AI drug discovery specialist Insilico Medicine Inc. has landed a multiyear research deal with Sanofi SA to develop candidates for up to six new targets in undisclosed indications. The collaboration included $21.5 million up front for Insilico, and as much as $1.2 billion in additional payments from Sanofi if key research, development and sales milestones are met. The agreement also includes mid-single to up to low double-digit tiered royalties for any products developed. Read More
Briefing documents related to the Nov. 9 meeting of the U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee augur well for Veru Pharmaceuticals Inc.’s request for an emergency use authorization to market VERU-111 (sabizabulin) as a treatment for COVID-19. Read More
Sensorium Therapeutics Inc. closed a $30 million series A round to fund the discovery and development of new psychiatric drugs, inspired by human ethnobotanical practices that date back hundreds or even thousands of years. Read More
Luye Pharma Group has received marketing approval from China’s NMPA for the triple monoamine reuptake inhibitor Ruoxinlin (toludesvenlafaxine hydrochloride) to treat patients with major depressive disorder, a condition that “has become one of the most prevalent mental disorders in China, causing a heavy burden on patients, their families and the entire society,” said Luye President Yang Rongbing. Read More
Innovent Biologics Inc. said that, compared to a placebo, both doses of its anti-PCSK-9 monoclonal antibody tafolecimab tested in a phase III trial “yielded significant and durable reductions” in low-density lipoprotein cholesterol levels and showed a favorable safety profile in Chinese patients with non-familial hypercholesterolemia. Read More
Europe is losing its innovative edge in biopharma, especially when it comes to advanced therapy medicinal products, including tissue, gene and cell therapies used to prevent, treat and cure rare conditions and some cancers. Read More
“We look at Japan with some envy with what they’ve been able to achieve and their approach to regenerative medicine, which has been supported significantly by their federal government,” said Silvio Tiziano, CEO of the Center for the Commercialization of Regenerative Medicine Australia, during the recent Ausbiotech conference in Perth. Read More
Despite coming out strong earlier this year, biopharma deals have slowed significantly, with values now falling behind 2021 by 7.6%. In August, deals were ahead of all recent years, showing a 7% increase over last year. Through early November, the industry has completed 1,296 deals, including licensings, joint ventures and collaborations, valued at $154.6 billion. Read More
New hires and promotions in the biopharma industry, including: Akari, Aviceda, Blue Water Vaccines, Frontier Medicines, Fulcrum, Fusion, Immune-Onc, Korro, Nacuity, Notch, Pharnext, Vectory. Read More
New and updated preclinical and clinical data presented by biopharma firms at the AASLD Liver Meeting, including: 89bio, Albireo, Ascentage, Gannex, Seal Rock, Vaccitech, Vir. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Heart Association Scientific Sessions including: Amgen, Incarda, Innovent, Lexicon, Renibus, Silence. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Nephrology Kidney Week including: Boehringer, Chinook, Eli Lilly, Horizon, Ionis, Lexicon, Vera. Read More
New and updated preclinical and clinical data presented by biopharma firms at the Society for Immunotherapy of Cancer Annual Meeting including: Affimed, Compugen, Genenta, Geneos, Hummingbird, Iovance, Nextcure, Nouscom, Oncolytics. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adverum, Brainstorm, Ferring, GSK, Rallybio, Regeneron, Scisparc, Telix. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brexogen, Inhibikase, Moderna, Sensorion, Sinovac, Verve. Read More