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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
In the wake of an avalanche of FDA warnings to Indian drugmakers, Dr. Reddy’s Laboratories is the latest to be hit for GMP deficiencies at three of its Indian sites. Read More
AstraZeneca has agreed to buy San Mateo, Calif.-based ZS Pharma, a seven-year-old company whose hyperkalemia candidate ZS-9 could prove to be a blockbuster, in a deal valued at about $2.7 billion. Read More
Members of an FDA advisory committee unanimously recommended Merck’s anesthesia candidate sugammadex for approval, a win for the drug giant, which saw the candidate previously held back over safety and data integrity concerns. Read More
To spur greater mutual inspection reliance between the FDA and EU, the agency and Congress are working to grant the EMA access to unredacted inspection reports. Read More