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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
Sponsors registering new drugs or updating existing drugs on the Australian Register of Therapeutic Goods will need to conduct biopharmaceutic studies and generate specific data on test results, the Therapeutic Goods Administration says. Read More
Sites should state clearly what patients can expect regarding access to personal results from clinical trials in their informed consent documents, an expert witness told the Secretary’s Advisory Committee on Human Research Protections in Rockville, Md., on July 22. Read More
Companies filing premarket approval applications for companion diagnostics may explain the clinical significance and clinical cut-off of their products using a summary of the clinical results for the corresponding drug product, recent technical guidance from Japan’s Pharmaceuticals and Medical Devices Agency says. Read More
Must investigators obtain informed consent anew in order to use aggregated clinical trial data for secondary purposes? What purpose does this data serve to improve standards of care? And are there risks inherent in using such data? Read More
The EU-based Innovative Medicines Initiative is launching a $4.5 billion decade-long effort to improve the success rate of clinical trials for certain drugs by 30 percent and boost exclusivity to entice sponsors to develop the drugs. Read More