New and updated preclinical and clinical data presented by biopharma firms at the American Association for Cancer Research Annual Meeting, including: Gracell, Hummingbird.
If these top-line phase III results were a grade card for 12- to 15-year-olds, they would be on the honor roll: The Pfizer Inc.-Biontech SE COVID-19 vaccine is 100% effective for the age group and produced robust antibody responses. The new results play out against a backdrop of increased production and big revenue estimates.
Zai Lab Ltd., China rights holder for the Deciphera Pharmaceuticals Inc. drug Qinlock (ripretinib), has obtained NMPA approval for the therapy, a treatment for adults with advanced gastrointestinal stromal tumors (GIST) previously treated with three or more kinase inhibitors, including imatinib, sunitinib and regorafenib.
Lianbio Co. Ltd. has inked a $200 million deal with Tarsus Pharmaceuticals Inc. for greater China rights to the phase IIb/III-stage candidate, TP-03 (lotilaner ophthalmic solution, 0.25%), designed to treat Demodex blepharitis and Meibomian gland disease (MGD). Lianbio will pay $15 million up front and up to $185 million in development and commercialization milestones.
As COVID-19 vaccinations continue to roll out, momentum builds with strong phase III data for what could become the fourth and fifth walls of defense in the U.S. With three vaccines already authorized, research reported in March offers hope for a second adenovirus vector vaccine candidate with Astrazeneca plc’s AZD-1222, as well as for the first protein subunit vaccine option with Novavax Inc.’s NVX-CoV2373.
Full rights to TAK-169, a CD38-targeted engineered toxin body that Takeda Pharmaceuticals Co. and Molecular Templates Inc. have been developing, are going to Molecular Templates as is the therapy’s clinical development. Making way for the new candidate, Molecular is discontinuing development of MT-3724, which is in a phase II study for treating diffuse large B-cell non-Hodgkin lymphoma but was placed on a partial clinical hold by the FDA after a treatment-related fatality in one of the subjects.
HONG KONG – SK Biopharmaceuticals Co. Ltd. partner Arvelle Therapeutics GmbH, now part of Angelini Pharma, has received European Commission (EC) approval for Ontozry (cenobamate), a treatment for drug-resistant focal-onset seizures. The approval was granted for focal-onset seizures with or without secondary generalization in adults who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicines.
RSS
