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A Senate committee has demanded answers from Danish pharma Novo Nordisk on what it labels “astronomically” high prices for the company’s Ozempic/Wegovy (semaglutide) diabetes/weight loss drugs, while a report points to weight loss drugs as the driver for a massive spike in drug spending. Read More
The FDA is soliciting input from interested parties on policy topics the CDER Office of Clinical Pharmacology (OCP) could develop and implement to support drug development programs. Read More
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including reference products, biosimilars, and interchangeable biosimilars have been issued by the FDA in a revised draft guidance.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