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Roche’s Tiragolumab Misses Primary Endpoints in NSCLC Trial, Study Halted
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Roche (SWX: ROG; SWX: RO; OTCMKTS: RHHBY), the Swiss pharmaceutical giant, has announced that a Phase II/III clinical trial for its TIGIT-targeted antibody tiragolumab, designed for non-small cell lung cancer (NSCLC), did not outperform Keytruda (pembrolizumab), a PD-1 inhibitor. The trial, known as SKYSCRAPER-06, was evaluating the efficacy of tiragolumab…
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Medigene AG Secures Chinese Patent for TCR-T Therapy Targeting NY-ESO-1 and LAGE 1a
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Medigene AG (ETR: MDG1), a biopharmaceutical company based in Germany, has announced that it has been granted patent protection in China for its T cell receptor (TCR) technology targeting NY-ESO-1 and LAGE 1a. This development pertains to the company’s lead pipeline candidate, MDG1015, which is a first-in-class, third-generation TCR-T therapy.…
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Doma Biopharmaceutical’s Bispecific ADC DM001 Receives FDA Clearance for Clinical Trial
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Doma Biopharmaceutical (Suzhou) Co., Ltd, a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the U.S. Food and Drug Administration (FDA) for its bispecific antibody drug conjugate (ADC), DM001. The molecule is set to be evaluated for safety, tolerability, and preliminary anti-tumor activity…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Green Light for HRS-9813 IPF Clinical Trial
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug HRS-9813, which is intended for the treatment of idiopathic pulmonary fibrosis (IPF). Preclinical efficacy data from…
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Luye Pharma’s Oxycodone/Naloxone Product Receives NMPA Approval for Severe Pain Management
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Luye Pharma Group (HKG: 2186), a pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its oxycodone, naloxone product, LY 021702. The drug is indicated for use in adults requiring opioid analgesics to manage severe pain, including both…
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Semaglutide Use Linked to Rare Eye Condition NAION in New Study
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A recent study has identified a potential link between the use of GLP-1-targeted diabetes and anti-obesity drug semaglutide, marketed as Wegovy/Ozempic by Novo Nordisk, and a rare ophthalmic condition. Research published in JAMA Ophthalmology revealed that physicians at Harvard and Brigham and Women’s Hospital in Boston discovered an increased risk…
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J&J’s Rybrevant Earns First-Line NSCLC Approval in Canada, a Milestone for EGFR Exon 20 Patients
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Johnson & Johnson (J&J; NYSE: JNJ) has announced that Rybrevant (amivantamab) has received its first market approval in Canada. The drug is approved as a first-line treatment in combination with chemotherapy for advanced or metastatic non-small cell lung cancer (NSCLC) in patients with activating epidermal growth factor receptor (EGFR) Exon…
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Sanofi’s RSV Preventative Therapy Beyfortus Launches in China
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Sanofi (NASDAQ: SNY), a leading French pharmaceutical company, has announced the commercial launch of Beyfortus (nirsevimab), a preventative therapy for Respiratory Syncytial Virus (RSV), in China. Nirsevimab, a long-acting monoclonal antibody (mAb), is the first and only RSV preventative therapy in China that covers a wide range of infants, including…
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Full-Life Technologies’ ²²⁵Ac-FL-020 Earns FDA Fast-Track Status for mCRPC
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Full-Life Technologies Ltd, a globally integrated radiotherapeutics company with a presence in Belgium, Germany, and China, has announced that the US Food and Drug Administration (FDA) has granted fast-track designation for its investigational drug ²²⁵Ac-FL-020 for the treatment of metastatic castration resistant prostate cancer (mCRPC). ²²⁵Ac-FL-020 is a PSMA-targeted radionuclide…
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HutchMed’s Tazverik for Follicular Lymphoma Accepted for Review by China’s NMPA
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HutchMed (NASDAQ: HCM), a China-based biopharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for Tazverik (tazemetostat) for review. The company is seeking initial approval for Tazverik as a treatment for recurrent or refractory follicular lymphoma (FL), and the filing has been…
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LG Chem and Yifan Pharmaceutical Launch Hyruan ONE for Knee Osteoarthritis in China
