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In a complaint filed in the District Court of the Central District of California, Immunex asserts Sanofi and Regeneron infringed on the Immunex patent for Dupixent, which the FDA approved in March to treat atopic dermatitis, a form of eczema. Read More
The Maryland state legislature has approved a bill to ban excessive price increases for generics and off-patent drugs, and is sending it to the state’s governor for final approval. Read More
Scott Gottlieb was grilled by a Senate panel over his support for the FDA’s approval standards, as well as his willingness to stand up to his future boss, President Trump. Read More
The PTO’s Patent Trial and Appeal Board upheld Shire’s patent claims — following a challenge from Green Cross — over methods for the manufacture of Elaprase (idursulfase), an enzyme replacement therapy for Hunter syndrome. Read More
Less than a month shy of mandating electronic submissions of drug and biologic master files in the eCTD format, the FDA has decided to postpone the requirement until May 2018. Read More
A broad group of industry organizations is urging the FDA to delay its quality metrics reporting program, which would require drugmakers to aggregate information on the number of lots started, released for distribution and found out-of-specification, as well as the number of quality complaints reported. Read More
Sponsors should include clear assessments of necessary future actions in their periodic safety update reports, not simply provide a list of adverse events, according to new guidance from the European Medicines Agency. Read More