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.
Immunotherapy-focused biotech company LTZ Therapetics Inc. raised $20 million in a series A round that will advance development of its myeloid engager pipeline to treat cancer and autoimmune diseases. Proceeds from the funds will accelerate development of lead asset LTZ-301, which is expected to enter the clinic in early 2025, LTZ founder and CEO Robert Li told BioWorld.
Radiopharmaceutical company Telix Pharmaceuticals Ltd. received a U.S. FDA refusal to file letter for its BLA seeking approval of renal cancer imaging agent TLX250-CDx (89Zr-DFO-girentuximab) for clear cell renal cell carcinoma (ccRCC).
Ideaya Biosciences Inc. bought global rights to Biocytogen Pharmaceuticals Co. Ltd.’s cancer-targeting bispecific antibody-drug conjugate (bsADC) program in a deal reaching up to $406.5 million. Announced July 31, San Francisco-based Ideaya agreed to license-in global rights to Biocytogen’s B7H3/PTK7 bispecific ADC program with topoisomerase-I (TOP1) payload to develop as either a monotherapy or combination therapy for solid tumors.
Investors wanted more from ALX Oncology Holdings Inc.’s phase II study testing evorpacept (evo) combination therapy in gastric tumors, and the stock (NASDAQ:ALXO) tumbled 36% or $1.77 to close Aug. 1 at $3.04.
Instil Bio Inc. plans re-energize the company by in-licensing the development and commercial rights to antibodies outside of China from Shanghai-based Immuneonco Biopharmaceuticals Inc. In return, Immuneonco is getting an undisclosed up-front payment and the chance for near-term payments of up to $50 million.
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