Although diversity was front and center, it wasn’t the only reason the U.S. FDA’s Oncologic Drugs Advisory Committee voted 14-1 that additional clinical trials demonstrating applicability to the U.S. non-small-cell lung cancer population are needed before sintilimab, a PD-1 inhibitor partnered in the U.S. by Innovent Biologics Co. Ltd. and Eli Lilly and Co., is ready for approval. Read More
Arkuda Therapeutics Inc., a company targeting lysosomal dysfunction to address neurodegeneration, has completed a $64 million series B financing co-led by Cormorant Asset Management and Pivotal Bioventure Partners. The funds will help advance its lead program, a small-molecule progranulin enhancer for frontotemporal dementia in people with an autosomal dominant mutation in the GRN gene, which codes for the protein. Read More
Curevo Vaccine Inc. closed on a $60 million series A financing designed to take the company through releasing top-line data for its phase IIb study of CRV-101 for treating shingles in older adults. That means taking on a blockbuster, Shingrix from Glaxosmithkline plc. Read More
Stocks that make up BioWorld’s Drug Developers Index have tumbled by more than 17% since the start of the year, with only five of the 30 component companies showing a rise in share price. The Nasdaq Biotechnology Index and the Dow Jones Industrial Average also are down by 12.2% and 2.41%, respectively, indicating the biotech industry, which has experienced huge stock surges during the past two years, is now struggling, dropping more sharply than the broader markets. Read More
Infectious disease specialist Aicuris Anti-infective Cures AG has signed a worldwide license agreement worth up to €100 million (US$114 million) with Hybridize Therapeutics for a potential therapy to prevent BK virus (BKV) infections in immunocompromised patients. Read More
Altesa Biosciences Inc. CEO Brett Giroir called the firm’s scientific co-founders George Painter and Dennis Liotta “the most important developers of drugs against viruses on the planet, and probably in history.” Giroir’s remarks came as the College Park, Ga.-based firm launched to develop and commercialize new antiviral drugs against common respiratory bugs such rhinovirus and parainfluenza, as well as vector-borne threats such as Dengue fever, yellow fever, Zika and Powassan. Read More
Cstone Pharmaceuticals Co. Ltd.’s orally administered Tibsovo (ivosidenib tablets) received the green light from China’s NMPA for use in adult patients with relapsed/refractory acute myeloid leukemia (r/r AML) with a susceptible isocitrate dehydrogenase 1 (IDH1) mutation. It is the first IDH1 inhibitor to reach market in China. Read More
The FDA’s November 2021 draft guidance for contents of premarket submission for device software functions may have been a desperately needed update for a legacy 2005 guidance, but stakeholders see one glaring omission from the draft. Both the Advanced Medical Technology Association and Pharmaceutical Research and Manufacturers of America pointed to the absence of sign-off by the FDA’s Center for Drug Evaluation and Research (CDER) for the draft, a conspicuous omission because a combination product with software may include a drug regulated by CDER. Read More
South Africa’s Competition Commission sent a warning this week to the biopharma industry when it announced that it is prosecuting Roche Holding AG for what it called excessive pricing of the company’s breast cancer drug, Herceptin, which is also marketed as Herclon in South Africa. Read More
Aiming to spur development of non-addictive pain therapies, as part of ongoing efforts to tackle the opioid crisis, the U.S. FDA released draft guidance Feb. 10 that outlines recommendations regarding development of opioid alternatives. Read More
New hires and promotions in the biopharma industry, including: Ampio, Elios, Finch, Generation, Gentibio, Indapta, Ixaka, Toragen, Transgene. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie,Affimed, Akso, Cell and Gene Therapy Catapult, Generium, Glaxosmithkline, Healis,Huadong Medicine, Mediwound, Merck, Mica, Nanobiotix, Quris, Second, Selexis, Vir, Virpax. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cstone, Dermata, Elpiscience, Eureka, Gamida, Glenmark, Polypid, Qurient, Sanotize, Synthetic Biologics. Read More
