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Sarepta Gene Therapy Misses in Phase 3; Prospects Now Rely on FDA Flexibility

MedCity News

Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy fell short of its main Phase 3 goal, but the firm contends the full body of evidence supports expanding the therapy’s label to all patients who have the muscle-wasting disease.

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FDA slaps partial hold on Biogen, InnoCare MS drug

pharmaphorum

Biogen’s efforts to replenish its multiple sclerosis pipeline have suffered a setback, after the FDA placed a clinical hold on a drug candidate it licensed from China’s InnoCare last year for $125 million upfront. billion buyout of Principia Biopharma.

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Second phase 3 trial extends Astellas’ lead in claudin 18.2 cancers

pharmaphorum

The Japanese pharma says it will now start talking to regulatory authorities around the world about potential marketing applications for zolbetuximab as a first-line treatment for patients with locally advanced unresectable or metastatic gastric and gastro-oesophageal (GEJ) cancer. Claudin 18.2 Claudin 18.2

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15 Top Venture Capital for Biotech Companies

Medico Reach

Whether you are a start-up looking for investment or are interested in working in venture capital (VC), the worldwide biopharma and MedTech industries are growing. In 2022, over $14 billion was funded in biopharma setup globally, and 37 major IPOs of VC-backed biotech company businesses raised a combined $4.2 CEO : Samuel Isaly.

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The evolution of AAVs in cell and gene therapy

European Pharmaceutical Review

Dr Baghirzade continued, highlighting that since a particular defining moment for the industry in the late 90s, which resulted in an unfortunate patient fatality, “there is a lot more focus on safety” in gene therapy clinical trials today. More recently, the FDA granted approval of Roctavian in June 2023.

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In Conversation: Dr. Shane Hegarty from Axonis Therapeutics

Zymewire

Skip to a topic Axonis' journey and purpose The impact of the economic client on emerging biopharma The place of Artificial Intelligence in drug development & discovery Working with NASA Relationships with CROs, CDMOs, and other service providers What made you want to start Axonis? What unmet needs are you hoping to address for patients?

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From viral vectors to nucleic acids: biopharma’s evolving manufacturing landscape

European Pharmaceutical Review

What are the top three trends that you are seeing in the biopharma manufacturing space? Let’s talk about continuous biopharma manufacturing. Speaking of your biopharma clients, what are you hearing about their main priorities? I believe this is going to be an emerging trend in the market.