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…
Valeant has sued Zydus over the alleged infringement of a patent covering the company’s extended-release hypertension drug, Cardizem LA. Source: Drug Industry Daily
FDA served Porton Biopharma a warning letter after an inspection revealed failures to notify the agency of changes affecting drugs, and failing to follow procedures to prevent microbiological contamination. Source:…
Mezzion filed a lawsuit accusing its former manufacturer Dr. Reddy of fraud for concealing significant GMP deficiencies that resulted in the FDA’s refusal to approve an NDA for udenafil, an…
The drug industry is launching a new ad campaign to push back against the negative media attention over increasing drug prices. Source: Drug Industry Daily
Pfizer is standing firm on its allegations that Texas violated federal laws when it disclosed the company’s Medicaid rebate information to local lawmakers. The company is challenging the state’s argument…
The FDA Philadelphia district office has issued a warning letter to a compounding pharmacy in Allentown, PA over misbranded drugs and sterility issues. Source: Drug Industry Daily
British Prime Minister Theresa May is working toward a deal with the UK’s life sciences industry to increase the sector’s productivity and maximize the country’s investment in research and development.…
Pressed for details by a Senate committee Tuesday, Rep. Tom Price (R-Ga.) — President Donald Trump’s pick to lead HHS — refused to confirm whether or not he would push…
The European Medicines Agency said 30 drugs across four therapeutic classes have received conditional marketing authorization in the EU since the expedited approval pathway became available a decade ago. Source:…