PharmaFocus Today – Page 198 – media

Insulet applauds NICE guidance on hybrid closed loop insulin delivery

BY SEAN WHOOLEY The Omnipod 5 hybrid closed-loop insulin delivery system worn on the back of an arm. [Image courtesy of Insulet] Insulet (Nasdaq:PODD) supports new National Institute for Health and Care Excellence (NICE) guidance supporting automated insulin delivery for type 1 diabetes. NICE published guidance recommending hybrid closed-loop systems for eligible people with type 1 diabetes in England and Wales. Hybrid closed-loop systems, like the Insulet Omnipod 5, deliver insulin automatically based on calculations from glucose monitors. Medtronic, Tandem Diabetes Care and Beta Bionics also compete with Insulet in the automated insulin delivery space. Medtronic applauded automated insulin delivery recommendations from NICE last month. NICE’s guidance, published this week, outlines that the systems require less input from the user, but manual insulin dosing is still needed sometimes, for example, around mealtimes. So, they may reduce the mental burden and improve people’s quality of life. In a LinkedIn post from ...
- Source: drugdu
- 96
- January 1, 2024
Medicaid Spending on Prescriptions Has Risen Despite Lower Utilization

A new KFF report analyzed recent trends in Medicaid outpatient prescription drug utilization and spending. It discovered that although there’s been lower utilization of prescription drugs in recent years, Medicaid spending on prescription drugs has increased. By MARISSA PLESCIA Although there’s been lower utilization of prescription medications, Medicaid spending on prescription drugs has increased, a recent report shows. The KFF report relied on 2016 to 2022 State Drug Utilization Data, as well as CMS-64 Financial Management Reports from fiscal year 2017 to fiscal year 2022. It comes as states unwind the continuous enrollment provision, which prevented states from disenrolling Medicaid enrollees during the Covid-19 public health emergency. Because of the continuous enrollment provision, Medicaid and CHIP enrollment reached historic highs, peaking at 94.5 million people in April. This represents an increase of 23.1 million people from 2020. But despite the growth in Medicaid enrollment, Medicaid prescription drug utilization was below ...
- Source: drugdu
- 177
- January 1, 2024
Angelica gigas extract emerges as a potential treatment for vascular disease

A new research paper was published in Aging (listed by MEDLINE/PubMed as “Aging (Albany NY)” and “Aging-US” by Web of Science) Volume 15, Issue 23, entitled, “Angelica gigas extract inhibits acetylation of eNOS via IRE1α sulfonation/RIDD-SIRT1-mediated posttranslational modification in vascular dysfunction.” Angelica gigas NAKAI (AG) is a popular traditional medicinal herb widely used to treat dyslipidemia owing to its antioxidant activity. Vascular disease is intimately linked to obesity-induced metabolic syndrome, and AG extract (AGE) shows beneficial effects on obesity-associated vascular dysfunction. However, the effectiveness of AGE against obesity and its underlying mechanisms have not yet been extensively investigated. In this new study, researchers Geum-Hwa Lee, Hwa-Young Lee, Young-Je Lim, Ji-Hyun Kim, Su-Jin Jung, Eun-Soo Jung, Soo-Wan Chae, Juwon Lee, Junghyun Lim, Mohammad Mamun Ur Rashid, Kyung Hyun Min, and Han-Jung Chae from Jeonbuk National University and Jeonbuk National University Hospital supplemented 40 high fat diet (HFD) rats with 100–300 mg/kg/day ...
- Source: drugdu
- 123
- January 1, 2024
GFH009 disrupts growth signals and triggers apoptosis in hematologic malignancies

A new research paper was published in Oncotarget’s Volume 14 on December 20, 2023, entitled, “The pharmacodynamic and mechanistic foundation for the antineoplastic effects of GFH009, a potent and highly selective CDK9 inhibitor for the treatment of hematologic malignancies.” To evade cell cycle controls, malignant cells rely upon rapid expression of select proteins to mitigate pro-apoptotic signals resulting from damage caused by both cancer treatments and unchecked over-proliferation. Cyclin-dependent kinase 9 (CDK9)-dependent signaling induces transcription of downstream oncogenes promoting tumor growth, especially in hyperproliferative ‘oncogene-addicted’ cancers, such as human hematological malignancies (HHMs). In this new study, researchers Fusheng Zhou, Lili Tang, Siyuan Le, Mei Ge, Dragan Cicic, Fubo Xie, Jinmin Ren, Jiong Lan, and Qiang Lu from GenFleet Therapeutics Inc. and Sellas Life Sciences Group aimed to summarize current knowledge underlying the mechanism of action (MOA) of GFH009 and explain its robust anti-cancer activity. “Understanding GFH009’s MOA allows for a ...
- Source: drugdu
- 130
- January 1, 2024
Sanofi’s ‘SR604 Injection’ Approved in China, ‘Yipian Lida’ Supports Lipid Management with ‘Dual Standards’

