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 has voluntarily withdrawn its U.S. BLA for its dengue fever vaccine, Qdenga (TAK-003), following discussions with the FDA centered on “aspects of data collection, which cannot be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, such as Puerto Rico.

Look sharp: Tenpoint Therapeutics closes $70M series A round to pursue vision

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. In addition to its in-house programs, which it has yet to disclose, it has acquired a preclinical, mutation-independent gene therapy program, SPVN-20, from Paris-based gene therapy firm Sparingvision SA, which is in development for retinitis pigmentosa.

TIGIT in troubled waters as Novartis, Beigene end $1B deal for ociperlimab

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 TIGIT immunotherapy ociperlimab, with the checkpoint inhibitor going back to Beigene. Novartis’ retreat was made after assessing the “totality of the current information, including phase II data, benefit and risk, competitive space, timing, development programs and future investments,” it said.

Lifearc earmarks £100M to repurpose drugs for epidermolysis bullosa

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. In the initial tranche of funding Lifearc will invest £40 million to set up translational centers, each specializing in different aspects of rare disease research. The intention is to add in Lifearc’s expertise in translational science to bridge the gap between the outputs of academic research and clinical development.

Antimicrobial resistance has administrative resistance too

The counterintuitive side of preventing a health crisis prompted by antimicrobial resistance showed itself at a July 11 U.S. Senate hearing. The system, according to Christine Miller, CEO of Melinta Therapeutics LLC, speaking to the Health, Education, Labor and Pensions Committee, is off kilter because of a flawed reimbursement structure that separates physicians from the newest, safest and most appropriate drugs. Plus, she added, since antimicrobial companies rarely recoup their investment under traditional volume-based payment structures for drugs alone, many are unable to remain commercially viable and fail shortly after they launch. Another speaker at the hearing, Helen Boucher, of Tufts University, recommended creating an antimicrobial fast-track program to prepare for a pandemic.

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