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Novartis UK signs digital partnership with Cievert for chronic disease management 29th March 2021

Novartis UK and digital health company Cievert have announced a digital innovation partnership to help streamline the management of rheumatological and dermatological diseases. The initiative aims to support patient care in rheumatology and dermatology by utilising patient-reported data and allowing clinicians to prioritise appointments on a needs-based model of care. The partnership, which was identified via the Novartis BIOME selection procedure, will see Novartis and Cievert work closely with the NHS to launch pilot programmes across the UK. The digital platform will aim to collaborate with patients, healthcare professionals (HCPs) and the NHS across the UK and support them in three areas. Firstly, the partnership will aim to capture patient digital health records in one platform to reduce misalignment among healthcare teams. Secondly, the programme will aim to coordinate and prioritise appointments based on patient need, rather than routinely scheduled reviews. Lastly, the initiative will collect real-time patient data in ...
- Source: drugdu
- 303
- March 29, 2021
Novartis
Cambridge start-up PhoreMost raises £33m to progress PLK1 programme

Cambridge, UK-based PhoreMost has announced the closing of a £33m Series B investment round from new and existing investors. The completed financing round was led by UK growth economy investor BGF as well as new investors XtalPi Inc., Astellas Venture Management, Trend Investment Group and o2h ventures. Additional contributions were made by existing investors Parkwalk Advisors, Morningside Ventures and Jonathan Milner. PhoreMost will use the financing to progress its PLK1 programme, which is initially targeted for the treatment of brain cancer, into the clinic within 18 months. The biopharma company will also advance multiple additional internal drug discovery programmes in oncology and ageing therapeutic indications. PhoreMost platform – SITESEEKER – is designed to identify new therapeutic targets for any disease setting, and identify how to develop novel drugs against these targets. In a statement, the company said it had recently used the platform to identify novel E3-ligands, which could have ...
- Source: drugdu
- 272
- March 26, 2021
PLK1
FDA nod for Kiniksa’s Arcalyst in recurrent pericarditis

The US Food and Drug Administration (FDA) has approved Kiniksa Pharmaceuticals’ interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) inhibitor Arcalyst (rilonacept) for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and children 12 years and older. Recurrent pericarditis is an autoinflammatory cardiovascular disease that often presents with chest pain, and is associated with changes in electrical conduction and build-up of fluid around the heart. The FDA approval is based on positive data from the RHAPSODY trial in recurrent pericarditis. Data from this trial showed that Arcalyst treatment improved clinically meaningful outcomes associated with the significant unmet medical need in recurrent pericarditis. There were rapid and sustained reductions in both reported pain and inflammation as early as after the first dose of Arcalyst. “The approval of Arcalyst in recurrent pericarditis is an extremely important achievement for those suffering from this disease as there can be significant ...
- Source: drugdu
- 200
- March 23, 2021
Kiniksa
UK approval for Daiichi Sankyo’s cholesterol-lowering treatments

Daiichi Sankyo’s cholesterol-lowering drugs Nilemdo and Nustendi have been approved by the UK National Institute for Health and Care Excellence (NICE) for use on the NHS. Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/ezetimibe) have been recommended for the treatment of primary hypercholesterolaemia or mixed dyslipidaemia (heterozygous familial and non-familial). It is authorised as an adjunct to diet and when statins are contraindicated or not tolerated, or when the standard cholesterol treatment ezetimibe alone does not control low-density lipoprotein cholesterol (LDL-C) adequately. “Today’s decision is a landmark step forward for patients and the NHS in working towards a national ambition of preventing cardiovascular disease and events in line with the Long Term Plan,” said Manuel Reiberg, managing director, Daiichi Sankyo UK. “We are now more dedicated than ever to reduce the impacts of the UK’s biggest killer through our ongoing collaboration with the medical community and the NHS,” he added. In the UK, ...
- Source: drugdu
- 214
- March 19, 2021
cholesterol-lowering
Frontline charities sign open letter backing COVID-19 vaccination drive

A partnership of frontline health charities has signed an open letter encouraging people with underlying conditions to book in for a COVID-19 vaccine. The charities, including Mencap, Diabetes UK and Lupus UK, have urged people with conditions including cancer, diabetes and heart disease to protect themselves and others around them from the coronavirus by receiving a vaccine. Although over half of those in this priority group – known as cohort six – have already received their first vaccine dose, the charities’ letter is ‘hoped’ to further increase take-up among this group. Cohort six includes individuals aged 16 to 64 years old who have certain long-term conditions, identified by the Joint Committee on Vaccination and Immunisation (JCVI), that puts them at a higher clinical risk from COVID-19. It also includes carers who are eligible for a carer’s allowance, as well as those who are the sole or primary carer of an ...
- Source: drugdu
- 273
- March 18, 2021
Covid vaccine
AZ’s vaccine safety review shows ‘no evidence’ of an increased risk of blood clots

AstraZeneca (AZ) has issued an update on the safety of its COVID-19 vaccine, saying a review showed no evidence of an increased risk of blood clots among people vaccinated with its jab. In a statement, AZ said that across the EU and UK, there have been 15 events of deep vein thrombosis (DVT) and 22 events of pulmonary embolism reported among people given its vaccine – based on the number of cases the company has received as of 8 March. AZ added that a ‘careful’ review of all available safety data – including more than 17 million people vaccinated in the EU and UK with its COVID-19 vaccine – has shown ‘no evidence of an increased risk of pulmonary embolism, DVT or thrombocytopenia, in any defined age group, gender, batch or in any particular country.’ The cases reported so far are ‘much lower’ than what would be expected to naturally ...
- Source: drugdu
- 332
- March 16, 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
- 241
- March 12, 2021
GSK
Researchers identify early changes in BRCA1-positive breast cells

A new study has found that BRCA1-positive breast cells appear to undergo changes before becoming cancerous, which could help identify which patients can benefit from preventative surgery. The study in mice, funded by Cancer Research UK and published today in Nature Communications, found that breast cells with the BRCA1 gene mutation develop changes similar to those seen in late pregnancy before becoming cancerous. The researchers suggest that women with BRCA1 mutations could be screened in the future to monitor changes to their breast cells. This could help to inform decision-making revolving around preventative surgery, by showing who could benefit from this option. After analysing the mammary tissue of mice at various ages carrying the BRCA1 mutation, the researchers analysed breast cells from 12 women who had a BRCA1 mutation and had undergone preventative surgery. The team found that four out of the 12 women had detectable levels of markers of early stages ...
- Source: drugdu
- 215
- March 10, 2021
breast cells
Albireo submits rare liver disease med odevixibat to FDA and EMA

Albireo Pharma has submitted odevixibat to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), seeking approval for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC). The US-based biopharmaceutical company has previously received fast track, rare paediatric disease and orphan drug designations for odevixibat in the US for PFIC. The drug also has orphan drug designations for the treatment for Alagille Syndrome, biliary atresia and primary biliary cholangitis. Odevixibat is a one-daily non-systemic ileal bile acid transport inhibitor (IBATi) currently being developed for the treatment of a number of rare paediatric liver diseases, such as PFIC, biliary atresia and Alagille syndrome. In a phase III trial evaluating the efficacy and safety of odevixibat in PFIC, the drug met two primary endpoints, demonstrating the ability to reduce serum bile acid responses and improve pruritus assessments with a single digit diarrhoea rate. “With randomised, placebo-controlled PEDFIC data, ...
- Source: drugdu
- 191
- March 5, 2021
Albireo Pharma
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
- 324
- March 3, 2021
NICE

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