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CDC Provisionally Recommends Pfizer’s Abrysvo for Maternal Immunization Against RSV
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The US Centers for Disease Control and Prevention (CDC) has issued a provisional recommendation for the use of Pfizer’s (NYSE: PFE) bivalent respiratory syncytial virus (RSV) vaccine, Abrysvo, as a seasonal maternal immunization strategy. This measure aims to prevent RSV lower respiratory tract infection in infants, a significant cause of…
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Boehringer Ingelheim and Eli Lilly’s Jardiance Wins FDA Approval for CKD Prevention
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Boehringer Ingelheim (BI) and Eli Lilly (NYSE: LLY) have received regulatory approval from the US Food and Drug Administration (FDA) for their SGLT2 inhibitor, Jardiance (empagliflozin), marking a significant advancement in the treatment of chronic kidney disease (CKD). The drug is now approved for the prevention of kidney function decline,…
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MSD’s Keytruda Meets Endpoints in Urothelial Carcinoma Trial but Misses in NSCLC Study
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Merck, Sharp & Dohme (MSD; NYSE: MRK), a leading global pharmaceutical company, last week released clinical data from separate late-stage studies for its anti-PD-1 biologic, Keytruda (pembrolizumab), in combination with other oncology therapies from different partners. The results presented a mixed picture of success and challenges in the field of…
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Betta Pharmaceuticals’ CFT8919 Accepted for Review by China’s NMPA for EGFR L858R Solid Tumors
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Betta Pharmaceuticals Co., Ltd (SHE: 300558), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) in China has accepted a clinical trial filing for its Category 1 drug candidate, CFT8919. This development marks a significant step forward in the drug’s journey towards clinical evaluation and potential…
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CNIPA Upholds Alynlam Pharmaceutical’s PCSK9 siRNA Patent Against Junshi Biosciences Challenge
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The China National Intellectual Property Administration (CNIPA) has rejected a challenge filed by Junshi Biosciences (SHA: 688180) against a patent held by Alynlam Pharmaceutical (NASDAQ: ALNY), which is related to the development of PCSK9-targeted small-interfering RNA (siRNA) therapies. CNIPA’s decision to fully maintain Patent No. 561449, associated with application number…
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Sanofi’s Dupixent Secures NMPA Approval for Pruritigo Nodosa Treatment in China
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France-based pharmaceutical company Sanofi (NASDAQ: SNY) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) in China for its drug Dupixent (dupilumab), which is now approved to treat prurigo nodosa (PN) in adults. This makes Dupixent the first and only drug approved for…
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Suzhou Zelgen Biopharmaceuticals’ ZG005 Receives NMPA Approval for Solid Tumor Trial
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its pipeline drug candidate, ZG005. The trial will evaluate the efficacy of ZG005 in combination with the Category 1 anti-cancer drug donafenib…
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Antengene’s Anti-CD24 Antibody ATG-031 Gets Green Light for Phase I Study at MD Anderson
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Antengene Corporation Ltd (HKG: 6996), a China-based biopharmaceutical company, has announced that the Institutional Review Board (IRB) of The University of Texas MD Anderson Cancer Center in Houston, Texas, has approved a Phase I study for its best-in-class anti-CD24 antibody, ATG-031. The clinical study, codenamed the PERFORM trial and led…
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Mabwell Bioscience’s 9MW3011 Earns US FDA Fast Track Designation for Polycythemia Vera Treatment
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced that it has received Fast Track Designation (FTD) from the US Food and Drug Administration (FDA) for its drug candidate 9MW3011 (MWTX-003/DISC-3405) for the treatment of patients with polycythemia vera (PV). This designation underscores the potential impact…
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Novartis’s Aimovig Approved by China’s NMPA for Preventive Migraines Treatment
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Aimovig (erenumab), a calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb), which can now be used as a preventive treatment for adult migraines in China. Phase III…
