Cerevel Therapeutics Inc.’s positive results from the long-shot pivotal phase III Tempo-3 trial with tavapadon – the first D1/D5 receptor partial agonist being studied as a once-daily treatment for Parkinson’s disease – added gravy to the $8.7 billion takeover by Abbvie Inc., disclosed late last year. The buyout’s centerpiece was the late-stage asset emraclidine, a positive allosteric modulator of the muscarinic M4 receptor, touted as a potential best-in-class, next-generation antipsychotic for schizophrenia, which strikes more than 5 million people in the G7 (U.S., France, Germany, Italy, Spain, U.K. and Japan). Read More
Led by executives who helmed The Medicines Co., Metsera Inc. has launched with $290 million in financing to develop drugs for treating weight loss, obesity-related conditions and metabolic diseases. The company is stepping into high profile and lucrative glucagon-like peptide-1 territory forged by Eli Lilly and Co.’s Zepbound (tirzepatide) for chronic weight management and Novo Nordisk A/S’s Wegovy (semaglutide), also approved for long-term weight management. Read More
Biopharma firms amassed a total of $47.07 billion in the first quarter of 2024, the second-highest quarter recorded by BioWorld since 2011, trailing only behind $48.18 billion raised in 2Q20. This robust fundraising was driven by exceptional performances in IPOs, follow-ons and public/other financings, as well as sustained trends in venture capital raises. The amount marks a 118% increase from $21.62 billion raised in the fourth quarter of 2023 and a 257% rise from 1Q23’s $13.19 billion. Read More
China’s National Medical Products Administration has cleared Immuneonco Biopharmaceuticals Co. Ltd.’s’ IMM-01 (timdarpacept) to enter a pivotal phase III trial in combination with Beigene Co. Ltd.’s PD-1 inhibitor, tislelizumab, in relapsed or refractory classical Hodgkin lymphoma patients who relapsed or progressed after treatment with PD-1 inhibitors. Read More
Newco Outrun Therapeutics Ltd. has raised $10 million in a seed round to develop small-molecule E3 ubiquitin ligase inhibitors that prevent programmed protein degradation. The lead program targeting an E3 ligase that tags a tumor suppressor protein for destruction will now advance to preclinical development. Read More
South Korea’s SK Biopharmaceuticals Co. Ltd. and Shanghai-based Ignis Therapeutic Co. Ltd. signed a ₩804 billion (US$58 million) licensing deal on April 18, granting the latter global rights to a non-narcotic pain treatment candidate dubbed SKL-22544. A sodium channel blocker, SKL-22544 is in late discovery. Read More
The new merger guidelines released by the U.S. Department of Justice and the Federal Trade Commission have proven controversial on several fronts, but now the House of Representatives is weighing in. Read More
Because artificial intelligence is such a new technology it comes with a mountain of unknowns. Integrating it into a pharmaceutical company presents a unique series of challenges, as a new survey from Verix shows. Doron Aspitz, the CEO of Verix, talked about the new findings with the BioWorld Insider podcast and the profound shift that executives face as the new technology takes over an entire industry. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amgen, Artiva, Atai, Celldex, Clene, Eli Lilly, Enterome, Evaxion, GSK, Neurobo, Novartis, Organovo, Roche, Sage, Sanofi, Tscan, Ventus, Ventus. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Biocryst, Bivictrix, Immutep, Paxmedica, Teva, UCB. Read More