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TransThera Announced Global Phase 3 Clinical Trial for Cholangiocarcinoma Authorized in the European Union and Orphan Drug Designation for Tinengotinib to Treat Biliary Tract Cancer Granted by European Medicines Agency

TransThera, a clinical-stage biopharmaceutical company dedicated to innovating differentiated drugs globally, today announced that the randomized, controlled, global multicenter Phase 3 trial (FIRST-308) of tinengotinib versus physician’s choice to evaluate the efficacy and safety in subjects with FGFR-altered, chemotherapy- and FGFR Inhibitor-refractory/relapsed cholangiocarcinoma (CCA), has been authorized by regulatory agencies in the European Union (EU) after the authorizations from US, South Korea and Taiwan region. Furthermore, European Medicines Agency (EMA) granted the Orphan Drug Designation(ODD) for tinengotinib for the treatment of biliary tract cancer (BTC) . Tinengotinib, a next-generation FGFR inhibitor with high potency against a variety of FGFR2 kinase domain mutations, has shown promising clinical benefit in subjects with FGFR-altered metastatic CCA who were heavily pretreated with chemotherapy and refractory/relapsed to FGFRi(s). The results of tinengotinib in CCA from the phase I/II clinical trials were presented orally at 2023 ESMO and 2024 ASCO GI conferences. The FRIST-308 clinical trial ...
- Source: drugdu
- 83
- March 12, 2024
KIHE 2024

Organiser: ITE Group Time:15 – 17 May 2024 address：42 Timiryazev str., Almaty, 050057 Almaty, Kazakhstan Exhibition hall: Atakent International Exhibition Centre Product range: Medical equipment: Medical technology equipment, laboratory equipment, medical electronic equipment, medical diagnostic equipment, ophthalmic equipment and protective products, surgical instruments, first aid and emergency equipment, hospital & Dental & medical equipment, dental service equipment and disposable medical products, hospital and home disposable medical products, hospital dentistry, medical data processing systems, dental plastic surgery, rehabilitation equipment Drugs: foreign prescription drugs, herbal preparations, mineral supplements and vitamin and other nutritional health drugs, dietary nutritional products, homeopathic preparations, dermatological preparations, maternal and infant medical care products and baby food, personal hygiene products, incontinence products, medical consumer products, cosmetics Pharmaceutical Industry: Pharmaceutical production equipment and technology, pharmaceutical packaging equipment, pharmaceutical packaging materials, pharmaceutical production, cleaning and disinfection configuration system, pharmaceutical industry raw materials and ingredients, intermediates, pharmaceutical equipment, pharmaceutical packaging, laboratory ...
- Source: drugdu
- 192
- March 11, 2024
FDA Approves Fresenius Kabi’s Tyenne, a Biosimilar of Actemra for the Treatment of Autoimmune Diseases

Don Tracy, Associate Editor Medication is the first tocilizumab biosimilar approved in the US for both IV and subcutaneous use for autoimmune diseases, such as rheumatoid arthritis and juvenile idiopathic arthritis. Fresenius Kabi announced today that the FDA has officially approved Tyenne (tocilizumab-aazg), a biosimilar referencing tocilizumab (Actemra; Genentech), for the treatment of multiple autoimmune diseases, including rheumatoid arthritis and juvenile idiopathic arthritis. Developed with the focus of being more accessible and affordable for patients, Tynne is the first tocilizumab biosimilar to be approved by the FDA for intravenous (IV) and subcutaneous use. This is Fresenius Kabi’s third biosimilar approved in the United States, following Stimufend (pefilgrastim-fpgk), a biosimilar to Neulasta, and Idacio (adalilmumab-aacf), a biosimilar to Humira.1 “Offering the first FDA-approved tocilizumab biosimilar therapy option in both IV and subcutaneous formulations to people living with autoimmune diseases in the U.S. is a moment of great pride for Fresenius Kabi. ...
- Source: drugdu
- 185
- March 11, 2024
An Entire Flu Strain Was Seemingly Wiped Out During COVID-19 Pandemic

Mike Hollan Researchers are debating whether to still include protection for this strain in vaccines. A new victim of the COVID-19 pandemic has been revealed, and it’s a strain of the flu. Every year, multiple strains of the flu make their way through the population. There are four main strains that generally impact the population: two strains of the A variant and two strains of the b variant. Typically, flu vaccines are designed to protect against these four strains. However, after the pandemic, researchers believe that they made no longer need to protect against one of the B strains. The specific strain, known as the Yamagata clade, has not been detected since 2020, according to a report from CNN.1 It’s not yet known if the strain has been wiped out or if instances of infection are so low that they haven’t been reported. Due to this, researchers are still uncertain ...
- Source: drugdu
- 109
- March 11, 2024
Sleep Meds Don’t Work for 9 out of 10 People with Chronic Insomnia – Here’s What Does

