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Sanofi’s Rilzabrutinib Meets Primary Endpoint in Phase III ITP Trial
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French pharmaceutical company Sanofi (NASDAQ: SNY) has announced that its Phase III trial for rilzabrutinib, a potential best-in-class BTK inhibitor, has successfully met its primary endpoint of durable platelet response in patients with immune thrombocytopenia (ITP). The trial also produced positive results in key secondary endpoints and did not raise…
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European Commission Approves Pfizer’s Antibiotic Emblaveo for Multiple Indications
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The European Commission (EC) has granted approval for Pfizer’s (NYSE: PFE) antibiotic Emblaveo (aztreonam + avibactam) for the treatment of complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), complicated urinary tract infections (cUTI), and infections caused by aerobic Gram-negative organisms in adults. The drug was reviewed under an accelerated assessment process…
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BeiGene’s Tislelizumab Secures EC Approval for Three NSCLC Indications
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the European Committee (EC) has granted approval for its programmed death-1 (PD-1) inhibitor, tislelizumab, for three distinct non-small cell lung cancer (NSCLC) indications. The approvals allow for the use of tislelizumab in the following scenarios: The approvals were supported by…
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Shanghai Henlius Biotech Achieves First Patient Dosing in Phase I Trial for Fibrosis Treatment HLX6018
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Shanghai Henlius Biotech Inc. (HKG: 2696), a biopharmaceutical company based in China, has announced the completion of the first patient dosing in a Phase I clinical study for HLX6018, a GARP/TGF-β1 compound monoclonal antibody (mAb). The drug is under development for the treatment of fibrosis-related diseases and has been tested…
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China Medical System Holdings’ Desidustat NDA Accepted for Review by China’s NMPA
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China Medical System Holdings (CMS; HKG: 0867) has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its desidustat. The oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) is under development to treat anemia in adult chronic kidney disease (CKD) patients who…
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Akeso Biopharma Submits sNDA for Cadonilimab in Cervical Cancer to China’s CDE
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China-based Akeso Biopharma (HKG: 9926) has announced the submission of a supplementary New Drug Application (sNDA) for its innovative bispecific antibody, cadonilimab (AK104), which targets both programmed death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). The sNDA filing seeks to expand the use of cadonilimab in combination with chemotherapy and…
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Huadong Medicine’s HDM1005 Receives US FDA Clinical Trial Approval for Weight Management
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its investigational drug HDM1005. This long-acting agonist targets the GLP-1 receptor and GIP receptor and is under development for weight management in overweight or obese…
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Sandoz’s Partner Samsung Bioepis Scores EC Approval for Stelara Biosimilar Pyzchiva
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Switzerland-headquartered Sandoz (SWX: SDZ) has announced that the European Commission (EC) has granted approval for Pyzchiva, a biosimilar version of Johnson & Johnson’s (J&J; NYSE: JNJ) IL-12/23 blocker Stelara (ustekinumab), developed in partnership with South Korea’s Samsung Bioepis. Both biologics are indicated for the treatment of plaque psoriasis, psoriatic arthritis,…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Go-Ahead for Camrelizumab Combination Therapy Study in Pancreatic Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, randomized, controlled Phase II/III clinical study. The study will assess the efficacy and safety of its programmed death-1 (PD-1)…
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CanSino Biologics Receives NMPA Approval for Haemophilus influenzae type B (Hib) Conjugate Vaccine Clinical Trial
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China-based biopharmaceutical company CanSino Biologics (HKG: 6185) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its freeze-dried Haemophilus influenzae type B (Hib) conjugate vaccine. Haemophilus influenzae, a Gram-negative bacterium, is a leading cause of acute lower respiratory tract infections in children.…
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CANbridge Pharmaceuticals’ CAN008 Fails to Meet Phase II Endpoints in Glioblastoma Multiforme
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CANbridge Pharmaceuticals (HKG: 1228) has announced that its Phase II clinical study for CAN008 (asunercept) in newly diagnosed glioblastoma multiforme (GBM) did not achieve progression-free survival (PFS) or overall survival (OS) benefits. As a result, the Sino-US biopharma company has decided to discontinue the development of CAN008 for GBM. The…
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GenScript’s Subsidiary Legend Biotech Expands EU Approval for CAR-T Therapy Carvykti
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China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), has secured an expanded indication approval from the European Union for its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). The therapy is now approved as a…
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Ipsen’s Somatuline Receives First Prescription in China for GEP-NETs Treatment
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French biopharmaceutical company Ipsen (EPA: IPN; OTCMKTS: IPSEY) has announced that the first prescription of its Somatuline (lanreotide) sustained-release injection has been issued in China for the treatment of gastrointestinal pancreatic neuroendocrine tumors (GEP-NETs). Somatuline, the only somatostatin analogue (SSA) for deep subcutaneous self-injection, received approval in China in December…
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Jiangsu Hengrui’s SHR-A2102 Earns FDA Fast Track Status for Urothelial Carcinoma Treatment
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its pipeline candidate, SHR-A2102. This designation is in recognition of the drug’s potential to treat advanced urothelial carcinoma,…
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Hengrui Pharmaceuticals Gets Green Light from NMPA for Two Anti-Cancer Drugs
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its drug candidates, SHR-3276 and HRS2398. SHR-3276 is slated for study in patients with general advanced solid…
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GSK’s Gepotidacin Shows Non-Inferior Efficacy in Phase III Gonorrhoea Tria
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GlaxoSmithKline (GSK; NYSE: GSK, LON: GSK), a leading UK pharmaceutical company, last week announced positive results from a Phase III clinical trial for gepotidacin, a first-in-class triazaacenaphthylene antibiotic, in the treatment of uncomplicated urogenital gonorrhoea (GC). The study demonstrated non-inferiority to the standard azithromycin-based treatment, with a microbiological response rate…
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Joincare Pharmaceutical’s TG-1000 Shows Promise in Phase III Flu Treatment Trial
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Joincare Pharmaceutical Group Co., Ltd (SHA: 600380), a Chinese pharmaceutical company, has reportedly completed the unblinding of a Phase III trial for TG-1000, an investigational influenza antiviral drug. The trial has shown positive preliminary data, indicating that the company is now preparing to file a New Drug Application (NDA) in…
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Roche’s Alecensa approved by FDA as First ALK Inhibitor for Adjuvant Treatment of NSCLC
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Roche Holding AG (SWX: ROG; OTCMKTS: RHHBY), a Swiss multinational healthcare company, announced last week that the US Food and Drug Administration (FDA) has granted regulatory approval for Alecensa (alectinib) as an adjuvant treatment for patients with ALK-positive non-small cell lung cancer (NSCLC). This marks the first approval of an…
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Takeda Scores FDA Nod for Subcutaneous Vedolizumab to Treat Inflammatory Bowel Disease
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The US Food and Drug Administration (FDA) has granted Takeda Pharmaceutical Company Limited (NYSE: TAK), a Japanese pharmaceutical company, registration authorization for a subcutaneous formulation of its alpha4beta7 integrin antagonist Entyvio (vedolizumab). This new formulation is intended for use as a maintenance therapy in patients with moderately to severely active…
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China’s Health Authorities Investigate Alleged Price Manipulation in Pharma Procurement Tenders
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Chinese health regulators are delving into allegations of irregular pricing practices during the national volume-based procurement (VBP) tenders for several pharmaceutical products. A joint statement issued by the National Drug Alliance Procurement Office and the Shanghai Pharmaceutical Centralized Bidding Procurement Management Office cited public complaints regarding the bidding and pricing…
