China’s National Medical Products Administration (NMPA) has cleared Shanghai Henlius Biotech Inc. to initiate a phase Ib/II trial of HLX-701 in combination with cetuximab and chemotherapy for the treatment of patients with advanced RAS/BRAF wild-type colorectal cancer.
Neok Bio Inc. has obtained IND clearance from the FDA for NEOK-001, enabling initiation of a phase I trial for solid tumors. Dosing is expected to begin in the coming months, and initial clinical data are anticipated next year.
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.
Boston Scientific Corp.’s intent to acquire Penumbra Inc. for $14.5 billion will not only allow it to expand its minimal invasive care portfolio in areas such as embolization and peripheral vascular disease, but to also reenter the neurovascular space, Kathleen Van Vlierberghe, vice president of Peripheral Interventions EMEA, told BioWorld.
Aidoc Medical Ltd.'s Care AI foundation model secured 11 new U.S. FDA-cleared indications for use in emergency department triage. Now, with 14 total cleared indications enabling comprehensive evaluation and prioritization of abdomen CTs in a single workflow, Aidoc Care can help health systems identify critical findings more quickly and mitigate delays caused by overcrowding and imaging backlogs.
The U.S. FDA’s final rule for regulation of lab-developed tests is now a part of regulatory litigation history, but Scott Whitaker, CEO and president of the Advanced Medical Technology Association, said that while Congress is still considering LDT legislation, any new legislation may differ substantially from previous bills.
The U.K.’s National Institute for Health and Care Excellence is revisiting its policy for osteoporosis and may recommend that clinicians include vertebral fracture assessment with dual energy X-ray absorptiometry procedures.
Boundless Bio Inc. has obtained IND approval from the FDA for its novel kinesin oral degrader program, BBI-940. A first-in-human trial (KOMODO-1) for metastatic breast cancer is expected to begin in the first half of this year.
After passing on one skinny label case a few years ago, the U.S. Supreme Court agreed to delve into the dark hole the Federal Circuit has dug for drug label carveouts that allow generic drugs and biosimilars to come to market even though some indications of the reference drug may still be protected by exclusivities or patents. The high court granted cert Jan. 16 to Hikma Pharmaceuticals v. Amarin Pharma Inc., which revolves around Hikma’s marketing of its generic version of Amarin’s blockbuster drug, Vascepa (icosapent ethyl).
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