BioSpace News Archive

The Swiss pharma continues its winning streak with the FDA’s approval of the intravenous formulation of Cosentyx for ankylosing spondylitis, axial spondyloarthritis and psoriatic arthritis.

Following rumors last week of a potential acquisition by Sanofi, Bristol Myers Squibb on Sunday announced that it paid $4.8 billion to gain access to Mirati Therapeutics’ oncology-focused portfolio.

Despite winning the backing of an FDA advisory committee, the regulator in a Complete Response Letter declined Alnylam’s bid to expand Onpattro’s label to cardiomyopathy in ATTR amyloidosis.

Sigrid Therapeutics announces the commencement of the SHINE clinical trial for SiPore21® – an innovative medical device designed for sustained diabetes and weight control.

Masimo announced the CE mark, under the European Union Medical Device Regulation, for the LiDCO® board-in-cable module.

LimmaTech Biologics AG announced the closing of a USD 37 million Series A financing round co-led by Adjuvant Capital, AXA IM Alts, and the Novo Holdings REPAIR Impact Fund.

Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that company management will attend and hold one-on-one investor meetings at the upcoming Jones Trading 2023 Healthcare Summit being held October 9-11, 2023 in Miami, FL

Ascensia Diabetes Care and Senseonics Holdings, Inc. have launched a new U.S. advertising and marketing campaign for Eversense® E3 CGM System.

HistoSonics®, (www.histosonics.com), the manufacturer of the Edison® System and novel histotripsy therapy platforms, announced today the marketing authorization of its “Breakthrough” platform via the U.S. Food and Drug Administration’s (FDA) De Novo Classification Request process, a rigorous pre-market review pathway for medical devices with no existing predicate.

Radiopharm Theranostics (ASX:RAD), a developer of a world-class platform of radiopharmaceutical products for both diagnostic and therapeutic uses, is pleased to announce it has been granted Human Research Ethics Committee (HREC) approval to commence its First-In-Human Phase I study in Australia for the Company’s therapy for patients with PDL1-positive non-small cell lung cancer (NSCLC).