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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
The FDA is eliminating the risk evaluation and mitigation strategy for rosiglitazone-containing diabetes drugs, deciding enough is understood about its side effects. Read More
A sweeping deal to keep the government running through next fall is expected to come to a vote Friday, under which the FDA would be awarded $4.68 billion in total funding for fiscal year 2016. Read More
The FDA is recommending that drugmakers create safety assessment committees and formalized surveillance plans to watch for serious adverse events in clinical trials to decide when safety data should be unblinded. Read More
Eli Lilly scored a win at the FDA Wednesday, with the agency approving the company’s insulin glargine injection, Basaglar, to improve glycemic control in patients with Type 1 and 2 diabetes. Read More
Citing significant price increases for certain generic drugs, House Republicans have sent a letter to Acting FDA Commissioner Stephen Ostroff with concerns about the agency’s process for approving ANDAs. Read More
Valeant Pharmaceuticals faced renewed scrutiny Wednesday on two fronts, with a lawmaker accusing the company of obstructing a congressional investigation and investors questioning the company’s long-term viability in the face of a dismal earnings report. Read More
FDA Lifts Clinical Hold on All Advaxis IND Applications
FDA Grants Priority Review for PaxVax’s Cholera Vaccine
FDA Grants Fast Track to MediciNova's Ibudilast for ALS
Array BioPharma’s Binimetinib Meets Primary Endpoint in Melanoma Read More