Search Results for “EC” – Page 457 – media

Medical registration for India —— What to do after the first official submission?

People who understand the process of medical registration for India would know that Indian registration is divided into two steps, which are Marketing Approval and Product Registration.You can find the details of the registration profile and flowchart from different countries we have prepared for you on Ddu (Drugdu.com). Ddu has listed the key points about what we need to do after the first official submission of Marketing Approval documents. 1. Wait for the official feedback, and follow the feedback to make the corresponding data revisions and supplements; 2. Get prepared for the plan of clinical Phase; You may have doubts while reading this point, why do we need to prepare a clinical plan during the first stage of registration, which is the Marketing Approval stage? First, the clinical Phase 3 study is a major premise for vaccine products to enter the Indian market; Secondly, the review ...
- Source: drugdu
- 948
- August 24, 2021
Ddu College：Pharmacovigilance

Pharmacovigilance,A discipline that collects, monitors, researches, and evaluates information about health care providers and patients regarding to the adverse drug reactions , biological products, herbs, and traditional medicine.
- Source: Ddu
- 2,072
- August 24, 2021
Over 600,000 COVID-19 tests genomically sequenced in the UK

The UK has sequenced over 600,000 positive COVID-19 tests, providing ‘invaluable data’ in the fight against the virus, the Department of Health and Social Care (DHSC) announced last Friday. According the DHSC, the UK is estimated to contribute around 23% of all COVID-19 sequencing across the globe uploaded to GISAID. In the early stages of the pandemic, the COVID-19 Genomics UK (COG-UK) consortium was created to enable the delivery of large-scale and rapid whole-genome virus sequencing for local NHS centres and the government. The data collected by COG-UK has aided public health agencies in decision making for managing COVID-19 outbreaks and for informing vaccine development efforts. When sequenced, virus genome data can then be combined with clinical and epidemiological datasets to help inform UK public health interventions and policies. In a statement, the DHSC added that this information will also enable the evaluation of novel treatments and non-pharmacological interventions in ...
- Source: drugdu
- 186
- July 5, 2021
COVID-19 tests
Scientists identify link between genetic changes and rare childhood cancer rhabdomyosarcoma

Genetic changes may help to improve decision making for the treatment of the rare and aggressive form of childhood cancer rhabdomyosarcoma, according to a new international study led by researchers at the Institute of Cancer Research, London (ICR). The study analysed the DNA from 641 patients with rhabdomyosarcoma – a rare and aggressive type of childhood cancer that resembles muscle tissue and mostly affects children. According to ICR, less than 30% of children with this type of cancer who have relapsed and whose disease has spread will survive. There are two main subtypes of rhabdomyosarcoma, including fusion gene-positive and fusion gene-negative, depending on the presence of a ‘fusion gene’. Researchers found that, when looking at those with fusion-negative rhabdomyosarcoma, children whose tumours had faults in the genes MYOD1 and TP53 had significantly poorer response to treatment and worse survival outcomes. The TP53 gene was found to be altered in 69 ...
- Source: drugdu
- 167
- June 28, 2021
rhabdomyosarcoma
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
- 165
- 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
- 235
- 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
- 158
- 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
- 283
- 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
- 317
- 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
- 277
- June 2, 2021
Sanofi

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