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U.S. FDA Approves AKEEGA™ (Niraparib and Abiraterone Acetate), the First-And-Only Dual Action Tablet for the Treatment of Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer
8/11/2023
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food & Drug Administration (FDA) has approved AKEEGA™ (niraparib and abiraterone acetate), the first-and-only dual action tablet combining a PARP inhibitor with abiraterone acetate, given with prednisone, for the treatment of adult patients with deleterious or suspected deleterious BRCA-positive mCRPC, as detected by an FDA-approved test.
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SaponiQx Announces Breakthrough in Scaling Up of STIMULON™ Cultured Plant Cell Adjuvant
8/9/2023
SaponiQx, the adjuvant subsidiary of Agenus Inc. (NASDAQ: AGEN), specializing in saponin-based adjuvant discovery and manufacturing, has achieved a milestone in scaling the production of its STIMULON cultured plant cell (cpc) QS-21 adjuvant, designed to amplify the efficiency and endurance of vaccines.
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Lyell Immunopharma Reports Business Highlights and Financial Results for the Second Quarter 2023
8/8/2023
Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical‑stage T-cell reprogramming company advancing a diverse pipeline of cell therapies for patients with solid tumors, today reported financial results and business highlights for the second quarter ended June 30, 2023.
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Arbor Biotechnologies Appoints Deanna M. Petersen as Chief Business Officer
8/7/2023
Arbor Biotechnologies®, a biotechnology company discovering and developing the next generation of genetic medicines, announced the appointment of Deanna M. Petersen, MBA, as its Chief Business Officer.
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GSK's Arexvy, the first respiratory syncytial virus (RSV) vaccine for older adults approved in Canada
8/4/2023
Arexvy (respiratory syncytial virus vaccine - recombinant, AS01E adjuvanted) has been approved in Canada for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older.
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Fulcrum Therapeutics Announces Recent Business Highlights and Financial Results for Second Quarter 2023
8/3/2023
Fulcrum Therapeutics, Inc.®, a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, reported financial results for the second quarter of 2023 and provided a business update.
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Deciphera Pharmaceuticals Announces Retirement of Daniel L. Flynn, Ph.D., and Appointment of Dashyant Dhanak, Ph.D., as Executive Vice President and Chief Scientific Officer
8/3/2023
Deciphera Pharmaceuticals, Inc. announced that the Company’s Founder, Executive Vice President, and Chief Scientific Officer, Daniel L. Flynn, Ph.D., will retire effective September 5, 2023 and will transition to a role as Senior Advisor to the Company.
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The lawsuit alleges that Pfizer infringed GSK’s patents on respiratory syncytial virus shots. The complaint comes just months after both companies had their respective RSV vaccines approved.
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Surface Oncology Reports Financial Results and Corporate Highlights for Second Quarter 2023
8/2/2023
Surface Oncology today reported financial results and corporate highlights for the second quarter 2023.
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The FDA has approved Jemperli as an add-on to chemotherapy for patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient or microsatellite instability-high.
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Zentalis Pharmaceuticals Appoints Kimberly Freeman as Chief Strategy Officer
8/1/2023
Zentalis ® Pharmaceuticals, Inc. today announced the appointment of Kimberly Freeman as Chief Strategy Officer. In this role, she will support and implement Zentalis’ long-term portfolio strategy.
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FDA Roundup: August 1, 2023
8/1/2023
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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Fina Biosolutions Selects Scorpius BioManufacturing for Production of cGMP CRM197
7/27/2023
Fina Biosolutions has selected Scorpius BioManufacturing, a biologics contract development and manufacturing organization, for the production of an E.coli-expressed CRM197 conjugate vaccine carrier protein.
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While GlaxoSmithKline is anticipating a slower uptake of respiratory syncytial virus vaccine Arexvy, CEO Emma Walmsley said Wednesday the company is pinning much of its growth on the vaccine’s performance.
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The Danish vaccine maker’s respiratory syncytial virus candidate did not meet all primary endpoints in a late-stage study in older adults and the company is discontinuing the program.
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The infectious diseases market is expected to reach $150 billion in sales by 2029, with three pharma giants reaping most of its benefits, according to data analytics and consultancy GlobalData.
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The company is handing back a multivalent Shigella vaccine candidate to LimmaTech Biologics, which spun out in 2015 after GSK’s acquisition of GlycoVaxyn for $190 million.
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GSK Grants LimmaTech Biologics License to Develop and Commercialize Shigella Vaccine
7/20/2023
LimmaTech Biologics AG signed an in-license agreement with GlaxoSmithKline Biologicals SA enabling LimmaTech Bio to further develop and commercialize a quadrivalent bioconjugate vaccine candidate for shigellosis that GSK added to its infectious disease pipeline when LimmaTech Bio’s predecessor company, GlycoVaxyn, was acquired by GSK in 2015.
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GSK is first to ship influenza vaccine doses for the 2023-24 flu season in US
7/13/2023
GSK plc announced it has started shipping doses of its quadrivalent influenza vaccines to US healthcare providers and pharmacies in preparation for the 2023-24 flu season.
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Maryland Tech Council Welcomes New Chair and Slate of Industry Leaders to its Board of Directors
7/11/2023
The Maryland Tech Council, the largest technology and life sciences trade association in the state, welcomed a new chair and slate of technology and life sciences leaders to its board of directors.