The FDA’s Center for Devices and Radiological Health posted two important guidances just in the first week of the new year. The agency seems determined to sustain that pace with a new draft guidance for cuffless blood pressure monitors, apparently in response to sales of unauthorized over-the-counter devices for this indication.
On the heels of more positive early data from the lead program derived from its tumor-activated T-cell engager (TRACTr) platform, Janux Therapeutics Inc. inked a collaboration with Bristol Myers Squibb Co. that comes with $50 million in up-front and near-term milestone payments, with the possibility of up to $800 million more tied to development, regulatory and commercial milestones.
Lexicon Pharmaceuticals Inc. announced that it received no objections from the U.S. FDA to move pilavapadin, its non-opioid candidate for diabetic peripheral neuropathic pain, into phase III study, pushing company shares up near 20% on the day.
Erasca Inc. priced an upsized public offering to raise $225 million to fund development of its therapies for patients with RAS/MAPK pathway-driven cancers.
The economic and societal implications of the underfunding of women’s health finally reached the agenda of the World Economic Forum (WEF), with the launch at the 2026 annual meeting in Davos, Switzerland, this week of the inaugural Women’s Health Investment Outlook. The neglect of women’s health is not only a public health issue, but also “a market inefficiency on a global scale,” the WEF report said.
In a move that could dramatically shorten some clinical development timelines for drugs targeting multiple myeloma, the U.S. FDA issued a draft guidance on the potential use of minimal residual disease and complete response to support accelerated approvals, following the recommendation of the agency’s Oncologic Drugs Advisory Committee, which voted 12-0 in favor of the change in April 2024.
Another day, another insider trading settlement involving a biopharma company employee. This time the U.S. SEC settlement is with Mohit Verma, who was a researcher and associate director of immunology at the San Diego-based Infinitybio Inc. at the time of the alleged violative trading activity.
Abbott Laboratories reported fourth quarter sales below expectations before the market opened on Jan. 22, sending the stock down nearly 12% from the prior day's closing. The biggest hits came from contraction in the nutrition group along with continued disruption in the diagnostics unit from volume-based procurement in China. Medical devices suffered from market share loss in electrophysiology and slower than expected uptake of continuous glucose monitors. The pharma group performed as anticipated, posting 7% growth.
Six months shy of the PDUFA date for its oral, selective glucocorticoid receptor antagonist relacorilant to treat platinum-resistant ovarian cancer, Corcept Therapeutics Inc. reported a 35% reduction in the risk of death, meeting the second primary endpoint of overall survival after reaching statistical significance with progression-free survival last March.
The good news is that the U.S. Congress is on track to pass a slate of fiscal 2026 spending bills before the current continuing resolution expires Jan. 30. So, barring any last-minute disputes or legislative hostage-taking, there should be no repeat of last year’s 43-day shutdown that impacted NIH grants and activities.
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