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A San Diego, Calif.-based clinical researcher received an FDA warning letter over its lack of documentation of standard operating procedures for overseeing studies and details of in-service protocol and specimen handling training in a Form 483 response. Read More
Amgen is seeking FDA approval for etelcalcetide — the first calcimimetic agent for secondary hyperparathyroidism in patients with chronic kidney disease that can be administered intravenously at the end of a dialysis session. Read More
Sucampo Pharmaceuticals is paying $278 million to acquire Japanese drugmaker R-Tech Ueno, which manufactures the constipation drug Amitiza for Sucampo and its commercialization partners, Takeda, Mylan and Harbin Gloria Pharmaceuticals. Read More
Mylan scored a potential win from the U.S. Patent and Trademark Office when it agreed to review challenges to two patents on Teva’s blockbuster multiple schlerosis drug Copaxone. Read More
Biologics makers developing drugs based on bacteria and viruses should conduct preclinical and clinical studies to determine if infection could be unintentionally transmitted from treated patients to other individuals, the FDA says. Read More
The FDA submitted Designation of Official Names and Proper Names for Certain Biological Products as a proposed rule to the Office of Management and Budget on Friday, but would not comment on whether it is the expected guidance on naming biosimilars. Read More
A drug pricing watchdog was rebuffed Monday in its attempt to get the U.S. Patent and Trademark Office to review two patents on Acorda Therapeutics’ blockbuster multiple sclerosis drug Ampyra — the first of 18 petitions the Coalition for Affordable Drugs has filed with the agency since February. Read More