Seaport Therapeutics Inc. has followed up its recent fundraiser with an oversubscribed $225 million series B financing that will help set it on the path to a phase IIb study in major depressive disorder. The company’s lead candidate is allopregnanolone, an endogenous neurosteroid that is taken orally and bypasses the liver. Once it is absorbed through the lymphatic system, allopregnanolone enters through a pathway that avoids the liver and the possibility of hepatoxicity and elevated liver enzyme counts, Michael Chen, Seaport’s chief scientific officer, told BioWorld. Read More
Astellas Pharma Inc. gained U.S. FDA approval of first-in-class claudin 18.2-targeted treatment Vyloy (zolbetuximab-clzb), now indicated as a first-line therapy for adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. Read More
The first bispecific antibody to win regulatory approval is about to make a comeback 10 years after being taken off the market in Europe for commercial reasons. Catumaxomab, then called Removab, and now reborn with the brand name Korjuny, received a positive opinion for the treatment of malignant ascites from the EMA’s Committee for Medicinal Products for Human Use (CHMP,) at its monthly meeting Oct. 14 to 17. Read More
Legislation that would give the U.S. government a cut of some big pharma profits has once again surfaced in Congress. First introduced in the 114th Congress and every Congress since, the Medical Innovation Act was reintroduced Oct. 18 as a way to tap into the profits of some large biopharma companies to augment research dollars at the FDA and NIH for future drugs and diagnostics, as well as for regulatory science and to support early career scientists. Read More
After raising $42 million in a series C1 round, Lanova Medicines Ltd. is advancing its lead phase III antibody-drug conjugate LM-302 that targets Claudin 18.2, as well as LM-299, an anti-PD-1/VEGF bispecific antibody, and LM-108, an anti-CCR8 monoclonal antibody. “Proceeds from this financing will allow us to expedite the development of our late-stage clinical programs, LM-302 and LM-108, moving us closer to market approval. We will also accelerate the clinical development of LM-299, which is currently in phase I clinical trials with best-in-class potential,” Lanova founder and CEO Crystal Qin said. Read More
The Japanese government, industry and academia are deliberating health care policies and initiatives to boost Japan’s role in the future of regenerative medicine, experts at Bio Japan 2024 said, as the fruits of cell and gene therapy research come to fruition with new approvals. Read More
In the newest BioWorld Insider podcast, Victoria Lipinska, the America's lead for Quantum Innovation Centers at IBM Quantum, talks about the future of drug development using quantum computing. “The new technology is a completely different branch of computing as opposed to what we know right now, and it's meant to complement what we know, not to really replace it,” she said. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amylyx, Anavex, Aura, Biodexa, Curevo, George Medicines, Innovent, Kezar, Merck, Nektar, Neuvivo, Supernus, Theratechnologies. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adjuvance, Amivas, Clearb, Emergex, Gylden, Jaguar Health, Kezar Life, Kiji, Napo, Oncozenge, Pharmanovia, Regimmune, Zosano. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcutis, Astrazeneca, Avadel, Ionis, Novartis, Novo Nordisk, PTC, Roche. Read More
