All treatment groups in Vertex Pharmaceuticals Inc.’s phase II study of the non-opioid VX-548 showed meaningful reductions in pain from baseline in treating diabetic peripheral neuropathy (DPN), pointing the company toward pivotal phase III studies and prompting analysts to applaud enthusiastically. Read More
Wall Street will be watching closely for such adverse effects as anemia that foiled Gilead Sciences Inc.’s CD47-binding magrolimab earlier this year, but so far Shattuck Labs Inc.’s SL-172154 looks strong in combination with azacitidine to treat front-line higher-risk myelodysplastic syndrome (HR-MDS) and TP53-mutant (TP53m) acute myeloid leukemia (AML). Read More
Astrazeneca Korea Co. Ltd. will pull its blockbuster diabetes drug, Forxiga (dapagliflozin), from the South Korean market, a company official confirmed to BioWorld, citing “multiple factors” like increasing local competition and continuing price cuts after patent expiry in 2023. Read More
Japan-California startup Shinobi Therapeutics Inc. has emerged from stealth mode with a $51 million series A round to advance its first off-the-shelf induced pluripotent stem cell (iPS)-T cell therapy against glypigan-3 (GPC3)-positive cancers toward the clinic. Read More
Just over a year since the last anti-nerve growth factor (NGF) antibody program was axed, the target is poised for a revival, with Levicept Ltd. announcing it has completed recruitment to a phase II trial of LEVI-04 in the control of chronic pain caused by osteoarthritis. Read More
The U.S. FDA is assembling a new advisory committee specifically focused on treatments for genetic metabolic diseases. The Genetic Metabolic Diseases Advisory Committee, or GeMDAC, will be tasked with providing agency reviewers independent expert recommendations regarding regulatory applications as well as advice on scientific and policy issues. Read More
One aspect of 2023 our group of executives completely agreed on: the past year was tough financially. And they all foresee a more vibrant year ahead for the market. Giving all of them hope were technological breakthroughs such as artificial intelligence, game changing weight loss drugs, the surging fascination with ADCs and hope for lower interest rates. But uncertainty looms about the upcoming general election in the U.S. and ground-shifting gene therapies. Read More
You asked and we listened. Now, in addition to the daily news lineup, you can create topic alerts to be delivered directly to your inbox or via an RSS reader. It’s easy to set up. Instructions can be found here: https://www.bioworld.com/featured-feeds. Read More
New hires and promotions in the biopharma industry, including: Altpep, Calidi, Charm, Corsair, Genentech, Immunoscape, Oncozenge, TFF, Triveni. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aeon, Athira, Axoltis, Curis, Icosavax, ISA, Lisata, Menarini, Obsidian, Qilu, Solascure, Toragen. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adma, Blueprint, Candel, Defence, Gigagen, GSK, Humacyte, Pfizer, Henlius, Viracta. Read More
