In a draft guidance released Friday, the FDA’s Center for Drug Evaluation and Research (CDER) offers advice for sponsors developing products for bowel cleansing prior to colonoscopy, suggesting the necessary…
In a 269-page report released Friday, the House Committee on Oversight and Reform challenges claims that high prescription drug prices are necessary to support innovation and details a slew of…
The FDA has published further draft guidance on real-world evidence (RWE), this time outlining regulatory considerations for noninterventional studies that use real-world data (RWD). Source: Drug Industry Daily
Minor changes to a drugmaker’s chemistry, manufacturing and controls (CMC) production processes for approved biologics must be documented in a yearly report, the FDA said in a final guidance released…
In a draft guidance released yesterday, the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) offer advice for sponsors on the development…
Aprea Therapeutics has received FDA clearance to continue its eprenetapopt development, with the lifting of a full clinical hold placed last summer on the drug’s nonHodgkin’s lymphoma clinical trial program.…
The FDA has revised Pfizer/BioNTech’s Emergency Use Authorization (EUA), allowing a booster of the companies’ COVID-19 vaccine in teenagers aged 16 and 17 six months following completion of a primary…
Roche has partnered with Recursion to generate up to 40 new neuroscience and cancer therapies using the Utah-based biotech firm’s machine-learning drug discovery platform. Source: Drug Industry Daily
The Pfizer/BioNTech and Moderna COVID-19 vaccines are 25-40 times less effective against the new Omicron variant than the original strain and Delta variants, two new laboratory studies have found. Source:…
Allergan has agreed to pay $200 million to resolve New York-based claims that it helped facilitate the state’s opioid crisis through deceptive marketing. Source: Drug Industry Daily