Alnylam Pharmaceuticals Inc. said the 164-patient Helios-A phase III study with next-generation RNAi drug vutrisiran hit its primary endpoint as well as both secondary goals in the treatment of hereditary transthyretin-mediated amyloidosis with polyneuropathy. The primary endpoint was change from baseline in the modified Neuropathy Impairment Score at nine months as compared to historical placebo data from the Apollo phase III study of Alnylam’s Onpattro, cleared by the FDA for ATTR polyneuropathy in August 2018. Read More
In less than a year, Scorpion Therapeutics Inc. has raised about $270 million and just closed on an oversubscribed series B financing that climbed to $162 million. The new financing quickly follows the Boston-based company’s founding at the end of the first quarter of 2020 and the closure of a $108 million series A financing in October. Read More
Lexeo Therapeutics Inc., a New York-based startup initially advancing clinical and near-clinical stage candidates for Friedreich’s ataxia, CLN2 and Alzheimer's diseases, has raised an $85 million series A financing round led by Longitude Capital and Omega Funds. Founded by gene therapy development veteran Ronald Crystal, the company is led by CEO Nolan Townsend, the former head of Pfizer Inc.'s rare disease efforts in North America. Read More
Abcuro Inc. raised $42 million in a series A-1 round to progress preclinical programs in autoimmune disease and cancer involving a largely overlooked immune checkpoint receptor, killer cell lectin-like receptor G1 (KLRG1). Read More
CAJICA, Colombia – Brazil's Butantan Institute and the government of the state of Sao Paulo released efficacy results on Jan. 7 for Coronavac, developed by China’s Sinovac Biotech Ltd., that suggest the COVID-19 vaccine is more than 78% effective. Read More
DUBLIN – Curevac AG has entered a global alliance with Bayer AG to accelerate its efforts to bring a third, desperately needed mRNA-based COVID-19 vaccine to market. The vaccine in question, CVnCoV, began a pivotal phase IIb/III trial on Dec. 14. Read More
LONDON – The U.K. is to make treatment with interleukin-6 (IL-6) inhibitors standard of care for critically ill COVID-19 patients after a randomized trial found the arthritis drugs significantly improve survival. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: Health care bills become U.S. law; MHRA releases safety review of epilepsy drugs. Read More
New hires and promotions in the biopharma industry, including: Advicenne, Constellation, Effector, Erasca, Forma, Moderna, Morphosys, Ocular, Peptomyc, Sana, Tarsus, Tryp, Tscan, Viking. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Aldeyra, Alnylam, AM-Pharma, Basilea, Pfizer, Pharmaessentia. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apollomics, Bluerock, Gemini, Glycomimetics, Inversago, Praxis Precision, Union, Visen. Read More
