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AscellaHealth Provides Specialty & Rare Pipeline Digest™ Recap: Navigating the Path to 2024 Groundbreaking Therapies
1/9/2024
AscellaHealth, a global healthcare and specialty pharmacy solutions organization, today released its latest Specialty & Rare Pipeline Digest™, the industry’s most comprehensive quarterly resource of new, pending and upcoming Specialty and Rare Disease drug launches and cell and gene therapies, biosimilars and generics.
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Harpoon has several antibodies in its pipeline that are engineered to redirect a patient’s T cells to recognize and kill cancer cells.
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Flagship Pioneering and Samsung Announce Collaboration to Advance Groundbreaking Technologies in Translational Science and Medicine
1/8/2024
Flagship Pioneering, the bioplatform innovation company, and Samsung announced a collaboration aimed at fostering cutting-edge biopharmaceutical innovation poised to transform the world of healthcare through groundbreaking advancements in translational science and medicine.
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Ginkgo Bioworks Announces Inaugural Members of New Biopharma Advisory Board
1/8/2024
f, which is building the leading platform for cell programming and biosecurity, announced the formation of its new Biopharma Advisory Board.
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Revance Provides Corporate Update, Preliminary Fourth Quarter and Full Year 2023 Financial Results, and Financial Outlook
1/8/2024
Revance Therapeutics, Inc. (NASDAQ:RVNC) today provided a corporate update as well as preliminary unaudited fourth quarter and full year 2023 financial results, 2024 guidance and financial outlook.
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FDA Accepts for Review BLA for DMB-3115 of Dong-A ST, a Proposed Biosimilar to Stelara® (Ustekinumab)
1/5/2024
Dong-A ST (President/CEO Min-young Kim, KRX:170900) announced that Accord BioPharma, Inc., a subsidiary of Intas Pharmaceuticals Ltd, in the United States has received a notification that the US Food and Drug Administration (“FDA”) has accepted its Biologics License Application (BLA) for DMB-3115, a proposed biosimilar to Stelara® (Ustekinumab), for substantive review.
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The pharmacy benefit management subsidiary of CVS Health is favoring Humira’s biosimilars for its major formularies, with AbbVie’s branded product to be nixed on April 1, 2024.
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Accord BioPharma, Inc. Announces U.S. FDA Acceptance of Biologics License Application for Proposed STELARA® Biosimilar DMB-3115
1/4/2024
Accord BioPharma, Inc. announced today the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for DMB-3115. DMB-3115 is a proposed biosimilar to STELARA®, a blockbuster drug developed by Janssen Biotech, Inc. and approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
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INOVIO and Coherus Announce Clinical Collaboration to Advance Development of INO-3112 in Combination with LOQTORZI™ (toripalimab-tpzi)
1/4/2024
INOVIO today announced a clinical collaboration and supply agreement with Coherus BioSciences, Inc. (Coherus, NASDAQ: CHRS) to evaluate the combination of INO-3112 and LOQTORZI.
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Amneal Launched Record Number of 39 New Retail and Injectable Products in 2023, Including 13 in Q4 2023
1/4/2024
Amneal Pharmaceuticals, Inc. announces that it has launched 39 new retail and injectable medicines in 2023, as compared to 26 new launches in 2022.
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ZILBRYSQ® (zilucoplan) Is Now Commercially Available in the U.S. for the Treatment of Generalized Myasthenia Gravis (gMG) in Adult Patients Who Are Anti-Acetylcholine Receptor (AChR) Antibody Positive
1/3/2024
UCB, a global biopharmaceutical company, announced today that ZILBRYSQ® (zilucoplan) is now available in the U.S. for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
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Alvotech Clinical Study Results Demonstrate Therapeutic Equivalence between Biosimilar Candidate AVT06 and Reference Product Eylea® (aflibercept)
1/3/2024
Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced positive top-line results from a confirmatory clinical study for AVT06, Alvotech’s proposed biosimilar to Eylea®.
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Innovent Dosed First Participant in Phase 3 Clinical Study (GLORY-2) of Mazdutide (IBI362) Higher Dose 9 mg in Chinese Adults with Obesity
1/2/2024
Innovent Biologics, Inc. announces that the first participant has been successfully dosed in a Phase 3 clinical trial of higher dose 9 mg mazdutide, a glucagon-like peptide 1 receptor and glucagon receptor dual agonist, in Chinese adults with obesity.
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Coherus Announces U.S. Launch of LOQTORZI™
1/2/2024
Coherus BioSciences, Inc. (“Coherus,” NASDAQ: CHRS) today announced that LOQTORZI™ (toripalimab-tpzi) is now available through select specialty distributors in the United States.
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Mabwell to attend 42nd JP Morgan Healthcare Conference and present at Biotech Showcase
1/2/2024
Mabwell, an innovative biopharmaceutical company with entire industry chain, announced that Dr. Hai Wu, R&D VP of Mabwell, will attend 42nd JP Morgan Healthcare Conference and present at Biotech Showcase in San Francisco, United States.
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Biodexa Appoints Ann Merchant to the Board of Directors
12/29/2023
Biodexa Pharmaceuticals PLC is pleased to announce the appointment of Ann Merchant to the Board of Directors of the Company as Non-executive Director with effect from 31 December 2023.
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Innovent and Xuanzhu Enter into Clinical Trial Collaboration Investigating Combination Therapy of Sintilimab (PD-1 inhibitor) and A Novel ADC Candidate for Advanced Solid Tumors in China
12/28/2023
Innovent Biologics, Inc. and Xuanzhu Biopharma, announce that they entered into a clinical trial collaboration and supply agreement for the combination therapies of sintilimab injection with KM-501, a novel HER-2 bispecific ADC, as potential treatment options for advanced solid tumors in China.
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Innovent and SanegeneBio Enter Strategic Collaboration to Develop siRNA Drug for the Treatment of Hypertension
12/27/2023
Innovent Biologics, Inc. and Sanegene Bio USA Inc. announce that they have entered into a collaboration agreement to co-develop SGB-3908, an siRNA drug candidate targeting angiotensinogen for the treatment of hypertension.
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Amgen Provides Regulatory Update on Status of LUMAKRAS® (Sotorasib)
12/26/2023
Amgen announced that the U.S. Food and Drug Administration has completed its review of the company's supplemental New Drug Application seeking full approval of LUMAKRAS®.
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Coherus Announces FDA Approval of UDENYCA ONBODY™, a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv
12/26/2023
Coherus BioSciences, Inc. announced that the U.S. Food and Drug Administration approved UDENYCA ONBODY™, the company's on-body injector presentation of UDENYCA®, a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.