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The FDA has asked Amicus Therapeutics to integrate data from two Phase 3 studies of its Fabry disease treatment migalastat, pushing back its NDA filing until early 2016. Read More
U.S. companies taking new biologicals to 11 Pacific Rim nations would get no more than eight years of marketing exclusivity — four less than what they enjoy in the U.S. — under a trade deal agreed to by all 12 countries. Read More
The Federal Trade Commission is taking drugmakers to task for tweaking products to maintain exclusivity and block generic competition, warning the practice — known as product hopping — may violate antitrust laws. Read More
A federal judge agreed with the FDA’s interpretation that marketing exclusivity begins with NDA approval — and not the date of controlled substance scheduling — rejecting Eisai’s bid to restore exclusivity for two of its drugs. Read More
Baxter Healthcare is recalling 139,104 bags of 0.9 percent sodium chloride injection produced at the company’s maligned Jayuya, Puerto Rico, facility following complaints of mold on the interior surface of the overpouch — the firm’s ninth recall since December 2013. Read More
The FDA has cleared Bristol-Myers Squibb’s new mixed-drug regimen for the treatment of advanced melanoma, in a first-ever approval of an immune-oncology combination. Read More
Teva is expanding its footprint in emerging markets with the $2.3 billion purchase of Mexico-based Representaciones e Investigaciones Medicas, or Rimsa, a specialty drugmaker with a portfolio of products and patents across Latin America. Read More
United Therapeutics has agreed to grant Sandoz a nonexclusive license to manufacture and sell a generic version of its hypertension drug Remodulin beginning in 2018, putting an end to ongoing patent litigation. Read More
Eli Lilly and Incyte’s new once-daily rheumatoid arthritis drug baricitinib outperformed the standard care in a Phase 3 clinical trial, putting the drugmakers on track for a regulatory filing this year. Read More