Search Results for “Clinical Trial” – Page 106 – media

NICE questions value and efficacy of five Covid-19 drugs with rejection

This week, NICE rejected five major Covid-19 therapies due to high costs and uncertainties in clinical evidence. The UK’s National Institute for Health and Care Excellence (NICE) has published a draft guidance that does not recommend the use of five major Covid-19 therapies. This news came as many organisations and patient advocacy groups have been campaigning for the adoption of some of the rejected drugs for several months, amidst concerns about access to medicines in the UK. The therapies with a negative appraisal included three anti-Covid-19 antibodies; Regeneron Pharmaceuticals’ Ronapreve (casirivimab +imdevimab), GSK’s Xevudy (sotrovimab) and, AstraZeneca’s Evusheld (tixagevimab + cilgavimab). Between November 5 and November 12, a total of 20,588 people have reported testing positive for Covid-19 in England, according to government data. This number is likely an underestimation given the lack of testing amongst the population. Furthermore, in that same period, 3,407 patients were admitted to a hospital in the country for severe cases of Covid-19. ...
- Source: drugdu
- 148
- March 17, 2023
NICE approves funding for Novartis gene therapy

Funding is for onasemnogene abeparvovec and concerns babies with spinal muscular atrophy NICE has published final draft guidance regarding the recommendation of routine NHS funding for onasemnogene abeparvovec. The treatment is a potentially curative one-off gene therapy for treating a rare genetic condition, spinal muscular atrophy (SMA). It will be used specifically among babies aged up to 12 months, before they develop symptoms. The drug – also known as Zolgensma – is produced by Novartis Gene Therapies. The recommendation has emerged after NICE reviewed the evidence to determine whether it should be available for routine NHS funding in England and Wales. Onasemnogene abeparvovec is designed to address the genetic cause of SMA and its effects are thought to be life-long. Under NICE’s original guidance, released in 2021, it was recommended for babies before they develop symptoms of SMA as part of a managed access agreement (MAA). The agreement ensured that ...
- Source: drugdu
- 126
- March 17, 2023
Brazil’s ANVISA approves Takeda’s dengue vaccine Qdenga

Qdenga’s approval is supported by the data obtained from 19 clinical trials, and follows similar decisions in other countries. The National Health Surveillance Agency (ANVISA) in Brazil has granted approval for Takeda’s tetravalent dengue virus vaccine, Qdenga. The vaccine, previously known as TAK-003, has received approval for preventing dengue disease in people aged four years to 60 years. Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes and is designed to provide protection against any of these. Qdenga is purported to be the only dengue vaccine approved in Brazil for use in people without the need for pre-vaccination testing and regardless of previous exposure. ANVISA’s approval follows similar decisions by the European Commission in December, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) last month. The company continues to advance regulatory filings in other dengue-endemic countries in Asia and Latin America. In ...
- Source: drugdu
- 139
- March 17, 2023
China’s NMPA accepts GSK’s drug application review for Nucala to treat SEA

China National Medical Products Administration has accepted the review of GSK’s drug application for Nucala (mepolizumab) as an add-on maintenance treatment for severe eosinophilic asthma (SEA). If given approval, Nucala will become the first targeted anti-Interleukin-5 (IL-5) treatment in the country for adult and adolescent patients with SEA. A first-in-class monoclonal antibody to target IL-5, Nucala was first approved in 2015 for SEA in the US. It prevents IL-5 from binding to its receptor on the surface of eosinophils, lowering blood eosinophils and maintains them under normal levels. The application to China National Medical Products Administration has been submitted based on positive data from Phase III trial undertaken on patients in China and the global SEA development programme, which included three important clinical trials – DREAM 2, MENSA3 and SIRIUS4. These trials established the efficacy and safety profile of mepolizumab for SEA patients. The Phase III trial for 52 weeks studied the ...
- Source: drugdu
- 128
- March 16, 2023
PBD Biotech reveals vital update to TB test

