BioSpace News Archive

Neurelis, Inc., today announced it will provide highlights of its clinical development program for VALTOCO® (diazepam nasal spray), an acute therapy for episodes of frequent seizure activity (seizure clusters), at the 16th EILAT Conference on New Antiepileptic Drugs and Devices, Madrid Spain, May 22-25, 2022.

Texas Oncology has selected proXimity™ as the primary tool to automate the transfer of clinical trial data from the oncology EMR to the electronic data capture (EDC) systems used by biotech, pharmaceutical, and contract research organizations providing clinical trials with Texas Oncology.

Filterlex Medical Ltd., a cardiovascular medical device startup, announced today results from a first-in-human (FIH) study demonstrating the safety, feasibility, and performance of the CAPTIS device.

Mapi Pharma Ltd. announced that it will present a poster featuring novel clinical data on the treatment of Primary Progressive Multiple Sclerosis with GA Depot at the forthcoming Consortium of Multiple Sclerosis Centers Annual Meeting 2022 to take place in-person only at the Gaylord National Resort & Convention Center, 201 Waterfront Street, National Harbor, Maryland, June 1-4, 2022.

Biora Therapeutics, Inc., the biotech company that is reimagining therapeutics, shared a presentation delivered during Digestive Disease Week®, May 21-24, 2022 in San Diego.

Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates, today announced the first participants have been dosed in a Phase 1 clinical trial to assess the safety and immunogenicity of several formulations of SCB-2020S.

Silk Road Medical, Inc. (Company) (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced that it has entered into a new five-year loan arrangement with Oxford Finance LLC (Oxford) comprising up to a $200 million term loan and up to a $50 million revolving line of credit.

Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) today announced that the Biologics License Application (“BLA”) for OMBLASTYS® (omburtamab) for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma has been accepted for priority review by the U.S. Food and Drug Administration (“FDA”).

Timber Pharmaceuticals, Inc. (“Timber” or the “Company”) (NYSE American: TMBR), a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to TMB-001, a topical isotretinoin formulated using the Company’s patented IPEG™ delivery system, for the treatment of congenital ichthyosis (CI).

SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy, announces FDA 510(k) premarket clearance of the iFuse Bedrock Granite Implant System (Granite).