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The European Medicines Agency’s medical literature monitoring service kicked into full operation Tuesday, allowing drugmakers to easily search for information on adverse reactions associated with their products. 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
The European Medicines Agency expects to receive the first generic drug application under a program that lets companies file joint submissions in the EU, Australia, Canada, Taiwan and Switzerland during the fourth quarter of this year. Read More
Just days before Sandoz is expected to launch Zarxio, its biosimilar of Amgen’s chemotherapy drug Neupogen, the FDA issued a proposed rule changing both drugs’ official names, at least temporarily. Read More
The FDA is seeking input on how it can make its Inactive Ingredients Database more useful and user-friendly, following complaints by generic drug and excipient makers that the current format delays ANDA filings. Read More
Industry questioned whether the FDA has the legal authority to enforce its quality metrics guidance during an Aug. 24 public meeting on the draft document. Read More
The FDA is amending its color additive regulations to allow for the use of spirulina extract in coating formulations for drug tablets and capsules — giving drugmakers an alternative blue color that is exempt from safety certification requirements. Read More
CDER has revised its policies and procedures guide on responding to inquiries about ANDAs, clarifying responsibilities for Office of Generic Drugs and Office of Pharmaceutical Quality staff. Read More
A drug pricing watchdog was rebuffed on Aug. 25 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
The FDA released long-awaited draft guidance on Aug. 27 on naming biological products, proposing that both reference products and biosimilars have nonproprietary names comprised of the core drug substance name and a different four-letter suffix. Read More