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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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Roche's Vabysmo shows potential to treat eye disorder common in Asia

Fierce Pharma

Few pharmaceutical products have taken the market by storm like Roche’s Vabysmo. Interim results from a late-stage trial of Roche's Vabysmo on Asian patients with polypoidal choroidal vasculopathy suggest that the injected treatment is effective.

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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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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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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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FDA lambasts Kilitch for unsanitary manufacturing conditions and issues warning letter to Natco, too

Fierce Pharma

It usually goes without saying that your pharmaceutical production workers need to be gowned and gloved while handling drug materials inside clean rooms. | In a four-observation warning letter issued this week, the U.S.

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