We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA issued a complete response letter for Newron Pharmaceuticals’ Parkinson’s disease adjunctive therapy Xadago, requesting clinical evaluations of abuse liability and dependency. Read More
A non-profit group is pressing the National Institutes of Health to bypass the patent rights of a drugmaker in a bid to lower the drug’s price, marking at least the third time the group has attempted this. Read More
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