BioSpace News Archive

Thermo Fisher Scientific Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the Thermo Scientific B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR novel biomarkers, the first and only immunoassays to receive breakthrough designation and clearance for the risk assessment and clinical management of preeclampsia, a severe pregnancy complication.

Aziyo Biologics, Inc. today announced that positive data from the HEAL Study will be presented at Heart Rhythm Society (HRS 2023) on May 21, 2023, at 12:30 PM CT at the Morial Convention Center in New Orleans, LA.

Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced that the complete study results from its Phase 3 KINECT™-HD study investigating valbenazine for the treatment of chorea associated with Huntington’s disease (HD) has been published in The Lancet Neurology online edition and will appear in the June 2023 print issue.

Genome & Company (CEOs: Pae, Jisoo, Park, Hansoo), a global leading microbiome therapeutics developer, announced that this phase II trial (NCT05419362) will continue without modifications to move on to the second stage, based on the positive result of the interim analysis.

Terran Biosciences (“Terran”), a biotech platform company dedicated to the development of transformational therapeutics for neurological and psychiatric diseases, has announced the publication of a PCT patent application covering what may be the first new salts, co-crystals, and polymorphs of psilocybin in history.

Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF) (the “Company” or “Telo”) is pleased to announce a non-brokered private placement of units (“Units”) at a price of $0.25 per Unit for gross proceeds of $2,000,000 (the “Offering”).

AbbVie announced that the U.S. Food and Drug Administration has approved EPKINLYTM, as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B–cell lymphoma, after two or more lines of systemic therapies.

Reflow Medical, Inc. announced that it has received FDA commercial clearance for its coraCatheters™, a complete line of state-of-the-art microcatheters engineered to access and cross complex and challenging lesions in percutaneous coronary interventions.

Today, the U.S. Food and Drug Administration approved Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.

Regeneron Pharmaceuticals, Inc. and Society for Science announced that Kaitlyn Wang, 17, of San José, CA, won the $75,000 top award in the 2023 Regeneron International Science and Engineering Fair, the world’s largest global pre-college science and engineering competition, for a project that explored planets that orbit very close around their suns.