-
Bayer Withdraws Aliqopa FDA Filing Following Missed Phase III Endpoint
•
Germany-based pharmaceutical major Bayer (ETR: BAYN) has announced its decision to withdraw the filing for the kinase inhibitor Aliqopa (copanlisib) with the US Food and Drug Administration (FDA). Aliqopa, which received accelerated approval in 2017 for the treatment of relapsed follicular lymphoma (FL), failed to meet the primary endpoint of…
-
Servier’s Tibsovo Receives FDA Approval for IDH1-Mutated R/R MDS, Expanding Indications
•
France-based pharmaceutical company Servier has announced that the US Food and Drug Administration (FDA) has granted market approval for its drug Tibsovo (ivosidenib) for the treatment of recurrent or refractory (R/R) myelodysplastic syndrome (MDS) with IDH1 mutation. This marks the fifth indication for the drug in the IDH1 mutant cancer…
-
Huadong Medicine’s Arcalyst (Rilonacept) Filing for CAPSs Accepted by China’s NMPA
•
Huadong Medicine Co., Ltd (SHE: 000963), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) in China has accepted its market filing for Arcalyst (rilonacept) for the treatment of cryo-pyrin-associated periodic syndromes (CAPSs). The drug is specifically filed for approval in treating familial cold autoimmune syndrome…
-
Jiangsu Hengrui Pharmaceuticals’ HR20031 Accepted for Review by China’s NMPA for Type 2 Diabetes
•
Jiangsu Hengrui Pharmaceuticals (SHA: 600276), a leading Chinese pharmaceutical company, has announced that the National Medical Products Administration (NMPA) in China has accepted its market filing for the drug candidate HR20031 for review. The drug is intended for type 2 diabetes patients with poorly controlled blood glucose who have previously…
-
AstraZeneca’s Imfinzi Gains NMPA Approval for First-Line Cholangiocarcinoma Treatment
•
The National Medical Products Administration (NMPA) of China has indicated on its website that it has approved AstraZeneca’s (AZ, NASDAQ: AZN) programmed death-ligand 1 (PD-L1) inhibitor, Imfinzi (durvalumab), for use in combination with chemotherapy for the treatment of first-line locally advanced or metastatic cholangiocarcinoma (BTC). This marks a significant expansion…
-
Hansoh Pharmaceutical’s HS-10511 Tablets for Hypertrophic Cardiomyopathy Cleared for Clinical Trials
•
Hansoh Pharmaceutical (HKG: 3692) has announced that its affiliated company’s self-developed Class 1 new drug, HS-10511 tablets, have received approval for clinical trials from the National Drug Administration. The drug is intended for the treatment of hypertrophic cardiomyopathy, a condition that requires significant medical innovation. Clinical Trial Approval and IndicationThe…
-
Novo Nordisk Commits Over DKK 42 Billion to Expand Chronic Disease Production in Denmark
•
Novo Nordisk (CPH: NOVO-B), a leading pharmaceutical company, last week announced a substantial plan to invest over DKK 42 billion (USD 6.0 billion) into expanding its production capacity for serious chronic diseases in Denmark. This significant investment underscores the company’s commitment to addressing the growing needs of patients with chronic…
-
Clinical Research on rAAV Gene Drug ZS805 for Fabry Disease Launched by Zhishan Weixin
•
Zhishan Weixin Biotechnology Co., Ltd, a China-based biotech company, has announced the launch of the first clinical research project in China focused on a recombinant adeno-associated virus (rAAV) genetic therapy for the treatment of Fabry disease. The study will evaluate the adeno-associated virus vector ZS805 as a potential treatment across…
-
Jiangsu Hengrui Pharmaceuticals’ Subsidiary Shengdi Pharmaceuticals Receives NMPA Approval for HRS-9057
•
Jiangsu Hengrui Pharmaceuticals (SHA: 600276), a leading pharmaceutical company in China, has announced that its subsidiary, Shengdi Pharmaceuticals, has received clinical trial approval from the National Medical Product Administration (NMPA) for HRS-9057 tablets. This Class 1 innovative drug will be assessed in clinical trials as a potential treatment for autosomal…
-
Beijing Aosaikang’s Combo Therapy for NSCLC Accepted for Clinical Trial by NMPA
•
Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755), a Chinese pharmaceutical company, has announced that the China National Medical Products Administration (NMPA) has accepted a clinical trial application for the combination of two pipeline candidates, ASKC202 tablets and ASK120067 tablets. The company is seeking to evaluate this combination therapy in adults…
