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Intercept’s failure to secure FDA approval for obeticholic acid (OCA) tablets in non-alcoholic steatohepatitis shines a light on safety challenges in the space, experts told BioSpace.
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The FDA has three upcoming action dates in the next two weeks, including a highly anticipated decision regarding Biogen and Sage’s depression drug zuranolone.
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With its hypoimmune technology, the company looks to reshape the future of cell and gene therapy.
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Amid U.S. shortages in crucial drugs, House Republicans have filed their own draft bill that seeks to increase the accountability of the FDA and provide more flexibility for generics manufacturers.
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Bionano Announces OGM Roadshow, TOUR, which Provides Education on the Company’s Workflow and Helps Build a Community of Users
7/31/2023
Bionano Genomics, Inc. announced the successful launch of its optical genome mapping roadshow, Bionano TOUR, a series of regional customer-led events that showcase the latest advancements to the OGM workflow and demonstrate applicable research applications.
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Positron Corporation Orders Six Attrius® PET Systems and Components from Neusoft Positron Medical Systems
7/31/2023
Positron Corporation is pleased to announce that in combination with its new Business Cooperative Partnership with Shenyang Intelligent Neuclear Medical Technology Co, a wholly owned subsidiary of Neusoft Medical Systems, Positron has agreed on terms to purchase the current inventory from the Company’s PET Joint Venture partner, Neusoft Positron Medical Systems.
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Inspire Medical Systems, Inc. Announces the Addition of Charisse Y. Sparks, M.D. as Chief Medical Officer
7/31/2023
Inspire Medical Systems, Inc., a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea, announced the addition of Charisse Y. Sparks, M.D., as Chief Medical Officer, effective July 27, 2023.
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Crinetics Hosting Key Opinion Leader Webinar to Discuss the Current Treatment Landscape and Unmet Need in Acromegaly
7/31/2023
Crinetics Pharmaceuticals, Inc. announced that it will host a Key Opinion Leader webinar on August 8, 2023 at 12:00 pm Eastern Time, featuring presentations by KOLs Beverly MK Biller M.D. and Karen JP Liebert, R.N., BSN, both of Massachusetts General Hospital, who will discuss the current landscape and unmet medical need in acromegaly, as well as the treatment burden associated with standard-of-care injectable somatostatin receptor ligands.
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Daré Bioscience Announces Grant Award Supporting Development of Potential New Therapeutic Intervention for the Prevention of Idiopathic Preterm Birth
7/31/2023
Daré Bioscience, Inc. today announced it was awarded a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH) in the amount of approximately $385,000 to support activities related to the conduct and completion of proof-of-concept target validation studies in support of a potential new approach for the prevention and treatment of idiopathic preterm birth.
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Amarin and Lotus Pharmaceuticals Announce Exclusive Partnership Agreement to Commercialize Vazkepa® (Icosapent Ethyl) in Southeast Asia and South Korea
7/31/2023
Amarin Corporation plc and Lotus Pharmaceuticals announced that the two companies have entered into a long-term exclusive partnership to distribute and commercialize VAZKEPA® across 10 countries, including nine in Southeast Asia and South Korea.
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Ultragenyx Announces Initiation of Dosing in Second Cohort of Pivotal Phase 1/2/3 Cyprus2+ Trial Evaluating UX701 Gene Therapy for the Treatment of Wilson Disease
7/31/2023
Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced it has begun dosing the second dose-escalation cohort in its pivotal Phase 1/2/3 Cyprus 2 + study following completion of dosing and safety review in the first cohort.
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SEKISUI Diagnostics announces the Launch of the OSOM® COVID-19 Antigen Home Test
7/31/2023
SEKISUI Diagnostics announces the launch of the OSOM COVID-19 Antigen Home Test to diagnose COVID-19 at home.
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Appendix 4C – Q4 FY23 Quarterly Cash Flow Report
7/31/2023
Alterity Therapeutics Limited, a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, releases its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 30 June 2023.
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Spero Therapeutics Announces Special Protocol Assessment Agreement with FDA for Phase 3 PIVOT-PO Trial of Tebipenem HBr
7/31/2023
Spero Therapeutics, Inc. announced today that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design and size of PIVOT-PO, a pivotal Phase 3 clinical trial of tebipenem HBr in patients with complicated urinary tract infection (cUTI), including acute pyelonephritis (AP).
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Globus Medical Announces Launch of the MARVEL™ Growing Rod System, the company’s first product designed specifically for early onset scoliosis
7/31/2023
Globus Medical, Inc. announced the commercial launch of the MARVEL™ Growing Rod System, which is designed for pediatric patients with early onset scoliosis to obtain and maintain correction while allowing for growth through minimally invasive distraction.
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HUTCHMED Reports 2023 Interim Results and Provides Business Updates
7/31/2023
HUTCHMED Limited, the innovative, commercial-stage biopharmaceutical company, reports its unaudited financial results for the six months ended June 30, 2023 and provides updates on key clinical and commercial developments.
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Neurona Therapeutics Appoints James Stutz as Chief Financial Officer and Chief Business Officer
7/31/2023
Neurona Therapeutics today announced the appointment of James Stutz, a business and finance executive with over 20 years of experience in the biopharma industry, as chief financial officer (CFO) and chief business officer (CBO).
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New Publication Highlights Real World Impact of Trilaciclib on Myelosuppressive Events in Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC)
7/31/2023
G1 Therapeutics, Inc. (Nasdaq: GTHX) today announced the publication of real world outcomes data from published and new unpublished studies showing the potential of trilaciclib to reduce single and multilineage myelosuppressive events associated with chemotherapy, cytopenia-related healthcare utilization, and hospitalizations in adults being treated for extensive stage small cell lung cancer (ES-SCLC).
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Solve GNE and Gradalis Sign Agreement to Develop a Novel Gene Therapy Targeting HIBM
7/31/2023
Solve GNE announced today that it has entered into a sponsored research agreement with Gradalis, Inc. to provide funding for a novel lipid nanoparticle gene therapy aimed at curing GNE Myopathy or Hereditary Inclusion Body Myopathy (HIBM).
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Immutep Quarterly Activities Report Q4 FY23
7/31/2023
Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune diseases, provides an update on the ongoing development of its product candidates, eftilagimod alpha (efti) and IMP761 for its fiscal fourth quarter ended 30 June 2023 (Q4 FY23).