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AstraZeneca and Amgen’s Tezspire Shows Positive Results in Phase III Study
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AstraZeneca (NASDAQ: AZN) and Amgen (NASDAQ: AMGN) have jointly announced positive results from the Phase III WAYPOINT study for their co-developed drug Tezspire (tezepelumab). Tezspire is a thymic stromal lymphopoietin (TSLP) – targeted monoclonal antibody (mAb) that has been approved for severe asthma in over 60 countries worldwide. Study ResultsThe…
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FDA Clears Amgen’s Lumakras and Vectibix Combo for KRAS G12C-mutated mCRC
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US-based Amgen (NASDAQ: AMGN) has announced receiving clearance from the US Food and Drug Administration (FDA) for its Lumakras (sotorasib) combined with Vectibix (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC). This approval is for patients whose cancer has been identified through an FDA-approved…
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GlycoNex Licenses SPD8 Biosimilar to Undisclosed Company for Osteoporosis Treatment
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Taiwan-based GlycoNex, Inc. (TPEx: 4168) has announced a licensing agreement with an undisclosed company for its SPD8, a biosimilar version of Amgen’s (NASDAQ: AMGN) Prolia and Xgeva (denosumab). The agreement involves an undisclosed amount of development and commercialization milestone payments, granting the licensee rights to develop, secure regulatory approval for,…
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Amgen’s Imdylltra Gains Conditional Approval in UK for Extensive-Stage Small Cell Lung Cancer
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US biotech company Amgen (NASDAQ: AMGN) has received conditional approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its drug Imdylltra (tarlatamab). The approval is for use in adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression after at least two prior…
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Kexing Pharmaceutical Partners with Shandong Boan for Biosimilar Commercialization in Hong Kong and Macau
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China-based Kexing Pharmaceutical (SHA: 688136) has entered into a commercialization cooperation agreement with fellow Chinese firm Shandong Boan Biotechnology Co., Ltd (HKG: 6955). The partnership aims to promote the marketing and sales of Shandong Boan’s biosimilars BA6101 and BA1102 in Hong Kong and Macau. BA6101 is a biosimilar version of…
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Amgen’s Blincyto Meets Primary Endpoint in Phase III AALL1731 Study for Pediatric B-ALL
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US-based biotechnology company Amgen (NASDAQ: AMGN) has published the results from the Phase III study (AALL1731) for its bispecific T-cell engager (BiTE) Blincyto (blinatumomab) at the 66th American Society of Hematology (ASH) annual meeting. The study assessed the potential of adding Blincyto to chemotherapy to improve disease-free survival (DFS) in…
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Amgen Expands Biomanufacturing Footprint in North Carolina with Second Facility
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US biotech company Amgen (NASDAQ: AMGN) has announced plans to construct a second drug substance manufacturing facility in Holly Springs, North Carolina, raising its total biomanufacturing investment in the region to USD 1.5 billion. This new plant, costing USD 1 billion, follows Amgen’s previously announced commitment of USD 550 million…
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Amgen’s MariTide Showcases Significant Weight Loss in Phase II Study
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US biotechnology company Amgen (NASDAQ: AMGN) has announced positive outcomes from the double-blind, dose-ranging Phase II study of MariTide (maridebart cafraglutide), formerly known as AMG 133, at 52 weeks. This investigational antibody peptide conjugate, administered subcutaneously on a monthly or less frequent basis, has demonstrated significant potential in obesity treatment.…
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AstraZeneca’s Tezspire Meets Phase III Co-Primary Endpoints in CRSwNP Study
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AstraZeneca Inc., (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has announced positive high-level results from the Phase III WAYPOINT study for Tezspire (tezepelumab) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The drug, a thymic stromal lymphopoietin (TSLP)-targeted monoclonal antibody (mAb) co-developed with US firm Amgen (NASDAQ: AMGN),…
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Amgen’s Tavneos Receives NMPA Approval for ANCA-Associated Vasculitis Treatment in China
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US biotechnology company Amgen (NASDAQ: AMGN) has announced that it has received market approval in China for its drug Tavneos (avacopan). The National Medical Products Administration (NMPA) has approved Tavneos for use as adjuvant therapy in adults with severe and active anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis, specifically granulomatous polyangitis…
