BioSpace News Archive

Investment to accelerate growth amid an increasing market demand for Immunohistochemistry instruments and reagents.

Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for aficamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that Suber Huang, MD, MBA, FASRS, Founder and CEO of the Retina Center of Ohio, will present safety and efficacy data from Outlook Therapeutics’ Phase 3 pivotal NORSE TWO trial evaluating ONS-5010 / LYTENAVA™ (bevacizumab-vikg).

VBI Vaccines Inc. today announced the filing of a New Drug Submission (NDS) to Health Canada for the Company’s 3-antigen prophylactic hepatitis B vaccine candidate, seeking approval in Canada for the prevention of infection caused by all known subtypes of the hepatitis B virus in adults.

NextVivo , a biotech company developing an immune organoid technology platform, emerged from stealth today with $7.9M in financing led by Khosla Ventures, with participation from Alexandria Venture Investments, Wilson Sonsini, and individual investors.

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), today announced that it has submitted a Phase 3, randomized, double blind, placebo controlled trial with the U.S. Food and Drug Administration (“FDA”) to evaluate the efficacy and safety of leronlimab in combination with standard of care for critically ill patients with COVID-19 pneumonia with need for invasive mechanical ventilation (“IMV”) or Extracorporeal Membrane Oxygenation (“ECMO”).

Rising prevalence of breast cancer and growing awareness about early detection of breast cancer to drive market growth.

Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), today announced that NovoCodex Pharmaceuticals Ltd. (NovoCodex), Ambrx’s partner in China, presented positive safety and efficacy data from its ongoing ACE-Breast-01 Phase 1 clinical study of ARX788 at the San Antonio Breast Cancer Symposium (SABCS).

According to Emergen Research, the global personalized therapy biosimulation market size was USD 1,061.7 million in 2020 and is expected to reach USD 3,164.1 million in 2028 and register a revenue CAGR of 14.6% during the forecast period, 2021-2028.

New results from the DESTINY-Breast03 Phase III trial showed that ENHERTU® (fam-trastuzumab deruxtecan-nxki) demonstrated a higher progression-free survival (PFS) and objective response rate (ORR) in pre-specified patient subgroups compared to trastuzumab emtansine (T-DM1) in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.