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Coronavirus: EU-funded project launches a clinical trial for coronavirus treatment in Italy

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The Italian pharmaceutical regulatory agency, AIFA, has greenlighted a clinical trial for the use of Raloxifene in patients with mild symptoms caused by the coronavirus. In June 2020, the EU-funded consortium Exscalate4CoV using European supercomputing had announced that the registered generic drug used to treat osteoporosis could be an effective treatment for coronavirus. The European Commission supported the E4C Consortium with €3 million.

This is one of many examples of how the EU's research and innovation programme Horizon 2020 helps counter the coronavirus pandemic and develop new treatments. The clinical study should validate the safety and efficiency of Raloxifene in blocking the replication of the virus in cells, and thus hold up the progression of the disease. The study will take place at the National Institute for Infectious Diseases ‘L. Spallanzani' in Rome, Italy and will also involve the Humanitas Research Hospital in Milan.

In the initial phase, up to 450 participants in three separate treatment groups will be administered a 7-day treatment of Raloxifene capsules in a randomised sample. Exscalate4CoV, using a unique combination of high performance computing power and AI with biological processing, screened 400,000 molecules and specifically tested 7,000 molecules in vitro. You will find more information in the consortium press release.

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EAPM: Keeping tabs on lung cancer and Commission pharma strategy

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Good day, and welcome, health colleagues, to the first European Alliance for Personalised Medicine (EAPM) update of the week. We have more news on the upcoming EAPM round table on lung cancer, as well as all the usual health-care updates, writes European Alliance for Personalised Medicine, Executive Director Denis Horgan.

Lung-cancer screening and European Beating Cancer Plan

Yes, we are all aware that by far the best way to reduce numbers of lung cancer patients is to persuade smokers to stop. Although not all sufferers are, or have ever been, smokers. High-risk groups exist, of course, and early diagnosis is vital. Currently, five-year survival rates stand at a mere 13% in Europe and 16% over in America. This will be discussed in our upcoming event on 10 December. 

It is the most commonly found cancer in men and lung cancer in women is being represented by a “worrying rise” according to the World Health Organization.  Some one billion people on the planet are regular smokers. And figures show that lung cancer causes almost 1.6 million deaths each year worldwide, representing almost one-fifth of all cancer deaths. 

The European Respiratory Society and the European Society of Radiology (also a supporter of the event, as is the European Cancer Patient Coalition - ECPC), the societies have recommended screening for lung cancer under the following circumstances: “In comprehensive, quality-assured, longitudinal programmes within a clinical trial or in routine clinical practice at certified multidisciplinary medical centres.”

NELSON and victory?

The NELSON study into computed tomography (CT) screening of lung cancer showed that such screening reduces lung cancer deaths by 26% in high-risk asymptomatic men.  The findings also indicated that, with screening, the results could be even better in women.

For screening to be cost effective, it has to be applied to the population at risk. For lung cancer, this is not simply based on age and sex, as it is in the majority of breast or colon cancer screening. Europe needs to involve all key groups in developing recommendations and guidelines for implementation, adapted according to the healthcare landscape of individual countries. 

Various member states have already shown a willingness to move forward in lung-cancer screening, and several countries representatives will take part in the event.

The Alliance and its stakeholders realize that, among other elements, what is required in Europe is: continuous screening monitoring, with regular reports; assured consistency and enhanced quality of commented data for the screening reports; reference standards for quality and process indicators should be developed and adopted. 

All of the above will be discussed at the lung-cancer screening event, and it is envisaged that a coordinated plan will emerge, which will make its way to Commission and Parliament policymakers and member state health system chiefs.

You can check out the agenda of the 10 December conference here, and register here.

EU Pharma strategy on the horizon 

Affordability, availability and sustainability are the main focus points of the EU’s new pharmaceutical strategy, due to be published tomorrow (25 November). Coming in the wake of the COVID-19 pandemic, the EU’s pharmaceutical strategy aims to “future-proof” the European health-care sector. The new strategy, set to be unveiled on Wednesday, is designed to improve and accelerate patients’ access to safe and affordable medicines while also supporting innovation in the EU pharmaceutical industry. 

