GSK Agrees to $3-Billion Settlement with US Justice Department GlaxoSmithKline has agreed to plead guilty and pay $3 billion to resolve criminal and civil liability resulting from unlawful promotion of certain drugs, failure to report safety data, and alleged false price reporting practices. More...
Bristol-Myers Squibb Agrees to Acquire Amylin for $5.3 Billion Bristol-Myers Squibb has agreed to acquire the biopharmaceutical company Amylin Pharmaceuticals for a purchase price of $5.3 billion and an additional $1.7 billion for assuming Amylin’s net debt and a contractual payment obligation to Eli Lilly based on Amylin’s recently terminated agreement with Eli Lilly over the diabetes drug exenatide. More...
FDA Issues Draft Guidance on OTC Products that Contain Acetaminophen FDA has issued a draft guidance on the labeling of OTC products that contain acetaminophen. The draft guidance would give manufacturers an alternative option to properly clarify the risk of liver damage in OTC acetaminophen-containing products. More...
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Does your company have a system in place to alert regulatory authorities when and if you foresee a shortage of your material or drug product?
Yes
36%
No
49%
No, but we are developing such a programme
15%
This week we would like to know...
Are you in favor of the US Supreme Court overturning the Affordable Care Act and its associated biosimilars pathway?