Takeda Pharmaceutical Co. Ltd. has voluntarily withdrawn its U.S. BLA for its dengue fever vaccine, Qdenga (TAK-003), following discussions with the FDA centered on “aspects of data collection, which cannot be addressed within the current BLA review cycle,” the company said in a statement. News of the withdrawal comes more than a month after the May 23 Qdenga PDUFA date. The future plan for Qdenga in the U.S. will be further evaluated given the need for travelers and those living in dengue-endemic areas of the U.S., such as Puerto Rico. Read More
Tenpoint Therapeutics Ltd. raised $70 million in a series A funding round to pursue ambitious plans to reverse vision loss using both ex vivo cell engineering and in vivo cell reprogramming approaches. Read More
From Roche Holding AG to Novartis AG, bad news abounds for anti-TIGIT immunotherapies. In an SEC filing on July 11, Chinese oncology R&D firm Beigene Ltd. and Basel, Switzerland-based Novartis announced an end to their $1 billion deal to develop the former’s TIGIT immunotherapy ociperlimab, with the checkpoint inhibitor going back to Beigene. Read More
The U.K. medical research charity Lifearc has launched the first part of a £100 million (US$130 million) plan to promote translation of biomedical research into therapies for rare diseases, opening the program with a £2.5 million call for projects to repurpose existing drugs to treat the debilitating inherited skin disease epidermolysis bullosa (EB). Read More
The counterintuitive side of preventing a health crisis prompted by antimicrobial resistance showed itself at a July 11 U.S. Senate hearing, with witnesses saying that antibiotics exist to treat current infections but they often don’t have staying power in the market. Read More
On the back of what Arthrosi Therapeutics LLC has called “remarkable efficacy and safety” data from a phase IIb trial of AR-882, a next-generation URAT1 inhibitor for treating gout, the company has padded its coffers with a $75 million series D round led by Guangrun Health Industry Co. Ltd. and backed by investors that include Reichstein Biotech Co. Ltd., a subsidiary of Arthrosi’s China joint venture partner Apichope Pharmaceuticals. Read More
New hires and promotions in the biopharma industry, including: Abivax, Aerovate, Arbutus, Azitra, Brainstorm Cell, Garuda, Neurocrine, Nymox, Ocular, Omega, Pharmajet, Syncromune, Ultragenyx. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Argenx, Astellas, Avrobio, Cytodyn, Iveric, Liminal, Raya, Theratechnologies. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abionyx, Adial, Genentech, Hansa, Lupin, Pulmatrix, Quralis, Renibus, Roche, Salarius. Read More
