The U.K. Medicines and Healthcare products Agency (MHRA) is to stop carrying out its own appraisals of drugs that are being reviewed by the U.S. FDA, the EMA or Japan’s PDMA, and will instead set up “global recognition routes,” through which companies can apply to place products on the U.K. market that have passed regulatory scrutiny elsewhere.
An investor has seen promise in First Wave Biopharma Inc.’s targeted, systemic gastrointestinal disease biotherapeutics, offering $4 million in a private placement as enrollment picks up pace in a phase II trial for the company’s lead candidate, adrulipase.
Seamless Therapeutics GmbH raised $12.5 million in seed financing to take forward a novel gene editing technology based on reprogramming recombinase enzymes.
Health Guard Biotechnology Inc. raised ¥294 million (US$43 million) in an IPO on the SME-focused Beijing Stock Exchange, with the funds going to push the development of its HPV vaccines.
Mediar Therapeutics Inc. emerged from stealth, unveiling $105 million in investment and bold ambitions to develop new ways of tackling fibrosis. Cambridge, Mass.-based Mediar is challenging what CEO Rahul Ballal called “the fundamental dogma” of fibrosis therapy: “You have to address fibrosis at its initiation, when inflammation is rampant.” Mediar, in contrast, is focused on developing therapies that either disrupt or reverse the fibrotic process, particularly when it progresses from a moderate to a severe state.
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