Health Commissioner Stella Kyriakides has previously described the strategy as a “cornerstone” of health policy over the next five years. It is considered a key pillar of the Commission’s vision to build a stronger health union, as President von der Leyen set out in her 2020 State of the Union speech. It will also inform the newly proposed EU4Health Programme and align with the Horizon Europe programme for research and innovation, as well as contribute to Europe’s Beating Cancer plan. 

And the European Commission has unveiled the first building blocks of a broader health package aimed at increasing the range of preparedness tools to respond to future cross-border health threats. Patient-oriented approach A first part of the strategy underlines that “research priorities should be aligned to the needs of patients and health systems.” 

Therefore, the whole EU system of pharmaceutical incentives should be reoriented to stimulate innovation in areas of unmet medical needs, such as neurodegenerative and rare diseases as well as pediatric cancer. An example of unmet medical needs mentioned in the document is antimicrobial resistance (AMR), which decreases a doctor's ability to treat infectious diseases and perform routine surgery. By 2022, the Commission will explore new types of incentives for innovative antimicrobials, as well as measures to restrict and optimise the use of antimicrobial medicines.

COVID 'mabs'

The US drug regulatory agency, FDA (Food and Drug Administration), has just issued an Emergency Use Authorization (EUA) for the treatment of mild to moderate intensity COVID-19 in adult and pediatric patients who they have not been hospitalized. The therapy, still under investigation, is based on monoclonal antibodies and goes by the name of bamlanivimab. This therapeutic agent, developed by the pharmaceutical company Eli Lilly, is a monoclonal antibody (mab) similar to those that were part of the cocktail of drugs for COVID-19 that was administered to Donald Trump. 

Beginning EU Health Union

The European Commission is beginning the building of the new European Health Union to help strengthen the EU’s health security framework, and to reinforce the crisis preparedness and response role of key EU agencies. The creation of the European Health Union was announced by the European Commission‘s President, Ursula von der Leyen, in her State of the Union address. The Commission is putting forward a set of proposals to reinforce Europe’s health framework as more co-ordination is needed at an EU level in order to step up the fight against the COVID-19 pandemic and future health emergencies. 

Protecting the health of European citizens

The proposals focus on revamping the existing legal framework for serious cross-border threats to health, as well as reinforcing the crisis preparedness and response role of key EU agencies such as the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA). President of the European Commission, Ursula von der Leyen stated: “Our aim is to protect the health of all European citizens. 

The coronavirus pandemic has highlighted the need for more coordination in the EU, more resilient health systems, and better preparation for future crises. We are changing the way we address cross-border health threats. Today, we start building a European Health Union, to protect citizens with high quality care in a crisis and equip the Union and its member states to prevent and manage health emergencies that affect the whole of Europe.” 

Von der Leyen urges gradual lifting of coronavirus lockdowns

European governments should lift coronavirus lockdowns and other social restrictions gradually to prevent a third wave of infections, according to European Commission President Ursula von der Leyen. Europe has been grappling with a second surge in Covid-19 infections since September which has led to the re-introduction of lockdowns in certain countries and an overall stepping up of restrictions across the region. 

Despite a slowdown in cases in some countries in recent days, the numbers are still high and are not yet showing clear signs of a cresting. In the meantime, Europeans are pondering whether they’ll be able to gather with their families over the holiday period.

Vaccine hope

News that the AstraZeneca/Oxford vaccine is effective and could have up to 90% efficacy was met with widespread joy on Monday (23 November). “We expect COVID-19 vaccines to develop into a significant market as new products gain approval and begin to meet the high demand for protection from the disease,” according to a brief analysis by Fitch Solutions. It notes that with more products looking likely to pass regulatory hurdles, “these products will help to develop COVID-19 vaccines into a multi-billion-dollar commercial opportunity”. 

