BioSpace News Archive

In the latest round of SNF’s $100 million global COVID-19 relief initiative, new grants continue the initiative’s focus on supporting organizations providing essential services to vulnerable populations

Pfizer Inc. (NYSE:PFE) today announced results from the Phase 3 CROWN trial of LORBRENA® (lorlatinib, available in Europe under the brand name LORVIQUA®) versus XALKORI® (crizotinib) in people with previously untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) were published online ahead of print in the New England Journal of Medicine.

Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for OTL-200, an autologous, hematopoietic stem cell, lentiviral vector-based gene therapy in development for the treatment of metachromatic leukodystrophy (MLD). The company also has applied for Regenerative Medicine Advanced Therapy (RMAT) des

Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company developing transformative therapeutics, today announced the Company has received guidance from the U.S. Food and Drug Administration (FDA) on a Phase 3 trial design for AVB-500 in platinum resistant ovarian cancer (PROC). The global, randomized, double-blind, placebo-controlled adaptive trial is designed to evaluate efficacy and tolerability of AVB-500 at a dose of 15 mg/kg in combination

Begins Enrollment in the First of Four Upcoming Late-Stage Trials in the U.S. Announces MIRA-1 Phase 2b Study Accepted for Peer-Reviewed Publication in Optometry and Vision Science

Freeline Therapeutics Holdings plc (Nasdaq: FRLN) (the “Company” or “Freeline”), a clinical-stage, fully integrated, next generation, systemic AAV-based gene therapy company with the ambition of transforming the lives of patients suffering from inherited systemic debilitating diseases, today announced that management will participate in a fireside chat at the 3rd Annual Evercore ISI Health CONx Conference on 3 December, 2020 from 08.00 – 8.20 am ET.

- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, recently announced the issuance of United States Patent No.10,709,713 (the ‘713 Patent) on July 14, 2020. The ‘713 Patent covers the use of ANJESO ® to treat moderate to severe pain, and has been listed in the United States Food and Drug Administration’s (FDA) Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations as

Swedish Orphan Biovitrum AB (publ) (SobiTM) (STO:SOBI) and Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the first patient has been dosed in the potentially registrational phase 2 MERIDIAN study of pegcetacoplan, a targeted C3 therapy, in approximately 200 adults with sporadic amyotrophic lateral sclerosis (ALS).

OpSens Inc. (“OpSens” or the “Company”) (TSX: OPS) (OTCQX: OPSSF) today reported its results for the fourth quarter and fiscal year 2020 ended August 31, 2020 . Financial Highlights Sales of product at $29.5 million in FY 2020 compared to prior FY 2019; Delivered Q4 2020 a $2.2 million improvement in

VolitionRx Limited (NYSE AMERICAN: VNRX) (“Volition”), a multi-national epigenetics company developing simple, easy to use, cost effective blood tests to help diagnose a range of cancers and other diseases, has announced that Dr. Mark Eccleston , a founding scientist and Business Development Director at Volition, will today present preli