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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 Prolia Secures NMPA Approval for Treating Glucocorticoid-Induced Osteoporosis in High-Risk Patients
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Biopharmaceutical giant Amgen has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug Prolia (denosumab) to treat glucocorticoid-induced osteoporosis (GIOP) in patients at high risk of fractures. This approval marks a significant expansion of Prolia’s indication in China, where it is already approved to treat osteoporosis…
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Novartis Halts Development of KRAS Inhibitor Opnurasib Due to Competitive Market
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Swiss pharmaceutical giant Novartis AG (NYSE: NVS) has reportedly halted the development of its Phase III KRAS inhibitor candidate, opnurasib, citing an increasingly competitive landscape in the sector. The drug was under development for the treatment of solid tumors, including non-small cell lung cancer (NSCLC). This decision comes in the…
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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…
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Sandoz Receives European Commission Approval for Biosimilars Wyost and Jubbonti
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The European Commission (EC) has granted registration approval to Sandoz, a Switzerland-headquartered pharmaceutical company (SWX: SDZ), for its biosimilars Wyost and Jubbonti. These products are reference treatments for Amgen’s (NASDAQ: AMGN) bone treatments Xgeva (denosumab) and Prolia (denosumab), respectively. Sandoz anticipates launching the biosimilars in November 2025. Wyost is indicated…
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Alvotech and Dr. Reddy’s Partner to Challenge Amgen’s Denosumab with Biosimilar AVT03
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Amgen’s (NASDAQ: AMGN) dominance in the bone treatment market with its blockbuster drugs Xgeva and Prolia (denosumab) may face a new challenge as Alvotech (NASDAQ: ALVO), an Iceland-based biopharmaceutical company, has licensed its biosimilar candidate AVT03 to India’s Dr. Reddy’s Laboratories (NYSE: RDY) for the European and US markets. This…
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FDA Gives Accelerated Nod to Amgen’s Imdelltra in Small Cell Lung Cancer
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The US Food and Drug Administration (FDA) has granted accelerated approval to Amgen (NASDAQ: AMGN) for its bispecific T-cell engager (BiTE), Imdelltra (tarlatamab), for the treatment of extensive-stage small cell lung cancer (ES-SCLC) that has proven unresponsive to chemotherapy. This accelerated approval is based on early Phase II data highlighting…
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Amgen’s Tezspire Shows Promise in Phase IIa COPD Trial, Reduces Exacerbations
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Amgen (NASDAQ: AMGN), a multinational biopharmaceutical company, has this week announced results from a Phase IIa proof-of-concept trial for its anti-thymic stromal lymphopoietin (TSLP) biologic, Tezspire (tezepelumab), in patients with moderate-to-very-severe chronic obstructive pulmonary disease (COPD). The trial indicated that Tezspire reduced the annualized rate of moderate or severe exacerbations…
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Qilu Pharmaceutical Gets NMPA Green Light for Generic Romiplostim for ITP Treatment
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The National Medical Products Administration (NMPA) in China has granted marketing approval to Qilu Pharmaceutical for its generic version of Amgen’s romiplostim, a treatment for chronic idiopathic thrombocytopenia (ITP) that has not responded well to other treatments such as corticosteroids and immunoglobulins. This marks the first approval of its kind…
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Dr. Reddy’s Launches Biosimilar Versavo in UK to Challenge Roche’s Cancer Therapy Avastin
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Dr. Reddy’s Laboratories (NYSE: RDY), a prominent Indian pharmaceutical company, has launched its biosimilar Versavo (bevacizumab) in the UK market, presenting a challenge to Roche’s established cancer therapy Avastin. Versavo, a biosimilar to Avastin, has been approved for the treatment of various metastatic cancers, including colorectal cancer, non-squamous non-small cell…
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Amgen Reports Positive Results for Otezla in Pediatric Psoriasis Trial
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Amgen (NASDAQ: AMGN) provided an update last week on a late-stage trial evaluating its PDE4 inhibitor Otezla (apremilast) for the treatment of moderate to severe plaque psoriasis in patients aged 6 to 17 years. The one-year data revealed that 56.3% of participants achieved clear or almost clear skin, while 71.4%…
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Sandoz Achieves FDA Milestone with Approval of First US Denosumab Biosimilars
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The US Food and Drug Administration (FDA) has granted Sandoz (SWX: SDZ), a Switzerland-based pharmaceutical company, registration approvals for its biosimilars Wyost (denosumab) and Jubbonti (denosumab). These biosimilars reference and share the same indications as Amgen’s (NASDAQ: AMGN) bone treatments Xgeva and Prolia, respectively. With this approval, Sandoz’s drugs become…
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Amgen’s Q4 2023 Results Showcase 9% YOY Growth, 18 Drugs Hit Record Sales
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Biopharmaceutical giant Amgen (NASDAQ: AMGN) has reported its financial results for Q4 2023, announcing annual sales of USD 26.9 billion, reflecting a substantial 9% year-on-year (YOY) increase, primarily driven by volume growth. In an earnings call, CEO Robert Bradway highlighted that a remarkable 18 of the company’s medicines achieved record…
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Cytokinetics Attracts Big Pharma Interest Amid Aficamten’s Phase III Success
