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Johnson & Johnson (NYSE: JNJ) announced today that the US Food and Drug Administration (FDA) has granted approval for Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). With this approval, Tremfya stands out as the sole fully-human, dual-acting monoclonal antibody that not only…
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Roche (SWX: ROG; OTCMKTS: RHHBY) , a leading Swiss pharmaceutical company, has secured US Food and Drug Administration (FDA) approval for its subcutaneous formulation of the programmed death-ligand 1 (PD-L1) inhibitor, Tecentriq Hybreza (atezolizumab, hyaluronidase). This new formulation has been approved for all 12 adult indications of intravenous Tecentriq, covering…
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Eli Lilly & Co. (NYSE: LLY) has announced that it has received market approval from the US Food and Drug Administration (FDA) for Ebglyss (lebrikizumab), a new treatment for adults and children aged 12 years and over suffering from moderate-to-severe atopic dermatitis (AD). Ebglyss is an interleukin-13 (IL-13) inhibitor that…
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Roche Group (SWX: ROG; OTCMKTS: RHHBY) , a Swiss pharmaceutical giant, has announced that the US Food and Drug Administration (FDA) has granted approval for Ocrevus Zunovo (ocrelizumab, hyaluronidase), marking a significant advancement in the treatment of multiple sclerosis (MS). This new formulation is the first and only twice-per-year treatment…
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Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has announced the presentation of clinical study results for its drug olverembatinib (HQP1351) at the 2024 European Society of Medical Oncology (ESMO) Congress. The study focused on patients with succinate dehydrogenase-deficient gastrointestinal stromal tumor (GIST), a rare and aggressive form…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has accepted its market filing for trastuzumab rezetecan (SHR-A1811), an antibody-drug conjugate (ADC) targeting HER2, with priority review status. The drug is intended for the treatment of adult…
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Johnson & Johnson (NYSE: JNJ), a leading healthcare company based in the U.S., has reported a second New Drug Application (NDA) filing for its FcRn blocker, nipocalimab. The company has submitted the application to the European Medicines Agency (EMA) for the treatment of adults with generalized myasthenia gravis (gMG) who…
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Keymed Biosciences Inc. (HKG: 2162), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has approved a market filing for its IL-4Rα monoclonal antibody (mAb) drug candidate, stapokibart (CM310), for the treatment of moderate to severe atopic dermatitis (AD). This marks a significant milestone…
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Sanofi (EPA: SAN; NASDAQ: SNY), a leading French pharmaceutical company, has announced positive results from two Phase III clinical trials for its drug Dupixent (dupilumab), indicating its potential for two distinct indications. The first trial, ADEPT, concentrated on the treatment of the rare skin condition bullous pemphigoid (BP), while the…
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Suzhou GenAssist Therapeutic Co., Ltd, a biopharmaceutical company based in China, has announced the commencement of an investigator-initiated-trial (ITT) for its base editing drug candidate, GEN6050X, in patients afflicted with Duchenne muscular dystrophy (DMD). DMD is a rare genetic disorder linked to the X-chromosome, typically caused by mutations in the…
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Innovent Biologics, Inc. (HKG: 1801), a biopharmaceutical company based in China, has presented significant findings from the Phase III DREAMS-2 study on its drug candidate mazdutide at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD). Mazdutide, a dual agonist targeting the glucagon-like peptide-1 receptor…
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Qilu Pharmaceutical, a leading pharmaceutical company based in China, has presented updated results from the Phase II INTELLECT study for its Category 1 drug iruplinalkib at the World Conference on Lung Cancer (WCLC). The study focuses on patients with cizotinib-resistant anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC).…
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Nuance Pharma, a China-based pharmaceutical company, has announced the completion of patient enrollment for the Phase III ENHANCE-CHINA study (NCT05743075) for its drug Ohtuvayre (ensifentrine). This Phase III trial is a randomized, double-blind, placebo-controlled investigation assessing the efficacy and safety of Ohtuvayre over a 24-week period in adult patients diagnosed…
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has unveiled Phase I clinical data for its innovative PD-1/IL-2α-biased bispecific antibody (BsAb) fusion protein, IBI363, at the 2024 World Conference on Lung Cancer (WCLC). The data, which pertain to the treatment of advanced non-small cell lung cancer…
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Betta Pharmaceuticals Co., Ltd (SHE: 300558), a pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its clinical filing for MCLA129, a Category 1 biologic product intended for the treatment of advanced solid tumors. The potential indications for MCLA129 include, but…
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Duality Biologics, Inc., a biopharmaceutical company based in China, has reached a significant milestone with the dosing of the first patient in its Phase I/IIa clinical study for the in-house developed antibody drug conjugate (ADC) DB-1419. The study is aimed at evaluating the safety and efficacy of DB-1419 in patients…
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AbbVie Sues BeiGene Over Alleged Trade Secret Theft in BTK Degrader ProgramU.S. pharmaceutical titan AbbVie Inc. (ABBV) has initiated legal proceedings against BeiGene Ltd. (NASDAQ: BGNE; HKG: 6160; SHA: 688235), accusing the Chinese biotech firm of pilfering trade secrets vital to its Bruton’s tyrosine kinase (BTK) degrader program. According to…
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Terns Pharmaceuticals Inc. (NASDAQ: TERN), a U.S.-based biotechnology company originally spun out from Eli Lilly’s China R&D center, has unveiled early data for its oral, once-daily glucagon-like peptide-1 receptor (GLP-1R) agonist, TERN-601. The top-line data originates from a Phase I clinical trial, which was a double-blind, placebo-controlled study involving single…
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GSK plc (LON: GSK, NYSE: GSK), a leading UK-based pharmaceutical company, has announced positive results from a Phase III trial for its auto-immune therapy Nucala (mepolizumab) in treating chronic obstructive pulmonary disorder (COPD). The MATINEE trial demonstrated that GSK’s interleukin-5 (IL-5) inhibitor met the primary endpoint, showing a significant and…
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China Isotope & Radiation Corporation’s (CIRC) subsidiary, HTA Co., Ltd. (HKG: 1763), has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its sodium fluoride [18F]. This product is primarily utilized in positron emission tomography (PET) to identify areas of altered osteogenic activity in…