Despite what University of Pennsylvania (Penn) immunotherapy pioneer Carl June referred to as a “cold slap last November” – a launched investigation by the U.S. FDA into a possible link between CAR T-cell immunotherapies and secondary cancers – new unpublished studies by Penn and Stanford University highlight the rarity of such cases. Read More
China and U.S. biotech Jacobio Pharmaceuticals Group Co. Ltd.’s shares (HKEX:1167) rose nearly 20% after it filed an NDA in China on May 6 for its independently developed KRAS G12C inhibitor, glecirasib (JAB-21822), to treat lung cancer. Read More
The bifunctional antibody approach continues to pay off for Zenas Biopharma Inc., which banked an upsized $200 million series C preferred stock financing led by SR One along with NEA, Norwest Venture Partners and Delos Capital. Enavate Sciences and Longitude Capital participated significantly as well. Read More
Memo Therapeutics AG has added a further CHF20 million (US$22 million) to its series C, bringing the total for the round to CHF45 million and enabling the company to expand the phase II trial of its lead program, AntiBKV, in neutralizing BK virus infection in immune compromised kidney transplant recipients. Read More
Prologue Medicines Inc. has launched to develop therapeutics created from the viral proteome, which are proteins produced across all viruses. It’s a newer twist on harnessing the power of the proteins that regulate biology. Read More
The use of psychedelics is seeing impressive results in treating psychiatric disorders like treatment-resistant depression and post-traumatic stress disorder, and Mindbio Therapeutics Ltd. is expanding the field to include microdoses of lysergic acid diethylamide (LSD) to treat depression and premenstrual syndrome. Read More
The theft of 110 units of a study drug containing a Schedule III controlled substance resulted in a warning letter from the U.S. FDA. Addressed to the clinical investigator, Kevin Bender, of the Tamarac, Fla.-based DBC Research Corp., the May 2 letter should serve as a reminder to all trial investigators handling controlled substances. Read More
BioWorld Managing Editor Karen Carey joins the podcast to talk about the numbers from the first quarter of 2024, along with a look back at some 2023 deals and indicators that signal better times are on the way. Financings for the quarter were better than expected, sporting some of the best numbers of the past 13 years. It’s part of a larger trend, Carey says, of investors being a lot pickier about where they put their money and demanding better data. The result is a strengthened market and a better outlook. Read More
The recent cyberattack on Change Healthcare, a part of the Unitedhealth Group, crippled reimbursement claims processing for thousands of providers for several weeks and potentially exposed troves of patient data. Congressional committees are investigating the attack, its scope, and Unitedhealth’s response. Please take a few minutes to fill out this short survey to help BioWorld understand how your company is responding to these threats. You can click through to the questions here. Read More
Biopharmas raising money in public or private financings, including: Ainos, Allarity, Alzamend, Bioversys, Eledon, Organon, Overt, Palisade, TC. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: ADC, Asclepix, Biomarin, Boehringer, Edgewise, Eyepoint, Ferring, Glycomimetics, Impact, Inmagene, Janssen, Johnson & Johnson, Kiora, Lineage, Lyra, Mind Medicine, Roche, Urogen. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agenus, Bioversys, Index, GSK, Ligand, Reneo, Ultimovacs. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioatla, BMS, Mannkind. Read More
