GSK – media

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
- 325
- June 4, 2021
GSK
EC clears GSK’s Benlysta for lupus nephritis

The European Commission approved expanded use of GlaxoSmithKline’s intravenous and subcutaneous Benlysta (belimumab) in combination with background immunosuppressive therapies for adults with active lupus nephritis (LN). The drug is already on the market to treat systemic lupus erythematosus (SLE); this latest approval now provides physicians and patients in Europe with the first and only biologic treatment specifically designed to work in lupus and LN. “Active lupus nephritis, which causes inflammation in the kidneys, is one of the most serious consequences of systemic lupus erythematosus and occurs in more than 1 million patients worldwide,” noted Dr Hal Barron, GSK’s chief scientific officer and president R&D. “Benlysta is the first biologic approved to treat lupus and lupus nephritis, representing a significant new treatment option for patients and physicians across Europe dealing with this complex autoimmune disease.” The drug’s marketing submission was based on data from the BLISS-LN (Efficacy and Safety of Belimumab ...
- Source: drugdu
- 498
- May 10, 2021
GSK
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
- 238
- March 12, 2021
GSK
GlaxoSmithKline will Shut Bangladesh Drug Manufacturing Operations by End 2018

GlaxoSmithKline will be closing its drug manufacturing operations in Bangladesh by the end of this year and will remain only with its healthcare business that produces Sensodyne, Horlicks and Glaxose-D.
- Source: Reuters
- 637
- July 31, 2018
Company Insight GSK Pharma Asia
GlaxoSmithKline Invests $300 Million in 23andMe

23andMe declared an investment of $300 million on Wednesday, made by GlaxoSmithKline to attain special access to their DNA database.
- Source: HealthcareIT News
- 584
- July 27, 2018
Company Insight genetic testing GSK
Enquiry for Nucala in COPD

Nucala (mepolizumab) was first approved as the first anti-IL5 treatment for adults and adolescents with severe asthma accompanied by eosinophilic phenotype in the United States during November 2015. Later it was approved to treat eosinophilic granulomatosis with polyangiitis (EGPA).
- Source: BioPharmaDive
- 773
- July 26, 2018
COPD GSK New Approvals
FDA backs GSK’s Tafenoquine for Malaria Cure

Sanction of a single 300mg dose of GlaxoSmithKline’s tafenoquine in patients 16 years and above for the "radical cure" of malaria was advocated by an FDA advisory committee on finding significant evidence for its efficacy and safety.
- Source: MedPageToday
- 4,421
- July 16, 2018
FDA GSK malaria New Approvals
Shingrix Orders Limited by GlaxoSmithKline

Order limits have been introduced by GSK owing to high demand for the product, as per a note on the CDC’s website. In the meantime, shipping delays are being experienced by providers and according to the CDC, the delays are likely to remain throughout the year.
- Source: FiercePharma
- 674
- June 22, 2018
GSK Market Views shingles
Adaptimmune Lends Credence to T-Cell Therapy

Updated clinical data on its T-cell therapies has been presented by Adaptimmune. The GlaxoSmithKline-partnered NY-ESO SPEAR T-cells have been linked by the latest readouts to a 50% partial response rate in heavily pretreated cancer patients and have led to the positioning of Adaptimmune for dialing up of dosing of two wholly owned assets.
- Source: FierceBiotech
- 574
- June 5, 2018
Company Insight GSK T-cell therapies
Shingrix approved in Europe and Japan for the prevention of shingles in adults aged 50 and over

The only shingles vaccine to achieve ≥90% efficacy across all age groups studied
- Source: gsk
- 615
- May 7, 2018
EC GSK post-herpetic neuralgia Shingrix

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