Prices are expected to rise in the short-term as countries look to secure access in light of positive Phase 3 trial results, but over the long-term are expected to fall back as new products enter the market,” the briefing added. “Companies will soon be in a position to capitalize on success in Phase III trials through commanding high prices for vaccines,” the analysis states.

Extra plenary session between Christmas and New Year’s Eve

The European Parliament is preparing for an extra plenary session between Christmas and New Year’s Eve to give its consent to a possible post-Brexit trade deal with the UK, according to several EU officials and diplomats. It is likely to be held on 28 December, to give EU governments the opportunity to have the very last say, as foreseen by the bloc’s procedures, before the end of the UK’s Brexit transition period on 31 December.

Private Greek hospitals compelled to take COVID-19 patients

The Greek government took over two private hospitals in Thessaloniki on 19 November in which transmission of the coronavirus has been particularly widespread. The decision was reached after the private clinics failed to voluntarily provide 200 beds for COVID-19 patients despite appeals by the Health Ministry. Public hospitals in Thessaloniki and other parts of northern Greece have been struggling to cope with the influx of coronavirus patients, adding beds from other wards and setting up isolation tents after reaching their official capacities. .

And that is everything from EAPM for now, do stay tuned during the week for further updates on all health-related issues, stay safe, and remember to check out the agenda of EAPM’s 10 December lung cancer round table here, and register here.

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German states favour extending COVID-19 lockdown to boost Christmas prospects

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Many of Germany’s 16 federal states favour extending a partial shutdown meant to slow the spread of the COVID-19 pandemic and make family gatherings over Christmas possible, two state premiers said on Monday (23 November). Germany, which is governed by a conservative-Social Democratic coalition, imposed a month-long “lockdown-lite” from 2 November. Infection numbers have plateaued since but not declined, write Christian Goetz, Thomas Seythal and Kirsti Knolle.

“The November shutdown has brought something, the (infection) numbers are subdued but they remain high,” Manuela Schwesig, premier of the northern state of Mecklenburg-Vorpommern, told Deutschlandfunk (DLF) radio.

“For this reason, many states believe that the November shutdown must continue, especially in the risk areas,” the Social Democrat said. Saxony-Anhalt state premier Reiner Haseloff, a member of Chancellor Angela Merkel’s conservatives, told a news conference there was a general agreement that current restrictions should be extended for about three weeks. State premiers and Merkel are due to discuss the measures on Wednesday.

They could extend them until 20 December, according to draft proposals from the Christian Democrats and the Social Democrats obtained by Reuters. Bars and restaurants are closed under the November lockdown but schools and shops remain open. Private gatherings are limited to a maximum of 10 people from two households. The number of confirmed coronavirus cases rose by 10,864 to 929,133 over the past 24 hours, 40 more than the corresponding rise from the previous Sunday last week, data from the Robert Koch Institute (RKI) for infectious diseases showed on Monday (23 NOvember).

The reported death toll rose by 90 to 14,112 in Germany, a country of 83 million with Europe’s biggest economy. Financial support for businesses could be extended into December, Economy Minister Peter Altmaier was quoted as saying on DLF. Preparations for COVID-19 vaccinations should be completed by mid-December to be able to immediately start inoculations should vaccines become available before the end of the year, Health Minister Jens Spahn told reporters. Such hopes have been boosted by Pfizer’s and BioNTech’s US application for emergency use authorization of their COVID-19 vaccine.

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AstraZeneca says COVID-19 'vaccine for the world' can be 90% effective

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AstraZeneca said on Monday (23 NOvember) its COVID-19 vaccine could be around 90% effective, giving the world’s fight against the global pandemic a new weapon, cheaper to make, easier to distribute and faster to scale-up than rivals, write Kate Holton, Josephine Mason and Kate Kelland.

