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- PMLiVE

neurodegenerative disorders

Biogen Idec building

Biogen’s Aduhelm unlikely to get approval in Europe

In another setback for the controversial Alzheimer’s disease antibody, the EMA’s review committee has voted against recommending the treatment

- PMLiVE

Eisai/Biogen present more data on antibody for Alzheimer’s disease

Phase 2 data shows lecanemab offers a consistent ‘robust’ effect against Alzheimer’s disease, while the phase 3 programme will test plasma biomarkers to identify preclinical disease

Biogen Idec building

Biogen investigating death linked to Aduhelm

The death of a 75-year-old patient taking Biogen’s Aduhelm has raised yet more questions around the recently approved Alzheimer’s therapy

Biogen Idec building

Biogen’s ALS drug tofersen misses phase 3 endpoint

Following these results, Biogen will now expand its early access programme for tofersen to enable all eligible SOD1-ALS patients worldwide to receive the drug free of charge

Biogen Idec building

Data shows patients treated with Biogen’s MS therapies mount an effective antibody response to COVID-19 vaccination

New MS PATHS data was presented at ECTRIMS 2021

Biogen Idec building

Rocky start for Biogen’s Alzheimer’s drug Aduhelm

Controversial Alzheimer’s treatment Aduhelm is struggling to realise its potential, with only 100 patients receiving the therapy so far in the US

Biogen Idec building

Biogen’s Vumerity recommended by CHMP in MS

A thumbs up for Vumerity in the EU could ease the way for Biogen’s follow-up to Tecfidera in multiple sclerosis

Biogen Idec building

Embattled Biogen talks up Aduhelm

Biogen CEO admitted the company was experiencing “near-term challenges” after the controversial approval of Alzheimer’s drug, Aduhelm

- PMLiVE

Congress “concerned by apparent anomalies” around FDA’s approval of Aduhelm

Congress demands more information from the FDA on its controversial approval of Biogen’s Alzheimer’s drug and its dealings with the company.

- PMLiVE

EC approves BMS cell therapy for multiple myeloma

The approval of Abecma is based on “rapid, deep and durable” trial responses

- PMLiVE

Biogen and Eisai present new data for controversial Alzheimer’s drug Aduhelm at AAIC

The data showed that high-dose Aduhelm treatment demonstrated consistent effects as measured by the Clinical Dementia Rating-Sum of Boxes

- PMLiVE

FDA leaders offer perspective on accelerated approval of Biogen’s Aduhelm

Leaders maintain that Aduhelm fits into the regulatory paradigm of the FDA’s accelerated approval pathway

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