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Latest From InvaGen Pharmaceuticals Inc.

More Than 100 Applications Lost Equivalence Rating Thanks To Allegedly Falsified Data At Two CROs

Sponsors must decide whether to repeat bioequivalence and other studies after two CROs were found to have potentially falsified data, causing the US FDA to reject all data produced by the firms.

Generic Drugs Compliance

Cipla-SIGA Antibacterial Alliance To Tackle Resistance, Biothreats

Cipla, which has long-standing experience in antibiotic development in India, strikes alliance with US firm SIGA Technologies. The partners are targeting novel antibacterials, especially against biothreats, and expect to cater to US agency BARDA, among others.

Commercial Deals

Keeping Track: Recent NDA Submissions Range From Acute Agitation To Von Hippel-Lindau Disease

News and highlights of applications submitted for US FDA approval, from the Pink Sheet’s FDA Performance Tracker

US FDA Performance Tracker Drug Review

Prices Plunge As Xarelto Generics Arrive In India

More than half a dozen generic rivaroxaban brands are now available in India, putting the heat on Bayer’s blockbuster anticoagulant Xarelto in the price-sensitive market. Many rival generics are priced over 50% lower than the innovator product.

Generic Drugs India
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