BioSpace News Archive

Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that the US Food and Drug Administration (FDA) has accepted for filing the initial Biologics License Application (BLA) for somatrogon, a long-acting human growth hormone that is intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency (GHD).

TransEnterix, Inc. (NYSE American: TRXC) announced today that Anthony Fernando, President and Chief Executive Officer, and Shameze Rampertab, Executive Vice President and Chief Financial Officer, will present at two upcoming virtual investor conferences:

SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy, announced today that the International Society for the Advancement of Spine Surgery (ISASS) published an early view of its updated Policy on MIS Sacroiliac Joint Fusion (For Chronic Sacroiliac Joint Pain) in the December 2020 issue of the International Journal of Spine Surgery (https://www.ijssurgery.com)

G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced the appointment of William C. Roberts as its Vice President, Investor Relations & Corporate Communications.

Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that management will participate in the following upcoming investor conferences in January:

Passage Bio, Inc. (Nasdaq: PASG), a genetic medicines company focused on developing transformative therapies for rare monogenic central nervous system (CNS) disorders, today announced that U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for the company’s lead product candidate, PBGM01,

Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company developing innovative medicines for people with serious diseases of the central nervous system (CNS), today announced that it will present a corporate overview at upcoming investor conferences:

Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small-molecule drugs for the treatment of cancer and other life-threatening diseases, today announced topline results from the CANTATA clinical study of the company’s glutaminase inhibitor telaglenastat in patients with advanced or metastatic renal cell carcinoma (RCC)

Enzo Biochem, Inc. (NYSE:ENZ) (“Enzo” or “The Company”), a leading biosciences and diagnostics company, announced today that it has received an expansion of its Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) authorizing the use of pooled samples containing up to five individual swab specimens with the Company’s AMPIPROBE® SARS-Cov-2 Test System utilizing tests

- Safety Review Committee approved Phase 1b expansion cohorts in study arm evaluating zandelisib in combination with zanubrutinib in various B-cell maligniancies - - MEI provides clinical pipeline outlook for 2021 - - MEI Pharma to present at the H.C. Wainwright BIOCONNECT 2021 Virtual Conference -