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Organon’s Liptruzet Approved in China for Hypercholesterolemia Treatment
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US-based Organon (NYSE: OGN) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Liptruzet (ezetimibe, atorvastatin), which is indicated for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH) in China. DYSIS China Study and Liptruzet’s ImpactThe DYSIS China study reveals…
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Hainan Poly Pharm Submits DMF for Tecovirimat API to US FDA
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced the filing of a Drug Master File (DMF) with the US Food and Drug Administration (FDA) for its tecovirimat active pharmaceutical ingredients (APIs). This move signifies the company’s initiative to bring a potential treatment for poxvirus infections, including smallpox and…
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Tonghua Golden-Horse’s Octohydroaminoacridine Succinate Meets Phase III Endpoints in Alzheimer’s Disease
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China-based Tonghua Golden-Horse Pharmaceutical Industry Co., Ltd. (SHE: 000766) has announced positive results from its Phase III clinical study for the in-house developed octohydroaminoacridine succinate, an oral acetylcholinesterase inhibitor designed for the treatment of mild to moderate Alzheimer’s disease (AD). Study Design and OutcomesThe Phase III study was a double-blind,…
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AIM Vaccine’s Serum-Free Rabies Vaccine Completes Phase III Safety Observation
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced the successful completion of the 7-day safety observation period in a Phase III clinical study for its investigational freeze-dried human rabies vaccine, developed using serum-free Vero cells. The study, which was conducted in a randomized, blinded, and similar vaccine parallel controlled…
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Jiangsu Yahong’s Cevira Meets Primary Endpoint in Phase III Cervical HSIL Study
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Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer treatments, has announced that its Phase III clinical study for Cevira (APL-1702) in high-grade squamous intraepithelial lesions (HSIL) of the cervix has successfully reached its primary endpoint. Study Design and ResultsThe global, multi-center Phase III study was…
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Hybio Pharmaceutical Gets NMPA Approval for COVID-19 Nasal Spray HY3000
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its Category 1.1 chemical drug, HY3000, a nasal spray designed to target COVID-19. Mechanism of Action and EfficacyHY3000 is a new type of polypeptide membrane…
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GSK’s Ojjaara Approved by FDA for Anemic Myelofibrosis Patients
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The US Food and Drug Administration (FDA) has granted regulatory approval to GlaxoSmithKline (GSK; NYSE: GSK), a UK-based pharmaceutical company, for its JAK1/JAK2/ACVR1 inhibitor Ojjaara (momelotinib). The drug is indicated for anemic adults with intermediate or high-risk myelofibrosis, a blood cancer affecting approximately 25,000 people in the United States. This…
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BeiGene Regains Full Rights to Tislelizumab After Terminating Novartis Deal
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China-based biotech company BeiGene (NASDAQ: BGNE) has reached a mutual agreement with Novartis (NYSE: NVS) to terminate their licensing deal from January 2021, under which Novartis held co-development and commercial rights to the programmed death-1 (PD-1) inhibitor, tislelizumab, in North America, Japan, the EU, and six other European countries. BeiGene…
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Jiangsu Hengrui Pharmaceuticals Wins NMPA Approval for Two Novel Drug Candidates
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced receiving clinical trial approvals from the National Medical Products Administration (NMPA) for two of its investigational drug candidates: the injectable SHR-3032 and HRS-7085 tablets. Details of the Investigational DrugsThe Category 1 drug SHR-3032 is under development…
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Pfizer’s Cibinqo and Everest Medicines’ Cefepime-Taniborbactam Selected for Priority Reviews by CDE
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The Center for Drug Evaluation (CDE) has indicated on its website that Pfizer’s (NYSE: PFE) Cibinqo (abrocitinib) and Everest Medicines’ (HKG: 1952) cefepime-taniborbactam are slated for priority reviews. These drugs target specific patient populations: teenage patients aged 12 years and above with refractory, moderate to severe atopic dermatitis (AD) who…
