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argenx Data Highlight Evidence that VYVGART and VYVGART Hytrulo Drive Transformative Outcomes for Patients with Debilitating Autoimmune Disease
4/16/2024
argenx SE announced that data from its Phase 3 ADHERE trial evaluating VYVGART Hytrulo in patients with chronic inflammatory demyelinating polyneuropathy were presented for the first time to the medical community during the Clinical Trials Plenary Session at the American Academy of Neurology Annual Meeting in Denver, CO.
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Integral Molecular Launches Virus Neutralization Assay Services to Drive Antiviral Discovery
4/16/2024
Integral Molecular announces the launch of its Virus Neutralization Assay Services enabling researchers to rapidly obtain high-quality data to advance their vaccines and therapeutic antibodies.
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Alvotech and Teva Announce U.S. FDA Approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab)
4/16/2024
Alvotech and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced that the U.S. Food and Drug Administration has approved SELARSDI injection for subcutaneous use, as a biosimilar to Stelara®, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older.
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Boehringer Ingelheim reports strong growth in 2023 and accelerates late-stage pipeline
4/16/2024
Boehringer Ingelheim announced a strong acceleration of its pipeline in 2023, as pivotal trials in key research areas progressed as planned.
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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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FDA Roundup: April 16, 2024
4/16/2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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Imugene and Kincell Bio Announce Strategic Manufacturing and Process Development Partnership
4/16/2024
Imugene, Ltd. and Kincell Bio, LLC, announce a strategic manufacturing and process development partnership, which includes the sale of Imugene’s North Carolina Current Good Manufacturing Practice manufacturing facility and the transfer of process and analytical development activities to Kincell.
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CureVac and MD Anderson Enter Strategic Collaboration to Develop Novel Cancer Vaccines
4/16/2024
CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), and The University of Texas MD Anderson Cancer Center today announced a co-development and licensing agreement to develop novel mRNA-based cancer vaccines.
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CancerVax Announces Promising New Drug to Treat a Deadly Children’s Cancer
4/16/2024
CancerVax, Inc., the developer of breakthrough cancer drugs that will use the body’s immune system to fight cancer, announced that its UCLA research team has created a promising new drug candidate for treating recurrent Ewing sarcoma, a deadly children’s cancer.
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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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AmplifyBio and RNAV8 Bio Announce Strategic Partnership to Support mRNA Therapeutic Developers from Sequence Design to GMP Manufacture
4/16/2024
AmplifyBio, a Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) focused on differentiating services that cover target optimization, preclinical safety studies, and manufacturing scale-up, and RNAV8 Bio, an emerging startup focused on mRNA engineering platforms, are partnering to provide a one-stop shop for the development of mRNA therapeutics.
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AMGEN TO PRESENT TEZSPIRE® PHASE 2A COPD DATA AT ATS 2024
4/16/2024
Amgen (NASDAQ:AMGN) today provided an update regarding the results of the Phase 2a COURSE trial for TEZSPIRE® (tezepelumab-ekko) in chronic obstructive pulmonary disease (COPD), which were accepted for presentation in the Clinical Trials Symposium at The American Thoracic Society (ATS) 2024 International Conference on Monday, May 20, from 9:15-11:15 a.m. PDT.
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Fresenius Accelerates Momentum in its (Bio)Pharma Business and Launches Tyenne®, its Third Approved Biosimilar in the U.S.
4/15/2024
Fresenius, via its operating company Fresenius Kabi, announced the immediate U.S. availability of Tyenne®, a biosimilar of Actemra®.
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Invivyd Receives Healthcare Common Procedure Coding System (HCPCS) Reimbursement Codes from the U.S. Centers for Medicare & Medicaid Services (CMS) Covering PEMGARDA™
4/15/2024
Invivyd, Inc. announced that the U.S. Centers for Medicare & Medicaid Services has granted a Healthcare Common Procedure Coding System Q code covering product reimbursement for PEMGARDA.
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U.S. Biopharmaceutical CMO & CRO Market Size, Share & Growth Report, 2033
4/15/2024
The U.S. biopharmaceutical CMO & CRO market size was estimated at USD 10.82 billion in 2023 and is projected to hit around USD 19.75 billion by 2033, growing at a CAGR of 6.2% during the forecast period from 2024 to 2033.
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Biologics Contract Development Market Size to Hit USD 18.68 Bn by 2033 | CAGR 8.2%
4/15/2024
According to Nova One Advisor, the global biologics contract development market size was accounted for USD 8.49 billion in 2023 and it is increasing around USD 18.68 billion by 2033 with a CAGR of 8.2% from 2024 to 2033.
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Active Pharmaceutical Ingredients Market Size to Increase USD 416.15 Billion By 2033
4/15/2024
The global active pharmaceutical ingredients market size was evaluated at USD 237.48 billion in 2023 and it is expected to increase around USD 416.15 billion by 2033 with a CAGR of 5.77% from 2024 to 2033.
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Bile Tract Cancer expansion study opens following clearance of Imugene’s MAST trial high dose cohort
4/15/2024
Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, is pleased to announce that enrolment has opened for its expansion study in bile tract cancer (cholangiocarcinoma) patients, having completed the fifth, high dose cohort in the intratumoural (IT) arm of the monotherapy dose escalation study evaluating its cancer-killing virus CF33-hNIS (VAXINIA).
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TFF Pharmaceuticals Announces Additional Positive Data from the Tacrolimus Inhalation Powder (TFF TAC) Phase 2 Trial Following Oral Presentation at the ISHLT 44th Annual Late Breaking Clinical Science Abstract Sessions
4/15/2024
TFF Pharmaceuticals, Inc. announced additional positive data from the ongoing Phase 2 study which is evaluating Tacrolimus Inhalation Powder for the prevention of organ rejection in lung transplant recipients.
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Nature Medicine Publishes Interim Results from Gritstone bio’s Phase 1/2 Study of “Off-the-Shelf” Neoantigen Vaccine Platform (SLATE)
4/15/2024
Gritstone bio, Inc., a clinical-stage biotechnology company working to develop the world’s most potent vaccines, announced that a paper detailing the development of its “off-the-shelf” neoantigen platform, SLATE, recently published in Nature Medicine.