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The Medicines Company to Divest Hemostasis Portfolio
GSK’s ViiV Healthcare to Scoop Up HIV Assets from BMS
EMA Marketing Decision on Merck Hep C Pill Delayed
Turing Pharmaceuticals Appoints Acting CEO After Shkreli Resignation Read More
A number of drugmakers got good news from the European Medicines Agency’s Committee for Medicinal Products for Human Use, including two companies looking to have their lung cancer candidates approved in Europe. Read More
The FDA is postponing its decision on BioMarin’s investigational drug drisapersen for Duchenne muscular dystrophy, saying the review is still under way. Read More
The FDA’s first public meeting on the 2017 reauthorization of the Biosimilars User Fee Act brought calls for increased transparency in terms of how the agency regulates biosimilars and a rethinking of how these products will be named. Read More
President Barack Obama signed into law on Friday the fiscal 2016 omnibus spending bill, which contains $4.68 billion in total funding for the FDA. Read More
Over the past decade, the number of privately funded clinical trials has nearly doubled, while the number of government-sponsored studies have fallen, according to a new report from Johns Hopkins University. Read More
Obama Signs Latest Stopgap Funding Bill to Avoid Government Shutdown
OIG Calls for Generic Drug Rebates Tied to Inflation
AstraZeneca to Spend $4B on Stake in Acerta Read More
For the third time in four months, a federal judge has delayed drugmaker Amarin’s lawsuit against the FDA as the two sides try to negotiate a settlement. Read More
Turing Pharmaceuticals CEO Martin Shkreli has been indicted on seven counts of securities and wire fraud for alleged conduct at several of his previous companies. Read More
Drugmakers that have not started complying with worldwide track and trace regulations are behind the eight ball, as most companies only allow for two to three years for implementation, a supply chain expert warns. Read More