Search Results for “FDA” – Page 119 – media

HANSIZHUANG Sets Sail in Indonesia Market

Shanghai, China, December 28, 2023 – Shanghai Henlius Biotech, Inc. (2696.HK) announces that recently, PT Kalbio Global Medika, the subsidiary of Henlius’ partner PT Kalbe Genexine Biologics (KGbio), has received the relevant registration certificates issued by Indonesia’s National Agency for Drug and Food Control (Indonesian: Badan Pengawas Obat and Makanan, the “BPOM”) for the approval of Henlius’ self-developed and manufactured anti-PD-1 mAb HANSIZHUANG (serplulimab) in Indonesia under the trade name Zerpidio® for the treatment of extensive stage small cell lung cancer (ES-SCLC). This is the first time HANSIZHUANG has been successfully approved for marketing in an overseas market, and it has become the first China anti-PD-1 mAb successfully approved for marketing in Southeast Asia. Currently, Henlius is joining hands with KGbio for the development and commercialisation in 22 countries, and the approval is expected to bring HANSIZHUANG to more patients in Indonesia. Lung cancer (LC) is one of the most ...
- Source: drugdu
- 346
- December 30, 2023
$15 million NCI grant awarded to investigate a type of radiation therapy for hard-to-treat cancers

The Radiopharmaceutical Therapy and Dosimetry Lab at Johns Hopkins Medicine, headed by George Sgouros, Ph.D., has been awarded a $15 million grant, to be dispersed over the next five years, from the National Cancer Institute at the National Institutes of Health. They will use these funds to investigate a type of radiation therapy for hard-to-treat cancers. The award will fund several research projects, all of which will investigate a promising cancer treatment known as alpha-particle emitter radiopharmaceutical therapy, or alpha-emitter RPT. This therapy has proved successful in treating widespread, treatment-resistant cancers through directly delivering radiation to cancer cells. Administered into the bloodstream, alpha-emitter RPT treatment delivers highly potent radiation directly to cancer cells. Radioactive atoms that emit alpha-particles (helium nuclei) are attached to special molecules that target, or latch on to, dispersed cancer cells in the body. Alpha-particles delivered to cancer cells cause massive DNA damage that kills the cancer. ...
- Source: drugdu
- 193
- December 30, 2023
Jemincare Announces 6 Approvals of Clinical Trials for its Innovative Drugs

SHANGHAI, Dec. 26, 2023 /PRNewswire/ — Jemincare, a leading pharmaceutical company from China, announced that its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co., Ltd., recently received 6 approvals of clinical trials for its innovative drugs in the field of cancer, kidney and anti-infectious diseases, including 4 approvals from National Medical Products Administration (NMPA) and 2 approvals from the U.S. Food & Drug Administration (FDA). On December 20, NMPA has approved a clinical trial for JMKX003801 to treat serious infection caused by Gram-negative bacteria. Drug resistance of antibiotics, especially carbapenem resistance, in Escherichia coli, Klebsiella pneumoniae, Acinetobacter baumannii and Pseudomonas aeruginosa has risen year by year. Preclinical studies on its mechanism show that JMKX003801 can overcome carbapenem resistance with very broad antibacterial spectrum. On December 12, NMPA has approved a clinical trial for JMKX003142 to treat renal edema. There are about 120 million patients of chronic kidney disease (CKD) in ...
- Source: drugdu
- 97
- December 30, 2023
Cytokinetics Heart Drug’s Trial Data Look Competitive With BMS Med Camzyos

Cytokinetics drug aficamten met the main goal of a pivotal test in obstructive hypertrophic cardiomyopathy. If approved, the daily pill would compete against a Bristol Myers Squibb drug projected to become a blockbuster seller. By FRANK VINLUAN An experimental Cytokinetics drug has Phase 3 data showing it improved the ability of the heart to work during exercise. In addition to meeting this main goal of its pivotal test in a rare cardiovascular disease, the results look competitive with a Bristol Myers Squibb product already on the market. The Cytokinetics drug, aficamten, is a potential treatment for obstructive hypertrophic cardiomyopathy (oHCM), a condition that leads to thickening of heart muscle that makes it harder for the organ to pump blood. Patients experience fatigue and shortness of breath. The condition can progress to heart failure. Cytokinetics reported preliminary Phase 3 results on Wednesday showing that after 24 weeks, treatment with its once-daily ...
- Source: drugdu
- 144
- December 29, 2023
Pfizer’s Hospira recall spree bleeds into 2024 with product pulls for multiple hospital drugs in shortage

After a year plagued by recalls, Pfizer’s sterile injectables unit Hospira seems no closer to righting the ship over its glass-contamination woes. What’s more, the company’s latest product pulls threaten to intensify the ongoing shortages of several critical hospital drugs. Shortly before the holiday, Pfizer’s Hospira announced two separate recalls over the potential presence of glass particulates in vials and syringes of certain meds. In the case of injectable cancer medication bleomycin—of which Hospira is recalling one lot—a confirmed customer report alerted the company to the presence of glass particulates within a single vial, the company said in a notice posted on the FDA’s website. The second recall, which covers three drugs—two strengths of injectable sodium bicarbonate, plus one lot of atropine sulfate injection—kicked off after the company flagged “the potential presence of glass particulate matter” during routine product inspection. In both cases, Pfizer and Hospira said they hadn’t received ...
- Source: drugdu
- 184
- December 29, 2023
BMS agrees to acquire Karuna Therapeutics for $14bn

