InterVene, Inc., a privately held medical device company pioneering interventional devices for venous occlusions, announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Recana® Thrombectomy Catheter System for treating venous in-stent restenosis and native vessel obstructions.
Regeneron Pharmaceuticals, Inc. announced five-year follow-up results on overall survival (OS) from the Phase 3 EMPOWER-Lung 3 trial, which evaluated Libtayo® (cemiplimab) plus platinum-based chemotherapy versus chemotherapy alone as a first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations.
Medtronic plc a global leader in healthcare technology, announced two U.S. Food and Drug Administration (FDA) regulatory milestones that broaden the MiniMed™ 780G system portfolio: clearance of the SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC), enabling integration with the Instinct sensor, made by Abbott, for type 1 diabetes, and approval of the MiniMed™ 780G system for use in adults 18+ with insulin-requiring type 2 diabetes.
SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, announced that it has submitted an IND (Investigational New Drug application) to the Ministry of Food and Drug Safety for a global Phase 3 clinical trial of SKYVaricella to add the 2-dose (two-shot) indication, aligning with evolving international standards that increasingly recommend two doses to provide stronger, longer-lasting protection against varicella.
GoodRx (Nasdaq: GDRX), the leading platform for medication savings in the U.S., announced that via a collaboration with Novo Nordisk, all strengths of Ozempic® (semaglutide) and Wegovy® (semaglutide) pens are available to eligible self-paying patients for $499-per-month through GoodRx, effective today.
PICO IV, the pioneers behind the world's first sterile CBD emulsion, have announced a strategic partnership with Liquivida®, a national leader in IV therapy and wellness. This partnership marks an exciting turn for both companies as they continue to innovate in IV hydration while upholding the highest standards of safety and education.
Switch Bioworks, a biotechnology company developing low-cost and sustainable fertilizers, announced the addition of two senior leaders to its executive team and a move into a new, dedicated corporate headquarters and R&D facility in San Carlos, California.
Daewoong Pharmaceutical (Co-CEOs Seong-Soo Park and Chang-Jae Lee) and Daewoong Therapeutics (CEO Bok-Ki Kang) announced that their proprietary semaglutide microneedle patch achieved more than 80%relative bioavailability compared to the injectable formulation in a pilot human pharmacokinetic study.
Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Modeyso™ (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.1 Continued approval for this indication may be contingent upon verification and description of clinical benefit in the Phase 3 ACTION confirmatory trial.
Asahi Kasei Life Science, a division of diversified global manufacturer Asahi Kasei, announced plans to construct a new spinning plant for its Planova™ virus removal filters in Nobeoka City, Miyazaki, Japan. The new facility will be the company’s fourth spinning plant for hollow-fiber cellulose membrane filters.