-
Semaglutide Use Linked to Rare Eye Condition NAION in New Study
•
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…
-
J&J’s Rybrevant Earns First-Line NSCLC Approval in Canada, a Milestone for EGFR Exon 20 Patients
•
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…
-
Sanofi’s RSV Preventative Therapy Beyfortus Launches in China
•
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…
-
Full-Life Technologies’ ²²⁵Ac-FL-020 Earns FDA Fast-Track Status for mCRPC
•
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…
-
HutchMed’s Tazverik for Follicular Lymphoma Accepted for Review by China’s NMPA
•
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…
-
LG Chem and Yifan Pharmaceutical Launch Hyruan ONE for Knee Osteoarthritis in China
•
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…
-
AstraZeneca’s Voydeya Receives South Korean Approval for PNH Treatment
•
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…
-
Astellas Pharma’s Xtandi Secures Third Market Approval in China for Prostate Cancer Treatment
•
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…
-
Eslicarbazepine Makes First Appearance in China at Sichuan University’s West China Lecheng Hospital
•
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…
-
China’s Jiangsu Hengrui First to Market Generic Exparel in the US with FDA ANDA Approval
•
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…
-
Shanghai Henlius Biotech Advances Serplulimab Phase III Trial for First-Line Metastatic Colorectal Cancer
•
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…
-
MabPharm’s Biosimilar Infliximab CMAB807 Receives Market Approval in Peru
•
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…
-
Legend Biotech’s Carvykti Shows Significant Overall Survival Improvement in Phase III CARTITUDE-4 Study
•
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…
-
Lilly’s Kisunla Poised to Shake Up Alzheimer’s Treatment Market with FDA Approval
•
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.…
-
Johnson & Johnson’s Talvey Gets Green Light in South Korea for Multiple Myeloma
•
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…
-
Eli Lilly & Co. Strikes Deal for Radionetics’ GPCR-Targeted Radiopharmaceuticals
•
Eli Lilly & Co. (NYSE: LLY), a leading pharmaceutical company based in the US, has entered into a strategic partnership with fellow US firm Radionetics Oncology to gain access to Radionetics’ pipeline of innovative small molecule G protein coupled receptor (GPCR) targeted radiopharmaceuticals. Under the terms of the agreement, Lilly…
-
Boehringer Ingelheim Initiates Clinical Trial for Novel Anti-Obesity Drug
•
Boehringer Ingelheim (BI), a German pharmaceutical company, has announced the commencement of clinical development for BI 3034701, a potential first-in-class anti-obesity drug. The molecule was originally developed by Denmark-based Gubra A/S (XCSE: GUBRA) and is a long-acting triple-agonist peptide designed to target receptors associated with inducing weight loss, positioning it…
-
Tracon Pharmaceuticals Halts Development of Envafolimab After Clinical Trial Failure
•
Tracon Pharmaceuticals (OTCMKTS: TCON), a US-based biopharmaceutical company, has decided to cease development of its programmed death-ligand 1 (PD-L1) inhibitor, envafolimab, following disappointing results from a clinical trial. The company had obtained the rights to develop this molecule for soft-tissue sarcomas in North America through a 2019 agreement with China’s…
-
Innovent Biologics Presents Positive Phase I Results for IBI343 at ESMO GI Congress 2024
•
Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced the presentation of new results from a Phase I clinical study of its anti-CLDN18.2 antibody-drug conjugate (ADC), IBI343, at the ESMO Gastrointestinal Cancers (ESMO GI) Congress 2024. The study focuses on advanced gastric and gastroesophageal junction…
-
Yantai Dongcheng Pharmaceutical’s 177LuLNC1011 Gets FDA Green Light for Prostate Cancer Clinical Trial
•
Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a pharmaceutical company based in China, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its prostate specific membrane antigen (PSMA)-targeted radioactive in vivo therapeutic drug, 177LuLNC1011. The molecule is intended for evaluation…
