Search Results for “Clinical Trial” – Page 107 – media

China’s Import and Export Market Report of Diabetes Drugs

Diabetes is one of the most common chronic diseases and is mainly classified into type 1 diabetes, type 2 diabetes, gestational diabetes and others. Worldwide, 90% of diabetic patients suffer from type 2 diabetes, which greatly promotes the development of the diabetes drug market.
- Source: Ddu
- 49,912
- August 25, 2021
Ddu College Diabetes Drugs
Ddu College——WHO vaccine pre-certification How to conduct effective consultation?

From November 1st to 2nd, 2018, the annual World Health Organization (WHO) Prequalification (PQ) consultation will be held in Kunming, China. Unlike previous years, this year’s consultation will only take the one-on-one format, namely the World Health Organization Vaccine Pre-Certification Review Team and small meetings of various domestic vaccine manufacturers. Although the part of the centralized consultation meeting will be cancelled, which means companies and international organizations are unable to discuss and share the importance of pre-certification, but it’s believed that after several years of consultations, everyone has already cooked up the importance and significance of pre-certification. Evidence? This year’s 14 vaccine manufacturers actively participate in the one-on-one consultation is the best proof. As of November 2018, there were 4 manufacturers and vaccines that successfully passed the pre-certification of vaccines in China, namely, Chengdu institution’s Yinao, Hualan’s Liugan, Kexing’s Miejia and Beishengyan’s bOPV. At the PQ consultation meeting in Beijing ...
- Source: drugdu
- 1,493
- August 25, 2021
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
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
Alchemab to collaborate with AstraZeneca on prostate cancer research

Cambridge-based biotech company Alchemab has announced a new collaboration with British pharma AstraZeneca (AZ), aiming to accelerate research for prostate cancer. As part of the collaboration, Alchemab and AZ will collaborate on a proof-of-concept study to improve understanding of the ‘fundamental biology’ of prostate cancer. Alchemab will utilise its novel drug discovery platform as a diagnostic tool through the identification of disease biomarkers, with the potential to inform the development of new antibody-based medications. Under the agreement, Alchemab will sequence and explore antibody repertoires in patient samples gathered from a clinical trial of an undisclosed immuno-oncology agent within AZ’s pipeline. Alchemab may also be able to identify antibody sequence patterns that could be used as biomarkers for early detection and patient stratification by classifying patients into two groups – responders and non-responders. The overall purpose of the collaboration is to identify novel and disease-relevant antibodies which may generate therapeutic insights into ...
- Source: drugdu
- 369
- May 7, 2021
AstraZeneca
Real-world data suggests Sputnik V vaccine is 97.6% effective, says RDIF

New real-world data has suggested that Russia’s Sputnik V vaccine is 97.6% effective against COVID-19, the Gamaleya Institute and the Russian Direct Investment Fund (RDIF) announced yesterday. The new efficacy rate is based on the analysis of data from 3.8 million Russians vaccinated with both components of Sputnik V from between 5 December 2020 and 31 March 2021. In a statement, the RDIF said the Ministry of Health of Russia maintains a register of those who have been vaccinated, as well as citizens who have been infected with COVID-19. According to the data, the infection rate starting from the 35th day from the date of the first injection was 0.027%. The incidence among the unvaccinated adult population was found to be 1.1% for a comparable period starting from the 35th day after the launch of the mass-scale vaccination in Russia. The data and calculations used to determine the vaccine’s efficacy will be ...
- Source: drugdu
- 226
- April 20, 2021
Sputnik V
Positive results for Pfizer/BioNTech’s COVID-19 vaccine in 12-15 year olds

Pfizer and BioNTech have revealed positive top-line data for their COVID-19 vaccine – BNT162b2 – in adolescents aged 12 to 15 years old. The vaccine demonstrated 100% efficacy in a Phase III trial in adolescents aged 12 to 15 years old, with or without prior evidence of SARS-CoV-2 infection. BNT162b2 also produced ‘robust’ antibody responses in the younger population, exceeding those reported in an earlier trial in participants aged 15 to 25 years old. The jab was also found to be well tolerated in the 12 to 15 age group. The companies are now planning to submit the data to the Food and Drug Administration (FDA) in the US and the European Medicines Agency (EMA) to extend the use of the vaccine for this age group ‘as quickly as possible’. Pfizer and BioNTech will also continue to monitor the participants for long-term protection and safety for an additional two years after their ...
- Source: drugdu
- 351
- April 2, 2021
Covid-19 vaccine
GSK to leverage the Cell and Gene Therapy Catapult’s facility in Stevenage

GlaxoSmithKline (GSK) is set to leverage the Cell and Gene Therapy (CGT) Catapult’s facility in Stevenage to expand its own clinical trial manufacturing capacity for cell and gene therapy. GSK will use the Stevenage facility to perform GMP cell processing to accelerate its pipeline of cell and gene therapy for clinical trials and streamline technical transfer. “The UK already has significant capabilities in cell and gene therapy, and this agreement illustrates how strategic investments by GSK can make them even stronger,” said Tony Wood, senior vice president, medicinal science and technology, GSK. “Working more closely with CGT Catapult will help us advance our promising cell and gene therapy programmes, and bring these transformative medicines more quickly to the patients who desperately need them,” he added. There has been a 48% increase in the UK GMP manufacturing space for cell and gene therapies in 2020, according to CGT Catapult. It added that ...
- Source: drugdu
- 232
- March 12, 2021
GSK
NICE backs selective internal radiation therapy for advanced liver cancer

The UK’s National Institute for Health and Care Excellence (NICE) has recommended selective internal radiation therapy (SIRT) for the treatment of advanced liver cancer in final draft guidance. NICE’s draft guidance recommends the use of SIR-Spheres – made by SIRTEX – and TheraSphere – made by Boston Scientific – for treating advanced liver cancer that can’t be removed surgically and when transarterial therapy is not appropriate. The recommendation also specifies that these two therapies should only be considered for people with Child-Pugh grade A liver impairment. Despite limited clinical trial data for SIRTs compared with other treatment options, NICE’s appraisal committee concluded that SIRT may have fewer and more manageable side effects compared to systemic therapy sorafenib. Although SIR-Spheres and TheraSphere are slightly less clinically effective than sorafenib, they cost less. The cost savings mean that these two therapies can be recommended as cost-effective options for people with Child-Pugh grade ...
- Source: drugdu
- 316
- March 3, 2021
NICE
Novo Nordisk’s Sogroya moves closer towards EU approval

Novo Nordisk’s Sogroya (somapacitan) has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use – moving closer towards approval in the EU. The CHMP has recommended marketing authorisation for Sogroya for the treatment of adults with growth hormone deficiency (AGHD). The recommendation is based on results from the Phase III REAL 1 clinical trial programme, which investigated the efficacy and safety of Sogroya in AGHD. “We are very pleased with the positive opinion for once-weekly Sogroya as we are committed to continuously developing innovative and efficient medicines for people living with growth hormone deficiency,” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk. “We are confident that Sogroya will make management of this serious chronic disease easier and help improve the quality of life for more people living with growth hormone deficiency,” he added. Sogroya is a ...
- Source: drugdu
- 256
- February 5, 2021
Novo Nordisk’s Sogroya

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