Rocket Pharmaceuticals Inc. CEO Gaurav Shah said his firm is investigating how its gene therapy for Danon disease may have created an “unexpected and paradoxical” effect that led to problems for a phase II patient who ultimately died.
A development deal with Biogen Inc. could eventually bring City Therapeutics Inc. about $1 billion in milestone payments. It’s a step in the direction the company had been going: looking for the right partners, including those from big pharma. Privately held City Therapeutics is getting $46 million in the deal. That includes $16 million as an up-front payment and an investment of $30 million in exchange for a City Therapeutics convertible note.
Cinclus Pharma Holding AB has chosen Zentiva k.s. to handle manufacturing and commercialization duties in Europe for linaprazan glurate, which is being developed to treat severe erosive gastroesophageal reflux disease.
GSK plc’s Blenrep (belantamab mafodotin) is heading back to the market three years after being withdrawn, with the EMA’s Committee for Medicinal Products for Human Use recommending approval of the antibody-drug conjugate in combination therapy for the treatment of adults with relapsed or refractory multiple myeloma.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Bioarctic, Celltrion, Eli Lilly, Kelun-Biotech, Relief, Urogen.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: AFT, Biodexa, Eikon, Eli Lilly, Emtora, Hyloris, Inside, OSE, Senti.
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