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Cytokinetics (NASDAQ: CYTK), a specialist in cardiovascular diseases, is reportedly attracting interest from multiple Big Pharma companies keen on its promising pipeline in cardiovascular and neuromuscular diseases. Sources indicate that Novartis (NYSE: NVS) was initially leading the charge against competitors AstraZeneca (AZ, NASDAQ: AZN) and Johnson & Johnson (J&J, NYSE:…
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NVIDIA Expands Healthcare Reach with Amgen’s deCode Partnership at JP Morgan Conference
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At the recent JP Morgan Healthcare Conference, US chip giant NVIDIA (NASDAQ: NVDA) announced a new collaboration with Amgen (NASDAQ: AMGN)’s subsidiary, deCode. This partnership will see deCode leverage NVIDIA’s advanced supercomputers and the BioNeMo generative artificial intelligence (AI) platform to bolster the development of its genomic foundational models. BioNeMo,…
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Amgen Licenses XeriJect Technology from Xeris Biopharma for Subcutaneous Tepezza Development
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Amgen (NASDAQ: AMGN) has entered into a licensing agreement with Xeris Biopharma (NASDAQ: XERS) for the XeriJect drug delivery technology, aimed at developing, manufacturing, and commercializing a subcutaneous formulation of its orphan drug Tepezza (teprotumumab). The XeriJect suspensions enable concentrations exceeding 400 mg/ml, which helps to reduce injection volumes, lessen…
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Amgen’s Lumakras Faces Full Approval Delay as FDA Requests New Study
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The US Food and Drug Administration (FDA) has declined to grant full approval for Amgen’s (NASDAQ: AMGN) Lumakras (sotorasib), a first-in-class KRASG12C inhibitor, for the treatment of locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC). The regulator has requested an additional confirmatory study, which Amgen intends to…
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Amgen’s Tarlatamab Receives FDA Priority Review for Advanced Small Cell Lung Cancer Treatment
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The US Food and Drug Administration (FDA) has granted priority review status to Amgen (NASDAQ: AMGN) for its potential first-in-class bispecific T-cell engager (BiTE) tarlatamab as a second-line treatment for advanced small cell lung cancer (SCLC). The action date for the review is set for June 12, 2024. This decision…
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MSD to Acquire Caraway Therapeutics for USD 610 Million to Boost Neurodegenerative Disease Portfolio
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced an agreement to purchase Caraway Therapeutics, a US-based pre-clinical company, for a potential total of USD 610 million, which includes upfront and milestone payments. This acquisition will enhance MSD’s portfolio with a range of small-molecule candidates targeting neurodegenerative and rare diseases.…
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Amgen Partners with PostEra for Small-Molecule Drug Discovery Initiative
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Biopharmaceutical company Amgen (NASDAQ: AMGN) has entered into a drug discovery collaboration with US-based PostEra, covering up to five small-molecule programs. As part of the agreement, Amgen will also secure a future option to leverage PostEra’s AI technology for its own pipeline development. Financial Details and PostEra’s Track RecordWhile the…
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Q32 Bio Reclaims Development Rights to Anti-IL-7Rα Biologic from Amgen
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Biotechnology firm Q32 Bio has announced its decision to reclaim full development and commercial rights to its anti-IL-7Rα biologic, bempikibart, from US-based Amgen (NASDAQ: AMGN). The biologic is currently in middle-stage trials for autoimmune diseases. This move follows Amgen’s acquisition of Horizon Therapeutics earlier this year, which had entered into…
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Amgen Reports Q3 2023 Financials: 5% Growth Driven by Volume Expansion
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Amgen (NASDAQ: AMGN) has released its Q3 2023 financial results, showcasing a 5% year-on-year (YOY) increase in global sales, reaching USD 6.5 billion. This growth comes despite a 3% decrease in net selling price, primarily fueled by an impressive 11% increase in volume. Notably, this marks the company’s fourth consecutive…
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Amgen Launches Global Collaboration Network to Advance Oncology Research
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Amgen (NASDAQ: AMGN) has announced the launch of a new collaboration network that connects its oncology team with eight prominent research centers across Australia, Canada, France, Germany, South Korea, Spain, and the United States. This initiative is designed to accelerate the development of new cancer treatments for conditions with unmet…
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China’s NHC Expands Rare Disease List, Includes 21 Cancer Types
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The National Health Commission (NHC) of China has released an updated national list of rare diseases, doubling the number of conditions to 86, including 21 cancer types. This marks the first update to China’s orphan disease schedule since the initial list of 121 conditions was introduced in 2018. Market Access…
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Amgen’s Lumakras Combo Shows Promising Results in KRAS-mutated NSCLC Early-Stage Trial
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Amgen (NASDAQ: AMGN) has announced positive early-stage data for its KRASG12C inhibitor Lumakras (sotorasib) when combined with carboplatin and pemetrexed in the treatment of KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) in adults. The confirmed objective response rate (ORR) and disease control rate (DCR) in treatment-naive patients were 65%…
