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Sanofi halts venglustat clinical programme in ADPKD

French pharma company Sanofi has announced that it has halted the clinical programme of venglustat in autosomal dominant polycystic kidney disease (ADPKD). Although the safety profile of venglustat remains consistent with previously reported results, a Phase II/III trial of the drug did not meet its futility criteria. In addition, the study confirmed venglustat effectively inhibits the glycosphingolipid (GSL) pathway by demonstration a reduction in the lip GL-1. The STAGED-PKD study was stopped for futility after an independent analysis of the annualised rate change in total kidney volume (TKV) in patients receiving venglustat compared to placebo. In a statement, Sanofi said that trends from this analysis showed venglustat did not provide meaningful reduction in TKV growth rate – the primary endpoint of stage one of the study. The company added that the analysis suggests the reduction of GSLs may not play a significant role in the prevention of kidney cyst growth, meaning ...
- Source: drugdu
- 285
- June 2, 2021
Sanofi
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
NHS-backed wellbeing app Thrive raises £2.5m

Thrive, a wellbeing approved for use by the NHS, has raising a total of £2.5m in funding in only ten days, the digital health company has announced. The latest funding round attracted investment from the Sumerian Foundation and Treebeard Trust, as well as from investment platforms such as Syndicate Room and Wealth Club. In a statement, Thrive said it would use the new funding to research and identify further areas of help that it can support and also develop the tech platform further. This will include increased integration with existing medical data, with the aim of giving users ‘seamless’ access to mental health care. Currently, the app provides whole-person solutions for workplaces and individuals, and is designed to help users overcome periods of stress while supporting long-term mental health. It uses clinical-grade, evidence-based techniques to achieve this, while also providing in-app access to trained therapists. The company was initially launched ...
- Source: drugdu
- 212
- May 26, 2021
wellbeing app
BMS’ Opdivo/Yervoy improves long-term survival for melanoma patients

Bristol Myers Squibb’s Opdivo (nivolumab) plus Yervoy (ipilimumab) combination has demonstrated ‘durable improvement in survival’, according to new long-term data from a Phase III trial. According to 6.5 year data from CheckMate-067, median overall survival (OS) for patients with advanced melanoma was 72.1 months with Opdivo plus Yervoy, compared with 36.9 months for patients received Opdivo alone and 19.9 months for Yervoy monotherapy. In a statement, BMS said this represented the longest reported median OS in a Phase III advanced melanoma trial. Opdivo plus Yervoy also demonstrated a 6.5-year progression-free survival (PFS) rate of 34%, versus 29% and 7% for Opdivo alone and Yervoy alone, respectively. In addition, of the 49% of patients who were alive and in follow-up, 77% who received Opdivo plus Yervoy, 69% of Opdivo-treated and 43% of Yervoy-treated patients have been off treatment and never received subsequent systemic therapy. Also, among melanoma patients with BRAF-mutant tumours, ...
- Source: drugdu
- 144
- May 24, 2021
Melanoma
EMA, MHRA to review Vertex’ Kaftrio for children with CF

The European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have validated Vertex’ applications to expand the scope of its cystic fibrosis (CF) treatment Kaftrio (ivacaftor/tezacaftor/elexacaftor). The drugmaker is seeking approval for the drug’s use in combination with ivacaftor in patients ages six years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. If approved, this will extend the indication for the triple combination therapy to children ages six through 11 years old in EU countries, Great Britain and Northern Ireland. In children with CF, symptoms and organ damage including lung disease manifest very early in life. “We are committed to working diligently with global regulators to expand the indication for our medicine such that younger people living with CF will also be able to access the triple combination therapy,” said Nia Tatsis, executive VP, chief regulatory ...
- Source: drugdu
- 595
- May 21, 2021
EMA
Janssen inks inflammatory disease collaboration with Mestag Therapeutics

Janssen, the pharma division of Johnson & Johnson, has entered an agreement with Cambridge, UK-based Mestag Therapeutics to research and develop novel fibroblast targets for the treatment of inflammatory disease. The collaboration will utilise Mestag’s specialist fibroblast subpopulation biology platform, as well as the biotech’s ‘state-of-the-art’ data analytics in a bid to identify novel therapeutic targets. Under the terms of the agreement, Mestag will grant Janssen an option to an exclusive license to develop and commercialise therapeutics directed against up to two targets resulting from the collaboration. In exchange, Janssen will pay Mestag option fees, milestone payments and royalties – however, the detailed financial terms of the agreement were not disclosed by the companies. Also, as part of the collaboration, Janssen Research & Development’s global immunology therapeutic head David Lee will join Mestag’s scientific advisory committee. “Mestag’s vision is to leverage our unique fibroblast biology platform and state-of-the-art data analytics ...
- Source: drugdu
- 250
- May 19, 2021
Janssen
Novo Nordisk’s weight loss drug semaglutide found to improve wellbeing

New results from a Phase IIIa study have demonstrated that Novo Nordisk’s weight loss drug semaglutide improved physical function and wellbeing among people with obesity. The STEP 1 trial demonstrated benefits for people with obesity treated with semaglutide 2.4mg ‘beyond weight loss’, Novo said in a statement. Over a 68-week period, treatment with once-weekly semaglutide 2.4mg was associated with greater improvements for all weight- and health-related quality of life scores in people with obesity or overweight in comparison to placebo. This included improved wellbeing, with 43.8% of patients treated with Novo’s drug achieving a clinically meaningful improvement in total weight-related quality of life score at week 68. On top of that, 51.2% of participants treated with semaglutide 2.4mg in the trial had an increased weight-related physical function score, reflecting improvements in the ability to perform daily activities. In addition, patients treated with semaglutide 2.4mg ‘simultaneously’ experienced significant weight loss of ...
- Source: drugdu
- 460
- May 17, 2021
weight loss drug
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
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
RPS makes new recommendations for pharmacist independent prescribers

The Royal Pharmaceutical Society of Great Britain (RPS) has made new recommendations to increase the use of pharmacist independent prescribers (PIP) in the UK. In a statement, RPS highlighted that the role of PIPs has become ‘increasingly’ important in delivering high-quality clinical care. The Society added that it wants to see increased use of PIPs in multi-disciplinary teams to expand patient access to care, as well as create capacity in the healthcare system and improve health outcomes. The three core recommendations call on governments and healthcare organisations to proactively: establish the right infrastructure, systems and tools to enable patients to benefit from PIPs develop the PIP workforce required to work routinely as part of multi-professional teams in all health care settings provide ongoing professional development for PIPs as well as expand their role in teaching and peer support. “Non-medical prescribing was introduced in the UK some 30 years ago, but ...
- Source: drugdu
- 201
- April 28, 2021
pharmacist independent prescribers

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