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Tipping the scales - Aduhelm’s hefty price under the spotlight cphi-online
July 07, 2021
Biogen’s Alzheimer’s drug Aduhelm has recently secured FDA approval to much fanfare.
House Committees to Investigate New Alzheimer Disease Drug Approval drugs
July 02, 2021
The U.S. Food and Drug Administration's controversial approval of a new drug for Alzheimer disease, along with its high price, is now being investigated by two House committees.
Denovo Biopharma In-Licenses Late-Stage Alzheimer's Disease Asset from Lundbeck firstwordpharma
July 02, 2021
Denovo Biopharma LLC, a pioneer in applying precision medicine to develop innovative therapies, today announced it has licensed global rights for idalopirdine from H. Lundbeck A/S.
Lilly's Donanemab receives U.S. FDA's Breakthrough Therapy Designation for Treatment of Alzheimer's disease drugs
June 29, 2021
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for donanemab, Eli Lilly and Company's (NYSE: LLY) investigational antibody therapy for Alzheimer's disease (AD).
Memos reveal internal FDA struggle over thorny Alzheimer's drug approval firstwordpharma
June 23, 2021
The FDA on Tuesday made public new documents laying bare a struggle within the agency ahead of its controversial decision on June 7 to grant accelerated approval to Biogen and Eisai's Alzheimer's drug Aduhelm (aducanumab) amid heated debate
Alzheimer’s Drug Price Uproar Grows as U.S. Weighs Coverage firstwordpharma
June 23, 2021
The $56,000 annual price tag for Biogen and Eisai's Aduhelm is drawing increasing criticism ahead of a US government decision on reimbursement policies for the recently approved Alzheimer's disease drug, reported Bloomberg.
Alzamend Neuro Announces Closing of Initial Public Offering and Full Exercise of Underwriter’s Over-allotment Option for Gross Proceeds of $14.4 Million firstwordpharma
June 18, 2021
Alzamend Neuro, today announced the closing of its initial public offering of 2,500,000 shares of its common stock and full exercise of the underwriter's over-allotment option to purchase 375,000 additional shares of common stock at a price to the public
Good News, Bad News From Alzheimer's Vaccine Trial drugs
June 15, 2021
An experimental Alzheimer's vaccine appears to safely clear abnormal tau protein from the brain, but it's not yet clear whether the shot will be able to save brain function.
Third member of FDA expert panel exits amid Alzheimer's drug flap firstwordpharma
June 11, 2021
The FDA's controversial decision to approve Biogen and Eisai's Alzheimer's disease treatment Aduhelm (aducanumab) has prompted a third member to resign from the advisory committee that had solidly voted down the drug during a consultation meeting.
First-of-its-kind Alzheimer’s drug gains US FDA approval cphi-online
June 09, 2021
Biogen and Eisai's Aduhelm approved using the accelerated approval pathway after clinical trials demonstrated it reduced amyloid beta plaques by up to 71%

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