Inosys Korea Co. Ltd. gained U.S. FDA 510(k) clearance for Unispace, a cervical spine cage manufactured with 3D printing technology. Unispace can be used during spinal fusion surgery, Busan-based Inosys said, wherein operators can remove a patient’s diseased or damaged disc and replace it with the cervical cage to maintain the original length of the spine.
A week after generating buzz with its proposed Nasdaq listing and plans to raise about $200 million, Telix Pharmaceuticals Ltd. withdrew its U.S. IPO filing, citing market conditions. The Australian radiopharma firm’s shares continue trading on the Australian Securities Exchange (TLX), where they closed June 14 at AU$16.61 (US$10.98), up AU15 cents.
As competition rises in the Keytruda (pembrolizumab) biosimilar space, Celltrion Inc. is the latest to announce that it filed an IND application to the U.S. FDA to start a global phase III trial for its own Keytruda biosimilar, dubbed CT-P51. Incheon, South Korea-based Celltrion, which previously said it would differentiate from the pack by developing an easier-to-administer subcutaneous biosimilar of pembrolizumab, announced June 17 plans to start a global comparative phase III study of CT-P51 and Keytruda.
The Biosecure Act missed its first chance at a congressional ride June 11 when the U.S. House Rules Committee didn’t include it, as many had expected, on the list of potential riders the House will consider for its version of the National Defense Authorization Act, a must-pass defense spending bill for fiscal 2025. But that doesn’t mean the bill will be stranded by the wayside.
South Korea’s Imbiologics Inc. scored a potential $940 million (₩1.3 trillion) technology transfer deal with U.S. biotech Navigator Medicines Inc. for its bispecific antibody drug candidate, IMB-101 (Oxtima), to treat autoimmune diseases.
Marea Therapeutics came out of stealth mode on June 18, after raising a combined $190 million through its series A and B financings. The series A round was led by Third Rock Ventures, and the series B round was led by Sofinnova Investments and co-led by Forbion, Perceptive Xontogeny Venture Fund and Venbio.
Following a day of deals that collectively bring a potential $3.75 billion into three biopharma companies – namely Ascidian Therapeutics Inc., Belharra Therapeutics Inc. and Mabcare Therapeutics – researchers will be busy discovering new therapies for neurological and immunological diseases, and advancing globally a candidate for solid tumors.
Boston Scientific Corp. continued its journey down the acquisition highway with its announced plan to acquire stroke products maker Silk Road Medical Inc. for $27.50 a share, or approximately $1.16 billion.
The U.S. FDA cleared Basel, Switzerland-based Roche Holding AG’s whole-slide imaging system, the Roche Digital Pathology Dx, for use as an aid in clinical diagnosis. The system helps pathologists review and interpret digital images of scanned pathology slides.
An interdisciplinary team of researchers from the University of Arkansas have filed for protection of an optical sensing platform and method for synovial fluid analysis to reduce diagnosis time leading to quicker results for doctors and patients. Their innovation allows for faster and non-destructive evaluation of biological samples.
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