BioSpace News Archive

Atara Biotherapeutics, Inc. (Nasdaq: ATRA) and Pierre Fabre today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the European Commission (EC) approval of Ebvallo.

BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, and its affiliate company ML Bio Solutions, today reported 12-month data from the Phase 2 study of BBP-418 in patients with limb-girdle muscular dystrophy type 2i (LGMD2i).

Enzo Biochem, Inc. (NYSE:ENZ), a leading biosciences and diagnostics company, today reported operating results for the fiscal year and fourth quarter ended July 31, 2022 and provided a business update on recent corporate and operational developments.

Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, reported today that dosing with ALG-125755, an siRNA targeting the production of hepatitis B surface antigen (HBsAg), was initiated in healthy volunteers in Study ALG-125755-501 (NCT05561530).

Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced two global advancements for LIVMARLI® (maralixibat) oral solution, an oral minimally absorbed ileal bile acid transporter (IBAT) inhibitor currently approved in the U.S. for the treatment of cholestatic pruritus in patients with Alagille syndrome one year of age and older.

Critical Path Institute (C-Path) announced October 13, 2022 that its Transplant Therapeutic Consortium (TTC), of which Veloxis Pharmaceuticals is a member, received a draft qualification opinion for the iBox Scoring System through the European Medicines Agency’s (EMA) qualification of novel methodologies for drug development.

NuGen Medical Devices Inc., a leader in needle-free drug delivery, is pleased to announce the appointment of Erik Emerson to the Company’s Advisory Board.

T2 Biosystems, Inc., a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced the publication of three new, peer-reviewed studies that demonstrate the clinical value of the use of the T2 Biosystems’ products, also referred to as T2 Magnetic Resonance Technology.

Bold Therapeutics, a clinical-stage biopharmaceutical company, announced that they are attending the BIO-Europe 2022 conference in Leipzig, Germany from October 24 – 26, as well as presenting at the BIO-Europe Virtual Conference from November 2 - 4.

-Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its CLIA/CAP-certified clinical laboratory Provista Diagnostics has filed an Emergency Use Authorization (EUA) application with the US Food & Drug Administration (FDA) for its PCR MonkeyPox Test.