Roche Holding AG’s investigational monoclonal antibody, crovalimab, which inhibits part of the innate immune system in patients with the rare blood condition paroxysmal nocturnal haemoglobinuria, met its co-primary efficacy endpoints in a phase III trial that will form the basis of its approval submissions worldwide. Read More
The science that led Garuda Therapeutics Inc. to a $62 million series B financing was a combination of hard work, luck and serendipity, according to co-founder and CEO Dhvanit Shah. At the Harvard Stem Cell Institute, Shah and his fellow researchers found that endothelial cells go through significant modifications before becoming hematopoietic stem cells. That simple discovery, as Shah told BioWorld, brought on research leading to the possibility that patients would not need a marrow donor before receiving a stem cell treatment. Read More
With the passage of the Inflation Reduction Act in the U.S. in August 2022, biopharma company leaders have re-evaluated pipelines, sought legal advice, and discussed ways to mitigate the potential impacts the legislation will have on pricing therapies and extending their reach to new indications. Read More
With readouts from three clinical studies of its lead oncolytic virus Tilt-123 due later this year, Tilt Biotherapeutics Ltd. secured €12 million (US$12.9 million) in new funding, to add to the €10 million it raised last June. That will enable the company to complete the ongoing studies, to prepare for a phase II in ovarian cancer, its lead indication, and to take forward several preclinical programs that are nearing the clinic. Read More
Beginning July 1, Australia’s Therapeutic Goods Administration will allow medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) to be prescribed by authorized psychiatrists for certain mental health conditions. Read More
Nodus Oncology Ltd. closed on the first £2.4 million (US$2.9 million) of £12 million it expects to raise in a number of tranches over the next 12 months, to source and take forward third-generation DNA damage response (DDR) programs. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Addex, Ashvattha, Atyr, Certa, Context, Daewoong, Defence, Idorsia, Immutep, Janssen, Lyra, Novartis, Pulmatrix, Seelos, Spyglass, Tonix. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accutar, Biogen, Bioxytran, Egret, Endogena, Gilead, Hinova, Inmagene, Neogap, Neurosense, Sage, Sandoz, Takeda. Read More