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Amgen Reports Q3 2024 Revenues of USD 8.5 Billion, Marking a 23% YOY Increase
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US biotechnology company Amgen (NASDAQ: AMGN) has announced its financial results for the third quarter of 2024, with revenues reaching USD 8.5 billion, an increase of 23% year-on-year (YOY). Product sales saw a 24% increase, with an 8% growth when excluding sales from the Horizon Therapeutics (Horizon) acquisition. In the…
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Shanghai Henlius and Organon Submit Biosimilar Application for Denosumab to FDA
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Shanghai Henlius Biotech Inc. (HKG: 2696) and its US partner Organon (NYSE: OGN) have jointly announced that the Biologic License Application (BLA) for HLX14, an investigational biosimilar of Amgen’s (NASDAQ: AMGN) Prolia/Xgeva (denosumab), has been accepted for review by the US Food and Drug Administration (FDA). Denosumab, a recombinant anti-RANKL…
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FDA Extends Review of Amgen’s Lumakras for KRAS G12C mCRC Treatment to January 2025
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On October 18, FirstWord reported that the U.S. FDA has extended the review period for Amgen (NASDAQ: AMGN)’s KRAS G12C inhibitor Lumakras (sotorasib) in combination with the anti-EGFR monoclonal antibody panitumumab for second-line treatment of KRAS G12C-mutated metastatic colorectal cancer (mCRC) by three months, pushing the decision date to January…
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MediLink Therapeutics Partners with Amgen for Clinical Trial in Small Cell Lung Cancer
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Suzhou-based biotech MediLink Therapeutics (Suzhou) Co., Ltd has announced a partnership with US pharmaceutical giant Amgen Inc. (NASDAQ: AMGN). The collaboration will see the two companies conduct a global clinical trial combining MediLink’s B7-H3-targeting antibody-drug conjugate (ADC) YL201 with Amgen’s DLL3- and CD3-targeting bispecific T-cell engager (BiTE) IMDELLTRA for the…
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Amgen’s Tepezza Receives Approval in Japan for Treating Thyroid Eye Disease
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Amgen (NASDAQ: AMGN), a prominent biotechnology company based in the U.S., has announced that its drug Tepezza (teprotumumab, genetical recombination) has received market approval in Japan. The country’s Ministry of Health, Labour, and Welfare (MHLW) has authorized the medication for treating active or high clinical activity score (CAS) thyroid eye…
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Amgen to Establish New Site in Hyderabad, India, with Focus on Technology and Digital Innovation
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Amgen (NASDAQ: AMGN), a leading biopharmaceutical company based in the U.S., has announced strategic plans to expand its presence in India with the establishment of a new facility in Hyderabad. The site, to be named Amgen India, is designed to accommodate up to 3,000 employees and is expected to be…
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Amgen Halts Development of Claudin 6-Targeting BiTE Immune Therapy AMG 794
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Amgen Inc. (NASDAQ: AMGN), a leading biopharmaceutical company based in the U.S., has decided to halt the development of AMG 794, a half-life extended BiTE (bispecific T-cell engager) immune therapy that targets the oncofetal antigen Claudin 6 (CLDN6). This decision was disclosed on the clinicaltrials.gov website under the identifier NCT05317078,…
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Amgen Secures Commercialization Rights for Avacopan in Asia and Latin America
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Amgen (NASDAQ: AMGN), a leading biopharmaceutical company, has entered into a licensing agreement with CSL Vifor, securing the commercialization rights to Tavneos (avacopan) in Asia and Latin America, including mainland China. Avacopan is a first-in-class drug for the treatment of anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis. Originally approved in the…
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Amgen’s Blincyto Secures New Indication Approval for B-ALL Consolidation Treatment in the US
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Amgen (NASDAQ: AMGN) has announced that its bispecific T-cell engager (BiTE) Blincyto (blinatumomab) has received a new indication approval from the U.S. Food and Drug Administration (FDA) for the U.S. market. The drug is now approved for the treatment of adult and pediatric patients aged one month or older with…
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Amgen’s Bkemv Becomes First Biosimilar to Challenge AstraZeneca’s Soliris with FDA Approval
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Amgen Inc. (NASDAQ: AMGN), a leading biopharmaceutical company, has been granted regulatory approval by the US Food and Drug Administration (FDA) for Bkemv, marking a significant milestone as the first biosimilar in the US to compete with AstraZeneca’s (AZ; NASDAQ: AZN) Soliris (eculizumab). Both the originator drug from AstraZeneca and…
