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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 updated 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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Follow along as BioSpace keeps you up-to-date on the latest pharma and biotech layoffs.
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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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DNA Diagnostics Market Size to Hit USD 16.05 Billion By 2033
4/19/2024
The global DNA diagnostics market size was estimated at USD 10.69 billion in 2023 and is projected to hit around USD 16.05 billion by 2033, growing at a CAGR of 4.15% during the forecast period from 2024 to 2033 according to a new report by Nova One Advisor.
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Liquid Biopsy Industry is Rising Rapidly Up to USD 32.54 Bn by 2033
4/19/2024
The global liquid biopsy market size was valued at USD 10.85 billion in 2023 and is projected to reach USD 32.54 billion by 2033, growing at a CAGR of 11.61% from 2024 to 2033 according to a new report by Nova One Advisor.
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Pharmaceutical CDMO Industry is Rising Rapidly Up to USD 295.95 Bn by 2033
4/19/2024
The global pharmaceutical CDMO market size was accounted for USD 146.29 billion in 2023 and it is increasing around USD 295.95 billion by 2033 with a CAGR of 7.3% from 2024 to 2033. according to a new report by Nova One Advisor.
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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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ACTG Announces Launch of Clinical Trial Evaluating Combination of Three Novel Immune-based Therapies for HIV CureStudy will enroll participants who initiated treatment shortly after acquiring HIV
4/19/2024
ACTG today announced the opening of A5374, a phase 1/2a study evaluating the safety, tolerability, and antiviral effect of a novel combination regimen that includes therapeutic T-cell vaccines, two broadly neutralizing antibodies (bNAbs), and an immune-system boosting treatment among people living with HIV who started antiretroviral treatment (ART) during acute (early) HIV infection.
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Cochlear receives FDA clearance to lower the age for the Osia System to 5-years-old
4/19/2024
Cochlear Limited (ASX: COH) obtained U.S. Food and Drug Administration (FDA) clearance to lower the age of the Cochlear™ Osia System from 12 years-old to 5-years-old for children with conductive hearing loss, mixed hearing loss and single-sided sensorineural deafness (SSD).
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Hepion Pharmaceuticals Initiates Wind-Down Activities in Phase 2b ‘ASCEND-NASH’ Trial
4/19/2024
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA) today announced that it has begun wind-down activities in its ASCEND-NASH Trial, while continuing to explore strategic alternatives, as previously announced in December 2023.
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TScan Therapeutics Announces Closing of Upsized Public Offering
4/19/2024
TScan Therapeutics, Inc. today announced the closing of an underwritten public offering of 2,472,581 shares of its voting common stock at a public offering price of $7.1300 per share.
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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.