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The UK’s National Institute for Health and Care Excellence (NICE) has announced details on a plan to evaluate its approaches towards developing guidance on drugs, medical devices and diagnostics. Read More
Acting FDA Commissioner Ned Sharpless identified four main focal points for the agency in its efforts to advance public health in an agency-wide e-mail sent Tuesday. Read More
The Senate Finance Committee Tuesday unveiled a far-reaching bipartisan legislative package that takes aim at the nation’s high drug prices, an effort that’s been in the works for over half a year. Read More
A federal judge in Delaware denied requests from Genentech to block the launch of biosimilars for its blockbuster treatments Avastin (bevacizumab) and Herceptin (trastuzumab). Following the court’s decision, Amgen and Allergan announced their products Mvasi (bevacizumab-awwb) and Kanjinti (trastuzumab-anns) were available for sale. Read More
On July 11, Amgen won an injunction against Praluent in a German court and the company’s attorneys have referenced that injunction in their U.S. court filing. Read More
“It is unacceptable as a matter of CGMP to continue manufacturing drugs using the same equipment that you use to manufacture toxic products,” the agency said. Read More
The Australian Therapeutic Goods Administration (TGA) has released updated guidance on the testing of biological drugs to reflect its most current practices. Read More
Biohaven Pharmaceuticals’ application for an amyotrophic lateral sclerosis (ALS) med drew a complete response letter from the FDA, who cited issues with the company’s use of an API made by an Indian drugmaker warned last year for repeat violations. Read More
The FDA has outlined the ways companies are expected to comply with postmarketing safety reporting (PMSR) requirements for combination products in final guidance issued Monday. Read More
The guidance says FDA’s Division of Antiviral Products will accept data from most NGS platforms, but sponsors ‘should submit a detailed protocol that describes sample processing and NGS analysis procedures.’ Read More
A federal grand jury in Cincinnati charged Ohio-based drug distributor Miami-Luken and two of its former executives with conspiring with doctors and pharmacies to illicitly sell millions of opioid pills in West Virginia, Ohio and Kentucky. Read More