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COVID-19: Keep Up To Date With The Latest Pharmaceutical And Healthcare News As The Pandemic Evolves

EU leaders pledge support for global COVID-19 effort

4th May 2020

The new initiate strives to raise 7.5 billion euros to aid the discovery and development of a coronavirus vaccine

As of this morning – Monday May 4 – the current recorded case count for COVID-19 (coronavirus) in the UK has hit 186,599 with 28,446 deaths.

European leaders have come together for a new initiate that strives to raise 7.5 billion euros to aid the discovery and development of a coronavirus vaccine.

In an open letter, country heads including Germany’s chancellor Angela Merkel and France’s president Emmanuel Macron highlight the ‘truly global challenge’ of novel coronavirus, and stress that the best chance of defeating it will be ‘bringing together the world’s best – and most prepared – minds to find the vaccines, treatments and therapies we need to make our world healthy again, while strengthening the health systems that will make them available for all’.

The group plans to raise an initial 7.5 billion euros in an online pledging conference (on May 4), to make up the global funding shortfall to cover the initial needs of the project, as ‘manufacturing and delivering medicines on a global scale will require resources well above the target’.

‘The funds that we raise will kick-start an unprecedented global cooperation between scientists and regulators, industry and governments, international organisations, foundations and health care professionals,’ the letter states.

‘If we can develop a vaccine that is produced by the world, for the whole world, this will be an unique global public good of the 21st century’.

According to BBC News, the UK’s prime minister Boris Johnson has described the initiative as “the most urgent shared endeavour of our lifetimes”, and will pledge £388 million for vaccine research, testing and treatment.

FDA issues ’emergency use’ green light for Gilead’s remdesivir

4th May 2020

The move follows data from a clinical trial showing that the drug accelerated recovery time in hospitalised patients

As of this morning – Monday May 4 – the current recorded case count for COVID-19 (coronavirus) in the UK has hit 186,599 with 28,446 deaths.

The US Food and Drug Administration has issued an emergency use authorisation for Gilead’s investigational antiviral remdesivir for the treatment of COVID-19 in adults and children hospitalised with severe disease.

The authorisation is temporary and does not take the place of the formal new drug application submission, review and approval process.

The move follows data from a clinical trial – sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) – showing that the drug accelerated recovery time in hospitalised patients.

Preliminary results indicate that patients who received remdesivir had a 31% faster time to recovery than those who received placebo. Specifically, the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo. Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group.

While data remains limited, it is thought that possible side effects of remdesivir include: increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and infusion-related reactions, which may include low blood pressure, nausea, vomiting, sweating, and shivering.

The emergency use authorisation allows for remdesivir to be distributed in the US and administered intravenously by healthcare providers to treat suspected or laboratory-confirmed COVID-19 in hospitalised patients with severe disease, that is patients who have low blood oxygen levels or need oxygen therapy or more intensive breathing support such as a mechanical ventilator.

It only valid until the circumstances justifying its emergency use change and can be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.

“This EUA opens the way for us to provide emergency use of remdesivir to more patients with severe symptoms of COVID-19,” said Daniel O’Day, chairman and chief executive of Gilead Sciences.

“We will continue to work with partners across the globe to increase our supply of remdesivir while advancing our ongoing clinical trials to supplement our understanding of the drug’s profile.”

Manchester Uni researchers develop domestic COVID-19 test

1st May 2020The prototype test is based on the fact that sugars coat all human cells

Researchers at Manchester University are working on the development of a test for COVID-19 that could be used at home like a domestic pregnancy test.

The prototype test is based on the fact that sugars coat all human cells and could be used in the fight to detect infectious agents like coronavirus.

This new screening new approach can help identify the COVID-19 virus – not by its genetic code, which can mutate, but by using its reliance on chains of sugars on human cells, which are constant, the researchers note.

Professor Rob Field and his team at the university are now working with spin-out company Iceni Diagnostics to get the new test ready and officially validated ready for the autumn.

