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An FDA advisory committee voted 12 to 8 Thursday that Akcea Therapeutics’ NDA for treatment of a rare genetic disease demonstrated safety and efficacy. Read More
As part of its increased focus on drug compounding, the FDA issued a final guidance clarifying the term “outsourcing facility” and detailing requirements for compounders operating under 503A that are next to an outsourcing facility. Read More
The most frequent defendants included Teva Pharmaceuticals and Teva Pharmaceutical Industries at 73 and 45 cases, respectively, Mylan at 46 cases and Apotex at 44 cases. Read More
Australia’s Therapeutic Goods Administration revised its guidelines for confidentiality obligations and conflicts of interest for members of advisory committees, overhauling the guidance with major content and structural changes. Read More
Ahead of an anticipated speech on drug pricing by President Trump on Friday, a group of House Democrats spelled out their own list of actions needed to deal with the problem. Read More
Novartis paid more than $1 million to a shell company controlled by President Trump’s embattled attorney, and the company confirmed it discussed the matter with Special Counsel Robert Mueller. Read More