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 EU’s drugs authority is advising manufacturers that routine inspections will now include a focus on compliance with pharmacovigilance reporting requirements. Serious violators will face the Pharmacovigilance Risk Assessment Committee. Read More
The FDA cited a trio of compounders for a wide swath of quality violations, igniting renewed criticism that the agency is “unjustified” in using a new law to enforce old violations. Read More
An FDA inspection of Impax Laboratories’ Taiwan plant has uncovered apparent manufacturing violations, raising new questions about the company’s plans to launch its proposed Parkinson’s disease drug Rytary. Read More
The FDA has downgraded its clinical hold on Tekmira Pharmaceuticals’ TKM-Ebola experimental RNA interference therapeutic, a move that could clear the way for the drug’s potential use in individuals infected with Ebola virus. Read More
Countries in the Caribbean are working to establish a unified registration process for generic drugs, an effort aimed to improve the quality, availability and access to essential therapies. Read More
Subsidiaries of generics maker Hetero Drugs can move forward with generic versions of kidney drug PhosLo despite an ongoing lawsuit brought by patent owner Roxane Laboratories. Read More
New Jersey-based Mutual Pharmaceutical and two other generic firms are suing brand manufacturer Reckitt Benckisser for breach of contract, alleging that RB reneged on a license agreement to provide generic supplies of its cold and flu medicine Mucinex for sale. Read More
Indian generics firm Dr. Reddy’s has filed the first patent challenge against Teva’s blockbuster multiple sclerosis drug Copaxone’s 40 mg, introducing a new chapter into the Israeli drugmaker’s efforts to protect its multibillion dollar product. Read More
A UK cost-effectiveness agency has recommended not covering Roche’s breast cancer drug Kadcyla because the treatment is too expensive, noting that a discount offered by the Swiss drugmaker wasn’t enough. Read More