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Investigators found that the FDA OK’d nearly 80 percent of these non-supported surrogate markers as appropriate endpoints for a traditional approval. Read More
Most postmarketing requirements (PMR) and postmarketing commitments (PMC) for NDAs and BLAs were on-schedule in 2022, according to figures just released by the FDA. Read More
Answers to questions biologics companies may have when developing promotional communications for prescription biologics including reference products, biosimilars, and interchangeable biosimilars have been issued by the FDA in a revised draft guidance. Read More
Peter Marks, director of CBER, is pushing to get more gene therapies targeting rare diseases to apply for accelerated approval (AA) to give the promising space a leg up in development. Read More
Almost 60 percent of surrogate markers supporting FDA approvals for nononcologic drugs for chronic diseases aren’t backed up by meta-analyses showing a strong association between the marker and relevant clinical endpoints, a new JAMA Network study says. Read More
Identifying and reducing production and delivery vulnerabilities are the focus of the European Medicines Agency’s (EMA) recent recommendations to ensure the availability of medicines identified as critical. Read More
Two pharmaceutical giants based in Japan — Takeda and Astellas — have signed a master agreement along with Sumitomo Mitsui Banking Corporation to establish a joint venture company dedicated to the incubation of early drug discovery programs in Japan. Read More
Allergan must still face allegations that it violated the False Claims Act by incentivizing physicians to prescribe off-label Botox for pediatric migraine, although a federal circuit court judge dismissed charges that the company defrauded Medicare by promoting the practice. Read More
Yet-to-be-finalized, a proposed FDA rule to update and condense prescription medication guides for consumers, will replace current prescription info that the agency says is confusing, repetitive and conflicting — potentially resulting in patients taking medications incorrectly. Read More