BioSpace News Archive

Tenaya Therapeutics, a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for its second gene therapy product candidate, TN-401, for the treatment of arrhythmogenic right ventricular cardiomyopathy (ARVC).

Gilead Sciences, Inc. and Arcus Biosciences announced a positive update from the fourth interim analysis of the randomized, open-label Phase 2 ARC-7 study in patients with first-line metastatic non-small cell lung cancer with PD-L1 tumor proportion score ≥50% without epidermal growth factor receptor or anaplastic lymphoma kinase mutations.

ValGenesis, Inc and LifeBee have partnered to deliver best-in-class business consulting and innovative digital validation solutions in GxP regulated areas such as manufacturing, quality assurance, laboratories, logistics, serialization, regulatory affairs and pharmacovigilance for biopharmaceutical, medical devices, and nutraceutical companies across Italy and Switzerland.

HALO Diagnostics, the leader in early disease detection using precision diagnostics, and Ikonopedia, a next-generation breast imaging reporting and tracking solution, today announced a genetic testing partnership to improve breast cancer detection and patient outcomes.

Heart Test Laboratories, Inc.d/b/a HeartSciences (NASDAQ: HSCS; HSCSW)(“HeartSciences” or the “Company”) today announced that Andrew Simpson, Chief Executive Officer of HeartSciences, will be presenting at the 2022 RHK Disruptive Growth Conference being held December 5-6, 2022 at the offices of Reed Smith in New York City.

Canon Medical Systems USA Inc. today announces the launch of SP Configurations, Orian SP and Galan SP.

BT BeaMedical Technologies (“BeaMed”), a private company developing a next-generation laser-based platform for epilepsy and cancer surgery, has notified Innovation Pharmaceuticals (OTC: IPIX) (the “Company”) that it has received U.S. Food and Drug Administration (FDA) clearance (K222701) for its MANTA surgical laser family.

Peptron, Inc. (KOSDAQ: 087010), a leading company in the development of peptide-based sustained-release drug products, announced on November 17 that it has successfully established bioequivalence of “PT105,” once-a-month injectable Leuprolide for the treatment of prostate cancer, breast cancer, endometriosis, and precocious puberty.

Blackford today announced their partnership to advance the real-time monitoring of AI performance with in-depth clinical intelligence.

Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (“Biocytogen”, HKEX: 02315) today announced that it has entered into an evaluation and option agreement with ADC Therapeutics SA.