BioSpace News Archive

SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy, announced today that effective November 25, 2020, Priority Health Michigan became the 36th U.S. payor with an exclusive, positive iFuse coverage policy.

Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, and its research alliance partners Fondazione Telethon and Ospedale San Raffaele, today announced that the European Commission (EC) granted full (standard) market authorization for Libmeldy (autologous CD34+ cells encoding the ARSA gene), a lentiviral vector-based gene therapy approved for the treatment of metachromatic leukodystrophy (MLD),

BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that in a Phase 1 clinical trial with BCX9250, an oral activin receptor-like kinase-2 (ALK-2) inhibitor discovered and developed by BioCryst for the treatment of fibrodysplasia ossificans progressiva (FOP), BCX9250 was safe and well tolerated at all doses studied, with linear and dose-proportional exposure supporting once-daily dosing.

Today, Annexon, Inc. (“Annexon”) (Nasdaq: ANNX), a clinical stage biopharmaceutical company developing novel therapies for patients with classical complement-mediated disorders of the brain, body, and eye, announced that patient dosing has started in a Phase 2/3 clinical study of full-length monoclonal antibody, ANX005, to treat Guillain-Barré Syndrome (GBS).

VOTIS Subdermal Imaging Technologies, Ltd., an Israeli corporation, and ii Ventures Private Limited, an Indian company, announced that they have entered into a memorandum of understanding to develop a system to screen the largely rural Indian population for peripheral artery disease.

PureTech Health plc (LSE: PRTC, Nasdaq: PRTC) (“PureTech” or the “Company”), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, today announced that members of its management team will present at the 38th Annual J.P. Morgan Healthcare Conference

AstraZeneca’s TAGRISSO® (osimertinib) has been approved in the US for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumor resection with curative intent.

Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, today announced the Company will present at the 39th Annual J.P. Morgan Healthcare Conference,

Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-centric gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations, today announced that Queen’s University in Ontario, Canada, received Clinical Trial Application (CTA) approval from Health Canada for its investigator-sponsored Phase 1/2 trial exploring TSHA-101,

Anjeza Gjino promoted to Chief Financial Officer; Bill Huyett to transition to Strategic Advisor Cheryl Gault promoted to Chief Operating Officer Amy Schulman stepping down from Board of Directors