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Data show the potential of Editas’ sickle cell disease and transfusion-dependent beta thalassemia gene therapy candidate, but it might not be enough to overtake Vertex and CRISPR Therapeutics.
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The FDA’s Antimicrobial Drugs Advisory Committee voted 21–0 that the companies’ respiratory syncytial virus antibody, nirsevimab, has a favorable benefit-risk profile in infants and young children.
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Stem Cell Therapy Market Size to Reach Around USD 31.41 BN by 2030
6/9/2023
The global stem cell therapy market size was estimated at USD 11.22 billion in 2022 and it is projected to reach around USD 31.41 billion by 2030 and growing at a compound annual growth rate (CAGR) of 13.73% during the forecast period 2023 to 2030.
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ACROBiosystems Aneuro Partners with Diagnostic Biochips to Accelerate Neuroscience Drug Discovery
6/9/2023
ACROBiosystems, through ACRO Certify and under its Aneuro brand, recently announced the launch of in vivo electrophysiology solutions for neuroscience research with Diagnostic Biochips.
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Inspire Medical Systems, Inc. Announces FDA Approval for Apnea Hypopnea Index Indication Expansion and Increased Body Mass Index Labeling
6/9/2023
Inspire Medical Systems, Inc. announced today that it has received approval from the Food and Drug Administration (FDA) on an expanded indication.
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Daré Bioscience Announces Publication of Phase 1/2 Pharmacokinetic, Safety and Pharmacodynamic Data for DARE-VVA1
6/9/2023
Daré Bioscience, Inc. today announced the publication of results of its Phase 1/2 clinical study of DARE-VVA1, a proprietary, investigational formulation of tamoxifen for intravaginal administration to treat vulvovaginal atrophy (VVA) in women without the use of hormones.
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NRx Pharmaceuticals Announces Closing of $6.28 Million Registered Direct Offering
6/9/2023
NRx Pharmaceuticals, Inc. today announced that it has closed its previously announced registered direct offering for the purchase and sale of 9,670,002 shares of common stock at a purchase price of $0.65 per share of common stock.
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Astellas Submits New Drug Application for Zolbetuximab in Japan
6/9/2023
Astellas Pharma Inc. announced the submission of a New Drug Application on June 9, 2023 to Japan's Ministry of Health, Labour and Welfare for zolbetuximab, a first-in-class investigational Claudin 18.2 -targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2-positive.
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Protagonist Therapeutics Plans a Follow-on Two-Year Extension Study to Enable Further Evaluation of the Long-Term Effects of Rusfertide
6/9/2023
Protagonist Therapeutics, Inc. announced today that Ronald Hoffman, MD, Icahn School of Medicine at Mount Sinai, provided a press briefing this morning on the late-breaking oral presentation abstract LB2710 : Targeted Therapy of Uncontrolled Erythrocytosis in Polycythemia Vera with the Hepcidin Mimetic, Rusfertide.
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TPG and AmerisourceBergen Announce Completion of Acquisition of OneOncology
6/9/2023
TPG and AmerisourceBergen Corporation (NYSE: ABC) today announced the completion of their previously announced acquisition of OneOncology, a network of leading oncology practices.
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Elevation Oncology Announces Pricing of $50 Million Public Offering
6/9/2023
Elevation Oncology, Inc. announced the pricing of an underwritten public offering of 17,810,000 shares of its common stock and, in lieu of common stock to investors that so choose, pre-funded warrants to purchase up to an aggregate of 4,440,000 shares of common stock and accompanying warrants to purchase one share of common stock for each share of common stock or pre-funded warrant sold.
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Shionogi Enrolls the First Participant in Japan in its Global Phase 3 Trial of Ensitrelvir for the Prevention of Symptomatic SARS-CoV-2 Infection
6/9/2023
Shionogi & Co., Ltd. today announced the first participant has been enrolled in Japan in its global Phase 3 study, Stopping COVID-19 pRogression with early Protease InhibitOr treatment – Post Exposure Prophylaxis (SCORPIO-PEP).
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China Approves the World's First Vaccine against XBB Descendent Lineages of SARS-CoV-2 for Emergency Use
6/9/2023
On June 8th, 2023, Coviccine® Trivalent XBB.1.5-Recombinant COVID-19 Trivalent Protein Vaccine developed by WestVac Biopharma/ West China Medical Center, Sichuan University was approved for EUA by relevant authorities in China.
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Servier Presents Updated Results for TIBSOVO® (ivosidenib tablets) in IDH1-mutated Relapsed/Refractory Myelodysplastic Syndromes at the 2023 European Hematology Association (EHA) Congress
6/9/2023
Servier today announced updated data from the Phase 1 trial of TIBSOVO® (ivosidenib tablets) as monotherapy for patients with isocitrate dehydrogenase 1 (IDH1)-mutated relapsed or refractory (R/R) myelodysplastic syndromes (MDS).
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Biorem Announces Stock Option Grant - June 9, 2023
6/9/2023
Biorem Inc. announces that, pursuant to its incentive Stock Option Plan, it has granted incentive stock options to certain directors, of the Company to purchase up to an aggregate of 50,000 common shares in the capital stock of the Company.
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UroGen Pharma Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4) - June 9, 2023
6/9/2023
UroGen Pharma Ltd. today announced the grants of inducement restricted stock units (“RSUs”) to 6 new employees in connection with their employment with UroGen.
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Aytu BioPharma Announces Pricing of $4.0 Million Public Offering Priced At-The-Market and the Appointment of a New Director
6/9/2023
Abhinav Jain of Nantahala Capital Management, LLC Joins the Company's Board of Directors Upon Closing Potential for Additional $7 Million in Event of Exercise of Common Warrants in Full.
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Abeona Therapeutics Announces Regulatory Update on Biologics License Application (BLA) for EB-101
6/9/2023
Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it received feedback from the U.S. Food and Drug Administration (FDA) on June 8, 2023, in which the Company gained the Agency’s alignment on the data required to establish retroviral vector (RVV) comparability, a critical Chemistry, Manufacturing and Controls (CMC) component for the EB-101 Biologics License Application (BLA).
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Zomedica Launches Revolutionary TRUVIEW(TM) Digital Microscope with Advanced Optics, Automated Slide Preparation, and Telepathology Services
6/9/2023
Zomedica Corp. announced today the launch of the revolutionary TRUVIEW TM digital microscopy platform, featuring the proprietary TRUprep TM system that automatically prepares slides, along with LiquiView TM liquid lens technology that provides best-in-class images.
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Disc Presents Positive Initial Data from Phase 2 BEACON Trial of Bitopertin in Patients with Erythropoietic Protoporphyria (EPP) at European Hematology Association (EHA) 2023 Congress
6/9/2023
Disc Medicine, Inc. today presented preliminary findings from its ongoing, Phase 2 open-label BEACON trial evaluating bitopertin, an orally administered glycine transporter 1 (GlyT1) inhibitor, in patients with erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) at the European Hematology Association (EHA) 2023 Congress in Frankfurt, Germany.