After years of turbulent development that included a clinical hold, a COVID-19 stumble, a withdrawn approval application and an extended PDUFA date, the FDA has approved CTI Biopharma Corp.’s Vonjo (pacritinib) for treating the bone marrow cancer myelofibrosis. Read More
Janssen Pharmaceutical Cos. Inc. has become the second company to get a BCMA-targeting CAR T therapy to market with the approval of ciltacabtagene autoleucel for adults with relapsed or refractory multiple myeloma (MM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
Abbvie Inc. has paid $130 million up front to acquire Syndesi Therapeutics SA, a company working on a new mechanism to mitigate synaptic dysfunction associated with cognitive deficits. The deal includes up to $870 million in milestone payments for Syndesi's first-in-class modulators of the synaptic vesicle protein 2A, which Abbvie said could have applications across a range of neuropsychiatric and neurodegenerative disorders, such as Alzheimer's disease and major depressive disorder. Read More
The U.S. Patent Trial and Appeal Board’s (PTAB) decision Feb. 28 that Broad Institute scientists were the first to invent the use of CRISPR/Cas9 genome editing in eukaryotic cells is just another chapter in the ongoing saga of who has patent rights to various elements of the CRISPR platform. Read More
Two years ago, BioWorld reported on 30 therapeutics and vaccines in development for COVID-19, about 3,000 people had died from the disease, and societal lockdowns began. Today, therapeutics and vaccines have ballooned to 1,048, deaths are at 6 million, and the world remains on edge due to highly transmissible variants and breakthrough infections. One thing remains the same: Scientists still do not know where the SARS-CoV-2 virus originated. Read More
Teclison Ltd. has raised $5.9 million to support further development of its lead candidate, TEC-001, an agent designed to induce tumor necrosis and enhance immune checkpoint inhibitors in solid cancers with liver metastasis. Wtt Investment Ltd., the Taiwan-based family office of the late Taiwanese banker Tsai Wan-tsai, led the financing.
New hires and promotions in the biopharma industry, including: 89bio, Biotheryx, Cellectar, Crinetics, Dyve, First Wave, F-star, Genmab, Ichnos, Invectys, Lycia, Mereo, Moleculin, Overland, Phoremost, Pulmatrix. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Harbour Biomed, JW, Lexicon, Merck KGaA, Reata. Read More
