Search Results for “EC” – Page 460 – media

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
- 211
- 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
- 186
- March 5, 2021
Albireo Pharma
Genomics plc scores $30m to expand patient-centric health platform

Oxford, UK-based Genomics plc has completed a $30m funding round, which the company will use to expand its work on its patient-centric, population health platform. The funding round included significant investments from life sciences investors Foresite Capital and F-Prime Capital, with existing backers Oxford Sciences Innovation and Lansdowne Partners also participating. Genomics plc uses large-scale genetic information to develop precision healthcare tools, working within the new area of genomic prevention. Genomic prevention allows for personalised estimates of risk for common diseases, ahead of actual disease manifestation. This enables targeted interventions and tailored screening to either prevent disease entirely or to catch it early when outcomes remain favourable. “We are delighted to be supported by leading life sciences investors who share our vision. We have known for over 50 years that genetics plays a key role in risk for all the common chronic diseases and cancers, and now we have a ...
- Source: drugdu
- 245
- March 2, 2021
Genomics
New social media campaign launched to support COVID-19 vaccine roll-out in the UK

A new social media campaign, launched by the UK government and the NHS, will allow people to show their support for the COVID-19 vaccine roll-out from today. The initiative will enable users to update their social media profiles with specially designed profile frames and graphics. This allows people to show either that ‘I’ve had my vaccine’ or make a pledge that ‘I will get my vaccine’ in an effort to bolster the nationwide vaccination programme. The range of Facebook frames and Instagram GIFs will be ready for use on social media from 19 February, and will be available in 13 languages from 22 February. “We know people are turning to social media more than ever to stay in touch with family and friends,” said Health and Social Care Secretary Matt Hancock. “These new graphics will make it easy for people to share their support for the jab and thank the ...
- Source: drugdu
- 364
- February 23, 2021
Covid-19 vaccine
GSK, Vir look beyond COVID-19 to develop new therapies for flu and other respiratory viruses

GlaxoSmithKline (GSK) and Vir Biotechnology have expanded their existing COVID-19 collaboration to include a new research and development agreement, focused on therapies for influenza and other respiratory viruses. The expanded collaboration will give GSK exclusive rights to collaborate with Vir on the development of monoclonal antibodies (mAbs) for the prevention or treatment of influenza. That includes an investigational mAb – VIR-2482 – designed as a universal prophylactic for influenza A, which has completed a Phase I trial. The agreement will also includes next-generation antibodies for the prevention or treatment of influenza during a three-year research period. While GSK will have the exclusive option to co-develop VIR-2482, following Vir’s completion and report of the Phase II trial outcomes, the company will share development costs for all other influenza mAbs. The companies will also conduct two additional research programmes as part of the expanded agreement. The first of these is an expansion ...
- Source: drugdu
- 325
- February 22, 2021
Covid-19
Novo Nordisk’s Sogroya moves closer towards EU approval

Novo Nordisk’s Sogroya (somapacitan) has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use – moving closer towards approval in the EU. The CHMP has recommended marketing authorisation for Sogroya for the treatment of adults with growth hormone deficiency (AGHD). The recommendation is based on results from the Phase III REAL 1 clinical trial programme, which investigated the efficacy and safety of Sogroya in AGHD. “We are very pleased with the positive opinion for once-weekly Sogroya as we are committed to continuously developing innovative and efficient medicines for people living with growth hormone deficiency,” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk. “We are confident that Sogroya will make management of this serious chronic disease easier and help improve the quality of life for more people living with growth hormone deficiency,” he added. Sogroya is a ...
- Source: drugdu
- 256
- February 5, 2021
Novo Nordisk’s Sogroya
EU approves Chiesi’s triple combination asthma therapy Trimbow

The European Commission (EC) has approved a marketing authorisation for Chiesi Group’s triple combination asthma therapy Trimbow (beclometasone/formoterol/glycopyrronium). The marketing authorisation indicates Trimbow for use as a maintenance treatment for adult asthma patients, whose condition is not adequately controlled with a combination of long-acting beta2-agonist (LABA) and medium dose of inhaled corticosteroid (ICS). Patients must have also experienced one or more asthma exacerbations in the previous year. Chiesi’s triple asthma therapy has been shown to reduce exacerbations and improve lung function in patients with uncontrolled asthma, compared to ICS/LABA. Both the CHMP’s recommendation and the EC’s approval are based on efficacy and safety data from four clinical studies, involving almost 3,000 patients. “This is the first step towards taking our triple therapy for moderate to severe COPD patients and providing the same treatment option for appropriate asthma patients,” said Alessandro Chiesi, chief commercial officer of Chiesi Group. “The European Commission’ ...
- Source: drugdu
- 211
- February 3, 2021
asthma therapy Trimbow
NHS has offered COVID-19 vaccine to all eligible care homes in England

The NHS has now offered COVID-19 vaccinations to residents at all eligible care homes in England, according to official figures. In a statement, the health service said this marked a ‘major milestone for the NHS vaccination programme’, with vaccines having been offered to people living in over 10,000 care homes with older residents. The NHS added that a small number of care homes have had visits by vaccination staff deferred for safety reasons, although these homes will be visited as soon as possible. “Today marks a crucial milestone in our ongoing race to vaccinate the most vulnerable against this deadly disease,” said Prime Minister Boris Johnson. “We said we would prioritise and protect care home residents, and that is exactly what we have done,” he added. Johnson also added that 8.9 million people have now received the first dose of a COVID-19 vaccine. Older care home residents and staff were ...
- Source: drugdu
- 364
- February 2, 2021
Covid-19 vaccine
Roche’s faricimab hits primary endpoint in wet AMD studies

Roche’s investigational bispecific antibody faricimab has hit the primary endpoint in two Phase III studies in people living with neovascular or wet age-related macular degeneration (nAMD). In the identically designed studies – TENAYA and LUCERNE – faricimab, administered via injections at fixed intervals, met the primary endpoint, showing that people receiving the treatment achieved visual acuity outcomes that were non-inferior to those receiving Regeneron’s Eylea (aflibercept) injections every eight weeks. Within both studies, nearly half (45%) of participants were treated with faricimab every 16 weeks during the first year. “These results show the potential of faricimab as a new class of medicine that could extend time between treatments for people living with neovascular age-related macular degeneration,” said Levi Garraway, chief medical officer and head of Global Product Development, Roche. “We have now seen positive and consistent results in four Phase III studies for faricimab across both neovascular age-related macular degeneration ...
- Source: drugdu
- 275
- January 31, 2021
Roche
Calquence tops Imbruvica in chronic lymphocytic leukaemia study

AstraZeneca’s Bruton’s tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) hit the primary endpoint in a Phase III study in chronic lymphocytic leukaemia (CLL). In the ELEVATE-RR trial, Calquence demonstrated non-inferior progression-free survival (PFS) compared to Janssen’s BTK inhibitor Imbruvica (ibrutinib) in adult patients with previously-treated, high risk CLL – the primary endpoint of the study. AZ’s drug also met a key secondary endpoint for safety, with Calquence-treated patients demonstrating a statistically significant lower incidence of atrial fibrillation compared to patients treated with Imbruvica. In a statement, AZ added that there was also a ‘descriptive’ trend for numerically favourable overall survival for Calquence. “With over forty months of follow-up, today’s results confirm that Calquence, a selective BTK inhibitor, displays superior safety in atrial fibrillation without compromising efficacy,” said José Baselga, executive vice president, Oncology R&D at AZ/ “The totality of the data confirm our confidence in the favourable benefit-risk profile of Calquence,” ...
- Source: drugdu
- 241
- January 26, 2021
Calquence

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