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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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Addex Therapeutics Reports Full Year 2023 Financial Results and Provides Corporate Update
4/18/2024
Addex Therapeutics, a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, reported its full-year 2023 financial results for the period ended December 31, 2023 and provided a corporate update.
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BillionToOne Mitigating RhoGAM(R) Shortage With Unity Fetal RhD™ Non-invasive Prenatal Test
4/17/2024
BillionToOne, a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, has reached a milestone of testing over 80,000 patients for Rh incompatibility, which develops when a pregnant patient has Rh-negative blood and the baby has Rh-positive blood.
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Essential Pharma Announces the Acquisition of Reminyl® (galantamine hydrobromide) Oral Capsules
4/17/2024
Essential Pharma announces that it has completed the acquisition of Reminyl® oral capsules from Janssen Pharmaceutica NV, a Johnson & Johnson company.
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MustGrow Biologics to Present at the Planet MicroCap Showcase
4/17/2024
Saskatoon, Saskatchewan--(Newsfile Corp. - April 17, 2024) - MustGrow Biologics Corp. (TSXV: MGRO) (OTCQB: MGROF) (FSE: 0C0) (the "Company" or "MustGrow") is pleased to announce...
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CORRECTING and REPLACING Johnson & Johnson Reports Q1 2024 Results
4/16/2024
Johnson & Johnson announced results for first-quarter 2024. “Johnson & Johnson’s solid first quarter performance reflects our sharpened focus and the progress in our portfolio and pipeline,” said Joaquin Duato, Chairman and Chief Executive Officer.
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Johnson & Johnson Reports Q1 2024 Results
4/16/2024
Johnson & Johnson announced results for first-quarter 2024. “Johnson & Johnson’s solid first quarter performance reflects our sharpened focus and the progress in our portfolio and pipeline,” said Joaquin Duato, Chairman and Chief Executive Officer.
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Unique molecular properties of nipocalimab enabling differentiated potential in treating generalized myasthenia gravis to be presented at American Academy of Neurology's 2024 Annual Meeting
4/11/2024
Johnson & Johnson today announced the planned presentation of new non-clinical studies underscoring the molecular properties of nipocalimab, an investigational fully human monoclonal antibody targeting the neonatal fragment crystallizable receptor (FcRn).
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Addex Therapeutics to Release Full-Year 2023 Financial Results and Host Conference Call on April 18, 2024
4/11/2024
Addex Therapeutics, a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug development, announced that it will issue its Full-Year 2023 Financial Results on April 18, 2024.
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7 Billion-Dollar Oncology M&As from Q1
4/10/2024
AbbVie’s $10.1 billion takeover of ImmunoGen paces the cancer sector in early 2024, as ADCs and radiopharmaceuticals remain hot. -
Genomics Market Size To Hit USD 157.47 Billion By 2033
4/9/2024
The global genomics market size was valued at USD 33.90 billion in 2023 and is poised to grow from USD 39.53 billion in 2024 to USD 157.47 billion by 2033, growing at a CAGR of 16.6% in the forecast period (2024-2033).
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Findings Presented at ACC.24 Showed XARELTO® (rivaroxaban) Reduced the Risk of Clinically Significant Bleeding and Net Adverse Clinical Events or Rehospitalization
4/8/2024
Johnson & Johnson announced a new analysis of data from the PIONEER AF-PCI clinical trial demonstrating that XARELTO® was associated with a reduced risk of clinically significant bleeding, and net adverse clinical events or rehospitalization compared to warfarin among both elderly and non-elderly patients with nonvalvular atrial fibrillation undergoing percutaneous coronary intervention, a nonsurgical procedure designed to relieve narrowing or occlusion of the coronary artery.
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Zura Bio Announces Robert Lisicki as CEO and Director
4/8/2024
Zura Bio Limited a clinical-stage immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, announced that Robert Lisicki has assumed the role of Chief Executive Officer and a Director of the Board at Zura Bio.
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Mestag Presents Preclinical Data at AACR on its M300 Program, a Conditionally Active LTBR Agonist Designed to Induce Tertiary Lymphoid Structures in Tumors
4/8/2024
Mestag Therapeutics (“Mestag”), a biotech company harnessing new insights into fibroblast-immune interactions, is today presenting data on its M300 program in a late-breaking poster session at the 2024 American Association for Cancer Research (AACR) meeting.
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The approvals, third line for BMS and 2seventy Bio’s Abecma and second line for J&J and Legend Biotech’s Carvykti, represent a new class of therapy for these blood cancer patients.
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Legend Biotech’s CARVYKTI® (ciltacabtagene autoleucel) Becomes the First and Only BCMA-Targeted CAR-T Cell Therapy Approved by the FDA for Second-Line Treatment of Multiple Myeloma
4/6/2024
Legend Biotech Corporation announced the U.S. Food and Drug Administration has approved CARVYKTI® for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor, and an immunomodulatory agent, and are refractory to lenalidomide.
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CARVYKTI® is the First and Only BCMA-Targeted Treatment Approved by the U.S. FDA for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy
4/6/2024
Johnson & Johnson announced that the U.S. FDA has approved CARVYKTI® for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.
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Johnson & Johnson to Showcase its Broad Scientific Leadership and Latest Innovations to Combat Cardiovascular Disease at ACC.24
4/4/2024
Johnson & Johnson announced that clinical and real-world evidence from its cardiovascular portfolio will be featured at the American College of Cardiology 73rd Annual Scientific Session & Expo taking place April 6-8, 2024, in Atlanta, Georgia.
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Odyssey Therapeutics Announces Strategic Collaboration to Advance AI-Driven Small Molecule Drug Discovery
4/4/2024
Odyssey Therapeutics, Inc. announced today it has entered into a strategic research collaboration with Janssen Pharmaceutica NV, a Johnson & Johnson company, to jointly discover and ooptimize small molecule medicines against select therapeutic targets.
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Neurosterix launches with $63M to Advance Allosteric Modulator Therapeutics for Neurological Disorders
4/3/2024
Neurosterix, a biopharmaceutical company dedicated to the development of allosteric modulator therapeutics for underserved neurological disorders, launched with a $63 million Series A financing led by Perceptive Xontogeny Venture Fund II, with participation from Perceptive Life Sciences Fund and Acorn Bioventures.