PharmaFocus Today – Page 140 – media

After AdCom rejection, FDA rebuffs Novo Nordisk’s once-weekly insulin

The US Food and Drug Administration (FDA) has rejected the biologics licence application (BLA) for Novo Nordisk’s once-weekly insulin icodec for the treatment of diabetes mellitus. The company did not disclose the details of the complete response letter (CRL) issued by the FDA. But did share that the CRL outlined concerns related to the “manufacturing process and the type 1 diabetes (T1D) indication”. Novo Nordisk also added that the company did not expect to fulfil the requests detailed in the CRL by the end of this year, and consequently will not be refiling the BLA for insulin icodec until next year, at the earliest. The BLA rejection news comes two months after the FDA Endocrinologic and Metabolic Drugs Advisory Committee (AdCom) voted against the approval of insulin icodec for T1D. In a 7-4 vote, the panel found that insulin icodec’s benefits do not outweigh its risks, especially the elevated risk ...
- Source: drugdu
- 159
- July 13, 2024
Indegene collaborates with Microsoft to promote use of GenAI in global life sciences companies

Indegene announced a strategic collaboration with Microsoft to empower global life sciences companies to scale up the adoption of purpose-built, enterprise-grade Generative AI services, thereby driving faster innovation at scale. Indegene and Microsoft have aimed to develop resources in highly specialised and skilled medical and technology tools to co-innovate generative AI services and workflows across commercial, medical, regulatory, and clinical functions. Some of the key use cases the strategic collaboration focuses on in the first phase, include: Content Super App: Using Azure OpenAI Service, the modular content value chain simplifies content creation and tagging for life sciences companies. This integrated approach offers a holistic view of the content value chain, enabling greater velocity, personalized content, and adoption of new conversation form factors. It also streamlines creative and video transformation while effectively engaging healthcare professionals (HCPs), patients and payers Future-ready medical content value chain: Generative AI capabilities are revolutionising the medical ...
- Source: drugdu
- 145
- July 13, 2024
The growing threat of antibiotic resistance

The alarming rise of multi-drug-resistant (MDR) superbugs is a significant threat to global health, with traditional antibiotics losing their efficacy at an unprecedented rate. Antibiotic resistance is one of our time’s most pressing public health issues. It occurs when microbes evolve mechanisms to withstand the drugs designed to kill them, rendering standard treatments ineffective and leading to persistent infections and increased risk of spread. This phenomenon poses a significant threat to global health, development, and sustainability. Microorganisms can become resistant to antibiotics through genetic mutation, horizontal gene transfer, Efflux pumps and enzymatic degradation. Several factors contribute to the rise of antibiotic resistance. Amongst them, overuse and misuse of antibiotics is the most distressing. Prescribing antibiotics when they are not needed such as for viral infections and patients not completing their prescribed courses of antibiotics also contribute to the resistance. The use of antibiotics in livestock for growth promotion and disease ...
- Source: drugdu
- 107
- July 13, 2024
FDA Approves Arcutis Biotherapeutics’ Zoryve to Treat Patients with Mild to Moderate Atopic Dermatitis

By Don Tracy, Associate Editor Zoryve is a steroid-free, once-daily treatment shown to offer rapid disease clearance and significant itch reduction for patients with mild to moderate atopic dermatitis. The FDA has approved Arcutis Biotherapeutics’ supplemental New Drug Application (sNDA) for Zoryve (roflumilast) cream 0.15% for mild to moderate atopic dermatitis (AD) in adults and children over six years of age. According to the company, the treatment is steroid-free and moves quickly to clear the disease, resulting in significant itch reduction. The approval was based on results from three Phase III studies, a Phase II dose-ranging study, and two Phase I pharmacokinetic studies.1 “The chronic nature of AD coupled with the disease instability often leaves patients and caregivers feeling that they are constantly chasing their AD flares,” said Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics, vice chair, department of dermatology, UC San Diego School of Medicine, INTEGUMENT study ...
- Source: drugdu
- 105
- July 12, 2024
Amylyx Aims to Help Patients With a Novel GLP-1 Drug, But Not the Way You Think

Unlike GLP-1 agonist drugs marketed for weight loss, new Amylyx Pharmaceuticals drug avexitide blocks its target receptor. Amylyx plans to advance this GLP-1 antagonist into Phase 3 testing for post-bariatric hypoglycemia, a rare condition in which blood sugar levels drop precipitously. By Frank VinluanBefore GLP-1 drugs became a wildly popular pharmacologic way to treat obesity, bariatric surgery was a top option for those seeking a medical intervention for losing weight. While this procedure is effective for weight loss, it turns out that changing the structure of the gut can lead to a debilitating disorder in some patients. Amylyx Pharmaceuticals, months removed from a clinical trial failure that shattered its prospects in neurodegeneration, is now planting a flag in metabolic disease with the acquisition of a Phase 3-ready drug for this rare disorder with no FDA-approved therapies. The drug comes from Eiger BioPharmaceuticals, which last month sold off its assets in ...
- Source: drugdu
- 114
- July 12, 2024
Arcutis bags FDA approval for atopic dermatitis cream after delay

