In what it says could be the largest disclosed patent settlement in the pharmaceutical industry, Roivant Sciences Ltd. has reached a potential $2.25 billion settlement with Moderna Inc. over the use of its lipid nanoparticle delivery technology in the Spikevax COVID-19 vaccine. Read More
China’s National Medical Products Administration has approved Asieris Pharmaceuticals Co. Ltd.’s cold light photodynamic drug-device combination product, Cevira (APL-1702, hexaminolevulinate hydrochloride), which is used as a nonsurgical therapy for treating patients with cervical intraepithelial neoplasia grade 2. Read More
Belgian pharma giant UCB SA is putting skin in the bispecific T-cell engager (TCE) game, announcing a potential $1.1 billion deal to license Antengene Corp.’s ATG-201. ATG-201 is a CD19/CD3 bispecific TCE antibody aimed at autoimmune disorders, though specific indications were not disclosed. Read More
Can-Fite Biopharma Ltd.’s namodenoson met the safety endpoint in its phase IIa open-label study in advanced pancreatic ductal adenocarcinoma patients, a readout that left investors hopeful for survival data, expected to be disclosed later this year. Read More
At the current pace of innovation in the U.S. rare disease space, developing and approving therapies for just half of the 10,000-plus known rare diseases would take more than 160 years, Bradley Campbell, president and CEO of Amicus Therapeutics Inc., recently told the Senate Committee on Aging. Read More
On the heels of China’s approval of Sino Biopharmaceutical Ltd.’s rovadicitinib, Sanofi SA is now inlicensing the first-in-class dual JAK/ROCK inhibitor in a deal worth more than $1.4 billion. Read More
Polares Medical SA raised $50 million in a series C financing round for Mrace, its posterior leaflet replacement system designed to treat mitral regurgitation. Read More
A therapeutic strategy based on alternative splicing of the MECP2 gene could restore protein levels in Rett syndrome, a neurological disorder caused by mutations in that gene. Scientists at Baylor College of Medicine have successfully tested this approach both in vitro in neurons from Rett patients that produce some functional protein, correcting the altered gene expression and improving neuronal functions, and in vivo in mice. Read More
New hires and promotions in the biopharma and med-tech industries, including: 4basebio, Babson, Beacon, Dimerx, Kivu, Latigo, Medivir, Protego, Seres. Read More
Biopharma and med-tech companies raising money in public or private financings, including: Antiverse, Beken, Informuta, Maia, Modular, Poplar, Prolium, Xsensio. Read More
Clinical updates for biopharma and med tech, including data readouts and publications: Bioaffinity, Biocardia, Chiesi, Cour, Delcath, Ensysce, Quell, Snipr, Theravance. Read More
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Adial, Celltype, Cirna, Congruence, Corstasis, Curie.Bio, Esperion, Forendos, Hepion, Kdventures, Molteni, Ono, Organon, Secarna, Senhwa, Sinopia. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Acadia, Asieris, Atara,Dxcover, Hua, Johnson & Johnson, Meiji Seika, Northsea,Pathai, Pharmaessentia, Pierre Fabre , Priovant, Recovryai, Splisense. Read More
