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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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Microbial burden assessment of solid pharmaceutical products

European Pharmaceutical Review

The post Microbial burden assessment of solid pharmaceutical products appeared first on European Pharmaceutical Review. cepacia complex and E. coli in tablets and capsules with water activity lower than 0.60”.

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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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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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The Benefits of a Sales Pilot for Pharmaceutical Products

MaBiCo

The Benefits of a Sales Pilot for Pharmaceutical Products A sales pilot is a short-term experiment that tests a product’s sales performance or a new sales approach. The post The Benefits of a Sales Pilot for Pharmaceutical Products appeared first on MaBiCo.

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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.