Probably no one was surprised by the FDA’s recent nod for the combination of Alameda, Calif.-based Exelixis Inc.’s tyrosine kinase inhibitor, Cabometyx (cabozantinib), which targets MET, AXL and VEGF, and PD-1 drug Opdivo (nivolumab) from Bristol Myers Squibb Co. as a first-line treatment for advanced renal cell carcinoma (RCC), but investors may feel less confident about the odds for the pairing in a competitive space.

HONG KONG – Japan’s Ministry of Health, Labor and Welfare (MHLW) has granted approval for Biocryst Pharmaceuticals Inc.’s Orladeyo (berotralstat), the first and only drug for prophylactic treatment of hereditary angioedema (HAE) approved in the country. Biocryst’ partner, Torii Pharmaceutical Co. Ltd., will launch the drug after completing pricing negotiations with the Japanese National Health Insurance System (NHI). Tokyo-based Orphanpacific Inc., Biocryst’s representative in Japan, holds the marketing authorization.

While the FDA’s Center for Drug Evaluation and Research met all action dates for the 53 new molecular entities approved in 2020, despite the COVID-19 pandemic, developers of at least 8 drugs continue to wait for a decision beyond their expected timelines.

The Medicare Part D rebate rule finalized by the Trump administration last November could be in limbo for a while. As it did with other so-called midnight rules issued in the waning days of the Trump presidency, the U.S. Department of Health and Human Services, under the Biden administration, is postponing the implementation of the rule, which was intended to simplify the U.S. drug pricing system by eliminating the rebates drug makers pay to pharmacy benefit managers for formulary placement or requiring plans to pass the discounts directly to patients.