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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
- 192
- 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
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
- 253
- March 2, 2021
Genomics
Tribunal upholds CMA’s decision to fine Lexon £1.2m

The Competition Appeal Tribunal (CAT) has maintained a decision made last year by the UK’s Competition and Markets Authority (CMA) to fine pharmaceutical firm Lexon £1.2m after finding the company guilty of breaking competition law. Last year, the CMA found that Lexon, along with King Pharmaceuticals and Alissa Healthcare Research, had illegally shared commercially sensitive information in an attempt to drive up prices of the antidepressant nortriptyline. The CMA concluded that from 2015 to 2017 – when the cost of the drug was decreasing – the three companies exchanged information about prices, the volumes they were supplying and Alissa’s plans to enter the market. The CMA then fined all three companies, fining Lexon a total of £1.2m – however, Lexon maintained it had not broken the law and appealed the decision and fine. However, the CAT has decided to uphold the CMA’s original finding that Lexon broke competition law and ...
- Source: drugdu
- 204
- March 1, 2021
Tribunal
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
- 371
- 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
- 332
- 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
- 261
- February 5, 2021
Novo Nordisk’s Sogroya

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