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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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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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Teva Pharmaceuticals and Alvotech got the FDA’s greenlight for their biosimilar to Johnson & Johnson’s blockbuster Stelara, which will launch in the U.S. in February 2025.
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On the heels of a late-stage victory for its antipsychotic drug Caplyta in patients with major depressive disorder, Intra-Cellular Therapies is now offering 6.8 million shares at $73 a piece.
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The first Bioversity cohort includes several graduates placed at Massachusetts life sciences companies.
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How to Deal With Layoff-Related Stress
4/18/2024
Employees worried about layoffs can practice self-care, use employer resources and contact a mental health professional, if needed. -
Plus, what to expect in a phone screen and how to handle an impending layoff.
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23andMe announces CEO’s intention to pursue a potential take-private
4/18/2024
23andMe Holding Co., a leading human genetics and biopharmaceutical company, has been made aware that Anne Wojcicki, Chief Executive Officer, Co-Founder, and Chair of the Board of Directors of 23andMe, is considering making a proposal to acquire all of the outstanding shares of 23andMe that she does not currently own, as she stated in an amendment dated April 17, 2024 to her Schedule 13D filing with the Securities and Exchange Commission.
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Panbela Announces Poster Presentation at American Association for Cancer Research:Ivospemin/doxorubicin combination modulates polyamine metabolism to improve survival in murine ovarian cancer models
4/18/2024
Panbela Therapeutics, Inc., a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer announces a poster presentation highlighting the results for ivospemin as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer Research, which took place April 10, 2024.