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Biogen’s Higher-Dose Spinraza Regimen Under Review by FDA and EMA
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US-based biopharmaceutical company Biogen (NASDAQ: BIIB) has submitted supplemental New Drug Applications (sNDAs) to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a higher-dose regimen of its spinal muscular atrophy (SMA) treatment, Spinraza (nusinersen). The applications are currently under review by both regulatory bodies,…
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YolTech Initiates Study for YOLT-204 in Transfusion-Dependent Beta-Thalassemia
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Shanghai-based YolTech Therapeutics, a biotech startup specializing in lipid nanoparticle delivery and gene editing, has announced the initiation of a dosage escalation study to preliminarily assess the safety and efficacy of a single-dose regimen with YOLT-204 in transfusion-dependent beta-thalassemia (TDT). This marks a significant step forward in the development of…
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Haichang Bio’s siRNA Drug HC016 Cleared for US Clinical Trials
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China-based Zhejiang Haichang Biotech Co., Ltd has announced that its siRNA drug, HC016 complex lipid, has been cleared by the US Food and Drug Administration (FDA) for clinical trials. This marks a significant milestone in the development of innovative treatments for solid tumors, leveraging Haichang Bio’s proprietary QTsome technology platform.…
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Abbott Labs Posts Q4 Growth, Projects Strong 2025 Outlook
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US-based Abbott Laboratories (NYSE: ABT) has released its Q4 2024 financial results, reporting an 8.8% increase in organic sales to USD 10.974 billion. Excluding COVID-19 testing-related sales, the company achieved a 10.1% growth rate. For the full year, Abbott generated USD 42.0 billion in revenues, up 7.1% on an organic…
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Haisco’s HSK44459 Approved for Clinical Trials in Behcet’s Disease
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its investigational product HSK44459 in Behcet’s disease. This rare disease is listed in China’s second catalogue of rare diseases, highlighting the significant unmet medical need it represents. Behcet’s…
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Belief BioMed’s BBM-D101 Receives FDA Approval for DMD Clinical Trial
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China-based gene therapy specialist Belief BioMed Inc. (BBM) has announced receiving clinical trial approval from the US Food and Drug Administration (FDA) for its BBM-D101. An open, single-dose clinical study is scheduled to commence, assessing the safety and efficacy of the gene therapy in boys aged 4 to 9 with…
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United Laboratories’ UBT251 Approved for Phase II Trials in Chronic Kidney Disease
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Hong Kong-based United Laboratories International Holdings Ltd (HKG: 3933) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct Phase II clinical trials for its Category 1 drug UBT251 in chronic kidney disease (CKD). This marks a significant step forward in the development of innovative therapies for…
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Sanofi’s Sarclisa Approved in EU for Newly Diagnosed Multiple Myeloma
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France-based Sanofi (EPA: SAN, NASDAQ: SNY) has announced receiving marketing approval in the European Union (EU) for its CD38 monoclonal antibody (mAb) Sarclisa (isatuximab) in combination with the standard-of-care regimen of bortezomib, lenalidomide, and dexamethasone (VRd). The approval is for the treatment of adult patients with newly diagnosed multiple myeloma…
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FDA Lifts Clinical Hold on Sanofi’s Cialis Over-the-Counter Trial
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France-based Sanofi’s (NASDAQ: SNY, EPA: SAN) Consumer Healthcare unit Opella has announced that the US FDA has lifted a clinical hold on its planned Actual Use Trial (AUT) for Cialis (tadalafil). This move allows Sanofi to initiate the AUT and potentially switch the PDE5 inhibitor from a prescription to an…
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Johnson & Johnson’s Spravato Approved as Monotherapy for Major Depressive Disorder
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US-based Johnson & Johnson (J&J; NYSE: JNJ) has announced that its Spravato (esketamine) CIII nasal spray has received clearance from the US Food and Drug Administration (FDA) as the first and only monotherapy for adults with major depressive disorder (MDD) who have had an inadequate response to at least two…
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CD Biopharma Initiates Phase I Trial for CD-001 in Advanced Solid Tumors
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Suzhou-based tumor immunotherapy specialist CD Biopharma has announced the first subject dosing of a Phase I study for its novel anti-tumor drug CD-001 in patients with advanced solid tumors. The patient is reported to be stable with all indicators being normal. This milestone marks the beginning of clinical evaluation for…
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Humanwell’s HWH340 Receives Clinical Approval for Prostate Cancer Treatment
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Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced that its Class 1 chemical drug HWH340 has received clinical approval from the National Medical Products Administration (NMPA). The drug is indicated for use in combination with abiraterone acetate for the treatment of advanced prostate cancer. This approval marks a significant…
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Huadong Medicine’s MediBeacon TGFR System Receives FDA Marketing Clearance
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving marketing clearance from the US Food and Drug Administration (FDA) for its MediBeacon Transdermal GFR System (TGFR), a medical device co-developed with US partner MediBeacon Inc. The system is designed to evaluate renal function in adult patients with both impaired…
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MediLink’s YL201 Receives Breakthrough Therapy Designation for Nasopharyngeal Carcinoma
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Suzhou-based biotech MediLink Therapeutics (Suzhou) Co., Ltd has announced receiving another breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC) YL201. The designation is for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC), following the…
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Jiangsu Lianhuan Completes Enrollment for Phase III Study of LH-1801 in Type 2 Diabetes
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China-based Jiangsu Lianhuan Pharmaceutical Co., Ltd (SHA: 600513) has announced the completion of subject enrollment for the Phase III clinical study of its Category 1 drug LH-1801, in combination with metformin. The study aims to evaluate the efficacy and safety of LH-1801 in treating type 2 diabetes, building on its…
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Arrowhead’s Plozasiran Accepted for FDA Review in Familial Chylomicronemia Syndrome
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US-based Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) has announced that the New Drug Application (NDA) for its plozasiran, targeting familial chylomicronemia syndrome (FCS), has been accepted for review by the US Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) target date for the review is set for…
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GSK’s Jemperli Approved for First-Line Endometrial Cancer Treatment in EU
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UK-based GSK plc (NYSE: GSK, LON: GSK) has announced receiving approval from the European Commission for a new indication for its PD-1-blocking antibody Jemperli (dostarlimab). The drug is now approved for use in combination with chemotherapy (carboplatin and paclitaxel) as a first-line treatment for adult patients with primary advanced or…
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Kelun-Biotech’s Tagitanlimab Receives NMPA Clearance for Nasopharyngeal Carcinoma
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced receiving another clearance from the National Medical Products Administration (NMPA) for its PD-L1 monoclonal antibody (mAb) Ketailai (tagitanlimab). The latest approval indicates the drug for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) when combined with chemotherapy. This follows…
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CARsgen Therapeutics Initiates Trial for Universal CAR-T Therapy KJ-C2320 in AML
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced the first subject dosing in an investigator-initiated trial (ITT) for its KJ-C2320, a universal chimeric antigen receptor (CAR)-T cell therapy targeting recurrent/refractory acute myeloid leukemia (R/R AML). This milestone marks a significant step forward in the development of innovative treatments for…
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Chongqing Genrix’s Xeligekimab Approved for Ankylosing Spondylitis by NMPA
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China-based Chongqing Genrix Bio Pharmaceutical Co., Ltd (SHA: 688443) has announced receiving approval from the National Medical Products Administration (NMPA) for an additional indication of its in-house developed Category 1 biologic product, xeligekimab. The anti-IL-17 antibody is now approved to treat ankylosing spondylitis (radiologically positive axial spondyloarthritis), following its initial…
