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Diabetes drugs carry special development challenges and can be the riskiest sector in pharmaceuticals, with one in 13 investigational drugs achieving U.S. approval, according to a report from the Tufts Center for the Study of Drug Development. Read More
The FDA will decide whether to require a Risk Mitigation and Evaluation Strategy after weighing known and potential adverse events, the seriousness of the condition, and the drug’s expected benefits, according to a draft guidance to industry. Read More
The U.S. Court of Appeals for the Federal Circuit affirmed the validity of Abbott’s protein-binding patent, handing yet another victory to the company in a decades-long dispute with Yeda Research and Development. Read More
California Gov. Jerry Brown (D) signed into law a bill that would allow companies, nonprofits and government agencies to purchase and maintain Mylan’s EpiPen for emergency use, while criticizing the company for the hiking the price of the allergy treatment. Read More
If Mylan wants to improve access to its emergency allergy treatment EpiPen, then the company should lower the price of the drug, instead of marketing a generic version, members of the House Committee on Oversight and Government Reform said Wednesday. Read More
The National Institutes of Health published a summary of the 240 comments received on a rule mandating that researchers post the results of their clinical trials on a public website. Read More
The Senate Finance Committee and West Virginia’s attorney general are requesting information on the rebates Mylan paid to Medicaid for its allergy treatment EpiPen, a day ahead of a hearing on the price of the combination product. Read More