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MCRA Expands Neurology Division into Medical Robotics, Exoskeletal and Brain Computer Interface Market

/PRNewswire/ MCRA, LLC, a leading medical device, in-vitro diagnostic, and biologics advisory firm and clinical research organization (CRO) integrating U.S..

New yorkUnited statesAlyssa howardDevjani sahaTim marjeninNeurology regulatory affairsNeurological regulatory affairsOffice of neurologyBreakthrough devices programViscogliosi brothersInternational regulatoryClinical research organizationClinical researchEarly feasibility programSafer technologies program steOffice of clinical evidence

Biogen s Aduhelm: US lawmakers launch investigation into FDA approval and price of new Alzheimer s drug

Biogen s Aduhelm: US lawmakers launch investigation into FDA approval and price of new Alzheimer s drug
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United statesCarolyn maloneyAaron kesselheimNaomi thomasTristan massieSarah branerJason karlawishG caleb alexanderFrank pallone jrSanjay guptaDrug administrationCentral nervous system drugs advisory committeeCommittee on oversightHarvard medical schoolOffice of neurologyCommittee on energy

US lawmakers launch investigation into FDA approval and price of new Alzheimer s drug

By Jacqueline Howard, CNN Two House committees have launched an investigation into the approval and pricing of the Alzheimer’s disease drug aducanumab, made by the company Biogen and sold under the brand name Aduhelm. The US Food and Drug Administration approved the drug earlier this month under its “accelerated approval” program, although an FDA advisory committee concluded last year that there was not enough evidence to support the effectiveness of the treatment. Biogen announced in early June that the wholesale cost of treatment which requires an infusion once every four weeks is about $4,312 per infusion, making the annual cost about $56,000 for a high dose.

United statesCarolyn maloneyAaron kesselheimNaomi thomasTristan massieSarah branerJacqueline howardJason karlawishG caleb alexanderFrank pallone jrWarnermedia companyDrug administrationCentral nervous system drugs advisory committeeOffice of neurologyCommittee on oversightHarvard medical school

Biogen s Aduhelm: US lawmakers launch investigation into FDA approval and price of new Alzheimer s drug

Biogen s Aduhelm: US lawmakers launch investigation into FDA approval and price of new Alzheimer s drug CNN 16 hrs ago By Jacqueline Howard, CNN © Steven Senne/AP People pass the Biogen Inc., headquarters, Wednesday, March 11, 2020, in Cambridge, Mass. (AP Photo/Steven Senne) Two House committees have launched an investigation into the approval and pricing of the Alzheimer s disease drug aducanumab, made by the company Biogen and sold under the brand name Aduhelm. The US Food and Drug Administration approved the drug earlier this month under its accelerated approval program, although an FDA advisory committee concluded last year that there was not enough evidence to support the effectiveness of the treatment.

United kingdomUnited statesCarolyn maloneyAaron kesselheimKristoffer tripplaar sipaTristan massieJason karlawishDominick reuterFrank pallone jrG caleb alexanderDrug administrationCentral nervous system drugs advisory committeeCommittee on oversightHarvard medical schoolOffice of neurologyBiogen inc

Questions raised on FDA s approval of Alzheimer s drug, Aduhelm

Questions raised on FDA s approval of Alzheimer s drug, Aduhelm
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