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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
- 114
- 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
- 264
- 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
- 234
- April 21, 2021
Epidyolex
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
- 228
- April 20, 2021
Sputnik V
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
- 180
- April 15, 2021
bladder cancer
Four medicines accepted for use by NHS Scotland

The Scottish Medicines Consortium (SMC) has approved NHS funding for four new medicines, including treatments for multiple myeloma and severe migraine in its April 2020 decisions. Firstly, Sanofi’s Sarclisa (isatuximab) has been accepted by the SMC for the treatment of relapsed or refractory multiple myeloma, in combination with two other medicines – pomalidomide and dexamethasone. This treatment was accepted following consideration through the SMC’s Patient and Clinician Engagement (PACE) process, which is used for medicines for end of life and rare conditions. Another medication developed by Sanofi – Dupixent (dupilumab) – was also accepted for use on NHS Scotland, for the treatment of a subgroup of patients with severe asthma. Dupixent will be offered as an option for patients with severe asthma who do not fully respond to standard treatment and require more intensive therapies, such as oral corticosteroids, to control their symptoms. “This is a very positive day for ...
- Source: drugdu
- 224
- April 14, 2021
Scotland
Novartis bags EU, UK licences for MS therapy Kesimpta

Novartis has received green lights from both the European Commission and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to market its multiple sclerosis (MS) therapy Kesimpta (ofatumumab). The drug is a fully human anti-CD20 monoclonal antibody (mAb) thought to work by binding to a distinct epitope on the CD20 molecule, inducing potent B-cell lysis and depletion. It enables faster repletion of B cells versus other anti-CD20 monoclonal antibodies and so may offer flexibility in the management of RMS, according to the drugmaker. As per its licence, Kesimpta can be used to treat adults with relapsing forms of multiple sclerosis (RMS) with active disease, defined by clinical or imaging features. Novartis says it has the potential to become a recognised treatment option for eligible UK patients that can be self-administered, with initial guidance from an appropriately trained healthcare professional, once monthly at home via the Sensoready autoinjector pen. Initial ...
- Source: drugdu
- 162
- April 8, 2021
MS therapy Kesimpta
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
- 359
- April 2, 2021
Covid-19 vaccine
BMS’ Opdivo plus LAG-3 antibody relatlimab show promise in melanoma

Bristol Myers Squibb (BMS) has revealed top-line data from a Phase II/III trial evaluating its PD-1 inhibitor Opdivo plus its investigational anti-LAG-3 antibody relatlimab in previously untreated metastatic or unresectable melanoma. The RELATIVITY-047 trial is evaluating a fixed-dose combination of Opdivo (nivolumab) and relatlimab compared to Opdivo alone in these patients. According to BMS, the trial met its primary endpoint of progression-free survival, with follow-up for the secondary endpoint of overall survival still ongoing. Although the company did not disclose the actual figures for the combination treatment, BMS said it would present the results at an upcoming meeting and discuss the findings with regulatory authorities. Lymphocyte-activation gene 3 (LAG-3) is expressed on effector T cells and regulatory T cells (Tregs). It regulates an inhibitory immune checkpoint pathway that limits the activity of T cells, which is believed to cause an impaired ability to attack tumour cells. In cancer, T cells exhibit progressive exhaustion ...
- Source: drugdu
- 301
- April 1, 2021
Melanoma
NHS extends ‘COVID-friendly’ at-home cancer care

The NHS has announced that thousands of people will benefit from the extension of ‘COVID-friendly’ cancer treatments which can be taken at home. Since April, approximately 8,000 people have benefitted from treatment swaps, to enable cancer treatment to continue during the COVID-19 pandemic, with over 250,000 people beginning treatment for cancer since the start of the pandemic. The NHS will continue to fund effective and ‘less risky treatment[s]’ for patients during the pandemic, with access to these drugs now extended until summer and potentially continuing until the end of March 2022. Among the options available are targeted hormone therapies such as enzalutamide (Xtandi; Astellas/Pfizer) for prostate cancer and broadened use of lenalidomide (Revlimid; Bristol Myers Squibb) for myeloma. Some ovarian cancer patients will also be able to receive trametinib (Mekinist; Novartis) as a tablet alternative to chemotherapy, to help reduce the impact on their immune systems. “Cancer has been a priority throughout ...
- Source: drugdu
- 164
- March 31, 2021
Covid

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