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US approves Pradaxa as oral blood thinning med for children

The Food and Drug Administration (FDA) has approved Boehringer Ingelheim’s Pradaxa as the first oral blood thinning medication to treat children aged three months to less than 12 years old in the US. The FDA has cleared Pradaxa (dabigatran etexilate) for use in children with venous thromboembolism, immediately after treatment with a blood thinner given by injection for at least five days. Pradaxa oral pellets have also been approved to prevent recurrent clots among children aged three months to less than 12 years old, who have complete treatment for their first venous thromboembolism. Lastly, the drug has been approved in capsule form to treat blood clots in patients eight years and older with venous thromboembolism, directly after they have been treated with a blood thinner given for at least five days, and to prevent clots in patients aged eight years and older who have completed treatment for their first venous ...
- Source: drugdu
- 172
- June 23, 2021
Pradaxa
Novartis’ Cosentyx wins NICE backing for non-radiographic axial spondyloarthritis

Novartis’ Cosentyx has been recommended by the National Institute for Health and Care Excellence (NICE) for the treatment of adults with non-radiographic axial spondyloarthritis (nr-axSpA). NICE has recommended Cosentyx (secukinumab) as an option for the treatment of active nr-axSpA with objective signs of inflammation that is not controlled well enough with non-steroidal anti-inflammatory drugs (NSAIDs) in adults. The IL-17A inhibitor is recommended only if tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough. “Axial SpA is a painful and progressive long-term condition affecting approximately one in 200 people in the UK,” said Dale Webb, chief executive of the UK’s National Axial Spondyloarthritis Society (NASS). “Axial SpA can result in long-term pain, impaired mobility and fatigue. Earlier diagnosis and treatment can have a significant impact on the progression of the condition and people’s long-term outcomes, and NASS welcomes new treatment options,” he added. The ...
- Source: drugdu
- 239
- June 21, 2021
Novartis
Cell and Gene Therapy Catapult forms consortium of over 20 organisations

The Cell and Gene Therapy (CGT) Catapult has announced the formation of a consortium of over 20 organisations, which will aim to accelerate technology development in cell and gene therapy manufacturing. The consortium consists of pharmaceutical companies, technology providers, therapy developers and charities. It will aim to assess the application and combination of a number of process analytic technologies (PAT) with the aim of developing cell and gene therapy specific PAT. In a statement, the CGT Catapult said the development of cell and gene therapy industry-specific PAT is key to enabling monitoring and control during the manufacturing process. The partners will utilise a collaborative work model, sharing data from each of their own research, to accelerate expertise in this area and develop industry-specific knowledge. This knowledge, according to the CGT Catapult, will enable technology providers and manufacturers to potentially develop lower cost and ‘more robust’ manufacturing processes for cell and ...
- Source: drugdu
- 163
- June 10, 2021
Cell and Gene Therapy Catapult
GSK’s PD-1 inhibitor Jemperli approved in the UK

GlaxoSmithKline’s (GSK) PD-1 inhibitor Jemperli has been authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of recurrent or advanced endometrial cancer. Specifically, Jemperli (dostarlimab) has been granted a conditional marketing authorisation for use in adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer, who have progressed on or following prior treatment with a platinum containing regimen. The authorisation is based on results from the open-label GARNET study, which included women with recurrent or advanced dMMR/MSI-H endometrial cancer who progressed on or after a platinum-based chemotherapy regimen. Jemperli treatment led to an objective response rate of 44.8% and a disease control rate of 57.1%, while a median duration of response (DoR) had not been reached in these patients. However, the probability of maintaining a response at six months and 12 months was 97.9% and 90.9% respectively, according to ...
- Source: drugdu
- 287
- June 7, 2021
Jemperli
NICE turns down GSK’s IV Benlysta for systemic lupus

The National Institute for Health and Care Excellence (NICE) has rejected NHS funding for an intravenous formulation of GlaxoSmithKline’s Benlysta (belimumab) as an add-on therapy for certain patients with active autoantibody-positive systemic lupus. The preliminary decision, outlined in an appraisal consultation document, relates to use of the drug in people aged five years and older when there is a high degree of disease activity (for example, positive anti-double-stranded DNA, low complement) and despite standard therapy, as per its marketing authorisation. According to NICE, while clinical trial evidence suggests that after a year of treatment Benlysta plus standard therapy reduces disease activity more than standard therapy alone, “the results are uncertain because the trials were short”. Also, it noted that the long-term benefit of Benlysta compared with standard therapy or rituximab is unknown, as long-term extension studies did not have comparator arms. Cost-effectiveness estimates are also uncertain, and are most likely ...
- Source: drugdu
- 326
- June 4, 2021
GSK
Sanofi halts venglustat clinical programme in ADPKD

French pharma company Sanofi has announced that it has halted the clinical programme of venglustat in autosomal dominant polycystic kidney disease (ADPKD). Although the safety profile of venglustat remains consistent with previously reported results, a Phase II/III trial of the drug did not meet its futility criteria. In addition, the study confirmed venglustat effectively inhibits the glycosphingolipid (GSL) pathway by demonstration a reduction in the lip GL-1. The STAGED-PKD study was stopped for futility after an independent analysis of the annualised rate change in total kidney volume (TKV) in patients receiving venglustat compared to placebo. In a statement, Sanofi said that trends from this analysis showed venglustat did not provide meaningful reduction in TKV growth rate – the primary endpoint of stage one of the study. The company added that the analysis suggests the reduction of GSLs may not play a significant role in the prevention of kidney cyst growth, meaning ...
- Source: drugdu
- 286
- June 2, 2021
Sanofi
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
- 265
- 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
- 213
- 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
- 145
- 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
- 597
- May 21, 2021
EMA

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