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Biogen, CHMP and Eisai

EU regulator reiterates positive recommendation for Eisai-Biogen's Alzheimer's drug

The European Union's medicines regulator on Friday reiterated its positive recommendation for Eisai and Biogen's Alzheimer's drug, Leqembi, after concluding a safety review.

BioSpace · 1d

Biogen, Eisai Continue Leqembi’s European Rally as CHMP Reaffirms Positive Opinion

Leqembi’s application now moves forward to the European Commission, which will issue a formal verdict for the injection that will apply to all EU member states as well as Norway, Liechtenstein and Iceland.

MarketWatch · 3d

Biogen, Eisai: CHMP Reaffirms Backing of Leqembi Alzheimer's Drug

Biogen and Eisai said the European Medicines Agency's Committee for Medicinal Products for Human Use has reaffirmed its recommended approval of their Alzheimer's drug Leqembi.

Reuters on MSN · 4d

EU regulator completes safety review of Eisai-Biogen's Alzheimer's drug without changes

The European Union's drugs regulator said on Friday it concluded a review into the safety of Eisai and Biogen's Alzheimer's drug Leqembi without finding the need for any changes to the drug's status.

Business Insider · 4d

Biogen, Eisai announces CHMP of EMA reaffirmed positive opinion of lecanemab

Eisai (ESAIY) and Biogen (BIIB) announced that the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA,

Eisai, Biogen announce TGA of Australia declined approval of lecanemab

Eisai (ESAIY) and Biogen (BIIB) announced that the Therapeutic Goods Administration, TGA, of Australia has confirmed the initial decision to ...

STAT23h

Pharmalittle: We’re reading about HHS reducing public comment, a Lilly obesity drug ad, and more

HHS Secretary Robert F. Kennedy Jr. is proposing to strip public participation from much of the business his agency conducts ...

pharmaphorum1d

Australia stands firm on 'no' to Alzheimer's drug Leqembi

Eisai and Biogen have been unable to persuade the medicines regulator in Australia to approve their Alzheimer's disease ...

11hon MSN

Drugmaker Eisai will cut 57 jobs at North Jersey headquarters

Japanese drugmaker Eisai Inc. will lay off 57 employees in Nutley between the end of March and May, public records show, as the pharmaceutical company shaves off 7% of its U.S workforce.

PharmiWeb46m

Eisai Receives Regulatory Review Outcome for Lecanemab as a Treatment for Early Alzheimer’s Disease in Australia

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced ...

FiercePharma3d

CHMP again backs Leqembi amid flurry of approval recommendations

Following a flurry of activity at this month’s meeting of the European Medicines Agency’s Committee for Medicinal Products ...

New tau candidates, including an RNA therapy from Voyager, drive a multi-pronged Alzheimer’s approach

Voyager Therapeutics’ progress with drug candidates targeting tau marks a step in how the industry is walking multiple paths toward new therapeutic options.

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