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Axsome Aims for FDA Filing in Alzheimer’s Agitation Despite Mixed Bag of Phase 3 Data

MedCity News

Axsome Therapeutics aims to offer an alternative to Rexulti, a Lundbeck and Otsuka Pharmaceutical product that is the only FDA-approved Alzheimers agitation drug. The post Axsome Aims for FDA Filing in Alzheimers Agitation Despite Mixed Bag of Phase 3 Data appeared first on MedCity News.

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Red Sea Shipping Disruptions Don’t Have Pharma Companies Seeing Red Just Yet

MedCity News

Generic drugs are the pharmaceutical products mainly affected by the missile attacks disrupting shipping in the Red Sea. While the extra costs borne by drug companies aren’t causing an immediate spike in product prices, experts say they’ll eventually be factored into prices if the attacks become a long-term problem.

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Automation to accelerate biopharma in next decade

European Pharmaceutical Review

A report on automation in the biopharma industr y has shown that the market is projected to grow at a compound annual growth rate (CAGR) of 5.7 Factors impacting the automation in the biopharma industry market The report found that 75 percent of pharmaceutical organisations want to use automated solutions more frequently.

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FDA Approves BioMarin Pharma’s Gene Therapy, the First for Hemophilia A

MedCity News

The regulatory decision makes the BioMarin Pharmaceutical product the first gene therapy for this inherited bleeding disorder. The FDA approved Roctavian for treating hemophilia A.

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Astellas Drug Acquired in $5.9B Deal Wins FDA Approval in Vision-Loss Disorder

MedCity News

The regulatory decision comes as safety concerns emerge around the first therapy for the disease, an Apellis Pharmaceuticals product. Izervay, a drug developed by Astellas Pharma subsidiary Iveric Bio, is now the second approved therapy for the degenerative vision-loss disorder geographic atrophy.

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AbbVie’s blockbuster drug Skyrizi gets FDA nod for treating Crohn’s disease

MedCity News

In other drug decision news, the Rhythm Pharmaceuticals product Imcivree added the rare disease Bardet-Beidl syndrome as a new approved indication. AbbVie drug Skyrizi is now approved for Crohn’s disease, making it the first treatment for the disorder that addresses a particular protein associated with inflammation.

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QbD for biopharmaceutical product lifecycle management

European Pharmaceutical Review

Given that early inconsistencies in a new drug can erode trust in novel products, pharma and biotech companies require rigorous manufacturing standards that can support their products from the early development stages through commercialisation and beyond.