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The biosimilars market could exceed $390 billion in value over the next five years, but only if nations improve the competitive landscape, according to a new market analysis. Read More
Despite limited data and only one positive Phase 3 trial, an FDA panel voted 12‒2 to recommend Acadia Pharmaceuticals’ Nuplazid for treating psychosis associated with Parkinson’s disease. Read More
To provide a more unified approach in evaluating biosimilars, India’s Central Drugs Standard Control Organization is requiring sponsors to conduct equivalence, non-inferiority or comparability Phase 3 clinical trials. Read More
The World Health Organization is calling for stricter enforcement of private vaccine management regulations in China to mirror the tight controls the country has over its public vaccine distribution system. Read More
Wockhardt’s CEO Habil Khorakiwala has characterized the FDA’s recent findings of nine Form 483 observations at its manufacturing plant in Shendra, India as minor, and predicted that the agency’s concerns would be resolved within a few months. Read More