Biovie Inc. Chairman Terren Peizer said Neurmedix Inc. “had been offered a better deal in the shorter term,” but the contract signed by the two firms – which installs entrepreneur Cuong Do the new CEO of Biovie, replacing Peizer – made more sense to both parties. Santa Monica, Calif.-based Biovie is taking over the assets of Neurmedix Inc., of San Diego, bringing aboard phase III-ready NE-3107, an oral small-molecule therapy designed to inhibit insulin resistance in Alzheimer’s disease (AD). Read More
If the FDA follows the advice of its Oncologic Drugs Advisory Committee (ODAC), both Keytruda and Tecentriq will remain on the U.S. market, for the time being, with accelerated approval as first-line treatments for certain patients with advanced or metastatic urothelial carcinoma. The committee voted 5-3 April 28 to recommend continuing accelerated approval for Merck & Co. Inc.’s Keytruda (pembrolizumab) and 10-1 for maintaining the accelerated approval of the Roche Group’s Tecentriq (atezolizumab) until the final data come in from a confirmatory trial that’s expected to be completed next year. Read More
Shares of Protalix Biotherapeutics Inc. (NYSE:PLX) fell 33% to $3.93 on April 28 after the company reported receiving an FDA complete response letter (CRL) in answer to its BLA for pegunigalsidase alfa, a galactosidase enzyme replacement therapy it has long advanced for the potential treatment of Fabry disease. Read More
Beigene Ltd.’s selective inhibitor, Brukinsa (zanubrutinib), made up for a 2019 miss in a head-to-head study against Johnson & Johnson and Abbvie Inc.’s Imbruvica (ibrutinib) with positive new data from a phase III trial in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma. Read More
The significant risks and high costs associated with neurological R&D has tended to keep companies and investors on the sidelines over the past few years. However, thanks to research progress and the development of new technologies, business development and investing in the space is heating up once again. Read More
HONG KONG – Canbridge Pharmaceuticals Inc. signed a collaboration and licensing agreement that could be worth $581 million, gaining global rights to develop, manufacture and commercialize gene therapy candidates from Logicbio Therapeutics Inc. for the treatment of Fabry and Pompe diseases. The candidates are based on Logicbio’s adeno-associated virus (AAV) sL65, the first produced from its Saavy capsid development platform. Read More
HONG KONG – South Korea’s securities exchange operator, Korea Exchange Inc., has relaxed the procedure for tech companies, including biopharma firms, to list on its KOSDAQ board. Under the simplified listing standard, which came into effect on April 26, companies with a market capitalization of ₩500 billion (US$449.26 million) and above will now need to submit only one assessment, with a result of “A” or higher, from a professional evaluation agency. Read More
BioWorld looks at translational medicine, including: Neurons forget who they are in Alzheimer’s disease; Sensor can predict hallucinogenic serotonin receptor effects. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amplyx, Bayer, Biomarin, Cannabics, Dermtech, Essa, Grifols, Homology, Lilly, Mallinckrodt, Neuraly, Okyo, Pfizer, Point, Silence, Soligenix, Triplet, Twist, VBI, Vifor, Vivlion. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akari, Amgen, Calliditas, Chiesi, Inmed, Nkarta, Protalix, Provention, Roche, Sorrento, Takeda, Tarus, Tetra, Vertex, Y-Mabs. Read More
