In Pumpkinseed Technologies Inc.’s first public patenting, the company’s co-founders describe their development of new proteomics platform that merges nanotechnology, biochemistry, silicon photonics and machine learning for high-resolution phenotyping to deliver new biological insights.
Vir Biotechnology Inc.’s focus will look a little different for the latter half of 2024, as the San Francisco-based firm disclosed a restructuring that will cut about a fourth of its workforce and phase out programs targeting influenza and COVID-19 as well as vaccines developed using its T-cell-based viral vector platform.
Inflation continues to take a toll on U.S. FDA drug and device user fees with some of the fees increasing as much as 44% for fiscal 2025. While most fee increases for generics and innovative drugs and biologics are below 10%, the ANDA fee is jumping 28% to $321,920.
Tokyo-headquartered Otsuka Pharmaceutical Co. Ltd. said Aug. 1 that it will acquire Boston-based Jnana Therapeutics Inc. through a potential $1.125 billion M&A deal. Under the terms, Otsuka will work to close the transaction by the third quarter of 2024, with $800 million paid out to Jnana shareholders, along with up to $325 million in additional development and regulatory milestones payments.
As the Sept. 21 PDUFA date looms for arimoclomol from Zevra Therapeutics Inc. in Niemann-Pick type C (NPC), the U.S. FDA’s newly formed Genetic Metabolic Diseases Advisory Committee (GeMDAC) decided in favor of the drug.
A T-cell therapy from Adaptimmune Therapeutics plc has received accelerated approval from the U.S. FDA to treat advanced synovial sarcoma (SS). Tecelra (afamitresgene autoleucel), a CAR T targeting MAGE-A4, is the first engineered T-cell therapy for solid tumors and the first treatment option for the indication in more than a decade.
The proposal to overhaul the use of terminal disclaimers in U.S. patent filings won over no fans among former directors of the U.S. Patent and Trademark Office, but device and drug makers, too, are concerned about the proposal.
Esperto Medical Inc. could soon offer a non-invasive method for blood pressure measurement for critically ill patients based on results seen in a study published in PNAS Nexus. Esperto’s Resonance Sonomanometry technology uses acoustic stimulation with ultrasound imaging to provide continuous, non-invasive readings.
Stryker Corp. continued its recent buying spree with the purchase of Molli Surgical Inc., a company that develops wire-free soft tissue localization technology for breast-conserving surgery. Styker said Molli’s offerings strengthen its advancing surgical solutions in breast cancer care.
U.S. federal preemption of state law for devices approved by the FDA is a matter of record, but a recent case affirms the staying power of Supreme Court jurisprudence on that point.
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