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• Chance Pharmaceuticals and Acorda Therapeutics Announce Agreement to Provide INBRIJA® in Greater China

  5/8/2023

  Chance Pharmaceuticals and Acorda Therapeutics, Inc. today announced that they have entered into distribution and supply agreements to provide INBRIJA ® in Greater China (Mainland China , Taiwan , Hong Kong , and Macao ). INBRIJA is indicated in the United States for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson's disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor.

• Singlera Genomics Receives FDA Breakthrough Device Designation for PDACatch, a Liquid Biopsy Assay for Pancreatic Cancer Detection in High-Risk Individuals

  5/8/2023

  Singlera Genomics today announced that it had received Breakthrough Device Designation from the Food and Drug Administration (FDA) for its PDACatch assay, a novel DNA methylation-based liquid biopsy assay for the detection of pancreatic adenocarcinoma in individuals at high risk for the disease.

• MCRA Assists Noctrix Health with FDA Marketing Authorization via the De Novo Pathway for the NTX100 Tonic Motor Activation System

  5/8/2023

  MCRA, LLC is pleased to announce its role in assisting Noctrix Health obtain marketing authorization via a De Novo Request from the U.S. Food and Drug Administration (FDA) for the NTX100 Tonic Motor Activation (NTX100 TOMAC) System.

• Viridian Therapeutics Announces Partnership with Drug Delivery Innovator Enable Injections

  5/8/2023

  Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today announced a new partnership with Enable Injections, a company developing and manufacturing the enFuse® innovative wearable drug delivery system for volumes of up to 25mL.

• Sana Biotechnology Announces Preclinical Data Published in Nature Biotechnology Demonstrating its Hypoimmune-Engineered Cells Escape Immune Detection and Survive While Remaining Fully Functional

  5/8/2023

  Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced that Nature Biotechnology has published a paper titled “Hypoimmune induced pluripotent stem cells survive long term in fully immunocompetent, allogeneic rhesus macaques.”

• Insmed Unveils New Research Platforms and Capabilities at Investor and Analyst Event, "The Future of Rare at Insmed: Functional Genes, AI-Enhanced Proteins, Glowing Algae, and More"

  5/8/2023

  Insmed Incorporated today announced progress across its early-stage research programs, which will be discussed in greater detail this morning at the Company's investor and analyst event, The Future of Rare at Insmed: Functional Genes, AI-Enhanced Proteins, Glowing Algae, and More.

• Codexis Announces New Employment Inducement Grants - May 08, 2023

  5/8/2023

  Codexis, Inc., a leading enzyme engineering company, announced the approval of equity grants to five new employees as approved by the Compensation Committee of Codexis’s Board of Directors.

• Quest HealthConnect(TM): Personalized Access to Quality Healthcare

  5/8/2023

  Enabled by a national network of trusted, long-standing relationships with medical professionals, Quest HealthConnect provides a personalized approach, often at members' homes, through an on-site Health Risk Assessment.

• Ironwood Presents New Data on Potential of Linaclotide for Functional Constipation in Children and Adolescents Ages 6-17 Years-Old at Digestive Disease Week® 2023

  5/8/2023

  Ironwood Presents New Data on Potential of Linaclotide for Functional Constipation in Children and Adolescents Ages 6-17 Years-Old at Digestive Disease Week ® 2023.

• Baxter Signs Definitive Agreement to Divest its BioPharma Solutions Business to Advent International and Warburg Pincus for $4.25 Billion

  5/8/2023

  Baxter International Inc., a leading global medtech company, announced that it has signed a definitive agreement to divest its BioPharma Solutions business to Advent International, one of the largest and most experienced global private equity investors, and Warburg Pincus, a leading global growth investor.

• Citius Pharmaceuticals Announces Closing of $15 Million Registered Direct Offering

  5/8/2023

  Citius Pharmaceuticals Inc. announced the closing of its previously announced registered direct offering with certain healthcare-focused and institutional investors for the purchase of an aggregate of 12,500,001 shares of its common stock and accompanying warrants to purchase up to an aggregate of 12,500,001 shares of its common stock, at a purchase price of $1.20 per share and accompanying warrant.

• Acasti Successfully Submits Pivotal GTX-104 Phase 3 Safety Study Protocol with FDA and Implements Strategic Realignment Plan That Extends Projected Cash Runway Through Calendar Q2 2025

  5/8/2023

  Acasti Pharma Inc. today announced the successful submission to the FDA of GTX-104's full protocol of its pivotal Phase 3 Safety Study and implementation of a strategic realignment plan to maximize shareholder value.

• CureVac Announces Dosing of First Participant in Combined Phase 1/2 Study of Multivalent, Modified Influenza Vaccine Candidates Developed in Collaboration with GSK

  5/8/2023

  CureVac N.V. today announced that the first participant was dosed in the Phase 1 part of a combined Phase 1/2 study of multivalent, modified mRNA seasonal flu vaccine candidates, developed in collaboration with GSK.

• Ginkgo Bioworks Partners with Boehringer Ingelheim to Develop Breakthrough Therapies for Hard-to-Treat Diseases

  5/8/2023

  Ginkgo Bioworks today announced a new partnership with Boehringer Ingelheim.

• Bliss Biopharmaceutical Enters Into a Clinical Trial Collaboration Agreement With an Option of Strategic Collaboration With Eisai for BB-1701

  5/8/2023

  Bliss Biopharmaceutical Co., Ltd announced a clinical trial collaboration agreement with option for strategic collaboration with Eisai Co., Ltd., for BB-1701, eribulin-payload based ADC directed against Human Epidermal Growth Factor Receptor 2 for the treatment of cancers.

• INmune Bio, Inc. Announces FDA Clearance of IND Application for INKmune™, a Natural Killer Therapy, for a Phase I/II Trial in Metastatic Castration-Resistant Prostate Cancer

  5/8/2023

  INmune Bio, Inc. (NASDAQ: INMB) announced today the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for INKmune™, a novel natural killer (NK) cell immunotherapy, for a Phase I/II open-label clinical trial for the treatment of metastatic Castration-Resistant Prostate Cancer (mCRPC).

• Genome Insight Launches in the U.S. with Innovative Whole Genome Sequencing Approach that Offers Unprecedented, Actionable Insights in Cancer Care

  5/8/2023

  Genome Insight announced today the U.S. launch of CancerVision, their innovative whole genome sequencing (WGS) test designed to provide accurate, timely and medically meaningful insights that collectively guide personalized healthcare decisions.

• Edwards' Aortic Valve With Resilia Tissue Shows Favorable Durability, Safety and Efficacy Outcomes in Seven Year Data

  5/8/2023

  Edwards Lifesciences announced new data from the COMMENCE aortic trial, demonstrating low rates of structural valve deterioration in bioprosthetic aortic valves with the company's innovative RESILIA tissue.

• Enlivex Announces Issuance of European Patent Covering the Use of Allocetra™ to Prevent Cytokine Release Syndrome (CRS) Resulting from CAR T-Cell Therapy

  5/8/2023

  Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the issuance of a European patent, numbered 3865189, entitled, “Combination Immune Therapy and Cytokine Control Therapy for Cancer Treatment.”

• Myriad Genetics Earns 2023 Great Place to Work Certification™

  5/8/2023

  Myriad Genetics, Inc., a leader in genetic testing and precision medicine, announced it has achieved the Great Place to Work® certification for 2023.