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Roche’s Xofluza Receives FDA Approval for Reducing Influenza Transmission in Phase III Study
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Roche (SWX: ROG; OTCMKTS: RHHBY) has announced that its antiviral drug Xofluza (baloxavir marboxil) has received approval from the US Food and Drug Administration (FDA) based on positive results from the Phase III CENTERSTONE study. The study demonstrated that a single dose of Xofluza significantly reduced the transmission of influenza…
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J&J’s Rybrevant Secures FDA Approval for EGFR/c-MET Non-Small Cell Lung Cancer Treatment
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Johnson & Johnson (J&J; NYSE: JNJ)has announced that the US Food and Drug Administration (FDA) has granted approval for its EGFR/c-MET bispecific antibody, Rybrevant (amivantamab-vmjw), in combination with standard chemotherapy, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor…
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Beijing’s Apollobio Receives NMPA Approval for HPV Therapeutic Vaccine VGX-3100
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Beijing’s Apollobio, has announced that the National Medical Products Administration (NMPA) has granted market approval for its innovative therapeutic vaccine VGX-3100. This vaccine, which targets HPV-16/18 related anal precancerous lesions, is a significant advancement in the treatment landscape for conditions associated with Human Papillomavirus (HPV). The vaccine’s approval follows a…
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Insilico Medicine’s AI-Generated Drug Candidate ISM001-055 Shows Positive Phase II Results in IPF Study
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China-based artificial intelligence (AI) drug developer Insilico Medicine has reported initial positive data from its Phase IIa study for ISM001-055, an in-house generative AI-generated drug candidate for idiopathic pulmonary fibrosis (IPF). The molecule, which targets TNIK (Traf2- and NCK- interacting kinase), has shown a positive safety profile and dose-dependent lung…
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Lee’s Pharmaceutical’s Zhaoke Ophthalmology Receives NMPA Approval for Generic Lumigan
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced that it has received market approval from China’s National Medical Products Administration (NMPA) for its generic version of Allergan’s (NYSE: AGN) Lumigan (bimatoprost), a treatment for glaucoma. The product, marketed under the Chinese trade…
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Jiangsu Hengrui Medicine’s SHR-1701 Combo Therapy for Gastric Cancer Accepted for Review by China’s NMPA
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its market filing for SHR-1701 in combination with fluorouracil and platinum for the first-line treatment of locally advanced unresectable, recurrent, or metastatic adenocarcinoma of…
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JiCui Cell Therapy Forms Partnership with Fosun Kite to Advance Bispecific CAR-T Cell Therapy Industrialization
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JiCui Cell Therapy Drug Research Institute, also known as Jiangsu Jicui Juechuang Biotechnology Research Institute Co., Ltd, has entered into a strategic partnership with Fosun Kite Biotechnology Co., Ltd, a joint venture between Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) and Gilead’s subsidiary Kite Pharma. The collaboration…
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Apeloa Pharmaceutical Invests in Ji Xing Pharmaceuticals’ Series D Financing Round
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China-based Apeloa Pharmaceutical Co., Ltd (SHE: 000739) has announced its participation in the Series D financing round of fellow Chinese firm Ji Xing Pharmaceuticals, contributing USD 2.75 million for a 0.58% stake in the Shanghai-based company. The investment round also saw contributions from Ji Xing’s founder, RTW Holding Limited, and…
