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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
Adding Bristol-Myers Squibb and AbbVie’s immune-based cancer drug elotuzumab to standard therapy extends remission rates for multiple myeloma patients by about four and a half months, compared with standard care alone, data from a late-stage study shows. Read More
The former chairman of the Senate Veterans Affairs Committee is pressing the VA to invoke a wartime provision to break the patents on Gilead Sciences’ pricey hepatitis C drug Sovaldi, after the agency stopped treating veterans because it had exceeded the more than $400 million budgeted for hep C treatment. Read More
The FDA has issued draft guidance spelling out in detail how to prepare and submit an IND if the sponsor is an investigator and not a commercial entity — saying sponsor-investigators often lack the regulatory know-how to submit a proper IND. Read More