Search Results for “antibody” – Page 60 – media

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
- 132
- March 16, 2023
Why Small Biotech Needs To Plan Ahead For Global Reach

If small biotech does more to plan ahead for ex-US market requirements, companies and their investors – and crucially patients – will benefit.
- Source: https://invivo.pharmaintelligence.informa.com/IV124998/Missed-Opportunities-Why-Small-Biotech-Needs-To-Plan-Ahead-For-Global-Reach
- 1,718
- April 6, 2022
biotech commercializing
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
- 461
- April 5, 2022
SARS-CoV-2 viruse
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
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
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
- 373
- May 7, 2021
AstraZeneca
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
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
- 179
- April 15, 2021
bladder cancer
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
- 161
- 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

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