Search Results for “EC” – Page 458 – media

NICE green lights Tremfya to treat active psoriatic arthritis

Janssen’s IL-23 inhibitor Tremfya has been accepted for NHS use by the UK’s National Institute for Health and Care Excellence (NICE) for the treatment of active psoriatic arthritis (PsA). Tremfya (guselkumab) is a fully human monoclonal antibody (mAb) designed to selectively bind to and inhibit the IL-23 receptor – an key driver of progression in inflammatory diseases such as PsA. NICE’s final appraisal document (FAD) recommends Tremfya to treat moderate-to-severe PsA in adults who have responded inadequately to disease-modifying antirheumatic drug (DMARD) therapy or who cannot tolerate them. The positive recommendation is supported by results from the Phase III DISCOVER-1 and DISCOVER-2 clinical trials, which evaluated the safety and efficacy of Tremfya in adults with active PsA. Across both studies, Janssen’s drug demonstrated a favourable risk-benefit profile, showing statistically significant benefits compared to placebo on disease activity, joint and skin symptoms, functional capacity and health-related quality of life. “[Tremfya] is ...
- Source: drugdu
- 259
- May 31, 2021
Janssen
NHS-backed wellbeing app Thrive raises £2.5m

Thrive, a wellbeing approved for use by the NHS, has raising a total of £2.5m in funding in only ten days, the digital health company has announced. The latest funding round attracted investment from the Sumerian Foundation and Treebeard Trust, as well as from investment platforms such as Syndicate Room and Wealth Club. In a statement, Thrive said it would use the new funding to research and identify further areas of help that it can support and also develop the tech platform further. This will include increased integration with existing medical data, with the aim of giving users ‘seamless’ access to mental health care. Currently, the app provides whole-person solutions for workplaces and individuals, and is designed to help users overcome periods of stress while supporting long-term mental health. It uses clinical-grade, evidence-based techniques to achieve this, while also providing in-app access to trained therapists. The company was initially launched ...
- Source: drugdu
- 209
- May 26, 2021
wellbeing app
BMS’ Opdivo/Yervoy improves long-term survival for melanoma patients

Bristol Myers Squibb’s Opdivo (nivolumab) plus Yervoy (ipilimumab) combination has demonstrated ‘durable improvement in survival’, according to new long-term data from a Phase III trial. According to 6.5 year data from CheckMate-067, median overall survival (OS) for patients with advanced melanoma was 72.1 months with Opdivo plus Yervoy, compared with 36.9 months for patients received Opdivo alone and 19.9 months for Yervoy monotherapy. In a statement, BMS said this represented the longest reported median OS in a Phase III advanced melanoma trial. Opdivo plus Yervoy also demonstrated a 6.5-year progression-free survival (PFS) rate of 34%, versus 29% and 7% for Opdivo alone and Yervoy alone, respectively. In addition, of the 49% of patients who were alive and in follow-up, 77% who received Opdivo plus Yervoy, 69% of Opdivo-treated and 43% of Yervoy-treated patients have been off treatment and never received subsequent systemic therapy. Also, among melanoma patients with BRAF-mutant tumours, ...
- Source: drugdu
- 136
- May 24, 2021
Melanoma
EMA, MHRA to review Vertex’ Kaftrio for children with CF

The European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have validated Vertex’ applications to expand the scope of its cystic fibrosis (CF) treatment Kaftrio (ivacaftor/tezacaftor/elexacaftor). The drugmaker is seeking approval for the drug’s use in combination with ivacaftor in patients ages six years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. If approved, this will extend the indication for the triple combination therapy to children ages six through 11 years old in EU countries, Great Britain and Northern Ireland. In children with CF, symptoms and organ damage including lung disease manifest very early in life. “We are committed to working diligently with global regulators to expand the indication for our medicine such that younger people living with CF will also be able to access the triple combination therapy,” said Nia Tatsis, executive VP, chief regulatory ...
- Source: drugdu
- 574
- May 21, 2021
EMA
Janssen inks inflammatory disease collaboration with Mestag Therapeutics

Janssen, the pharma division of Johnson & Johnson, has entered an agreement with Cambridge, UK-based Mestag Therapeutics to research and develop novel fibroblast targets for the treatment of inflammatory disease. The collaboration will utilise Mestag’s specialist fibroblast subpopulation biology platform, as well as the biotech’s ‘state-of-the-art’ data analytics in a bid to identify novel therapeutic targets. Under the terms of the agreement, Mestag will grant Janssen an option to an exclusive license to develop and commercialise therapeutics directed against up to two targets resulting from the collaboration. In exchange, Janssen will pay Mestag option fees, milestone payments and royalties – however, the detailed financial terms of the agreement were not disclosed by the companies. Also, as part of the collaboration, Janssen Research & Development’s global immunology therapeutic head David Lee will join Mestag’s scientific advisory committee. “Mestag’s vision is to leverage our unique fibroblast biology platform and state-of-the-art data analytics ...
- Source: drugdu
- 243
- May 19, 2021
Janssen
Novo Nordisk’s weight loss drug semaglutide found to improve wellbeing

