Kalvista Pharmaceuticals Inc. is promising to “change the paradigm” in the treatment of hereditary angioedema, after announcing positive phase III data for its oral on-demand kallikrein inhibitor sebetralstat. Rather than waiting four to five hours to self-administer therapy, as is the case for approved injectable on-demand therapies, there was a median time to dosing of 10 minutes after the start of an attack in the ongoing open label extension trial and a median time to dosing of 41 minutes in the 136-patient placebo-controlled phase 3 trial. Read More
Weeks after Roche Holding AG paid a $40 million milestone payment to partner Repare Therapeutics Inc. when the first cancer patient in the phase II Tapistry trial was dosed with camonsertib, the Basel, Switzerland-based pharma backed out of the 20-month-old deal. Read More
Bioage Labs Inc.’s $170 million series D financing will pay for phase II trials with azelaprag, an apelin receptor agonist, to be tried in combination with Zepbound (tirzepatide), the glucose-dependent insulinotropic polypeptide receptor and glucagon-like peptide-1 (GLP-1) receptor agonist from Bioage partner Eli Lilly and Co. Read More
The European Commission approved two therapies for progressive, genetic diseases: Biogen Inc.’s Friedreich’s ataxia drug, Skyclarys (omaveloxolone), and Crispr Therapeutics AG’s CRISPR/Cas9 gene therapy for sickle cell disease and transfusion-dependent beta-thalassemia, Casgevy (exagamglogene autotemcel, exa-cel). Read More
Otsuka Pharmaceutical Co. Ltd.’s AVP-786 missed the primary endpoint for a third time in a phase III trial for agitation associated with dementia due to Alzheimer’s disease (AD). Two previous phase III trials also failed to show statistical significance for AVP-786. Read More
Concluding 2023 on a strong note, the BioWorld Biopharmaceutical Index ended the year up 11.62%, surpassing the end of November increase of 3.37%. BBI kicked off the new year with a solid 4.77% increase by January’s end. Read More
One down, eight to go. That’s the scorecard for the constitutional challenges to mandatory Medicare drug price negotiations now that a U.S. federal court has dismissed a suit filed by the Pharmaceutical Research and Manufacturers of America, the National Infusion Center Association and the Global Colon Cancer Association. Read More
The U.S. Patent and Trademark Office (PTO) has released a draft version of patent examiner guidelines to address the increasing use of artificial intelligence (AI) in the inventive process, reflecting the standing U.S. position that AI cannot be an inventor. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4DMT, AN2, Anixa, Cervomed, Connecta, Gritstone, Larimar, Mediwound, Nuvalent, Nuvig, Polypid, Shionogi. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biovaxys, BMS, Celyad, Coya, Curasight, Delsitech, Exscientia, Freeline, IMV, J&J, Lianbio, Meiragtx, MGC, Ono, Shattuck, Syncona, Tolmar, VantAI. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioxcel, GSK, Novartis, Novelmed, Pharmather, Radiomedix, Sangamo, Tonix, Xspray. Read More
