Summary : –Japanese pharma Eisai has backed away from its 50:50 profit-sharing arrangement with Biogen for troubled Alzheimer’s therapy Aduhelm, handing over…
Alzheimer
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Global MarketPharma Science & Research
Lilly, Roche Push Back Against CMS Draft Guidance on Aduhelm
by adminby adminSummary The U.S. Centers for Medicare & Medicaid Services (CMS) just completed the open comment period for their draft national coverage decision…
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BiogenGlobal Market
Biogen Officially Weighs in On Medicare Draft Guidance for Aduhelm
by adminby adminSummary – In mid-January, the Centers for Medicare & Medicaid Services (CMS) issued a draft national coverage decision for Biogen’s Alzheimer’s drug…
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AgrochemicalsBiogenGlobal Market
Biogen’s Aduhelm Grabs the Spotlight at User Fee Renewals Hearing
by adminby adminSummary – The House Energy and Commerce Committee’s health panel met to discuss renewing user fee agreements used to fund the U.S.…
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AgrochemicalsGlobal Market
Biogen, Eisai face Down Another Aduhelm Refusal—this Time from Japanese Regulators
by adminby adminSynopsis: After a special meeting, the Japanese drug reviewers ruled that existing data didn’t support an approval and are therefore seeking additional…
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Synopsis: The EMA’s human medicines committee has said it cannot approve Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm, saying it was unconvinced…
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Global Market
Neuland Donepezil Hydrocholoride Becomes the first API to get Certificate of Suitability (CEP)
by adminby adminNeuland announces that The European Directorate for the Quality of Medicines & HealthCare (EDQM) recently granted a Certificate of Suitability (CEP) for Neuland’s API,…