PharmaFocus Today – Page 72 – media

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
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- 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
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- 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
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- 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
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- 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
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- July 11, 2024
Masimo offered up to $950M for consumer business

Dive Brief Masimo received a non-binding offer on July 2 from a company prepared to buy its consumer business for a range of from $850 million to $950 million. The offer, which Masimo disclosed Monday in a federal filing, is less than the price the unnamed partner proposed in a term sheet in May and less than what Masimo paid to expand in the consumer market in 2022. Masimo plans to negotiate for a higher price. The update comes as Masimo prepares for an annual meeting at which an activist shareholder will try to remove the company’s CEO and founder Joe Kiani from the board of directors. Dive Insight Masimo, a pulse oximetry specialist, expanded in the consumer space by acquiring Sound United for $1 billion in 2022. The company saw Sound United’s consumer channel expertise as a way to accelerate its expansion beyond healthcare settings. However, Masimo’s share price ...
- Source: drugdu
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- July 11, 2024
FDA Approves Cordis’ Vascular Closure Device for Cardiac Ablation Procedures

By Don Tracy, Associate Editor Approval of the Mynx Control Venous vascular closure device was based on results from the ReliaSeal trial, which demonstrated 100% procedural and device success in cardiac ablation procedures. The FDA has approved Cordis’ Mynx Control VenousVascular Closure Device (VCD), designed for cardiac ablation procedures with access sites ranging from 6F to 12F. According to the company, the device utilizes grip technology, which leverages a hydrophilic, bioinert polyethylene glycol (PEG) sealant that resorbs three times faster than collagen-based alternatives and reportedly provides the fastest time to hemostasis among venous closure devices. Additionally, the device was approved based on promising results from the ReliaSeal trial, which found that the Mynx Control VenousVCD demonstrated 100% procedural and device success in cardiac ablation procedures. “Using Mynx Control VenousVCD following ablation procedures, investigators achieved consistent and effective closure, facilitating quick and safe patient ambulation,” said John Summers, MD, director of ...
- Source: drugdu
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- July 11, 2024
With New Huntington’s Gene Therapy Data, uniQure Hopes for Faster Path With FDA

A uniQure gene therapy for Huntington’s disease has interim clinical data showing an 80% slowing of disease progression. An accelerated approval pathway is one of the topics the company wants to discuss with the FDA. By Frank Vinluan on July 09, 2024A uniQure gene therapy for Huntington’s disease has interim data showing the one-time treatment slows progression of this rare neurodegenerative disorder that has no FDA-approved therapies. Based on these encouraging data, the company said Tuesday it now plans to discuss with regulators the potential for a faster clinical and regulatory path forward. Huntington’s stems from a genetic mutation that leads to abnormal versions of the huntingin protein. The disease leads to motor dysfunction, behavioral changes, and cognitive decline. The uniQure gene therapy, code-named AMT-130, uses an engineered virus to deliver microRNA that silences the huntingin gene and the toxic protein fragment that drives the disease. Amsterdam-based UniQure is evaluating ...
- Source: drugdu
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- July 11, 2024
Chinese expert consensus on polymyxin nebulized inhalation therapy released

Bacterial drug resistance is a global problem and challenge in anti-infective treatment, and multi-drug-resistant bacterial infections are facing the situation of having no choice of drugs in the clinic. (hereinafter referred to as “Consensus”) was authoritatively released, aiming to provide clinicians with an authoritative treatment guideline to help them choose treatment options more scientifically and rationally when facing multidrug-resistant bacterial infections. Multi-drug resistant bacteria (MDRB) refers to bacteria that are resistant to three or more classes of commonly used antibacterial drugs that are usually sensitive. In the treatment of MDRB infections, polymyxins, such as polymyxin B and polymyxin E (CMS), have become a powerful weapon against drug-resistant bacteria due to their unique antimicrobial mechanisms and remarkable efficacy. These drugs exert their antimicrobial effects by binding to lipopolysaccharide on the bacterial cell membrane and disrupting the integrity of the cell membrane. Polymyxin E sodium methanesulfonate has been widely used in the ...
- Source: drugdu
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- July 11, 2024
Dual HER2 Blockade Therapy Presented on MED and ESMO GI

Recently, results of the phase 2 study of HLX22, an innovative anti-HER2 monoclonal antibody (mAb), in combination with HANQUYOU (HLX02, trastuzumab, trade name: HERCESSI™️ in the U.S., Zercepac® in Europe) and chemotherapy for the first-line treatment of HER2-positive advanced gastric/gastroesophageal junction (G/GEJ) cancer were presented on 2024 ESMO Gastrointestinal Cancers Congress (ESMO GI) and MED, a flagship clinical and translational research monthly journal by Cell Press. The leading principal investigator for this study is Professor Jin Li from Shanghai East Hospital, School of Medicine, Tongji University. The results showed that the addition of HLX22 to HLX02 (trastuzumab) plus chemotherapy as first-line therapy improved efficacy in HER2-positive G/GEJ cancer patients with manageable safety. The results of HLX22-GC-201 were first presented at the 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI). The study data and updated results with another 7.8 months of follow-up were accepted for publication on MED ...
- Source: drugdu
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- July 11, 2024

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