By John Pinching Lyophilized PCR reaction bead reduces the cost of transport and extends shelf life for the test. PBD Biotech has developed a lyophilized PCR reaction bead for its Actiphage blood test which identifies active tuberculosis (TB). The new function enables transportation without the need for a cold chain, which reduces the cost associated with shipment and also extends the shelf life for test components. TB treatment and testing must occur close to the point of infection and the update meets these criteria. Typically, products that contain enzymes are temperature-sensitive and require cold chain transport to ensure their functional integrity. Lyophilization, however, is a water removal system that can be used to extend the life of a product. PBD Biotech has also established PCR primers and probes that allow specific detection of DNA from mycobacteria TB isolated from a whole blood sample. By enabling early detection of TB disease ...
- Source: drugdu
- 121
- March 16, 2023
An overview of COVID-19-associated neurological complications in children

In a recent study posted to the Research Square* preprint server, an international team of researchers review current literature to understand the association between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, abnormal neuroimaging manifestations, and neurological symptoms among individuals under the age of 18. Background The clinical presentation of the coronavirus disease 2019 (COVID-19) varies widely across individuals, ranging from asymptomatic or mild to severe cases involving acute respiratory distress syndrome (ARDS), pneumonia, and multi-organ complications. Emerging evidence suggests that the thrombogenic reactions and cytokine storm that develop during acute COVID-19 contribute to psychiatric and neurological complications, with a high incidence of intracerebral hemorrhage and ischemic stroke. While many studies have investigated the neurological complications associated with acute SARS-CoV-2 infections among adults, COVID-19 manifestations among children have largely been asymptomatic or mildly symptomatic and not require hospitalization. However, emerging evidence indicates that systemic symptoms such as secondary inflammatory responses, which are collectively known ...
- Source: drugdu
- 291
- March 15, 2023
What Mutations of SARS-CoV-2 are Causing Concern?

As viruses are exposed to environmental selection pressures, they mutate and evolve, generating variants that may possess enhanced virulence. Some of the primary concerns that public health officials have as these new variants continue to emerge include their viral transmissibility, reinfection rates, disease severity, and vaccine effectiveness. SARS-CoV-2. Image Credit: ImageFlow/Shutterstock.com How do RNA viruses mutate? The mutation rate of single-stranded ribonucleic acid (ssRNA) viruses is observed to be much higher than organisms that possess single-stranded deoxyribonucleic acid (ssDNA), and many times more than those with double-stranded DNA (dsDNA). Not all mutations necessarily increase virulence and, in the majority of cases, may in fact be deleterious or inconsequential. Therefore, organisms must find an equilibrium between a high mutation rate that allows them to adapt to changing environmental conditions, and a low one that lessens the incidence of catastrophic mutations. Small DNA viruses may encode their own DNA repair, and ...
- Source: https://www.news-medical.net/health/What-Mutations-of-SARS-CoV-2-are-Causing-Concern.aspx
- 452
- April 5, 2022
SARS-CoV-2 viruse
Early data shows CanSinoBIO’s inhaled COVID-19 vaccine triggers immune response

CanSinoBIO’s inhaled COVID-19 vaccine candidate was found to trigger immune responses with no serious side effects reported, according to an early-stage clinical study. The inhaled two-dose candidate is modified from CanSinoBIO’s injected COVID-19 jab Ad5-nCoV vaccine, which is already approved in China and other countries around the world. Results from a Phase I clinical trial, published in The Lancet, found that two-doses of the inhaled Ad5-nCoV vaccine can trigger a similar immune response to a single-dose of the injected version. The inhaled version was also found to trigger neutralising antibodies and T cell responses after one dose. The study also found that the inhaled version of the vaccine did not cause serious side effects, demonstrating an encouraging safety profile in the early-stage trial. A number of drugmakers are also developing inhaled treatments for COVID-19, including Verona Pharma. UK-headquartered Verona announced at the beginning of the year that it had completed enrolment ...
- Source: drugdu
- 962
- September 1, 2021
CanSinoBIO
China’s Import and Export Market Report of Vitamins

Vitamins are trace organic substances that humans and animals must obtain from food to maintain normal physiological functions. They play an important role in human growth, metabolism, and development.
- Source: Ddu
- 49,021
- August 26, 2021
Market Reports vitamin
China’s Import and Export Market Report of Rheumatoid Arthritis Drugs

Rheumatoid arthritis (RA) is an autoimmune disease with complex pathogenesis and an extremely high morbidity rate, which seriously affects the quality of the life of patients and brings economic burden to society. Thus, effective treatments of RA has become a global concern of the pharmaceutical industry.
- Source: Ddu
- 3,910
- August 26, 2021
Ddu College Market Reports RA

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