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Alvotech Appoints Interim Chief Quality Officer
2/29/2024
Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced that Christina Siniscalchi will join its corporate leadership team as interim Chief Quality Officer.
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This week Lori, Greg and Tyler discuss AbbVie: how longtime CEO Richard Gonzalez navigated Humira's LOE, his victorious retirement announcement, and the future of biosimilars.
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Plus, last week Richard Gonzalez announced his retirement from AbbVie, PhRMA appointed Gilead’s O’Day to chair its board and Joseph Papa became president and CEO of Emergent.
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UCB on Growth Path for a Decade Plus
2/28/2024
Our 2023 performance showcases our unwavering commitment to ensuring people with severe diseases can live the life they like, as free as possible from challenges of disease, reaching more than 3.2 million patients globally with severe immunological and neurological conditions.
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Kamada to Announce Fourth Quarter and Fiscal Year 2023 Financial Results, and Provide 2024 Financial Guidance on March 6, 2024Company to Host Conference Call at 8:30am ET
2/28/2024
Kamada Ltd. announced that it will release financial results for the fourth quarter and fiscal year ended December 31, 2023, as well as provide 2024 financial guidance, prior to the open of the U.S. financial markets on Wednesday, March 6, 2024.
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First product based on LTS Sorrel™ wearable drug delivery platform launched in the US
2/28/2024
LTS LOHMANN Therapie-Systeme AG announced that its customer Coherus BioSciences, Inc has launched its UDENYCA® on-body injector utilizing the LTS Sorrel™ wearable drug delivery platform.) UDENYCA® is a biosimilar pegfilgrastim administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.
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Viatris Reports Fourth-Quarter and Full-Year 2023 Financial Results and Provides 2024 Financial Guidance
2/28/2024
Viatris Inc. announced its financial results for the fourth quarter and full year 2023.
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Fresenius Kabi Further Expands Oncology Portfolio with Launch of Cyclophosphamide for Injection, USP
2/28/2024
Fresenius Kabi announced today it has introduced Cyclophosphamide for Injection, USP, a generic substitute for Cytoxan, for use in treating several forms of cancer.
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Revance Reports Fourth Quarter and Full Year 2023 Financial Results, Provides Corporate Update
2/28/2024
Revance Therapeutics, Inc. (NASDAQ: RVNC), today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a corporate update.
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Amphastar Pharmaceuticals Reports Financial Results for the Three Months and Full-Year Ended December 31, 2023
2/28/2024
Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) ("Amphastar" or the "Company") today reported results for the three months and full-year ended December 31, 2023.
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FDA Grants Fast Track Designation to 9MW2821
2/27/2024
Mabwell (688062.SH) announces that its self-developed novel ADC drug targeting Nectin-4 (R&D Code: 9MW2821) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma (hereinafter referred to as "ESCC").
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Amneal Enters into Exclusive European Licensing Agreement with Zambon Biotech for IPX203
2/27/2024
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced that it has entered into an exclusive licensing agreement with Zambon Biotech SA, part of the Zambon group (“Zambon”), for IPX203 in the European Union, United Kingdom, and Switzerland.
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TG Therapeutics Announces Issuance of Additional Patents for BRIUMVI® (ublituximab-xiiy)Newly issued patents extend exclusivity of ublituximab through 2042
2/27/2024
TG Therapeutics, Inc. (NASDAQ: TGTX) (TG) today announced the issuance of three additional patents by the United States Patent and Trademark Office (USPTO) for BRIUMVI® (ublituximab-xiiy), the first and only anti-CD20 monoclonal antibody approved in the US for patients with relapsing forms of multiple sclerosis (RMS) that can be administered in a one-hour infusion following the starting dose.
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On Friday, Alvotech and Teva Pharmaceuticals finally secured the FDA’s greenlight for their Humira biosimilar Simlandi, which now has the regulator’s interchangeability designation.
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Teva and Jiangsu Nhwa Forge Strategic Partnership to Promote Patient Access to AUSTEDO® in China
2/26/2024
Teva Pharmaceutical Investments Singapore Pte Ltd, a subsidiary of Teva Pharmaceutical Industries Ltd. and Jiangsu Nhwa Pharmaceutical Co., Ltd announced it formed a partnership for the marketing and distribution of Teva’s AUSTEDO for the treatment of neurodegenerative and movement disorders - chorea associated with Huntington’s disease and tardive dyskinesia in adults.
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Amgen Opens State-of-the-Art Biomanufacturing Site in Central Ohio
2/26/2024
Amgen announced the opening of its manufacturing site in Central Ohio, the newest in its global operations network and the most advanced facility to date.
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Alvotech Accepts Offer for the Sale of Shares for a value of approximately USD 166 million at a Purchase price of USD 16.41 (ISK 2,250) per Share
2/26/2024
Alvotech announced that it has accepted an offer from investors for the sale of 10,127,132 of its ordinary shares, for an approximate value of USD 166 million, par value USD 0.01 per share, at a purchase price of USD 16.41 per Share, or ISK 2,250 per share at foreign exchange rates on February 23, 2024.
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Alvotech and Teva Announce U.S. Approval of SIMLANDI® (adalimumab-ryvk) injection, the first interchangeable high-concentration, citrate-free biosimilar to Humira®
2/24/2024
Alvotech and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced that the U.S. Food and Drug Administration has approved SIMLANDI injection, as an interchangeable biosimilar to Humira, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis.
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Thanks to the success of outgoing CEO Richard Gonzalez, biopharma executives will be studying for years to come how AbbVie navigated the decline of blockbuster Humira.
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Celltrion presents new two-year data for subcutaneous infliximab (CT-P13 SC) in inflammatory bowel disease (IBD) at the 19th ECCO Congress
2/23/2024
Celltrion today presented positive two-year results from the extended LIBERTY studies (LIBERTY-CD1 and LIBERTY-UC2) in patients with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC).