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The FDA is taking steps toward getting more patient input during the drug development process, a move that puts the agency more in line with its EU counterparts, agency officials said Thursday at the DIA annual meeting. Read More
The U.S. Court of Appeals for the Federal Circuit has affirmed a lower court ruling that Celgene did not infringe on a Teva subsidiary’s patent when it marketed its cancer drug Abraxane. Read More
Concerned about high treatment costs, the UK’s healthcare cost watchdog wants Gilead Sciences to provide more information on its blockbuster leukemia drug Zydelig before it will consider recommending its use. Read More
The FDA wants generics makers to design tablets and capsules to be similar in size and shape to their reference listed drug to ensure patient acceptance and compliance, according to final guidance issued Thursday. Read More
Merck & Co. has agreed to pay $5.9 million to settle a federal lawsuit claiming a former subsidiary promoted its pink eye drug for off-label uses. Read More
Compounding pharmacies continue to be plagued by sterility issues, as the FDA handed warning letters to facilities in Florida and Kentucky — bringing to nine the number of compounders cited for such deficiencies since October. Read More
Drugmakers are asking the European Commission to clarify new requirements for equipment used in the manufacturing process, including when it’s okay to test such equipment at the factory instead of on site. Read More
The label the FDA issued for Hetlioz omitted “in blind patients without light perception,” thus allowing anyone with Non-24 disorder to use the drug. Read More
Industry groups want the FDA to clarify its rules around manufacturer promotion of off-label drug use and are using the lawsuit to press their case. Read More