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CMS issued a letter to four drug companies that produce or sponsor HCV treatments — AbbVie, Gilead, Johnson & Johnson and Merck — seeking answers as to why these drugs are so costly. Read More
FDA Grants Breakthrough Therapy to Teva for Tardive Dyskinesia Drug
Collegium Wins Tentative Approval for Xtampza ER
FDA Accepts Amgen’s NDA for Etelcalcetide Read More
The International Society for Pharmaceutical Engineering has launched a drug shortage assessment and prevention tool that helps drugmakers identify risks early on. Read More
Amgen has struck a deal with Harvard Pilgrim Health Care, through which it could pay rebates if its new cholesterol drug Repatha does not perform as well as it did in clinical trials. Read More
Days after signing a diabetes deal with Sanofi for $4.2 billion, South Korean Hanmi turned around to sign another diabetes deal with Janssen Pharmaceuticals. Read More
Since January, the FDA has issued 16 drug GMP warning letters covering 19 facilities, and more than three-fourths of those letters cited data integrity issues. Read More
Underdeveloped Countries Get 17-Year Exemption From WTO Patent Requirements Sanofi Signs Second Diabetes Deal in Two Days Pfizer Recalls Lot of Anxiety Drug Xanax FDA AdComm Votes Unanimously to Recommend Changing Fluoroquinolone Label Endo CEO Distances Himself from Ties to Valeant Read More
Manufacturers of new biologics could receive up to eight years of exclusivity in 12 countries under the Trans Pacific Partnership, a close reading of the deal shows. The specific terms of the contentious trade pact, which President Barack Obama inked with 11 other countries in October, were publicly released Nov. 6. Read More
The European Medicines Agency outlines the basic steps companies should follow when conducting post-approval efficacy studies to ensure the data meet regulatory standards for EU member-countries. Read More