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The Patent Trial and Appeal Board ruled last year that Native American tribes cannot use sovereign immunity as a defense against inter partes reviews. Read More
Sponsors should consider whether they need to conduct nonclinical safety experiments on drugs before moving on to pediatric trials, according to an ICH draft guideline the FDA released for comment on Tuesday. Read More
UnitedHealthcare accused dozens of generic drugmakers of a price-fixing conspiracy in a lawsuit that echoes previous complaints by Humana and a coalition of state attorneys general. Read More
The FDA released final guidance for sponsors on the indications and usage labeling section of drugs on the agency’s accelerated approval pathway. Read More
“With time running out we hope Parliament will come together and quickly find a solution to the stalemate,” said ABPI Chief Executive Mike Thompson. Read More
Companies should have to report the problem causing the manufacturing interruption, the degree of shortage and how long it’s expected to last, the association said. Read More
The FDA issued Immunomedics a complete response letter for a BLA seeking accelerated approval for its antibody-based breast cancer treatment, sacituzumab govitecan, for patients who have tried at least two prior treatments. Read More
Marking the end of the fourth week of the partial government shutdown, FDA Commissioner Scott Gottlieb said the agency will be forced to furlough drug reviewers as user fee funding runs out. Read More