The U.S. FDA rolled out its anticipated “plausible mechanism” draft guidance, enabling ultrarare disease drug developers to generate evidence of effectiveness and safety to support approval when randomized controlled trials are not possible due to small patient populations.
Vanda Pharmaceuticals Inc. gained U.S. FDA approval for Bysanti (milsaperidone), cleared for use in acute bipolar I disorder and schizophrenia and ensuring continuation of the firm’s atypical antipsychotic franchise, with Fanapt (iloperidone) set to start losing patent protection in 2027. It also offered a rare straightforward regulatory win for Vanda, which has tussled with the FDA in recent years.
U.S. FDA approvals began 2026 at a slower pace than usual, with eight approvals recorded in January. The total falls below the 2025 monthly average of about 19 approvals and trails every month last year, which ranged from 12 to 27 approvals.
Grail Inc.’s share price dropped more than 50% in premarket trading Feb. 20 after it reported late the day before that the NHS-Galleri trial did not meet its primary endpoint. The U.K study, done though the National Health Service with 142,000 individuals enrolled, evaluated the ability of Grail’s Galleri multicancer early detection test to look for cancer-specific methylation patterns in blood.
U.S. President Donald Trump’s foreign-imports tariff policies did not hold up well at the Supreme Court, which ruled unconstitutional his edicts under the International Emergency Economic Powers Act. The sharply worded 6-3 opinion was authored by Chief Justice John Roberts.
Medtronic plc this week reported that the first commercial surgical cases using its Hugo robotic-assisted surgery system have been completed in the U.S. Hugo is expected to be a key growth driver for the company, especially with opportunities in the underpenetrated U.S. soft tissue surgical robotics market. The company also posted third-quarter fiscal year 2026 organic revenues of $9.02 billion, up 6% year‑on‑year.
CSL Ltd. is out-licensing its interleukin-6 (IL-6) monoclonal antibody, clazakizumab, to Eli Lilly and Co. in a deal that brings CSL $100 million in up-front fees. A CSL spokesperson told BioWorld the deal includes undisclosed milestone payments and sales-based royalties. CSL will retain rights to develop and commercialize clazakizumab for prevention of cardiovascular events in patients with end-stage kidney disease, while Lilly will explore the MAb in all other indications.
Driven by prescription drug prices and oft-repeated claims that nearly every drug developed in the U.S. owes its origins to taxpayer-funded research, watchdog groups and some lawmakers have led demands over the years for price to be considered a “reasonableness” factor in determining whether the government can march in on patents under the Bayh-Dole Act.
A week after catching Moderna Inc. and its investors off guard with a refuse-to-file letter, the U.S. FDA has reversed course on the company’s BLA submission seeking approval of seasonal influenza vaccine mRNA-1010, now agreeing to review the application and setting an assigned PDUFA date of Aug. 5, 2026.
U.S. NIH Director Jay Bhattacharya will be a lot busier in the days and weeks ahead. As if helming the NIH isn’t enough, Bhattacharya has been tapped to also serve as acting director of the CDC, an administration official confirmed to BioWorld.
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