An autumn launch this year is key, as the application of this screening kit can support diagnoses of ‘flu vs coronavirus’, given the typical trend of flu season which can initially present similar symptoms.

“Our existing prototype product for influenza can detect the virus in less than 20 minutes and could be adapted to identify other pathogens such as coronavirus,” noted Prof Field.

“A low-cost, easy to use screening test that can be performed at the point of care would be an ideal way to limit initial disease transmission in the community and at points of entry to hospitals, or at national borders, for instance,” he added.

“Current COVID-19 tests are largely based on PCR (polymerase chain reaction) that requires a laboratory setting for analysis and relies on prior knowledge of the viral genetic code. This code can change as the virus evolves, potentially limiting the effectiveness of the test.”

Vicore Pharma bags MHRA nod for COVD-19 trial in record time

1st May 2020ATTRACT (Angiotensin II Type Two Receptor Agonist Covid-19 Trial) is targeting hospitalised patients treated with basic respiratory care, but not mechanical ventilation

As of this morning – Friday May 1 – the current recorded case count for COVID-19 (coronavirus) in the UK has hit 171,253 with 26,771 deaths.

Vicore Pharma has been given the green light by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to start a Phase II clinical trial assessing a potential COVID-19 therapy in record time.

The firm received approval for the study, which will evaluate VP01 in patients with COVID-19, SARS CoV- 2 infection, just four weeks after submitting a Letter of Intent to file a clinical trial application to the MHRA.

The study, named ATTRACT (Angiotensin II Type Two Receptor Agonist Covid-19 Trial), is targeting hospitalised patients treated with basic respiratory care, but not mechanical ventilation.

These patients have an intense inflammatory drive in the lungs which can lead to acute respiratory failure if it progresses.

VP01, a first in class low molecular weight angiotensin II receptor type 2 (AT2R) agonist, activates the ‘protective arm’ of the renin angiotensin system (RAS).

The RAS is understood to play a role in the development of COVID-19 because angiotensin II (ANG II) is upregulated and contributes to the inflammatory reaction in the lungs. The protective arm of the RAS is disarmed by SARS-CoV-2, which binds to the enzyme ACE2 and thereby inhibits the conversion of ANG II to endogenous protective molecules stimulating the AT2R.

Because VP01 directly stimulates the AT2R, researchers believe the drug could bypass the negative effects of viruses like SARS-CoV2 on the protective RAS functions, and according to Vicore internal preclinical findings with VP01 suggest that it may be useful in the treatment of COVID-19.

The drug is under development for idiopathic pulmonary fibrosis (IPF) and is also being studied in Raynaud’s phenomenon in patients with systemic sclerosis.

The company is working with clinical research organisation Orphan Reach on the drug’s development.

NICE joins international COVID-19 pandemic response

1st May 2020

NICE is sharing its work with initiatives such as the WHO’s Evidence Collaborative for COVID-19

As of this morning – Friday May 1 – the current recorded case count for COVID-19 (coronavirus) in the UK has hit 171,253 with 26,771 deaths.

The National Institute for Health and Care Excellence (NICE) says it is supporting a growing number of international collaborations striving to share knowledge and identify new treatments in response to the COVID-19 pandemic.

Initiatives such as the Evidence Collaborative for COVID-19 established by the World Health Organisation, the International Network of Agencies for Health Technology Assessment, and the European Network for Health Technology Assessment are working to identify evidence on the prevention, diagnosis and treatment of COVID-19.

NICE is sharing its work on COVID-19 with these partners, and is also helping select priority areas for research through the Cochrane collaboration’s rapid reviews on COVID-19.

The collaborations will also help NICE ensure that its rapid guidelines – which are being made available for access without the normal licencing fee – are developed and updated to internationally recognised standards of best practice.

