The deal that could bring IGM Biosciences Inc. more than $6 billion is 2022’s largest and cracks the BioWorld top 10 list as the ninth biggest ever. Sanofi SA and IGM agreed to develop, manufacture and commercialize immunoglobulin M (IgM) antibody agonists in treating cancer and immunology/inflammation targets. IGM is getting $150 million up front once the deal closes, which the company expects to happen in the second quarter of 2022. Read More
Sanofi SA’s enzyme replacement therapy, Xenpozyme (olipudase alfa), has been approved for use in Japan, making it the world’s first and only approved therapy to treat acid sphingomyelinase deficiency (ASMD), also known as Niemann-Pick type B disease. Sanofi’s executive vice president and global head of R&D, John Reed, hailed it as a “watershed moment” that was the culmination of 20 years of research. Read More
Regenerative medicine company Sanbio Co. Ltd. submitted its BLA for its lead mesenchymal stem cell-based treatment, SB-623, to Japan’s Ministry of Health, Labour and Welfare for chronic motor deficit due to traumatic brain injury. The application was submitted through Japan’s Sakigake designation system. Read More
Though conceptually understood for decades, antibody-drug conjugates (ADCs) haven’t begun to come into their own until recently, but oncology drug developers continue to wrestle with challenges, large among them the problem of antigen selection. Lately, companies including names such as Adagene Inc., Bioatla Inc. and Cytomx Therapeutics Inc., have taken particular interest in exploiting features of the cancer growth itself to add more oomph, with focus on special features of the tumor microenvironment (TME). Read More
Policymakers shouldn’t look to march-in rights as a simple solution to make medical products more affordable, according to experts speaking at an Information Technology & Innovation Foundation discussion on how using the march-in provisions of the Bayh-Dole Act as price controls would threaten America’s research universities. Read More
Innovent Biologics Inc. has acquired exclusive rights to commercialize Eli Lilly and Co.’s oncology drugs Cyramza (ramucirumab) and Retsevmo (selpercatinib) in mainland China, where it will be responsible for the pricing, importation, marketing, distribution and sales of the two products. Read More
Leading clinicians in the U.K. have set out a blueprint for integrating pharmacogenomic testing into prescribing in all cases where there is a known association between a gene variant and how an individual will respond – or not – to a particular drug. Read More
Ninnion LLC, a startup developing psychedelic medicines focused on brain injury, chronic pain, inflammation and addiction disorders, has formed a new scientific board (SAB) that Chief Development Officer Bill Massey said will ”be a tremendous asset in navigating the uncharted waters of psychedelic drug development." Read More
New hires and promotions in the biopharma industry, including: Dice, Edesa, Karyopharm, Laekna, Monte Rosa, Nkarta, Shorla, Shouti, Turning Point. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Academy of Dermatology annual meeting, including: Almirall, Amryt, Aslan, Boehringer, Cara, Eli Lilly, Evelo, Incyte, Novartis, Rapt, Regeneron, Senhwa, UCB. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Axsome, Biosion, Caris, Ebvia, Eloxx, Gain, GB Sciences, Grunenthal, Iama, Jazz, Navrogen, Novaquest, Passage, Prestige, Pyxis, Recce, Relief, Saniona, Taysha, Tyme, Vaxine and Zentalis. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biontech, Blue Lake, Cormedix, CSL, Cynavac, Galapagos, GSK, Hansa, Helsinn, Immorna, Innocare, Medison, Moberg, Moderna, Pfizer, Pipeline, Sanofi, Seqirus, Stealth, Tolerogenixx, UCB, Vir. Read More