Sanofi and Regeneron’s Praluent could draw even with Amgen’s US Repatha in approved FDA indications in 2019. While the injectable PCSK9 inhibitors battle for payers and prescribers, Esperion is readying its oral bempedoic acid to join the lipid-lowering fray – and strategizing towards what could be the first statin intolerance indication.
FDA is reviewing three supplemental biologics license applications (sBLAs) that could help Sanofi and Regeneron Pharmaceuticals Inc.'s Praluent (alirocumab) return to labeling parity with Amgen Inc.’s competing PCSK9 inhibitor Repatha (evolocumab).
Praluent beat Repatha to approval by six weeks in 2015 to an indication in high-risk patients – those with the...
Exploring How Everyday Industrial Compounds Enter Our Systems, Their Health Implications, and the Ongoing Quest for Safer Alternatives .
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.
The US FDA commissioner also said the hub is looking for an executive director who will work with the CBER and CDER heads, who will serve as co-leads.
Brazil has also published its recent regulatory reliance regulations in English, a move designed to increase confidence in its decisions as it presses on with aligning its national practices with global best practices.
The US FDA commissioner also said the hub is looking for an executive director who will work with the CBER and CDER heads, who will serve as co-leads.
The FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion; Intercept’s COBALT trial of obeticholic acid was negatively impacted by product safety labeling changes and a high crossover rate to commercial drug.
