Sanofi SA has added to its general medicines portfolio with a $1.9 billion acquisition of Kadmon Holding Inc. and its recently-approved graft-vs.-host disease drug Rezurock (belumosudil). Read More
DUBLIN – With more than six months to go before an initial interim readout from its phase III pivotal trial of ilofotase alfa (recombinant human alkaline phosphatase) in sepsis-associated acute kidney injury (SA-AKI), AM-Pharma BV has already found a buyer for Japanese rights to the product. Kyowa Kirin Co. Ltd. is paying €20 million up front and could pay up to €225 million more in milestones attached to the progress of the program. Read More
Hillevax Inc., a company developing a vaccine to prevent moderate to severe acute gastroenteritis caused by norovirus infection, has raised $135 million in crossover financing to support further clinical development of the candidate, HIL-214. Read More
Attralus Inc.’s $116 million series B will advance pan-amyloid removal (PAR) therapeutics, putting lead prospect AT-03 into a phase I biodistribution study soon in systemic amyloidosis patients while advancing other programs, including AT-01, an amyloid-specific imaging radiotracer for diagnosis in the same indication. Read More
Replicate Bioscience Inc. secured a $40 million series A round to take a portfolio of preclinical projects employing self-replicating RNA into the clinic. Read More
Abion Inc., which focuses on precision oncology, raised ₩38.76 billion (US$33.36 million) in its debut on the Korean Stock Exchange’s Kosdaq board on Sept. 8. Read More
Chinese companies are finding that their COVID-19 vaccines are effective as booster shots and against variants of the virus, as data from more studies emerge. Read More
PERTH, Australia – Engeneic Ltd. has begun a phase I trial of its nanocellular COVID-19 vaccine, which in preclinical animal studies stimulated a broad antiviral response against mutant strains of the virus, including the virulent Delta strain sweeping across Australia. Read More
Diaccurate SAB has scooped a cancer drug from Germany’s Merck KGaA, transforming the small French biotech into a clinical-stage company. With expertise on its scientific advisory board from Nobel prize winner Tasuku Honjo, famously credited with the work establishing PD-1 as a target in immune-oncology, Diaccurate said it has fought off other competitors to acquire M-2698. Read More
Illumina Inc. and Merck & Co. Inc. are partnering to commercialize tests identifying genetic mutations used in the assessment of homologous recombination deficiency. Read More
The U.S. Department of Health and Human Services (HHS) reported a rescission of a September 2020 policy that would require that the secretary of health and human Services sign off on any rulemaking by HHS agencies. Despite the firestorm of criticism that followed the issuance of the September 2020 policy, attorney Jim Shehan, of Lowenstein Sandler, told BioWorld that the rulemaking process will remain exceptionally cumbersome, leaving in place a status quo that itself has been the target of repeated criticism. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adaptimmune, Alnylam, Candel, Horizon, Inversago, Knopp, Lexaria, Newron, Onquality, Pliant, Redhill, Servier, Sobi, Trisalus, United, Valbiotis, Zynerba. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alpha Cognition, Ascletis, Biomarin, Cormedix, Gensight, Global Blood, JW, Merck & Co., Moderna, RDIF, Underdog, Versantis. Read More