The British drugmaker said it will have as many as 200 million doses by the end of 2020, around four times as many as U.S. competitor Pfizer. Seven hundred million doses could be ready globally as soon as the end of the first quarter of 2021. “This means we have a vaccine for the world,” said Andrew Pollard, director of the Oxford University vaccine group that developed the drug. The vaccine was 90% effective in preventing COVID-19 when it was administered as a half dose followed by a full dose at least a month later, according to data from late-stage trials in Britain and Brazil. No serious safety events were confirmed, the company said.

The vaccine’s cost to governments works out at just a few dollars a shot, a fraction of the price of shots from Pfizer and Moderna, which use a more unconventional technology. It can also be transported and stored at normal fridge temperatures, which proponents say would make it easier to distribute, especially in poor countries, than Pfizer’s, which needs to be shipped and stored at -70C. The faster roll-out means both rich and poor countries that had been drawing up plans to ration vaccines can distribute them more widely, helping to eventually halt the massive social and economic disruption of a pandemic that has killed 1.4 million people.

“The bulk of the vaccine rollout programme will be in January, February, March. And we hope that sometime after Easter things will be able to start to get back to normal,” said Matt Hancock, health secretary of Britain which has pre-ordered 100 million doses for its 67 million people.

Some signs AstraZeneca vaccine durability could be a year - chief investigator Oxford COVID-19 vaccine efficacy would look higher if trial tested for severe virus See more stories In poor countries, where the logistics of distributing rival vaccines posed a bigger challenge, the effect of a cheaper and easier alternative could be even more pronounced. Zahid Maleque, health minister of Bangladesh, which is buying in 30 million doses of the AstraZeneca vaccine made in India, called the findings “really good news”.

“The big advantage of having the vaccine is that it can be stored, transported and handled at 2-8 degrees Celsius, and we have that storage facility,” he said. “

The results showed the effectiveness of AstraZeneca’s vaccine depended on the dosing, and fell to just 62% when given as two full doses rather than a half-dose first. Scientists cautioned, however, against seeing this as evidence that it would be less useful than rivals. Vaccines from Pfizer and Moderna each prevented about 95% of cases according to interim data from their late-stage trials. The researchers did not say what proportion of the 131 cases of COVID-19 in the study received the smaller initial dose. “I think it is a real fool’s errand to start trying to pick these three (Pfizer/Moderna/Astra) apart on the basis of snippets of phase 3 data from press releases,” said Danny Altmann, professor of immunology at Imperial College London. “For the bigger picture, my suspicion is that by the time we are a year down the line, we’ll be using all three vaccines with about 90% protection - and we’ll be a lot happier.”

Researchers don’t know the exact reason why a smaller first dose proved more effective. “There are some examples where changing the way you prime the immune system, can result in a better response,” Pollard said. Pascal Soriot, Astra’s chief executive, said it was good news, as more people could be vaccinated faster with a limited supply. Shares and oil prices rose amid hopes another vaccine candidate would revive the global economy with U.S. stock futures trading higher and the STOXX index of Europe’s 600 largest shares gaining 0.5% to its highest since February. AstraZeneca’s own shares fell 1.8% as traders perceived the efficacy data as disappointing compared with rivals.

Pfizer and Moderna set the bar for success sky-high. The US Food and Drug Administration has said any shot would need to prevent disease or decrease severity in at least 50% of those vaccinated. The AstraZeneca vaccine uses a modified version of a chimpanzee common cold virus to deliver instructions to cells to fight the target virus, a traditional approach to vaccine development and different from the path taken by Pfizer and Moderna, which rely on new technology known as messenger RNA (mRNA). AstraZeneca, one of Britain’s most valuable listed companies, will now immediately prepare regulatory submission of the data to authorities around the world that have a framework in place for conditional or early approval.

It will also seek an emergency use listing from the World Health Organization to speed up availability in low-income countries. In parallel, the full analysis of the interim results is being submitted for publication in a peer-reviewed journal. The US Food and Drug Administration is likely to approve in mid-December the distribution of the vaccine made by Pfizer, according to a top official of the US government’s vaccine development effort.

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