Pfizer Inc.’s Beqvez (fidanacogene elaparvovec) won FDA approval for use in adults with hemophilia B, making it the second adeno-associated viral (AAV) vector-based gene therapy available for patients in the U.S., following the late 2022 approval of CSL Behring’s Hemgenix (etranacogene dezaparvovec). Read More
Amidst a slew of end-of-week, positive EMA Committee for Medicinal Products for Human Use (CHMP) opinions is Takeda Pharmaceutical Co. Ltd.’s Fruzaqla (fruquintinib). The selective inhibitor of vascular endothelial growth factor receptors-1, -2 and -3 is for adults with previously treated metastatic colorectal cancer. Read More
Space Liintech Co. Ltd., of Daejeon, South Korea, raised ₩4 billion (US$2.9 million) in a series A financing round to advance new drug research, development and production in outer space, as the private sector races to harness the orbit for pharmaceutical experiments. Read More
The government of Colombia, after signaling its intent to do so at the end of 2023, issued a compulsory license on April 24 for access to generic versions of HIV drug dolutegravir, without the permission of patent owner Viiv Healthcare Ltd. Read More
Gilead Sciences Inc. is aiming to capitalize on the early August 2022 buyout of privately held U.K. biotech Mirobio Ltd. with the advancement of PD-1 agonist GS-0151 into phase Ib trials for rheumatoid arthritis, a decision that Leerink analyst David Risinger hailed as positive for others at work with the intriguing mechanism. Paying $405 million for Oxford-based Mirobio, Gilead took ownership of the firm’s checkpoint agonists to treat autoimmune diseases. Read More
In March 2024, BioWorld reported on 261 phase I-III clinical trials updates, showing a 10.6% increase from February's count of 236 and up from January’s 252. However, March’s tally is an 18.2% decline from March 2023’s 319 updates. The average monthly count of phase I-III updates in the first three months of 2024 stood at roughly 277, compared to 305 for all of 2023. Read More
In one of the biggest financings of the year so far, former Prometheus Biosciences Inc. CEO Mark McKenna helped raise $400 million to launch a new company, Mirador Therapeutics Inc. He didn’t sit on the sidelines for long after Merck & Co. Inc. bought Prometheus for $10.8 billion in 2023. He recruited key Prometheus executives to focus on Mirador’s genetic approach to drug discovery and precision medicine. McKenna said there was too much left undone to just hang back. In this BioWorld Insider episode, he talks about the new company and the multi-billion-dollar drugs that he believes provide sub-optimal efficacy compared to the tailor-made therapies he wants to develop. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Aphaia, Biovie, Eyenovia, Hookipa, Immunitybio, Kinevant, Pep-Therapy, Roivant, Sarton, Vistagen. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alligator, Biodexa, Emtora, Esteve, Orion, Perrigo, Sernova. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apollomics, Avistone, Compass, Freedom, Junshi, Medvir, Onconic. Read More
