Barely a month and a half after its radioconjugate approach landed a potential $1.7 billion deal with Novartis AG, Bicycle Therapeutics plc drew another big radiopharma player to the table, signing a collaboration agreement with Bayer AG to use Bicycle’s peptide technology to discover and develop radiotherapies against cancer targets. Terms are similar to the Novartis deal, with Bayer paying $45 million up front and Bicycle eligible for development and commercial milestones totaling up to $1.7 billion, and underline the growing interest in the radiopharma space.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hubly Surgical, Omeq, Singlera Genomics, Sphingotec.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acarix, Ascensia, Ascertain, Cue Health, Heart Test Labs, Heartsciences, Optain, Oura Health, Proxy.
The recent decision by the EU to delay the implementation dates for the Medical Device Regulation (MDR) initiative is having ripple effects across the globe as other regulatory jurisdictions amend their policies to keep pace. The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) and Australia’s Therapeutic Goods Administration (TGA) have both revised their strategies to align with the latest MDR delay, giving devices that will remain available in the EU a similar extension in the U.K. and Australia.
The regulatory record for successful replacements of the human meniscus is thin, but the latest attempt came up short as a U.S. FDA advisory committee voted 6-2 that the benefits of the Nusurface device by Active Implants LLC did not present an acceptable benefit-risk ratio. The device is commercially available in both the European Union and in Israel, however, suggesting that Memphis, Tenn.-based Active will not give up on the massive U.S. market, which offers a patient population that will undergo a tsunami of total knee replacements in the decades ahead unless a solution for the epidemic of cartilage degeneration can be found.
With AU$20 million (US$13.56 million) in new funding, 4dmedical Ltd. is ramping up its commercialization efforts of its four-dimensional lung imaging platform in the U.S.
Eitan Medical Ltd. plans to launch its Avoset infusion system into the U.S. later this year, following the introduction of the multi-therapy ambulatory infusion system into the European market. The connected Avoset infusion system is expected to transform the way patients receive treatment in post-acute care, as it enables remote monitoring of infusion treatment which will enhance patient safety and improve the user experience.
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