Data from an interim analysis have convinced Syros Pharmaceuticals Inc. to stop enrollment in its phase II study of treating newly diagnosed acute myeloid leukemia (AML) and retinoid alpha receptor agonist gene overexpression. Analysts seemed unconcerned about the repercussions for Syros’ phase III study in myelodysplastic syndrome.
Aiming to offer an advantage over Dupixent (dupilumab, Regeneron Pharmaceuticals Inc.), dermatology-focused Galderma Holding SA won clearance from the U.S. FDA for Nemluvio (nemolizumab) as a prefilled pen providing a subcutaneous injection to treat adults with prurigo nodularis (PN).
Neuren Pharmaceuticals Ltd.’s NNZ-2591 met the primary endpoints in a phase II trial in children with Angelman syndrome, with improvements seen in clinically important aspects of the disease, including communication, behavior, cognition and motor abilities, Neuren CEO Jon Pilcher said during an Aug. 9 conference call.
Cullinan Therapeutics Inc. terminated development of Harbour Biomed Holdings Ltd.’s bispecific B7H4 x 4-1BB immune activator, CLN-418 (HBM-7008), after reviewing phase I data.
More than 18 months after announcing plans to spin off its kidney care division as a standalone public company, Baxter International Inc. reached an agreement to sell the business for $3.8 billion to global equity investor Carlyle and Atmas Health instead. The transaction is expected to close in late 2024 or the first quarter of 2025.
The U.S. FDA warning letter to Globus Medical Inc., highlights some long-running concerns at the agency about medical device reporting practices, but the agency was keen to point to a problem with the company’s complaint trending practices.
The U.S. National Institutes of Health sponsored a study that was designed to establish whether there are any biomarkers that are strongly associated with the constellation of symptoms known as long COVID, but the study shed little light on the question.
China’s Genor Biopharma Co. Ltd. agreed to out-license GB-261, its bispecific antibody candidate primarily targeting B-cell lymphomas, to TRC 2004 Inc., a U.S.-based newco co-founded by Third Rock Ventures LLC and Two River Group Holdings LLC.
With a move into Lilly Gateway Labs in Boston’s Seaport District, privately held Tevard Biosciences Inc. is ramping up development of its transfer RNA (tRNA)-based therapies to cure everything from Dravet syndrome and other neurological conditions to cardiology indications and muscular dystrophies.
With inter partes reviews (IPR) once feared as patent killers, the mere fact that an IPR petition challenging a drug or device patent had been filed with the U.S. Patent and Trademark Office was enough to send a company’s stock tumbling. That initial fear has “kind of ebbed and flowed” over the past 12 years as the patent reviews established by the America Invents Act have come of age, Aziz Burgy, a partner and patent litigator at Axinn, Veltrop & Harkrider LLP, told BioWorld.
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