-
China’s NMPA Grants Conditional Approval for Juventas’ CAR-T Therapy Inaticabtagene Autoleucel
•
The National Medical Products Administration (NMPA) has conditionally approved the marketing of inaticabtagene autoleucel (CNCT 19), a chimeric antigen receptor (CAR)-T cell therapy developed by Chinese firm Juventas Cell Therapy Ltd. The drug is indicated for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in China. Inaticabtagene Autoleucel’s…
-
Eli Lilly’s Zepbound Approved by FDA for Chronic Weight Management in Adults
•
Eli Lilly (NYSE: LLY) has received registration approval from the US Food and Drug Administration (FDA) for its once-weekly injection Zepbound (tirzepatide). The drug is indicated as an adjunct to diet and exercise for chronic weight management in adults with obesity or overweight conditions, including those with at least one…
-
Yantai Dongcheng Pharmaceutical Gets Singapore HSA Nod for Phase I Study of 177Lu-LNC1003
•
China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced receiving approval from the Health Sciences Authority (HSA) in Singapore to conduct a Phase I clinical study for its investigational drug, 177Lu-LNC1003. 177Lu-LNC1003: A Radiopharmaceutical for Advanced Prostate Cancer177Lu-LNC1003 is a radioactive in vivo therapeutic drug that targets prostate…
-
Chongqing Lummy Pharmaceutical’s Generic Ramosetron Passes GQCE in China
•
China-based Chongqing Lummy Pharmaceutical Co., Ltd (SHE: 300006) has announced that its generic version of Astellas Pharma’s Nasea (ramosetron) has become the first to pass the generic quality and efficacy consistency evaluation (GQCE) process in China. The product received marketing approval in China in May 2005. Ramosetron’s Indications and Market…
-
Sirius Therapeutics Pursues First-in-Human Trial for SRSD107 in Australia
•
Sino-US biotech Sirius Therapeutics has announced its pursuit of Investigational New Drug (IND) approval in Australia to conduct a first-in-human clinical trial for its pipeline candidate, SRSD107. This next-generation small interfering RNA (siRNA) therapeutic is under development for the treatment of thromboembolic disorders and targets coagulation factor XI (FXI). Notably,…
-
ImmVira’s MVR-T3011 IV Achieves Positive Outcomes in US Phase I Clinical Study
•
Shenzhen-based biotechnology company ImmVira has announced the successful completion of Phase I clinical studies in the United States for its intravenous oncolytic virus product, MVR-T3011 IV. The trial, which focuses on late stage patients with various tumor types, yielded “exceptional” safety results and demonstrated initial efficacy for certain indicationsThe study…
-
Novartis’ Remibrutinib Meets Milestones in Late-Stage Chronic Spontaneous Urticaria Studies
•
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that two late-stage studies for its Bruton’s tyrosine kinase (BTK) inhibitor, remibrutinib, used in the treatment of chronic spontaneous urticaria (CSU), have successfully met all primary and secondary endpoints at the 12-week mark of a 52-week trial. After three months of treatment…
-
Roche’s Lymphoma Therapy Columvi Receives NMPA Approval for Adult Patients with Relapsed DLBCL
•
Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its novel lymphoma therapy, Columvi (glofitamab). The drug is now approved to treat adult patients with recurrent or refractory diffuse large B-cell lymphoma (DLBCL) who have…
-
Janssen Presents Real-World Data on Tremfya’s Efficacy in Treatment-Resistant Psoriatic Arthritis
•
Johnson & Johnson’s (J&J; NYSE: JNJ) pharmaceutical unit, Janssen, has presented real-world efficacy data for Tremfya (guselkumab), an IL-23p19-subunit inhibitor, in the treatment of treatment-resistant active psoriatic arthritis (PsA). The data provides valuable insights into the drug’s performance in alleviating pain, improving physical function, and reducing fatigue in patients with…
-
ImmuneOnco Biopharmaceuticals’ Timdarpacept (IMM01) Earns Orphan Drug Designation for CMML
•
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its investigational drug timdarpacept (IMM01). This marks a significant milestone for the company’s first SIRPαFc fusion protein targeting CD47, which was designed in China.…
