctic's partner Eisai has stated that the safety profile of lecanemab reported in clinical practice in the United States, Japan, and other countries is consistent ...
Biogen, Eisai: EC Asks CHMP to Take Another Look at Leqembi
Biogen and Eisai said they believe that EC's requests can be addressed with existing information, and that no new safety signals have been identified for Leqembi. The U.S. Food and Drug Administration ...
Biogen provides update on EU regulatory review of lecanemab in Alzheimer’s
Biogen (BIIB) and Eisai announced an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as ...
AstraZeneca: CHMP Recommends Approval Of Imfinzi In The EU
AstraZeneca (AZN.L, AZN) announced Imfinzi was recommended for approval in the European Union by CHMP as first and only immunotherapy ...
pharmaphorum3d
CHMP backs Bavarian Nordic's chikungunya jab
Valneva's Ixchiq vaccine – which was cleared in the EU, the US, and Canada last year – is currently indicated for preventing ...
Pharmabiz3d
BioArctic’s partner Eisai announces update on regulatory review of lecanemab to treat early Alzheimer’s disease in EU
BioArctic’s partner Eisai announces update on regulatory review of lecanemab to treat early Alzheimer’s disease in EU: Stockholm Monday, February 3, 2025, 13:00 Hrs [IST] BioA ...
Nasdaq5d
Eisai and Biogen Provide Update on Lecanemab Regulatory Review for Alzheimer’s Disease in the European Union
Eisai and Biogen update on lecanemab's EU regulatory review for early Alzheimer’s disease treatment following positive CHMP opinion. Eisai Co., Ltd. and Biogen Inc. have provided an update on ...
The Pharma Letter2d
BRIEF—EC calls for update on regulatory review of lecanemab
Japan’s Eisai and US partner Biogen have announced today update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab (trade name Leqembi) as a treatment for early ...
Bristol Myers Gets CHMP Backing for Expanded Breyanzi, Opdivo/Yervoy Uses
Bristol Myers on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Breyanzi for the treatment of adults with relapsed or refractory ...
Investing6d
BioArctic stock sinks on EU regulatory concerns
Despite the regulatory setback ... "The EC intervention is a surprise and raises some risk that the CHMP could change its position again to the negative. However, BioArctic has confirmed that ...