Fierce Pharma

MAY 14, 2024

regulators last month, Eisai and Biogen’s effort to deploy a more convenient version of their Alzheimer’s disease drug Leqembi appears to be back on track. After suffering a setback with U.S.

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Regulation Drugs 81

Pharmaceutical Technology

SEPTEMBER 30, 2022

After several setbacks, bluebird bio bounces back with two major FDA gene therapy approvals. Shortly after this, the FDA announced the accelerated approval of bluebird's Skysona (elivaldogene autotemcel), or eli-cel, on 19 September. They usually face resistance from insurers and may struggle to gain coverage at launch.

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Gene Therapy FDA Approval Gene Genetic Disease 289

pharmaphorum

DECEMBER 24, 2021

Biogen and Eisai head towards the end of the year with some much-needed good news in their Alzheimer’s programmes, as the FDA awards a fast-track designation to lecanemab, their follow-up to recently approved Aduhelm. The post Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA appeared first on.

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Drugs FDA Approval Trials Marketing 111

XTalks

NOVEMBER 3, 2022

Demand for Lilly’s GIP/GLP-1 receptor agonist Mounjaro is also rising because of high patient demand since the drug’s May 13 FDA approval and expanding insurance coverage. Related: Mounjaro (tirzepatide), Eli Lilly’s Highly Awaited Type 2 Diabetes Injection Gets FDA Nod. billion in sales in the third quarter of the year.

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Sales FDA Approval Production Insulin 98

pharmaphorum

MAY 10, 2022

With Aduhelm largely sidelined, Biogen and Eisai are hoping for a better fortunes with their next Alzheimer’s disease therapy lecanemab, which is now fully filed with the FDA.

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FDA Approval Trials Clinical Trials Clinical Trials 40

XTalks

FEBRUARY 27, 2024

The US Food and Drug Administration (FDA) has approved a number of new rare disease drugs in recent years, including gene therapies. Casgevy (exa-cel) and Lyfgenia (lovo-cel) were the first gene therapies to be approved by the FDA for the treatment of sickle cell disease (SCD). The FDA introduced its Orphan Drug Act in 1983.

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Research Drugs Gene Therapy Clinical Trials 59

pharmaphorum

DECEMBER 2, 2020

US biotech TG Therapeutics has begun a rolling filing with the FDA for its combination therapy for chronic lymphocytic leukaemia, in a challenge to Roche. The FDA had already granted fast-track designation to the combination therapy, allowing extra help during the development process on the basis of earlier clinical data.

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