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Pfizer Inc.

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Latest From Pfizer Inc.

Mylan Weighs In On Coronavirus Drug Shortage Concerns

Hours before the US FDA confirmed the first drug shortage due to active pharmaceutical ingredient constraints because of the coronavirus situation in China, generics industry leader Mylan came under pressure about the potential impact on its business. 

Generic Drugs Manufacturing

Rare Disease Gene Therapy Guidance Gives More Flexibility On Placebo-Controlled Trials

US FDA declined stakeholder requests to remove recommendation for placebo controls from a final guidance but added qualifying language on their use ‘when feasible.’ While the agency excised language on biomarker validation from the final guidance, it reaffirmed the need for early establishment of critical quality attributes and critical process parameters.

Gene Therapy Rare Diseases

Xarelto And Eylea Keep Bayer Buoyant

The German major's two leading products continue to perform well but there are not many potential blockbusters in the pipeline.

Companies Legal Issues

Generics Firms Deterred From Continuous Manufacturing

Rutgers University professor testifies in support of bill directing the FDA to designate National Centers of Excellence in Continuous Manufacturing; other bills target generic labeling, orphan exclusivity and counterfeit devices.

Manufacturing Generic Drugs
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