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MicroPort CardioFlow’s VitaFlow Liberty Receives Marketing Approval in Turkey
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China-based MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160) has announced that its second-generation transcatheter aortic valve implantation (TAVI) product, VitaFlow Liberty, has received marketing approval from the Turkish Medicines and Medical Devices Agency (TITCK). This marks another global milestone for the product, following its approval in multiple countries and regions,…
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Vcanbio’s VUM02 Secures NMPA Approval and FDA ODD for Cirrhosis and aGvHD
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China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced significant progress for its in-house developed VUM02 for injection, receiving approval from the National Medical Products Administration (NMPA) in China to study the treatment of decompensated cirrhosis and obtaining Orphan Drug Designation (ODD) from the Food and Drug…
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Novo Nordisk Invests DKK 8.5 Billion in New Odense Manufacturing Facility
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Denmark-based pharmaceutical giant Novo Nordisk A/S (NYSE: NVO) is making a significant investment in its homeland by establishing a brand-new manufacturing facility in Odense, marking the first time this century the company has embarked on such a project. The capital infusion of DKK 8.5 billion (USD 1.2 billion) will go…
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Johnson & Johnson Submits sBLA to FDA for Simponi in Pediatric Ulcerative Colitis
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US pharmaceutical major Johnson & Johnson (J&J, NYSE: JNJ) has announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for its drug Simponi (golimumab), seeking approval to treat children aged two years and older with moderately to severely active ulcerative colitis…
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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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MicroPort NeuroTech Leads Investment Fund to Advance Brain Science Industry
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China-based MicroPort NeuroTech Limited (HKG: 2172) has announced its commitment to invest RMB 200 million (USD 27.46 million) to jointly establish an investment fund aimed at fostering the development of the brain science and brain-Inspired Intelligence industry, aligning with MicroPort NeuroTech’s strategic future direction. Collaboration with Other InvestorsJoining MicroPort NeuroTech…
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Candid Therapeutics Expands TCE Portfolio with Strategic Partnerships in Autoimmune Disease Treatment
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US-based Candid Therapeutics Inc. is fulfilling its ambition to become a leader in advancing T-cell engagers (TCEs) for B-cell depletion to treat autoimmune diseases, with the signing of Chinese firms Nona Biosciences and EpimAb Biotherapeutics, Inc., as well as compatriot firm Ab Studio, Inc., in a single day to strengthen…
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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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Bio-Thera Solutions Expands License Deal with SteinCares for Latin American Market
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China-based Bio-Thera Solutions (SHA: 688177) has announced the addition of a third biosimilar to its existing license agreement with Costa Rican partner SteinCares, which was initially struck in March of this year. Under the revised accord, SteinCares will gain exclusive rights to distribute and market the new biosimilar in Brazil…
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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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Roche’s cobas 6800/8800 Systems 2.0 Earn CE Certification, Set for US Market Entry
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Global healthcare company Roche (SWX: ROG) has announced that its state-of-the-art cobas 6800/8800 Systems 2.0 has received CE certification. This marks a significant advancement in the Swiss company’s polymerase chain reaction (PCR) technology. Optimizing Laboratory Efficiency with cobas 6800/8800 Systems 2.0The new cobas 6800/8800 Systems 2.0 update represents a major…