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LG Chem, a leading chemical company based in South Korea, and Yifan Pharmaceutical Co., Ltd (SHE: 002019) from China, have announced the market launch of Hyruan ONE (sodium hyaluronate) in China for the treatment of knee osteoarthritis. Hyruan ONE, originally developed by LG Chem, is a single-dose preparation designed to…
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AstraZeneca’s Voydeya Receives South Korean Approval for PNH Treatment
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical giant, has reportedly secured market approval in South Korea for its drug Voydeya (danicopan), the world’s first-in-class oral D-factor inhibitor. The Ministry of Food and Drug Safety (MFDS) in Korea approved Voydeya for use as an adjunct therapy for extravascular hemolysis (EVH) in…
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Astellas Pharma’s Xtandi Secures Third Market Approval in China for Prostate Cancer Treatment
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Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced that it has secured market approval in China for a new indication of its drug Xtandi (enzalutamide), marking its third such approval in the country. The drug is now approved for the treatment of metastatic hormone-sensitive prostate cancer…
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Eslicarbazepine Makes First Appearance in China at Sichuan University’s West China Lecheng Hospital
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Eslicarbazepine, a voltage-gated sodium channel blocker, co-developed by Bial-Portela, Eisai, and Sumitomo Pharma, was first prescribed at the West China Lecheng Hospital of Sichuan University late last month. This epilepsy therapy marks the first special novel drug program implemented through the “first pilot, first trial” policy of the Boao Lecheng…
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China’s Jiangsu Hengrui First to Market Generic Exparel in the US with FDA ANDA Approval
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for its generic version of Pacira’s Exparel (bupivacaine liposome). This approval positions Hengrui as the first…
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Shanghai Henlius Biotech Advances Serplulimab Phase III Trial for First-Line Metastatic Colorectal Cancer
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Shanghai Henlius Biotech Inc. (HKG: 2696), a biopharmaceutical company based in China, has announced that it has received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan to conduct a global, multi-center Phase III study. The study will evaluate the anti-programmed death-1 (PD-1) inhibitor HanSiZhuang (serplulimab, HLX10) in…
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MabPharm’s Biosimilar Infliximab CMAB807 Receives Market Approval in Peru
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MabPharm Ltd (HKG: 2181), a biosimilar specialist in monoclonal antibody (mAb) based in Taizhou, has announced that it has received market approval for CMAB807, a biosimilar version of Johnson & Johnson (J&J)’s Remicade (infliximab), in Peru. The approval encompasses all six indications, which include adult ulcerative colitis, ankylosing spondylitis, rheumatoid…
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Legend Biotech’s Carvykti Shows Significant Overall Survival Improvement in Phase III CARTITUDE-4 Study
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Legend Biotech Corporation (NASDAQ: LEGN) has announced positive results from the CARTITUDE-4 study, a global, randomized, open-label Phase III trial. The study assessed the efficacy and safety of Legend Biotech’s BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy Carvykti (ciltacabtagene autoleucel) compared to standard therapies of pomalidomide, bortezomib, and dexamethasone…
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Lilly’s Kisunla Poised to Shake Up Alzheimer’s Treatment Market with FDA Approval
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Eli Lilly & Co. (NYSE: LLY) has announced that the U.S. Food and Drug Administration (FDA) has granted approval for donanemab as a treatment for adults with early symptomatic Alzheimer’s disease (AD), including those with mild cognitive impairment (MCI) and individuals with mild AD-related dementia, confirmed to have amyloid pathology.…
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Johnson & Johnson’s Talvey Gets Green Light in South Korea for Multiple Myeloma
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Johnson & Johnson (J&J; NYSE: JNJ) has announced that its subsidiary Janssen Korea has received approval in South Korea for Talvey (talequetamab), a treatment for multiple myeloma (MM). The drug is indicated for monotherapy in adult patients with relapsed/refractory MM who have received at least three prior therapies, including proteasome…
