Provention Bio Inc. scored approval from the U.S. FDA of the BLA for Tzield (teplizumab-mzwv), an intravenously given, anti-CD3-directed antibody, as the first and only immunomodulatory treatment to delay the onset of stage 3 type 1 diabetes (T1D) in adult and pediatric patients ages 8 and older with stage 2 T1D. Read More
An investigational dendritic cell vaccine from Northwest Biotherapeutics Inc., administered with standard of care, extended both median overall survival (OS) and "the ‘long tail' of the survival curve" vs. matched external controls in newly diagnosed and recurrent glioblastoma multiforme brain cancer patients, according to results published Nov. 17 in JAMA Oncology. Read More
As Wall Street waits to find out later this year whether Stoke Therapeutics Inc.’s positive results with a low, single dose of STK-001 for Dravet syndrome pans out in more extensive research, a number of players large and small are investigating candidates for the rare but dismal form of epilepsy. Read More
The stock rally by Tango Therapeutics Inc. over the past month or so has further revved the long-percolating interest in protein arginine methyl transferase 5 (PRMT5) and in synthetic lethality, where a number of parties have programs ongoing. Read More
An in-depth investigation of the underlying causes of pulmonary symptoms that in some cases persist for months following recovery from the acute stage of COVID-19 has found a distinctive proinflammatory signature in the plasma and airways of affected patients. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astellas, Azura, Cocrystal, Editas, Evaxion, Immunic, Kinevant, Kiora, Organicell, Pfizer, Takeda, Visen, Vyne. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alloy, Bavarian Nordic, ERS, Invivyd, Marinus, Normunity, Raesedo, Stealth, Tenacia. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABVC, Ardelyx, Ascletis, Beigene, PTC, Skye. Read More