Sanofi announced that its rosuvastatin and ezetimibe tablets (I) (Yipian Lida®) have been approved by the National Medical Products Administration (NMPA) of China for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH) patients. As the first approved and marketed combination formulation of rosuvastatin and ezetimibe in China, Yipian Lida® marks the beginning of a new era in potent combination lipid-lowering therapy. A single dose achieves a greater than 50% reduction in low-density lipoprotein cholesterol (LDL-C), effectively and continuously lowering LDL-C to target levels, supporting ‘Dual Standards’ in lipid management, and providing a new and powerful option for patients with lipid abnormalities. Academician Ge Junbo from Zhongshan Hospital, affiliated with Fudan University, stated, “In the face of the increasingly serious burden of cardiovascular diseases, effective control and management of risk factors are crucial. Only by controlling LDL-C to ideal levels early can we reduce the incidence of adverse events and ...
- Source: drugdu
- 171
- January 1, 2024
Shanghai RAAS’s New Drug ‘SR604 Injection’ Clinical Trial Application Accepted

On December 21, 2023, Shanghai RAAS received the ‘Acceptance Notification’ from the National Medical Products Administration regarding the clinical trial application for ‘SR604 Injection.’ SR604 Injection is a humanized monoclonal antibody that combines with human activated protein C with high affinity and specifically inhibits the anticoagulant function of human activated protein C. It is intended for the prophylactic treatment of bleeding in patients with hemophilia A/B and congenital coagulation factor deficiency. Currently, routine prophylactic treatment for hemophilia worldwide involves intravenous injection of blood-derived or recombinant coagulation factors 2-3 times a week. SR604 is intended to undergo a Phase I clinical trial for subcutaneous injection prophylactic treatment every 4 weeks. Some preclinical research findings from this project have already been published in the international hematology research journal Blood in the form of a cover article. As of the disclosed information, there are no products on the global market targeting the same ...
- Source: drugdu
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- January 1, 2024
NFL players to kick off ‘My Cause My Cleats’ with a focus on Type 1 diabetes

NFL players aim to boost awareness of Type 1 diabetes under a new charitable campaign. The “My Cause My Cleats” campaign will see NFL players wear custom-painted cleats during some football games to raise awareness and funds for charitable causes. In 2024, Type 1 diabetes has become a core theme, with Mark Andrews of the Baltimore Ravens, Orlando Brown Jr. of the Cincinnati Bengals, Blake Ferguson of the Miami Dolphins, Collin Johnson of the Chicago Bears, Chad Muma of the Jacksonville Jaguars, Nate Peterman of the Chicago Bears, and Kevin Radar of the Tennessee Titans, all lacing up for the cause. More than 1.4 million Americans are affected by Type 1 diabetes, an autoimmune disease that causes the pancreas to produce little or no insulin. The disease typically hits at a young age, and is separate from Type 2 diabetes, which typically affects adults and can be related to obesity. ...
- Source: drugdu
- 185
- January 1, 2024
Amgen’s request for full approval of Lumakras in lung cancer denied by FDA

Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. The California pharma will now have to conduct an additional confirmatory trial to gain the coveted FDA nod. Lumakras was granted accelerated approval in May 2021 to treat second line KRAS G12C-mutated NSCLC. The company was asked by the FDA to launch a confirmatory trial and a dose optimization study to gain a full approval. The therapy faced an advisory committee meeting in October where a panel was asked to consider whether the primary endpoint for the phase 3 CodeBreak 200 trial could be reliably interpreted in Amgen’s study. The committee voted 10-2 against the measure, suggesting that they were unimpressed with Amgen’s trial design. Despite the negative vote, the agency was not expected to remove Lumakras from the market, but instead request another confirmatory trial. Amgen now says that’s exactly ...
- Source: drugdu
- 217
- January 1, 2024
Opdualag licensed for patients with advanced melanoma

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (27 December) approved the advanced melanoma medicine Opdualag (nivolumab-relatlimab) for patients from the age of 12. This is a cancer medicine used to treat advanced melanoma, a type of skin cancer that can spread to other areas of the body. The main risk factor for melanoma is exposure to ultraviolet light, which comes from the sun and is used in sunbeds. Around 17,000 cases of melanoma are diagnosed every year in the UK, although not all of those are advanced melanoma. Opdualag has been authorised through Project Orbis, a global partnership between the MHRA, the Therapeutics Goods Administration in Australia, Health Canada, the Health Sciences Authority in Singapore, Swissmedic, Agência Nacional de Vigilância Sanitária in Brazil and Israel’s Ministry of Health, coordinated by the US Food and Drug Administration. This programme reviews and approves promising cancer drugs, helping patients to ...
- Source: drugdu
- 104
- January 1, 2024
The latest domestic innovative COVID-19 drug Taizhongding® is exclusively available on Meituan’s online drug shopping website

On December 28, the innovative COVID-19 drug Taizhongding® developed by Guangsheng Zhonglin Technology Co., Ltd. (hereinafter referred to as Guangsheng Zhonglin), an innovative drug subsidiary of Fujian Guangshengtang Pharmaceuticals, was exclusively launched on the Meituan drug purchase online . It is understood that Taizhongding® is currently the only small molecule antiviral drug in China that widely covers the XBB series of mutant strains. The relevant person in charge of Fujian Guangshengtang Pharmaceutical stated that they chose Meituan Medicine as the online launch channel for Taizhongding® because they hope to cooperate with Meituan Medicine to further enhance the awareness and accessibility of innovative drugs. Give patients in need more treatment options. Search volume for COVID-19 drugs increases, domestic innovative drugs provide new solutions for patients Recently, the new coronavirus variant JN.1 has once again attracted public attention. Authoritative data shows that in early November this year, JN.1 accounted for about 4% ...
- Source: drugdu
- 99
- January 1, 2024

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