Sleeplessness in America is on the rise, due to many external factors including increasingly negative news cycles, international conflicts and economic uncertainty. Collectively, these factors have caused more Americans to have more recurrent sleepless nights. When those nights reach three or more a week for three or more months, it’s considered chronic insomnia, which affects more than 25 million Americans. The condition can lead to both mental and physical health issues, ranging from trouble concentrating to sleep apnea and heart attacks. As we approach Sleep Awareness Week® 2024, which emphasizes the importance of sleep as a major contributor to a person’s overall health, it is also an important reminder to prioritize getting enough quality sleep. Sleep Awareness Week, which starts this year on March 10, always begins at the start of Daylight Saving Time. That’s when the clocks go forward by one hour and Americans lose an hour of sleep ...
- Source: drugdu
- 100
- March 11, 2024
Novo Nordisk Obesity Pill Flashes the Potential to Beat Wegovy in Weight Loss

An experimental Novo Nordisk obesity pill led to weight loss of 13.1% in a clinical trial, topping results posted in studies of the company’s approved injectable medication Wegovy. It’s early days and more testing is needed, but the preliminary data suggest that this pill has the potential to offer patients superior weight shedding in a more convenient oral formulation. Phase 1 data for the once-daily Novo Nordisk pill, amycretin, were presented Thursday during a company investor event. The study followed participants for 12 weeks. In that span, those who received a placebo lost 1.1% of their body weight. Wegovy, which is administered as a once-weekly injection, was not part of this clinical trial. Published clinical trial results for that drug show it led to weight loss of 5.9% measured at 12 weeks. Wegovy, whose main ingredient is the peptide semaglutide, offers one mechanism of action: activating the GLP-1 receptor to ...
- Source: drugdu
- 165
- March 11, 2024
BIO-THERA’s BAT8010 (ADC-HER2) for injection in combination with BAT1006 (HER2) for injection for the treatment of locally advanced or metastatic solid tumors was approved in clinical trial

BIO-THERA Biopharmaceutical Co., Ltd. (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company today announced that it has received a Notice of Approval of Drug Clinical Trial from the State Drug Administration of the People’s Republic of China (“SDA”), which approves the application for a clinical trial of the investigational drug BAT8010 for injection in combination with BAT1006 for injection for the treatment of locally advanced or metastatic solid tumors. BAT8010 consists of recombinant humanized anti-HER2 antibody and toxin small molecule topoisomerase I inhibitor, connected by self-developed shearable linker.BAT8010 has highly efficient anti-tumor activity, the toxin small molecule has strong cell membrane permeability, and it can be released and kill nearby cancer cells after ADC kills the cancer cells, generating the bystander effect, effectively overcoming the tumor cells’ heterogeneity of tumor cells. Meanwhile, BAT8010 has ...
- Source: drugdu
- 189
- March 10, 2024
Achieving first full year of profitability, and ushering in a new phase of high-quality development

Henlius (2696.HK) released a positive profit forecast. Based on the preliminary assessment of the unaudited consolidated management accounts for the year ended 31 December, 2023 (the “Reporting Period”) and the information currently available to the Board, it is expected that the company will record a profit for the year of no less than RMB500 million for the Reporting Period. This is the first time for Henlius to achieve full-year profits following the company’s achievement of its first half-year profits for the six months ended 30 June 2023. The full year of profitability is primarily contributed by the continuous growth in sales revenue of the company’s core products HANQUYOU and HANSIZHUANG, as well as cost reduction and efficiency improvement through refined management. Wenjie Zhang, Chairman and Executive Director of Henlius, said: “2023 is a milestone as we reported a full-year profit for the first time. Benefiting from the efficient synergy and ...
- Source: drugdu
- 135
- March 10, 2024
Landmark Clinical Approval for YOLT-201 Obtained by the NMPA

YolTech Therapeutics, a biotech company developing in vivo gene editing therapies to treat rare genetic diseases, today announced the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has officially approved the YOLT-201 investigational new drug (IND) application for a Phase I study, marking that the drug candidate has officially entered the registration clinical development stage.. The first patient has been dosed with YOLT-201 in Investigator initiated trial(IIT) by the end of 2023, achieving promising preliminary efficacy and safety results. ATTR is a debilitating genetic disease, caused by misfolded transthyretin protein (TTR) forming amyloid fibrils and depositing in various organs and tissues in the body such as myocardium in the heart and peripheral nerves in the limbs. Depending on the mutation involved, hATTR can occur in people in their teens and 20s, though other forms are typically diagnosed in people over 50 years of age. YOLT-201 is ...
- Source: drugdu
- 103
- March 10, 2024
AACR 2024 | Ascentage Pharma to Present Three Preclinical Studies at 2024 American Association of Cancer Research Annual Meeting

Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, age-related diseases, and chronic hepatitis B (CHB), announced today that the latest results from three preclinical studies of the company’s novel drug candidates olverembatinib, MDM2-p53 inhibitor alrizomadlin, FAK/ALK/ROS1 tyrosine kinase inhibitor APG-2449, and EED inhibitor APG-5918, have been selected for presentations at the 2024 American Association of Cancer Research Annual Meeting (AACR 2024). These abstracts are now available on the AACR’s official website. The AACR annual meeting is one of the world’s largest and longest-standing scientific gatherings in the field of cancer research. Covering some of the most cutting-edge advances in all the areas of oncology research and innovation, the annual event attracts tremendous interest from the global cancer research community. This year’s AACR annual meeting will be held from April 5-10 2024, in San Diego, California, USA. These three preclinical abstracts from Ascentage Pharma include: ...
- Source: drugdu
- 114
- March 10, 2024

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