The third quarter could bring US approvals for a range of novel drugs, including the first treatment for a common eye disease, the first US approval of PD-1/L1 inhibitor from a Chinese firm, and the first oral therapy for postpartum depression.
PDUFA for NDA - Second Review 24 July
Despite launching the product as Vanflyta in 2019, Daiichi Sankyo Co., Ltd
Join thousands of industry professionals who rely on Scrip for daily insights
Already a subscriber?
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
The company’s FcRn inhibitor nipocalimab was approved by the US FDA for generalized myasthenia gravis (gMG), where it will join a competitive market.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
The German group is paying $3.9bn to get hold of the US firm and its two approved products.
The biotech saw a slight quarter-over-quarter decline in sales from the BTK inhibitor Brukinsa, which it attributed to seasonality, while revenues overall missed some analyst estimates.
Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a 232 investigation.
The US FDA has ordered compounders of the Danish firm's obesity drug semaglutide to shut up shop later this month, but competition from Eli Lilly is only increasing.
