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In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA's decisions in 2024.
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hC Bioscience Announces Lead Program in Hemophilia and Reports Positive Preclinical Data on Novel Protein Editing Approach Using Anticodon Engineered tRNA
4/23/2024
hC Bioscience today announced preclinical data supporting its lead program in severe hemophilia A at the World Federation of Hemophilia 2024 World Congress in Madrid, Spain.
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Be Biopharma to Present at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting
4/23/2024
Be Biopharma, Inc. (“Be Bio”), a company pioneering the development of engineered B Cell Medicines (BCMs), today announced that it will present at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting being held May 7-11, 2024, in Baltimore, MD.
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From gene-corrected cell therapies to a new CAR-T, the cell and gene therapy space looks to expand its reach into the market.
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Centessa Pharmaceuticals Announces Open IND for ORX750; Proof-of-Concept Data in Sleep-Deprived Healthy Volunteers Planned for 2H 2024
4/22/2024
Centessa Pharmaceuticals plc today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) to initiate a Phase 1 first-in-human, clinical trial of ORX750 for the treatment of narcolepsy.
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Amarna Therapeutics announces appointment of Aurelia Caparrós as new Chief Business Officer
4/19/2024
Amarna Therapeutics, a privately-held biotechnology company developing transformative gene therapies in a range of rare and prevalent diseases, including Type 1 Diabetes Mellitus, announces the appointment of Aurelia Caparrós as the Company’s new Chief Business Officer, effective 1st of April 2024.
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Form Bio Establishes Scientific Advisory Board, Comprised of Renowned Experts in Cell and Gene Therapy, for Advancing AI-Driven Therapies
4/18/2024
Form Bio today announced the creation of a new Scientific Advisory Board (SAB).
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Cell and Gene Therapy Clinical Trials Market Experiencing Rapid Growth 15.09%
4/18/2024
The global cell and gene therapy clinical trials market was evaluated at US$ 11.57 billion in 2023 and is expected to attain around US$ 40.98 billion by 2032
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Gene Therapy Market Size Poised to Surge USD 52.40 Billion by 2033
4/18/2024
The global gene therapy market size was valued at USD 8.75 billion in 2023 and is poised to grow from USD 10.47 billion in 2024
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Poseida Therapeutics Announces Strong Lineup of Presentations at the American Society of Gene and Cell Therapy 27th Annual Meeting
4/18/2024
Poseida Therapeutics, Inc. today announced that six data presentations highlighting the Company's preclinical gene therapy programs and platforms will be presented at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting, being held in Baltimore, MD and virtually on May 7-11, 2024.
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Biologics Market Size to Hit Around USD 1. 37 Trillion By 2033
4/17/2024
According to the latest Research by Nova One Advisor, the global biologics market size was exhibited at USD 511.04 billion in 2024 and is projected to hit around USD 1,374.51 billion by 2033, growing at a CAGR of 10.4% during the forecast period 2024 to 2033.
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Poseida Therapeutics Hosts Gene Therapy R&D Day Highlighting New Scientific Advancements and Pipeline Focus
4/17/2024
Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell therapy and genetic medicines company advancing a new class of treatments for patients with cancer and rare diseases, today announced that the Company plans to highlight progress across its proprietary non-viral genetic engineering and delivery platform and rare disease pipeline during a virtual R&D Day to be held today at 10:00am ET / 7:00am PT.
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GeneVentiv Therapeutics Awarded $2.5 Million SBIR Grant to Advance Gene Therapy for All Hemophilias, with or without Inhibitors
4/16/2024
GeneVentiv Therapeutics, developer of GENV-HEM for all hemophilias, announced it has been awarded a Direct to Phase II Small Business Innovation Research grant for approximately $2,500,000 from the National Heart Lung Blood Institute at the National Institutes of Health.
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Avenacy Announces Launch of Desmopressin Acetate for Injection in the U.S. Market
4/15/2024
Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, announced it has launched Desmopressin Acetate for Injection in the United States as a therapeutic equivalent generic for DDAVP® for Injection approved by the U.S. Food and Drug Administration.
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Metagenomi to Present at Upcoming Scientific Meetings
4/8/2024
Metagenomi, Inc. today announced that two upcoming scientific meetings: a late breaking oral presentation at The World Federation of Hemophilia (WFH) World Congress, taking place April 21 – 24, 2024 in Madrid, Spain and two poster presentations at the American Society of Gene & Cell Therapy (ASGCT) 2024 Annual Meeting, taking place May 7 – 11, 2024, in Baltimore, MD and virtually.
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Hinge Bio Presents Preclinical Data from its GEM-DIMER Program Targeting B Cell Depletion at the American Association for Cancer Research (AACR) Annual Meeting 2024
4/8/2024
Hinge Bio, Inc. today announced that Daniel Capon , Ph.D., Chief Scientific Officer are presenting data from the company's GEM-DIMER program targeting B cell depletion at this year's American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego.
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Aanastra Inc to Present Multiple Posters on RNA Therapeutics at the American Association for Cancer Research (AACR) Annual Meeting 2024
4/3/2024
Aanastra, Inc. announced poster presentations at the 2024 American Association for Cancer Research, taking place April 5-10, 2024, in San Diego, CA.
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MaxCyte Signs Strategic Platform License with Be Biopharma to Support the Development of Engineered B Cell Medicines (BCMs)
4/2/2024
MaxCyte, Inc. and Be Biopharma announced the signing of a strategic platform license to support the development of Be Bio’s BCMs programs.
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With several recent approvals in the space and more on the horizon, BioSpace looks at some of the key decisions and their larger significance both for patients and science.
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Centessa Pharmaceuticals Reports Business Highlights and Financial Results for the Fourth Quarter and Full-Year 2023
3/28/2024
Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company, today reported recent business highlights and financial results for the fourth quarter and full-year ended December 31, 2023.