The FDA and other government agencies are being ordered to identify two regulations to be eliminated for each new one they propose and to reconsider the industry’s costs of compliance,…
Teva’s subsidiary Barr Laboratories agreed to pay $225 million to settle a class action lawsuit alleging it reached pay-for-delay settlements that postponed the launch of generic versions of Bayer’s antibiotic…
The U.S. Court of Appeals for the Federal Circuit affirmed Cumberland Pharmaceuticals’ patent for its second-generation version of Acetadote, barring Mylan from marketing a generic of the overdose therapy. Source:…
The European Medicines Agency’s Committee for Medicinal Products for Human Use issued positive opinions for eight medicines — including two biosimilars. Source: Drug Industry Daily
The FDA had to postpone meetings with Capitol Hill staff to discuss upcoming user fee legislation, after the Trump Administration directed agencies to halt correspondence with members of Congress. Source:…
Small businesses sponsoring approved generics can expect a 90 percent discount on annual user fees, offering them some relief when GDUFA II takes effect in fiscal 2018. Source: Drug Industry…
Sen. Charles Grassley (R-Iowa) put pressure on the Centers for Medicare and Medicaid Service to release records on Mylan’s classification of the epinephrine auto-injector the EpiPen for Medicaid. Source: Drug…
Dozens of healthcare organizations, including several drugmakers and payers, wrote an open letter to President Donald Trump, urging him and Congress to continue the pursuit of value-based care. Source: Drug…
Several large drugmakers and industry groups commented on FDA’s proposal to require higher quality management standards for nonclinical studies used to support product applications. Source: Drug Industry Daily
The FDA rejected two citizen petitions urging the agency to allow biosimilar sponsors to use the same nonproprietary names as their reference products, finding them incompatible with final guidance on…