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Denmark-based Genmab A/S (NASDAQ: GMAB) has secured approval from the Japan Ministry of Health, Labour and Welfare for its Tivdak (tisotumab vedotin) to treat advanced or recurrent cervical cancer that has progressed on or after chemotherapy. Drug Profile and TechnologyTivdak is an antibody-drug conjugate (ADC) comprising Genmab’s human monoclonal antibody…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving separate clinical trial approvals from the National Medical Products Administration (NMPA) for its anti-tumor drugs SHR-9803 and SHR-A2102. This marks a significant step forward in the development of these promising therapies. SHR-9803: Targeting Regulatory T CellsSHR-9803, a Category 1 biologic…
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US-based pharmaceutical giant Pfizer Inc. (NYSE: PFE) announced a significant leadership and organizational restructuring in China, effective March 18, 2025. The move aims to enhance the company’s growth and innovation capabilities in the Chinese market. Organizational ChangesThe restructuring involves merging the retail business team and national bidding team with the…
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China-based Everest Medicines (HKG: 1952) announced the start of construction for a manufacturing plant in Jiashan, Zhejiang province, dedicated to producing its S1P receptor modulator etrasimod (formerly known as velsipity). The project, valued at RMB70 million (USD9.7 million), is expected to produce up to 50 million tablets of etrasimod upon…
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Switzerland-based Basilea Pharmaceutica Ltd (SWX: BSLN) announced that its antifungal Cresemba (isavuconazole), commercialized by Pfizer Inc. (NYSE: PFE), has achieved significant sales milestones in the Asia Pacific region and China. This performance has triggered a milestone payment of USD2.5 million to Basilea. Drug Profile and CommercializationCresemba, co-developed with Japan’s Astellas…
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Partners Arvinas, Inc. (NASDAQ: ARVN) and Pfizer Inc. (NYSE: PFE) announced positive topline results from the Phase III VERITAC-2 study. The trial assessed vepdegestrant alone versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer who experienced disease progression following prior…
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US giant Pfizer (NYSE: PFE) announced receiving conditional approval from China’s National Medical Products Administration (NMPA) for its bispecific antibody (BsAb) Elrexfio (elranatamab). The drug is now approved to treat triple-class exposed (TCE) relapsed or refractory multiple myeloma (r/r MM). Mechanism of ActionElrexfio works by binding to CD3 on T…
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Shanghai’s Sunshine Medical Procurement All-In-One (SMPA) announced the suspension of procurement for indobufen, manufactured by Hunan Jiudian Pharmaceutical and Zhejiang Tongwu Biomedical, following a patent infringement verdict by the Hangzhou Intellectual Property Office. The decision highlights ongoing disputes over the drug’s patent status in China. BackgroundIndobufen, an isoindolylphenylbutyric acid derivative…
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Pfizer Inc. (NYSE: PFE) announced the implementation of its hemophilia therapy Hympavzi (marstacimab) in China’s Boao Lecheng Medical Tourism Pilot Zone. The drug, approved in the U.S. and European Union, is the first innovative therapy to be administered subcutaneously once weekly via a pre-filled injection pen for hemophilia A and…
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Summit Therapeutics Inc. (NASDAQ: SMMT), the U.S. partner of China-based Akeso Inc. (HKG: 9926) for ivonescimab, announced a clinical collaboration with Pfizer (NYSE: PFE) to evaluate the combination of ivonescimab, Akeso’s PD-1/VEGF bispecific antibody (BsAb), with Pfizer’s antibody drug conjugates (ADCs) in multiple solid tumors. Collaboration DetailsUnder the agreement, Summit…
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Pfizer Inc. (NYSE: PFE) has terminated the development and commercialization of Beqvez (fidanacogene elaparvovec), its hemophilia B gene therapy, globally, citing “limited interest” from patients and physicians, according to reports in Nikkei Asia and Reuters. The move marks the U.S. pharma giant’s exit from virally delivered gene replacement treatments. Decision…
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Taiwan-based TAHO Pharmaceuticals announced positive preliminary results from a pivotal study for its TAH3311 oral dissolving films, a generic version of Bristol-Myers Squibb/Pfizer’s Eliquis (apixaban). The study demonstrated that TAH3311 was bioequivalent to the reference drug under fasting conditions. Study ResultsThe trial involved 60 healthy subjects, with 48 completing the…
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US giant Pfizer (NYSE: PFE) has announced that it has received another indication approval from the US FDA for its Adcetris (brentuximab vedotin). The antibody-drug conjugate (ADC) can now be used in combination with lenalidomide and a rituximab product. It is approved for the treatment of adult patients with relapsed…
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US pharmaceutical giant Pfizer (NYSE: PFE) has entered into a multi-year partnership with compatriot firm Alloy Therapeutics Inc. The alliance is designed to develop a new platform aimed at enhancing Pfizer’s ability to discover potent, specific, and effective antibodies against targets that are difficult to address with existing antibody discovery…
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US-based pharmaceutical giant AbbVie (NYSE: ABBV) announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Emblaveo (aztreonam and avibactam). The drug is the first and only fixed-dose, intravenous, monobactam/β-lactamase inhibitor combination antibiotic approved for use in combination with metronidazole for patients 18…
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US major Pfizer Inc. (NYSE: PFE) has released its financial results for the fourth quarter and full year of 2024. The company recorded revenues of $63.627 billion for the full year, up 7% year-on-year (YOY) in constant currency terms. Excluding COVID-19 products Paxlovid and Comirnaty, revenues grew by 12%. During…
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US-based Pfizer Inc. (NYSE: PFE) has reported positive topline results from its pivotal Phase III CREST study. The study evaluated sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).…
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PostEra, a Boston-based biotech company powered by machine learning, has announced an expanded partnership with US pharmaceutical giant Pfizer (NYSE: PFE). The collaboration includes the launch of a new antibody drug conjugate (ADC) program, as well as the expansion of an existing USD 260 million AI Lab collaboration project. Financial…
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US pharmaceutical giant Pfizer (NYSE: PFE) has entered into a research collaboration with compatriot firm Atavistik Bio, with the aim of bolstering the discovery of novel precision allosteric therapeutics to address significant unmet medical needs. Leverage of Atavistik Bio’s AMPS PlatformUnder the agreement, Atavistik Bio will utilize its proprietary AMPS…
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US-based Pfizer (NYSE: PFE) has announced receiving an indication extension approval from the US Food and Drug Administration (U.S. FDA) for Braftovi (encorafenib) in combination with cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. Braftovi’s Existing…