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Drugmakers are asking the European Commission to clarify new requirements for factory acceptance and site acceptance testing, including when it is okay to perform only the factory tests. Read More
Endo International has agreed to buy Par Pharmaceutical from private equity firm TPG for $8 billion in a deal the companies say will put them in the top five firms in the U.S. generics market. Read More
The FDA is considering expanding access to naloxone to cut down on deaths from opioid overdoses and wants industry and others to weigh in on the clinical, legal and regulatory barriers to doing so. Read More
The FDA has dubbed AbbVie’s autoimmune disease treatment Humira an orphan drug for the investigational treatment of moderate-to-severe hidradenitis suppurativa — paving the way for the drug’s ninth indication and seven years added exclusivity. Read More
The FDA may be considering new label warnings for type 2 diabetes drugs containing the active ingredients canagliflozin, dapagliflozin and empagliflozin, in the wake of reports linking the drugs to a serious blood condition. Read More
Washington State Gov. Jay Inslee has signed legislation allowing pharmacists to substitute biosimilars for brandname biologics, joining a growing list of states that have passed such laws. Read More
Beleaguered Indian generics maker Wockhardt is recalling 93,393 bottles of its blood pressure medicine Captopril in the U.S., after discovering the tablets failed to meet specification for thickness. Read More
The FDA wants to know how patient perceptions of medications change when pharmacies switch from brand to generic drugs or from one generic to another, as in the case of a change in suppliers. Read More
India’s Supreme Court has temporarily barred Glenmark Pharmaceuticals from making new copies of Merck’s diabetes drugs Januvia and Janumet, but the Mumbai-based company may continue to sell its existing stock. Read More
The Saudi Food and Drug Authority has set strict new requirements for the import, clearance and export of commercial and investigational drugs, including provisions on drugs for compassionate use and drugs meant for use in clinical trials. Read More