The RNAi therapeutic zilebesiran, which was the focus of a 2023 $2.8 billion deal between Alnylam Pharmaceuticals Inc. and Roche Holding AG, demonstrated significant systolic blood pressure reductions in patients with mild to moderate hypertension who were part of the Kardia-2 phase II study. Read More
While members of the U.S. FDA’s Imaging Drugs Advisory Committee weren’t blown away March 5 by the trial performance of Lumicell Inc.’s Lumisight (pegulicianine) in helping breast cancer patients avoid second surgeries due to negative margins following a lumpectomy, they voted 16-2, with one abstention, that the benefits of the imaging drug outweigh its risks, even though those benefits are incremental. Read More
Apogee Therapeutics Inc.’s phase I home run put IL-13-targeting antibody APG-777 on an accelerated development path in atopic dermatitis, and the company touted its similarity to further-along IL-13 competitor lebrikizumab, from Eli Lilly and Co., as a likely indicator of further success. Read More
Taiwan’s Formosa Pharmaceuticals Inc. and Aimmax Therapeutics, Inc. said the U.S. FDA approved APP-13007 (clobetasol propionate ophthalmic suspension 0.05%), a twice-daily corticosteroid eye drop for postoperative eye pain and inflammation. Read More
In a move to build up its dominance in the radiopharma market, Telix Pharmaceuticals Ltd. said it plans to acquire radioisotope production technology firm Artms Inc. and its advanced cyclotron-based isotope production platform, manufacturing plant and stockpile of ultra-pure rare metals. Read More
Three U.S. federal government agencies announced that their focus on consolidation in health care markets may soon ramp up, given concerns that consolidation may be affecting the cost and quality of patient care. Read More
On March 4, 2024, several groups of scientists discussed the challenges of investigating the effects of HIV in the central nervous system (CNS) at the oral abstract session on neuropathogenesis of HIV held during the 31st Conference on Retroviruses and Opportunistic Infections (CROI), in Denver. A cure for HIV will require eliminating the virus in all its reservoirs, those tissues where HIV remains latent but retains the capacity for reactivation and replication. However, despite antiretroviral therapy (ART), the virus could continue to replicate continuously at a low level in some reservoirs, including the CNS. Read More
Exonate Ltd. is preparing to advance its eye drop candidate to treat retinal vascular diseases, EXN-407, into a phase IIb study following promising tolerability and early signs of efficacy in a phase Ib/IIa study. A small-molecule SRPK1 inhibitor, EXN-407 is designed to be administered twice daily and works by selectively targeting specific (proangiogenic) isoforms of VEGF that lead to vascular retinal disease progression via aberrant growth of leaky blood vessels within the eye. Read More
Organoids are 3D models created from human stem cells and resemble fetal tissues. In an article published in Nature Medicine on March 4, 2024, researchers from University College London provided details on the possibility of generating organoids from epithelial cells collected from amniotic fluid without terminating the pregnancy. Read More
Discover a wealth of industry insights with BioWorld’s extensive collection of infographics, covering the latest trends and developments in both biopharma and med-tech. Our weekly infographics are curated to provide concise summaries of key topics: financings (IPOs, private financings, public/other and follow-on offerings), deals and M&As (top deals, and monthly value and volume), regulatory (including U.S. FDA and worldwide approvals), clinical trials and more. In addition, you’ll find access to BioWorld’s year-in-review reports, as well as special infographics about obesity, pain and addiction, biosimilars and the aging space. Read More
Biopharmas raising money in public or private financings, including: Akero, Arcutis, Armata, Bridgebio, Innoviva, Mithra, Quoin, Viking, Xbrane. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akero, Atai, Audion, Avidity, Berlin, Biocardia, Neurogene, Novartis, Nrx, Solascure, Ultimovacs, Vaxcyte, Vivoryon. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akari, Bit.bio, Cyprium, Erganeo, Everzom, Fibrocor, Lava, Novalix, Organicell, Peak, Pfizer, Redhill, Scilex, Sumitomo, Vaxil, Vistin, Zeo Scientifix. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: A2, Astrazeneca, Gri, Hugel, Iovance, J&J, Pepgen, Springworks, Synaptixbio. Read More
