Novartis AG didn’t say why the FDA has put off action until September – a delay of three months – on the sBLA for multiple sclerosis (MS) prospect Arzerra (ofatumumab, OMB-157), first cleared in October 2009 for chronic lymphocytic leukemia, but the holdup brought renewed attention to the bustling space, and Immunic Inc. – which held its R&D Day on May 27 – is coming on strong.
Prescient Therapeutics Pty Ltd. is poised to develop next-generation CAR T therapies after signing a deal with the University of Pennsylvania for a universal immune receptor technology platform.
DUBLIN – Johnson & Johnson’s Janssen Biotech arm is on the brink of a historic first vaccine approval, having secured a positive vote May 29 from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for its prime-boost Ebola virus vaccine combo, Zabdeno (Ad26.Zebov) plus MVABEA (MVA-BN-Filo).
PERTH, Australia – Melbourne-based Prescient Therapeutics Pty Ltd. is poised to develop next-generation CAR T therapies after signing an exclusive global licensing deal with the University of Pennsylvania for a universal immune receptor technology platform.
BEIJING – Shandong, China-based Luoxin Pharmaceuticals Group Stock Co. Ltd. said its PIK3α inhibitor, LX-086, has been approved by China’s National Medical Products Administration (NMPA) to enter clinical trials for advanced solid tumors.
BEIJING – Shandong, China-based Luoxin Pharmaceuticals Group Stock Co. Ltd. said its PIK3α inhibitor, LX-086, has been approved by China’s National Medical Products Administration (NMPA) to enter clinical trials for advanced solid tumors, two weeks after Novartis AG’s alpelisib, which aims at the same target, was also granted IND clearance in China.
DUBLIN – Dyno Therapeutics Inc., an early stage gene therapy firm applying artificial intelligence to advanced capsid engineering, has entered partnerships with Novartis AG and Sarepta Therapeutics Inc., in ophthalmic indications and muscle diseases, respectively, which have over $2 billion in biobucks attached.
Novartis AG won accelerated FDA clearance for Tabrecta (capmatinib, formerly INC-280), an oral MET inhibitor, for adult patients with metastatic non-small-cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14) as detected by a companion diagnostic, also given the green light.
Taysha Gene Therapies Inc., a new Dallas-based company reuniting former executives of Avexis Inc. and its funders, has launched with a $30 million seed financing intended to advance a pipeline of 15 new AAV-based candidates. Its team expects to file four INDs by the end of 2021, starting with one for GM2-gangliosidosis that could move to the clinic later this year.
Both ballyhooed and questioned as a potential savior from COVID-19, hydroxychloroquine is about to get a high-profile test by Basel, Switzerland-based Novartis AG. The company has reached an agreement with the FDA to run a phase III trial evaluating the drug for the treatment of hospitalized patients with COVID-19, with enrollment of 400 patients beginning within weeks and results to be reported as soon as possible.
