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Biogen and Eisai’s Alzheimer’s drug secures support in closely watched AdCom

Pharmaceutical Technology

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has unanimously voted in support of Eisai and Biogen’s Leqembi and its clinical benefit in patients with early Alzheimer’s disease , raising the drug’s full approval prospects. Notably, an FDA AdCom voted largely against Aduhelm in November 2020.

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Cala® Launches The Cala kIQ™ System, Offering Meaningful Tremor Relief for Patients With Essential Tremor and Now Parkinson’s Disease

Legacy MEDSearch

Cala , the bioelectronic medicine leader setting a new standard of care for chronic disease, today announced the commercial launch of its next generation system: the Cala kIQ System, the first and only FDA-cleared wearable device that delivers effective therapy for action hand tremor relief in people with essential tremor and Parkinson’s disease.

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ASH roundup: late breakers take the stage

pharmaphorum

Amgen’s Blincyto (blinatumomab) was the first bispecific T cell engager to be approved for marketing way back in 2014, but has been a slow burner product for Amgen, with sales rising slowly to $472 million last year in its main indication in B-cell acute lymphoblastic leukaemia (B-ALL).

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The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. In the past, obesity medications were often dismissed due to insufficient efficacy data and the fact that they were associated with a high occurrence of side effects.

Medical 105
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The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. In the past, obesity medications were often dismissed due to insufficient efficacy data and the fact that they were associated with a high occurrence of side effects.

Medical 98