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While the overall price of generics under Medicare Part D fell since 2010, hundreds of products experienced “extraordinary” price hikes of at least 100 percent, the U.S. Government Accountability Office said. Read More
The FDA will revise its recommendations for the submission of quality metrics and provide advice on comparative analyses for drug-device generics before the year ends. Read More
The U.S. Department of Justice issued grand jury subpoenas to Taro Pharmaceuticals and two of the company’s senior officials over the pricing of its generics, the drugmaker revealed in an SEC filing. Read More
Plasma fibrinogen can be used as a biomarker in interventional clinical trials examining patients at high risk for exacerbations or all-cause mortality in chronic obstructive pulmonary disease, according to final guidance to industry issued by FDA. Read More
FDA granted a Qualified Infectious Disease Product designation to MGB-BP-3, developed by MGB Biopharma, for the treatment of Clostridium difficile-associated diarrhea. Read More
A federal judge rescinded his own verdict backing the FDA’s decision to not grant Ferring exclusivity for its bowel preparation drug Preponik, ruling that the agency must give the company five-years of retroactive exclusivity. Read More
Teva intends to meet with the FDA to renew its efforts to launch a generic version of Mylan’s EpiPen by 2018, after many have called into question the price of Mylan’s allergy treatment. Read More