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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 (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 (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 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 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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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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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 (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 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 (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, 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 (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 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, 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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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 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 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 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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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 (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…