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Astellas Pharma’s Xtandi NDA for mHSPC Treatment Accepted by China’s CDE
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Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that the Center for Drug Evaluation (CDE) has accepted for review the New Drug Application (NDA) for its medication Xtandi (enzalutamide), which is intended for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). NDA Basis and Study ResultsThe NDA is…
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Pfizer’s Litfulo Earns EU Approval as First Treatment for Severe Alopecia Areata in Teens
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Pfizer (NYSE: PFE) has been granted registration authorization by the European Commission (EC) for Litfulo (ritlecitinib), a JAK3/TEC inhibitor, for the treatment of severe alopecia areata in adults and adolescents. This once-daily drug is the first to be approved in the region for this autoimmune disease, including teenage patients. The…
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Tianjin Century Kangtai Biomedical Raises Hundreds of Millions in Series A+ and B Financings
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Tianjin Century Kangtai Biomedical Engineering Co., Ltd, a China-based company, has reportedly secured hundreds of millions of renminbi through Series A+ and Series B financing rounds. The Series B round was led by SDIC, with participation from Efung Capital, Lake VC, Morning Spring Venture, and Jinju Capital. The funds raised…
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Walvax Biotechnology Receives Indonesian FDA Approval for Phase III Pneumococcal Vaccine Trial
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced that it has received approval from the Food and Drug Supervisory Agency of Indonesia to initiate a Phase III clinical study for its Weuphoria, a 13-valent pneumococcal polysaccharide conjugate vaccine. Study Design and ObjectivesThe Phase III study is a randomized, blinded,…
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Sunshine Guojian Pharmaceutical Gets NMPA Approval for SSGJ-611 Phase II COPD Study
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, (SHA: 688336) a subsidiary of 3SBio Inc. (HKG: 1530), has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study for SSGJ-611, an IL-4Rα monoclonal antibody (mAb), for the treatment of moderate to severe chronic obstructive pulmonary…
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AbbVie’s Allergan Aesthetics Secures NMPA Approval for Juvéderm VOLUMA with Lidocaine
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Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for Juvéderm VOLUMA with Lidocaine, expanding its indications to include nose augmentation procedures. Product Description and BenefitsJuvéderm VOLUMA with Lidocaine is a cross-linked sodium hyaluronate gel designed…
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Northeast Pharmaceutical Partners with Muscat Changming for Middle East Expansion
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China-based Northeast Pharmaceutical Co., Ltd (SHE: 000597) has entered into an investment framework agreement with Muscat Changming Investments LLC, leveraging business development plans and market demand in Oman and the Middle East. Joint Venture Establishment and ObjectivesThe partnership aims to establish a joint venture (JV) in the Sultanate of Oman,…
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