Bristol Myers Squibb (BMS) has signed a definitive agreement for the acquisition of all outstanding shares of common stock of biopharmaceutical company Karuna Therapeutics for an equity value totalling $14bn in cash. The new strategic merger deal is part of BMS’ strategy to bolster its neuroscience portfolio. Karuna focuses on the discovery and development of therapies for psychiatric and neurological ailments. Through the transaction, BMS will gain access to Karuna’s lead asset KarXT (xanomeline-trospium). It is a potential antipsychotic therapy for patients with schizophrenia and Alzheimer’s disease psychosis. KarXT possesses a new mechanism of action with varied distinguished efficacy and safety profiles. The US Food and Drug Administration (FDA) recently has accepted Karuna’s new drug application (NDA) for KarXT to treat adult patients with an approval decision anticipated on 26 September next year under the Prescription Drug User Fee Act (PDUFA). The antipsychotic is currently being analysed in registrational clinical ...
- Source: drugdu
- 190
- December 28, 2023
Completion of Phase I Clinical Trial for GLP-1/GIP Dual Receptor Agonist (Injectable THDBH120) with First Subject Enrolled

Tonghua Dongbao Pharmaceutical Co., Ltd. (hereinafter referred to as “the Company” or “Tonghua Dongbao”), a wholly-owned subsidiary Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd., received the approval notice for the clinical trial of injectable THDBH120 (GLP-1/GIP dual receptor agonist) from the National Medical Products Administration Drug Evaluation Center. The company has initiated the Phase I clinical trial and recently completed the enrollment of the first subject. After the approval for clinical use of injectable THDBH120, the company completed the enrollment of the first subject in the Phase I clinical trial in just around half a month, showcasing the company’s accelerated progress in the research and development of innovative products, as well as its ability and determination to transition into an innovative pharmaceutical enterprise. The company will further explore and uncover the potential of injectable THDBH120 in other indications such as obesity, continually opening up new therapeutic areas to maximize the value ...
- Source: drugdu
- 188
- December 28, 2023
Moderna and Merck’s Novel Cancer Vaccine, Keytruda Combo Cuts Risk of Skin Cancer Death, Recurrence by Half

Pharmaceutical Executive Editorial Staff Adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Merck’s Keytruda lowered the risk of recurrence or death by 49% compared with Keytruda monotherapy. Findings from the KEYNOTE-942/mRNA-4157-P201 clinical trial show that Moderna’s investigational individualized neoantigen therapy plus Merck’s Keytruda (pembrolizumab) lowered the risk of death or relapse by nearly half in patients with resected high-risk melanoma (stage III/IV) following complete resection. A planned analysis of the Phase IIb randomized trial found that at a median follow-up of approximately three years, adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Keytruda continued to show a clinically meaningful improvement in recurrence-free survival (RFS) by lowering the risk of recurrence or death by 49% compared with Keytruda monotherapy. “As we continue to follow participants in the KEYNOTE-942/mRNA-4157-P201 study, we are excited to see such a robust clinical benefit with mRNA-4157 (V940) as adjuvant treatment in combination with Keytruda ...
- Source: drugdu
- 209
- December 27, 2023
Orthofix has positive spine stimulation tech data

BY SEAN WHOOLEY rthofix Medical (Nasadaq: OFIX)+ today announced new data investigating pulsed electromagnetic field (PEMF) stimulation with lumbar spinal fusion. Lewisville, Texas-based Orthofix evaluated PEMF stimulation as an adjunct to lumbar spinal fusion procedures in patients at risk for pseudoarthrosis. Patients treated with the SpinalStim bone growth device demonstrated a high rate of successful fusion. They also showed significant improvements in pain, function and quality of life, despite having risk factors for pseudoarthrosis. SpinalStim, an FDA-approved bone growth stimulation therapy, offers an adjunct treatment for lumbar spinal fusion. It also functions as a nonsurgical treatment for spinal pseudoarthrosis. The device utilizes PEMF technology that provides 360 degrees of treatment coverage around the fusion site. Orthofix says its system has an overall success rate of 92% in treating spinal fusion surgery patients. Researchers published their data evaluating the SpinalStim system in the International Journal of Spine Surgery. Lead author Dr. ...
- Source: drugdu
- 177
- December 27, 2023
GSK’s Jemperli Plus Zejula Produces Significant Survival Improvement in Endometrial Cancer

Pharmaceutical Executive Editorial Staff Jemperli plus standard-of-care chemotherapy with carboplatin and paclitaxel, followed by Jemperli plus Zejula as maintenance therapy produced a statistically significant and clinically meaningful benefit in progression-free survival in patients with primary advanced or recurrent endometrial cancer. GSK’s Jemperli (dostarlimab) produced a significant improvement in survival among adults with primary advanced or recurrent endometrial cancer in a Phase III trial.1 Findings from the RUBY/ENGOT-EN6/GOG3031/NSGO trial show that Jemperli plus standard-of-care chemotherapy with carboplatin and paclitaxel, followed by Jemperli plus Zejula (niraparib) as maintenance therapy, achieved the primary endpoint of progression-free survival (PFS). The combination led to a statistically significant and clinically meaningful benefit across the overall patient population and among a subpopulation of patients with mismatch repair proficient/microsatellite stable (MMRp/MSS) tumors in those with primary advanced or recurrent endometrial cancer. “Patients with MMRp/MSS primary advanced or recurrent endometrial cancer have few approved treatment options,” Hesham Abdullah, senior ...
- Source: drugdu
- 198
- December 26, 2023

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