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Ahead of launching its Humira biosimilar Simlandi, Alvotech and Teva on Friday announced they have signed a long-term agreement with an undisclosed strategic partner to help boost patient access to the drug.
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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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If a company’s final sales end up falling short of the consensus analyst estimate, then they have missed their number. Johnson & Johnson was close in the first quarter of 2024 but ultimately no cigar.
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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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Aurigene Pharmaceutical Services Ltd., and Vipergen announce a strategic partnership for offering DNA encoded library (DEL) screening and integrated drug discovery services.
4/19/2024
Aurigene Pharmaceutical Services Ltd. (Aurigene), a global contract research, development, and manufacturing services organization (CRDMO), and Vipergen ApS, a niche small-molecule drug discovery service provider specialized in DEL technologies, entered into a strategic partnership.
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Lifeward Announces the Appointment of Mike Swinford to its Board of Directors
4/19/2024
ReWalk Robotics Ltd. announced that the Board has approved the appointment of Mike Swinford to the Board of Directors, effective April 18, 2024.
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CorMedix Inc. Announces CMS Grants TDAPA to DefenCath
4/19/2024
CorMedix Inc. today announced that the Center for Medicare & Medicaid Services (CMS) has determined that DefenCath ® meets the criteria for a Transitional Drug Add-On Payment (TDAPA) in the anti-infective functional category, beginning on July 1, 2024.
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PharmAla Closes Private Placement and Concurrent Debt Settlement
4/19/2024
PharmAla Biotech Holdings Inc. is pleased to announce that, further to its press release dated April 10, 2024 (the “ April 10 Release ”), the Company has closed its previously announced non-brokered private placement offering.
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Concord Medical Files 2023 Annual Report on Form 20-F
4/19/2024
Concord Medical Services Holdings Limited today announced that it filed its annual report on Form 20-F for the fiscal year ended December 31, 2023 (the "Annual Report") with the U.S. Securities and Exchange Commission.
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Stemtech Corporation on Track for CEO and Chairman's Goal for Growth and Global Expansion
4/19/2024
Stemtech Corporation is proud to announce that it is on track to achieve the CEO and Chairman's goal of becoming cash flow positive.
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Prescient Healthcare Group Appoints Two New Members to its Board of Directors
4/19/2024
Prescient Healthcare Group , a leading biopharma product and portfolio strategy firm, has announced the appointment of two new members to its Board of Directors – Dr. Luke Solon and Debbie Allman – to help shape and drive Prescient's global mission.
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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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ProQR Achieves Successful Defense of New Challenge to its Axiomer™ IP Portfolio
4/19/2024
ProQR Therapeutics N.V. today announced it has again successfully defended against opposition filed against a key patent for its ADAR-mediated RNA editing platform Axiomer™.
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Tiziana Life Sciences Announces Study Results from Intranasal Anti-CD3 Foralumab in Multiple Sclerosis Patients with PIRA Highlighted in Neurology Today®
4/19/2024
Tiziana Life Sciences, Ltd. today announced that a study related to its lead candidate, foralumab, was highlighted in Neurology Today®, the official news source of the American Academy of Neurology (AAN), in an article titled, “Anti-CD3 Antibody Foralumab Shows Promise in PIRA, Measured by Novel PET Ligand.”