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Following a months-long safety review, the regulator on Thursday said it is now requiring black box warnings for all commercially available CAR-T therapies to reflect the risk of secondary malignancies.
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Roche’s subsidiary Genentech has successfully expanded the label of Alecensa to include the adjuvant treatment of anaplastic lymphoma kinase-positive, early-stage non-small cell lung cancer following resection.
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French healthcare and pharma company Sanofi will terminate an undisclosed number of positions in its U.S. vaccines commercial unit in an effort to streamline the strategic sales structure.
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Fierce competition. Thin pipelines. Patent cliffs. The stakes are sky-high for pharmaceutical companies and investors alike.
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Alvotech signs U.S. agreement to expand access for newly approved high-concentration interchangeable biosimilar to Humira® (adalimumab)
4/19/2024
Alvotech announced a long-term agreement with a strategic partner to further enhance access to Adalimumab-ryvk in the U.S. market, the newly U.S. Food and Drug Administration approved high-concentration interchangeable biosimilar to Humira.
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Vaccinologists Keith Klugman and Shabir Madhi Awarded Sabin’s Prestigious Gold Medal; Infectious Diseases Epidemiologist Nicole Basta Receives Rising Star Award
4/19/2024
The Sabin Vaccine Institute yesterday presented the Albert B. Sabin Gold Medal to physician-researchers Keith Paul Klugman and Shabir Ahmed Madhi, and its Rising Star award to infectious diseases epidemiologist Nicole Elaine Basta at a ceremony in the National Academy of Sciences building in Washington D.C.
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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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ARTHEx Biotech Announces Oral Presentation on ATX-01 at the Oligonucleotide & Peptide Therapeutics (TIDES) Conference 2024
4/19/2024
ARTHEx Biotech S.L. announced an oral presentation at the upcoming Oligonucleotide & Peptide Therapeutics Conference 2024, being held in a hybrid format May 14-17, 2024 in Boston and online.
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La Jolla Institute for Immunology and RevolKa started a Research Collaboration
4/19/2024
RevolKa Ltd., a venture-backed biotech company providing a game-changing protein engineering technology platform and La Jolla Institute for Immunology agreed to start a research collaboration to create antigens for the next-generation vaccines to deliver innovative solutions to unmet medical need in infectious diseases.
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Antibe Provides Update on CCAA Proceedings
4/19/2024
Antibe Therapeutics Inc. (“ Antibe ” or the “ Company ”) (TSX: ATE) announced that the Company sought an extension of its previously announced stay of proceedings (“ Stay ”) under the Companies’ Creditors Arrangement Act (the “ CCAA ”) at a hearing before the Ontario Superior Court of Justice (Commercial List) (the “ Court ”) on April 18, 2024.
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Ensysce Biosciences' Presentation from the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference Published
4/19/2024
Ensysce Biosciences, Inc. today announced the Company's webcast presentation and discussion during the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference on April 17, 2024 is available on Ensysce's Investor Relations website at ir.ensysce.com and can also be viewed here.
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Sunshine Biopharma's Nora Pharma Receives Health Canada Approval for Niopeg(R), a Biosimilar of Neulasta(R)
4/19/2024
Sunshine Biopharma Inc. is happy to announce that its wholly owned generic pharmaceutical subsidiary, Nora Pharma, has received approval for its first Biosimilar product.
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Ocugen Announces Dosing Completion of Subjects with Geographic Atrophy in Cohort 2 of Phase 1/2 ArMaDa Clinical Trial of OCU410—A Modifier Gene Therapy
4/19/2024
Ocugen, Inc. today announced that dosing is complete in the second cohort of its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV- hRORA ).
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Sensi.AI Appoints Renowned Home Care Advocate, Bob Roth, to its Advisory Board Combining Data-Driven Insights with Decades of Home Care Expertise to Revolutionize Aging in Place
4/19/2024
Sensi.AI , a leader in AI-native, data, and analytics in senior care, today announced the appointment of in-home care leader Bob Roth to its Advisory Board.
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Surmodics to Report Second Quarter of Fiscal 2024 Financial Results on May 1
4/19/2024
Surmodics, Inc today announced that second quarter of fiscal year 2024 financial results will be released before the market opens on Wednesday, May 1.
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Cerevel Therapeutics on Thursday reported positive data from its Phase III TEMPO-3 trial, showing that tavapadon can significantly improve symptom control in patients with Parkinson’s disease.
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Weight-Loss Drug Startup Metsera Launches with $290M, Looks to Tap Lucrative Obesity Market
4/18/2024
The clinical-stage biotech emerged from stealth on Thursday with several oral and injectable candidates, including a GLP-1 receptor agonist in Phase I trials, in an effort to challenge Novo Nordisk and Eli Lilly. -
Nearly all doses of Eli Lilly’s highly popular weight-loss drug Zepbound and type 2 diabetes medication Mounjaro will have limited availability through the second quarter of 2024, according to the regulator.
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Data from the Phase III OCARINA II study shows the subcutaneous version of Ocrevus achieved near-complete suppression of relapses and brain lesions in relapsing or primary progressive multiple sclerosis.
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The first Bioversity cohort includes several graduates placed at Massachusetts life sciences companies.