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GSK’s RSV Vaccine Arexvy Launches in US Pharmacies Ahead of 2023/24 Season
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GlaxoSmithKline (GSK; NYSE: GSK), a UK-based pharmaceutical giant, has announced that its respiratory syncytial virus (RSV) vaccine, Arexvy, is now available at all major pharmacies in the US. The vaccine received approval in the country earlier this year and was subsequently recommended by the Advisory Committee on Immunization Practices (ACIP)…
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GC Biopharma Presents Data Showing Higher Thrombotic Risk with Roche’s Hemlibra
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South Korea’s GC Biopharma (KRX: 006280) has presented evidence suggesting that Roche’s (SWX: ROG) hemophilia therapy, Hemlibra (emicizumab), may display a higher proportion of thrombotic adverse events (AEs) compared to coagulation factor VIII replacements. This finding is based on an analysis of US data reported to the FDA Adverse Event…
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Moderna Announces Immunogenicity of Updated COVID-19 Vaccine Against New Variants
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Moderna (NASDAQ: MRNA) has announced preliminary data indicating that an updated version of its SARS-CoV-2 vaccine is immunogenic against the EG.5 and FL.1.5.1 variants, recently renamed Eris and Fornax by the World Health Organization (WHO), with Eris being classified as a variant of interest (VOI). This development marks a significant…
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Luye Pharma Launches Rykindo in US, a First for Chinese CNS Drug
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China-based Luye Pharma Group (HKG: 2186) has announced the official commercial operation of its Rykindo (risperidone) extended-release injectable suspension in the United States. Developed on Luye Pharma’s microsphere technology platform, Rykindo is administered via intramuscular injection once every two weeks, utilizing long-acting and extended-release microsphere technology to deliver the active…
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CSPC Pharmaceutical Group Receives FDA Approval for NBL-028 Bispecific Antibody Clinical Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received the green light from the US FDA to conduct a clinical study for its bispecific antibody (BsAb), NBL-028, which targets CLDN6 and CD137. The initial focus of the study will be on advanced tumors with CLDN6 expression,…
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CanSino Biologics Receives Halal Certificate for COVID-19 Vaccine in Indonesia
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China-based CanSino Biologics (SHA: 688185, HKG: 6185) has announced that it has received a halal certificate from Indonesia’s LPPOM MUI for its recombinant novel coronavirus vaccine, which uses an adenovirus type 5 vector. This certification is a significant step for the company as it seeks to expand its vaccine’s reach…
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Innovent Biologics’ Tafolecimab Receives NMPA Approval for Hypercholesterolemia Treatment
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China-based Innovent Biologics Inc. (HKG: 1801) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its tafolecimab (IBI306), a recombinant fully human anti-PCSK-9 monoclonal antibody (mAb). The approved indication is for primary hypercholesterolemia, including heterozygous familial and non-familial hypercholesterolemia, as well as mixed…
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European Commission Approves AbbVie’s Aquipta for Migraine Prevention in Adults
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The European Commission (EC) has granted marketing approval to AbbVie (NYSE: ABBV) for its drug Aquipta (atogepant), marking a significant milestone in the prevention of migraine in adults with four or more migraine days per month. Aquipta becomes the first once-daily oral calcitonin gene-related peptide (CGRP) receptor antagonist to receive…
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BMS Announces Positive Phase I/II Results for Repotrectinib in ROS1-Positive NSCLC
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Bristol-Myers Squibb (BMS, NYSE: BMY) has released new data from a Phase I/II trial featuring the ROS1/TRK blocker repotrectinib, which is being investigated for the treatment of ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). The company celebrated the results, highlighting that the next-generation tyrosine kinase inhibitor (TKI)…
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Immunofoco’s IMC008 Earns Orphan Drug Designation for Gastric Cancer from FDA
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Suzhou-based cell therapy developer Immunofoco has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its next-generation autologous CAR-T therapy, IMC008, which is being developed to treat gastric cancer. IMC008: A Next-Generation CAR-T Therapy Utilizing SNR TechnologyIMC008 is grounded in Immunofoco’s…
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Seagen’s Tukysa Meets Primary Endpoint in Phase III Study for HER2+ Breast Cancer
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Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), has announced an update on an ongoing Phase III oncology study involving a combination therapy that includes the HER2 inhibitor Tukysa (tucatinib), one of Seagen’s four marketed drugs that attracted Pfizer’s interest. The trial successfully met…
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Inmagene Biopharmaceuticals Initiates Global Study for IMG-007 in Atopic Dermatitis
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China-based Inmagene Biopharmaceuticals has announced the first patient dosing in a global, multi-center, proof-of-concept study assessing the safety, pharmacokinetics, and efficacy of its pipeline candidate IMG-007. The molecule is being evaluated as a treatment for moderate-to-severe atopic dermatitis (AD), a condition that affects a significant patient population worldwide. IMG-007: An…
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Sandoz Achieves Primary Endpoint in Phase III Trial for Biosimilar Aflibercept
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Switzerland-based Novartis (NYSE: NVS) subsidiary Sandoz (SWX: SDZ) has announced that a Phase III confirmatory trial for its biosimilar version of Bayer’s (ETR: BAYN) Eylea/Wetlia (aflibercept) has successfully reached its primary efficacy endpoint in neovascular (wet) age-related macular degeneration (nAMD). The study demonstrated that Sandoz’s biosimilar product showed no clinically…
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Everest Medicines’ Partner Venatorx Pharmaceuticals Receives FDA Priority Review for Cefepime-Taniborbactam
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China-based Everest Medicines (HKG: 1952) announced that its partner, Venatorx Pharmaceuticals, has received acceptance from the US Food and Drug Administration (FDA) for a New Drug Application (NDA) for cefepime-taniborbactam, an investigational beta-lactam/beta-lactamase inhibitor (BL/BLI) antibiotic. The drug is intended for the potential treatment of adult patients with complicated urinary…
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Simcere Pharmaceutical’s Cosela Receives NMPA Review for ES-SCLC Indication
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced that the National Medical Products Administration (NMPA) has accepted an indication approval filing for its drug Cosela (trilaciclib). The CDK4/6 inhibitor is under development to treat extensive-stage small-cell lung cancer (ES-SCLC), with the aim of reducing the incidence of chemotherapy-induced bone marrow…
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SinoMab BioScience Receives NMPA Approval for Phase I Clinical Study of SM17 Asthma Therapy
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Hong Kong-based biotech company SinoMab BioScience Ltd (HKG: 3681) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study assessing the safety of SM17, a first-in-class asthma therapy, in the Chinese population. The study will also explore the clinical…
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J&J Subsidiary Janssen Wins FDA Approval for Akeega in BRCA-Positive mCRPC Treatment
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The US Food & Drug Administration (FDA) has granted marketing approval to Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen for its oral drug Akeega (niraparib + abiraterone) in combination with prednisone. This treatment is designated for adult patients with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer (mCRPC).…
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Medivir’s Fostrox in Combination with Lenvima Shows Promise in Phase IIa HCC Trial
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Sweden-based Medivir (STO: MVIR) has released interim data from a Phase IIa trial evaluating the combination of its experimental drug fostrox with Japan partner Eisai’s (TYO: 4523) kinase inhibitor Lenvima (Lenvatinib) for the treatment of advanced hepatocellular carcinoma (HCC). The trial focuses on patients for whom current first- or second-line…
