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J&J’s SC Amivantamab Faces Complete Response Letter from FDA for NSCLC Treatment
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Johnson & Johnson (J&J, NYSE: JNJ) has announced that the Biologics License Application (BLA) filed with the US FDA for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) has received a complete response letter (CRL). The application sought approval for the treatment of patients…
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Grand Pharmaceutical’s GPN01768 Accepted for Review by NMPA for Demodex Blepharitis Treatment
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Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) has announced that the National Medical Products Administration (NMPA) has accepted for review a New Drug Application (NDA) for its innovative drug GPN01768 (TP-03, lotilaner ophthalmic solution, 0.25%). The Chinese company is seeking approval for the drug to treat Demodex blepharitis, a condition…
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Jiangsu Hengrui’s Trastuzumab Rezetecan on Track for NMPA’s Breakthrough Therapy Designation
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), a leading pharmaceutical company based in China, has announced that its trastuzumab rezetecan (SHR-A1811), an HER2 targeted antibody-drug conjugate (ADC), is on course to receive Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The…
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Abbisko Therapeutics Receives NMPA Approval for Irpagratinib Regulatory Study
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to initiate a regulatory study for its novel small-molecule FGFR4 inhibitor, irpagratinib. Details of the Approved TrialThe approved trial, ABSK-011-205, is…
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Vocabria Receives Positive CHMP Opinion for HIV Treatment in Adolescents
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GSK plc (NYSE: GSK) has announced that ViiV Healthcare, an HIV specialist majority owned by GSK with Pfizer and Shionogi as shareholders, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The recommendation is for the approval of…
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GSK’s Jemperli Receives Positive CHMP Opinion for Endometrial Cancer Indication Extension
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The UK-based pharmaceutical giant GSK (NYSE: GSK) has received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for the indication extension approval of its PD-1 inhibitor Jemperli (dostarlimab). The drug is proposed for use in combination with chemotherapy (carboplatin and paclitaxel)…
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GSK’s Jemperli Receives FDA Breakthrough Therapy Designation for Rectal Cancer Treatment
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UK-based pharmaceutical giant GSK (NYSE: GSK) has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its drug Jemperli (dostarlimab). The designation is for the treatment of patients with locally advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) rectal cancer. Jemperli’s Background…
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CanSino Biologics’ DTcP Vaccine for Infants and Young Children Accepted by NMPA for Review
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China-based vaccines specialist CanSino Biologics Inc. (HKG: 6185) has announced that the National Medical Products Administration (NMPA) has accepted for review a New Drug Application (NDA) for its DTcP vaccine, designed for infants and young children under the age of 2. Quality Consistency and Market GapThe DTcP vaccine, a component…
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EMA Grants PRIME Designation to Hansoh Pharmaceutical’s HS-20093 in Collaboration with GSK
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The European Medicines Agency (EMA) has conferred Priority Medicines (PRIME) designation to HS-20093 (GSK5764227), a B7-H3-targeted antibody-drug conjugate (ADC) co-developed by China’s Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) and the UK pharmaceutical major GSK (NYSE: GSK). This PRIME designation follows Breakthrough Therapy Designations (BTDs) received in the United States…
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European CHMP Supports Conditional Approval of MSD’s Welireg for VHL Disease and RCC
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for its Welireg (belzutifan), a hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor. The CHMP recommends conditional approval for adult patients with von Hippel-Lindau (VHL) disease…
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EMA’s CHMP Recommends Approval of Bayer’s Acoramidis for ATTR-CM Treatment
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Bayer’s (ETR: BAYN) acoramidis has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM), the German pharmaceutical company announced last week. ATTR-CM and the Impact of AcoramidisATTR-CM is a rare disease…
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Sanofi’s Tolebrutinib Earns FDA Breakthrough Designation for Non-Relapsing Secondary Progressive MS
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Sanofi (NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to its Bruton’s tyrosine kinase (BTK) inhibitor, Tolebrutinib, for the treatment of adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS). Phase III HERCULES Study Results Influence FDA DecisionThe FDA’s decision is supported…
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ARS Pharmaceuticals’ Neffy Receives Market Filings in Asia-Pacific Region
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US-based ARS Pharmaceuticals, Inc. (NASDAQ: SPRY) has announced that market filings for its intranasal epinephrine product, neffy (epinephrine nasal spray) 2 mg, have been submitted by its licensing partners in China, Japan, and Australia. Neffy’s Role in Treating Type I Allergic ReactionsNeffy is indicated for the emergency treatment of Type…
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Fujian Cosunter Pharmaceutical’s GST-HG141 Earns Breakthrough Designation for Chronic Hepatitis B
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Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436), a China-based pharmaceutical company, has announced that it has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation of the National Medical Products Administration (NMPA) for its drug neracorvir (GST-HG141), which is intended to treat chronic hepatitis B virus (HBV). GST-HG141:…
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Accropeutics Gets FDA Green Light for Phase II UC Study of RIPK2 Inhibitor AC-101
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Accropeutics Inc., a clinical-stage biotechnology company with operations in New York, US, and Suzhou, China, has announced that it has received approval from the US Food and Drug Administration (FDA) to commence a Phase II clinical study for its RIPK2 inhibitor, AC-101, in the treatment of ulcerative colitis (UC). Design…
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EMA’s CHMP Supports Approval of Eli Lilly’s Omvoh (Mirikizumab) for Crohn’s Disease
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The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recently recommended the potential approval of Omvoh (mirikizumab) by US pharmaceutical giant Eli Lilly and Company (NYSE: LLY). This treatment is intended for adults with moderately to severely active Crohn’s disease who have not responded adequately…
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Wepon Medical’s WP107 for Myasthenia Gravis Accepted for FDA Review
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Wepon Medical Holding Group Co., Ltd. (SHE: 002082) has announced that the US Food and Drug Administration (FDA) has accepted its clinical filing for WP107 (huperzine A), an in-house developed drug, for review. The drug is intended to treat generalized myasthenia gravis (gMG), a serious neuromuscular disorder. WP107: A Promising…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for Lupus Nephritis Clinical Trial
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it has obtained approval from the National Medical Products Administration (NMPA) to proceed with clinical trials for its therapeutic biologic product, SHR-2173, in the treatment of lupus nephritis (LN). SHR-2173: A Novel Treatment for Lupus NephritisSHR-2173 is an in-house developed…
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Grand Pharmaceutical’s STC3141 Sepsis Therapy Completes Phase II Patient Enrollment
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China-based Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) has announced the completion of patient enrollment and dosing in its Phase II study for STC3141, a sepsis therapy developed by Grand Medical Pty Ltd, the company’s innovative drug R&D center in Australia. The preliminary results of the study are anticipated by…
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Innovent Biologics Initiates Phase I Trial for IBI3009 in Small Cell Lung Cancer and Neuroendocrine Tumors
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On December 13, 2024, Innovent Biologics, Inc. (HKG: 1801) registered a Phase I clinical trial for IBI3009 on the drug clinical trial registration and information public platform. The trial will investigate the efficacy of IBI3009 in treating small cell lung cancer (SCLC) and other neuroendocrine tumors. Exploring Biomarkers and Efficacy…
