The U.S. FDA’s emergency use authorization for two oral antivirals to be used to treat individuals at high risk of progressing to severe disease is just one hurdle cleared, as Pfizer Inc.’s Paxlovid and Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s molnupiravir still have many more laps to run.
There are many companies using artificial intelligence to aid drug development, with a seemingly overwhelming number of “world firsts” being claimed in this quickly evolving field. After signing a three-year neurology drug development deal with Eli Lilly and Co. worth up to $706 million in July, Verge Genomics is also making waves and just raised $98 million in series B financing to support development of its own AI drug development technology.
Cansino Biologics Inc. has entered a development and commercial supply partnership with Aerogen Ltd. for an inhalable version of its COVID-19 vaccine, Convidecia, also known as Ad5-nCoV. Cansino will combine Convidecia with Aerogen’s vibrating mesh aerosol drug delivery technology to produce a consistent droplet size for optimal lung deposition.
With 2021 coming to a close in just a few weeks, the U.S. FDA is racing to release the guidances it planned to get out the door this year. The regulator issued two draft guidances Dec. 7 detailing key clinical and production considerations to support applications for “N of 1,” or single-subject, clinical trials and drug development programs for severely debilitating or life-threatening diseases.
Antengene Corp. Ltd. has formed a partnership with Legochem Biosciences Inc. to jointly develop new antibody-drug conjugates (ADCs) primarily for cancer. The partners will integrate antibodies from Antengene with Legochem’s ADC technology.
Innovent Biologics Inc. has inked a $312 million licensing deal for the development and commercialization of Genfleet Therapeutics Inc.’s KRAS G12C inhibitor, GFH-925, in mainland China, Hong Kong, Macau and Taiwan. Innovent also has additional option-in rights for global development and commercialization.
Beyondspring Inc. and Jiangsu Hengrui Pharmaceuticals Co. Ltd. entered a ¥1.3 billion (US$200 million) deal to commercialize and co-develop the former’s selective immunomodulating microtubule-binding agent plinabulin in greater China.
Building on a March deal leveraging lipid nanoparticle (LNP) technology from Genevant Sciences Corp. to fight liver fibrosis, Takeda Pharmaceutical Co. Ltd. has signed a second agreement with the company for the development and commercialization of therapies for up to two rare liver diseases. The deal includes up to $303 million in up-front and potential milestone payments for Genevant, plus royalties on possible product sales, adding to the first deal's similarly structured $600 million package.
Lumicks BV raised $93 million in a series D financing led by new investors Farallon Capital Management and Lauxera Capital Partners. The proceeds are earmarked for expansion of the Lumicks’ product pipeline and for commercialization of its Z-Movi cell avidity analyzer.
Busting a logjam of inadequate data sharing methods and communications between pharmas and health authorities around the world is the impetus behind the creation of nonprofit Accumulus Synergy Inc., whose common, cloud-based platform is designed to make the regulatory process easier for everyone involved. The coalition’s initial membership is a Who’s Who of big pharma: Amgen Inc., Astellas Pharma Inc., Bristol Myers Squibb Co., Glaxosmithkline plc, the Janssen Pharmaceutical Cos. of Johnson & Johnson, Eli Lilly and Co., Pfizer Inc., Roche Holding AG, Sanofi SA and Takeda Pharmaceutical Co. Ltd.
