BioSpace News Archive

U.S. Food and Drug Administration Approves Expanded Indication of Gilead’s Biktarvy ® for Treatment of HIV-1 in Pediatric Populations

Saniona (OMX: SANION), today announced that it has completed the submission of all information previously requested by the U.S. Food and Drug Administration (FDA) regarding its chemistry, manufacturing and controls (CMC) program for Tesomet capsules.

Schrödinger (Nasdaq: SDGR) and Centessa Pharmaceuticals plc (“Centessa”) (Nasdaq: CNTA), together with subsidiary Orexia Therapeutics (“Orexia”), today announced an exclusive collaboration focused on the discovery of novel therapeutics targeting the orexin-2 receptor (OX2R), which is known to play a role in a broad spectrum of sleep disorders including narcolepsy.

LEO Pharma Inc. announced today the Health Canada approval of Adtralza® (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis (AD) in adults aged 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Theranica, a prescribed digital therapeutics company developing advanced electroceuticals for migraine and other pain conditions, announced today a new peer-reviewed article, with the publication of a chronic migraine study by Pain Reports.

LogicBio Therapeutics, Inc. (Nasdaq:LOGC), a clinical-stage genetic medicine company, today announced clinical trial results demonstrating the first-ever in vivo genome editing in children.

AnHeart Therapeutics (“AnHeart”), a clinical-stage global biopharmaceutical company committed to developing novel precision oncology therapies, today announced sponsored research to evaluate AB-329, an AXL inhibitor in metastatic breast cancer.

Takara Bio USA, Inc., a wholly owned subsidiary of Takara Bio Inc., today announced the launch of the SMART-Seq® Pro kit for the ICELL8® cx Single-Cell System.

Masimo (NASDAQ: MASI) today announced the findings of an abstract presented at ANESTHESIOLOGY 2021 in San Diego, in which Drs. Anita Kulkarni and Arti Dalal at the Rajiv Gandhi Cancer Institute in New Delhi, India evaluated the use of noninvasive, continuous Masimo PVi® as part of goal-directed fluid therapy (GDFT) to guide intraoperative fluid administration during major oncosurgery in which lung ultrasonography (LUS) is used to diagnose extravascular lung water (EVLW).

PerkinElmer, Inc. (NYSE: PKI) and Honeycomb Biotechnologies, Inc., announced today the commercial launch of the first of its kind HIVETM scRNAseq Solution for single-cell isolation and analysis.