Arcutis has won its third US Food and Drug Administration (FDA) approval for Zoryve (roflumilast) cream in two years, with the latest indication meant for adults and some children with atopic dermatitis. The FDA has approved the once-daily topical cream for mild to moderate atopic dermatitis in patients aged six years and older. Zoryve, a phosphodiesterase-4 (PDE4) inhibitor, was approved as a cream in July 2022 for the treatment of plaque psoriasis for patients aged 12 and older, and October 2023 for children aged 6-11 with psoriasis. The initial date for the label expansion in atopic dermatitis was set for 7 June 2024, but the decision was delayed by several days, with Arcutis releasing a statement on 9 June saying there had been no request for new information from the regulator at the time. The approval is supported by positive data from three Phase III studies, a Phase II dose-ranging ...
- Source: drugdu
- 128
- July 12, 2024
NICE recommends Ebglyss for atopic dermatitis patients

England’s National Institute for Health and Care Excellence (Nice) has recommended Almirall’s Ebglyss (lebrikizumab) for patients with moderate to severe atopic dermatitis, giving NHS patients another biological therapy option. In line with NICE guidelines, the NHS will now have 90 days to make the treatment available to patients. Patients over 12 years of age who have not responded to or are not able to take systemic immunosuppressants will be eligible for the therapy, as per a 10 July press release. Monoclonal antibody Ebgylss will join Sanofi / Regeneron’s Dupixent (dupilumab) and Leo Pharma’s Adbry (tralokinumab) as interleukin-targeting options for treating the skin condition. The Janus kinase (JAK) inhibitors Cibinqo (abrocitinib), Olumiant (baricitinib), and Rinvoq (upadacitinib) developed by Pfizer, Eli Lilly, and AbbVie, respectively, are also recommended by NICE. Atopic dermatitis, also known as atopic eczema, is an inflammatory skin condition characterised by intense itching. It has an estimated prevalence of ...
- Source: drugdu
- 118
- July 12, 2024
UK DRI and NHS collaborate on digitally enabled dementia care platform

by Jen Brogan | 10th Jul 2024 | News Around one in five dementia hospitalisations are due to potentially preventable causes The UK Dementia Research Institute (UK DRI), in collaboration with the NHS, aims to conduct a new two-year study to prepare its digitally-enabled dementia care platform, Minder, to be integrated into health and social care services. Funded by LifeArc, the study will enable digital care for people living with dementia while empowering the NHS and social care services to provide care of the highest quality in patients’ own homes. Estimated to affect 944,000 people in the UK, dementia is a general term for the impaired ability to remember, think, or make decisions that affects everyday life. Developed by the UK DRI Centre for Care Research and Technology, Minder is a home monitoring platform that harnesses artificial intelligence (AI) and digital technology and is integrated with public services to detect ...
- Source: drugdu
- 167
- July 12, 2024
Institutions to lead £1.7m-funded network to support people at risk of dementia

The neurodegenerative condition currently affects more than 944,000 people in the UK University College London (UCL) and the University of Exeter are set to co-lead a new national Dementia Network Plus initiative supported by more than £1.7m in funding. The Sustainable Prevention, Innovation and Involvement NETwork (SPIINNET) will help to reduce dementia risk and improve people’s experiences of living with dementia by supporting new projects and engaging with communities. Affecting more than 944,000 people in the UK, dementia is a neurodegenerative condition that affects the ability to remember, think or make decisions in everyday life. The new network will combine researchers from 14 universities with specialist organisations, including King’s College London, the University of Plymouth, Bangor, Cardiff Metropolitan, East Anglia, Northampton, Nottingham, Oxford, Southampton, Stirling, Strathclyde, Sunderland and Worcestershire. SPIINNET aims to utilise existing networks and umbrella organisations to deliver a programme to create connections between the experience, knowledge and ...
- Source: drugdu
- 156
- July 12, 2024
Philips recall of imaging coils tied to 12 injuries

Dive Brief Philips has recalled several models of Sense XL Torso coils due to the risk of the devices heating up during MRI scans and burning patients. Philips updated the instructions for six models of Sense XL Torso coils used with 1.5T and 3.0T MRI scanners, according to a recall notice posted Monday by the Food and Drug Administration. The recall does not require products to be removed from facilities or where devices are sold. Twelve reported injuries have been associated with the recall, the FDA said. No deaths were reported. Dive Insight Philips’ latest recall is yet another safety problem for the company, which has spent more than three years managing a recall of over 15 million respiratory devices. The company has had recent issues with imaging machines. In November, Philips recalled certain MRI scanners because of the risk of machines exploding. The FDA said at the time that ...
- Source: drugdu
- 155
- July 11, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.