New results from a Phase IIIa study have demonstrated that Novo Nordisk’s weight loss drug semaglutide improved physical function and wellbeing among people with obesity. The STEP 1 trial demonstrated benefits for people with obesity treated with semaglutide 2.4mg ‘beyond weight loss’, Novo said in a statement. Over a 68-week period, treatment with once-weekly semaglutide 2.4mg was associated with greater improvements for all weight- and health-related quality of life scores in people with obesity or overweight in comparison to placebo. This included improved wellbeing, with 43.8% of patients treated with Novo’s drug achieving a clinically meaningful improvement in total weight-related quality of life score at week 68. On top of that, 51.2% of participants treated with semaglutide 2.4mg in the trial had an increased weight-related physical function score, reflecting improvements in the ability to perform daily activities. In addition, patients treated with semaglutide 2.4mg ‘simultaneously’ experienced significant weight loss of ...
- Source: drugdu
- 454
- May 17, 2021
weight loss drug
Positive topline results for nirsevimab in RSV

Sanofi and AstraZeneca’s (AZ) monoclonal antibody (mAb) nirsevimab reached its primary endpoint in a Phase III trial, demonstrating protection against respiratory syncytial virus disease (RSV) in healthy infants. Nirsevimab, an investigational extended half-life mAb is designed to protect infants entering their first RSV season, when they are at a higher risk for developing severe RSV disease. In the Phase III MELODY trial, nirsevimab reduced lower respiratory tract infections (LRTI) requiring medical attention due to RSV in healthy preterm and term infants. There were no clinically meaningful differences observed in the safety results between the nirsevimab and placebo groups, with the overall safety profile for nirsevimab in the trial remaining consistent with previously reported results. “Respiratory syncytial virus is the leading cause of hospitalisations in all infants,” said Jean-François Toussaint, global head of research and development, Sanofi Pasteur. “In fact, most hospitalisations occur in otherwise healthy infants born at term. It’s ...
- Source: drugdu
- 111
- April 26, 2021
nirsevimab
New report suggests the gender pay gap for doctors increased during pandemic

A new report suggests that the gender pay gap for doctors has increased during the pandemic, with female doctors found to be disproportionately affected by falling earnings. The Medscape UK Doctors’ Salary and Sanctification Survey 2021, conducted between 10 November 2020 to 16 February 2021, includes responses from over 1,000 doctors in England, Scotland, Wales and Norther Ireland. This includes doctors from a range of specialities, with 73% working in the NHS, 23% working in both the NHS and private sector and 4% in the private sector only. The report considers changes in doctors’ average salaries since Medscape’s last salary and satisfaction survey released in 2019. It found that overall, 29% of UK doctors reported a drop in income, compared with 17% in 2019. Some doctors attributed the decrease in earnings to COVID-19 ‘multiple times’, while others cited different reasons. The report also suggests that women have suffered a greater ...
- Source: drugdu
- 259
- April 23, 2021
pandemic
GW Pharma’s Epidyolex scores new EU indication

GW Pharmaceuticals’ Epidyolex has received approval from the European Commission (EC) for the treatment of seizures associated with tuberous sclerosis complex (TSC) – its third indication in Europe. Specifically, Epidyolex (cannabidiol) has been approved as an adjunctive treatment of seizures associated with TSC for patients aged two years and older. TSC is a rare genetic condition that causes mostly benign tumours to grow in vital organs including the brain, skin, heart, eyes, kidney and lungs. The condition is typically diagnosed in childhood and the most common neurological feature in TSC is epilepsy. It is also associated with an increased risk of autism and intellectual disability, although the severity of the condition can vary widely. The EC approval is based on data from a Phase III trial evaluating Epidyolex for the treatment of seizures associated with TSC. This study hit its primary endpoint of reduction in seizure frequency, with seizure reduction ...
- Source: drugdu
- 230
- April 21, 2021
Epidyolex
Gilead’s Trodelvy scores accelerated approval in advanced bladder cancer

Gilead’s antibody drug conjugate (ADC) Trodelvy has received an accelerated approval from the US Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic urothelial cancer (UC), the most common form of bladder cancer. The approval covers the use of Trodelvy (sacituzumab govitecan-hziy) in patients with advanced UC who have previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. Trodelvy was approved on the basis of results from Gilead’s Phase II TROPHY study, which evaluated the drug as monotherapy or as a combination therapy in patients with metastatic UC after progression on a platinum-based chemotherapy and PD-1/L1 inhibitor. In 112 patients who were evaluable for efficacy, 27.7% of those who were treated with Trodelvy responded to treatment, with 5.4% experiencing a complete response and 22.3% experiencing a partial response. The study also found a median duration of response of 7.2 months for those treated ...
- Source: drugdu
- 174
- April 15, 2021
bladder cancer

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