A new deal between Adaptimmune Therapeutics plc and Roche Holding AG's Genentech Inc. aims to develop allogeneic cell therapies for up to five shared cancer targets. Should the agreement win regulatory clearance, still pending, Adaptimmune will receive $150 million up front and additional payments of $150 million over five years. In addition, it could be eligible for development, regulatory and commercial milestones payments from Roche exceeding $3 billion, plus royalties. Read More
The FDA has put a hold on a clinical study of a rare disease gene therapy BMN-307 from Biomarin Pharmaceutical Inc. after several mice developed liver tumors following a high dose in a preclinical trial. Read More
The phase III fizzle in autism spectrum disorder (ASD) by French firms Les Laboratoires Servier SAS and Neurochlore SAS was the latest in a disease that has proved challenging because of its heterogeneity, which – in the words of Yehezkel Ben-Ari, president of Neurochlore – “probably makes it impossible to offer a sole treatment for all autistic children.” Read More
China’s NMPA has approved JW Therapeutics Co. Ltd.’s relmacabtagene autoleucel, an autologous chimeric antigen receptor T (CAR T) therapy for the treatment of adults with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy. It marks the first CAR T product to be independently developed in China and approved as a category I biologic product there, as well as the sixth approved CAR T product globally. The anti-CD19 therapy, sometimes called relma-cel, will be marketed as Carteyva. Read More
LONDON – Microbiome specialist Enterobiotix Ltd. closed a $21.5 million series A to advance development of its live bacteria fecal transplant drug pipeline. Read More
One more completed stock market debut and 2021 will have officially matched last year with the highest number of biopharma IPOs on record, and amounts collected through venture capital financings have now risen to the top as well. Read More
India’s drug regulator has approved 31 fixed-dose combination (FDC) drugs out of more than 300 banned products, after an assessment by its drugs technical advisory board. It has also asked for more phase IV postmarketing data for 19 others. Read More
Eyegene Inc. has received the green light from South Korea’s Ministry of Food and Drug Safety (MFDS) for EG-COVID, its mRNA COVID-19 vaccine, to enter the clinic. Eyegene will now begin a phase I/IIa trial, to be conducted in two stages, to evaluate the vaccine’s safety, tolerability and immunogenicity. Read More
The question of whether an artificial intelligence (AI) algorithm can be an inventor has been making the rounds in the past couple of years, and the question came up again in the U.S. District Court for the Eastern District of Virginia. Stephen Thaler, who developed the Device for the Autonomous Bootstrapping of Unified Sentience (DABUS) algorithm that has been credited with two inventions, failed to persuade the court that an algorithm qualifies as an “individual,” and thus patents must still be assigned to humans, at least where the U.S. Patent and Trademark Office is concerned. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arctic Vision, Astrazeneca, Impel, Neuren, Oncopeptides, Pharmabcine, Supernus. Read More