“Having our guidelines all in one place, in an easily accessible format, means we are able to share our knowledge and recommendations with health care professionals around the world, and learn from each other’s findings,” said Paul Chrisp, director for the Centre for Guideline.

“NICE will continue to support, contribute to and learn from international efforts to coordinate the development and maintenance of high-quality evidence-based guidelines on COVID-19.”

NICE Scientific Advice is also providing free fast-track advice for researchers who are developing novel diagnostics or therapeutics for COVID-19, while NICE International is also continuing to provide an advisory service to international organisations, ministries and government agencies to support the use of evidence-based decision making in health and social care systems.

CHMP begins rolling review of Gilead’s remdesivir

1st May 2020

It is expected that the move will allow the EMA to complete its assessment of the drug significantly earlier than with a regular evaluation procedure

As of this morning – Friday May 1 – the current recorded case count for COVID-19 (coronavirus) in the UK has hit 171,253 with 26,771 deaths.

The European Medicines Agency’s human medicines committee (CHMP) says it has started a ‘rolling review’ of data on the use of Gilead’s antiviral remdesivir for the treatment of coronavirus disease (COVID-19).

The rolling review is used by the Agency to accelerate the assessment of a promising investigational medicine during a public health emergency, such as the current pandemic.

Under normal circumstances, all data supporting a marketing authorisation application must be submitted at the start of the evaluation procedure. In the case of a rolling review, CHMP Rapporteurs are appointed whilst development is still ongoing and the Agency reviews data as they become available.

Several rolling review cycles can be carried out during the evaluation of one product as data continue to emerge, with each cycle lasting around two weeks depending on the amount of data to be assessed. Once the data package is complete, the developer submits a formal marketing authorisation application which is then processed under a shortened timetable.

While the overall review timeline for remdesivir cannot be anticipated at this moment, it is expected that the move will allow the EMA to complete its assessment significantly earlier compared with a regular evaluation procedure, while still ensuring a robust scientific opinion is reached.

The CHMP’s decision to start the rolling review of remdesivir is based on preliminary results from the ACTT study, which suggest a beneficial effect of remdesivir in the treatment of hospitalised patients with mild-to-moderate or severe COVID-19.

However, the EMA stressed that it has not yet evaluated the full study and thus is it too early to draw any conclusions regarding the benefit-risk balance of the medicine.

Remdesivir is not yet authorised in the European Union but is available to patients through clinical trials and compassionate use programmes.

HCA launches free resource for NHS and health charities

30th April 2020The new website aims to help the NHS and health charities find potential volunteers to help support them during the coronavirus pandemic

As of this morning – Thursday April 30 – the current recorded case count for COVID-19 (coronavirus) in the UK has hit 165,221 with 26,097 deaths.

The Healthcare Communications Agency has launched a new website to help the NHS and health charities find potential volunteers from the sector to help support them during the coronavirus pandemic.

Any not-for-profit organisation looking for volunteer support from healthcare communicators – individuals or companies – can advertise their requirements on the site (https://healthcommsvolunteers.com).

“These are challenging times for everybody, but especially for the NHS and health charities. Never before has all our futures been so intrinsically linked. Healthcare communications professionals need to therefore consider what we can do to help support these organisations,” said Mike Dixon, HCA chief executive.

“This new website creates the platform for NHS organisations and health charities to connect with the healthcare communications community whose skills could be of benefit.”

The move was welcomed by the medical charity sector.

Abbott launches COVID-19 lab-based antibody test

30th April 2020The test will identify if a person has had the novel COVID-19 virus

As of this morning – Thursday April 30 – the current recorded case count for COVID-19 (coronavirus) in the UK has hit 165,221 with 26,097 deaths.

Abbott has announced the immediate availability of its lab-based antibody test for COVID-19 after it was granted a CE Mark.

The test will identify if a person has had the novel COVID-19, and will further understanding of the virus including how long antibodies stay in the body and if they provide immunity.

According to Abbott, it has demonstrated specificity and sensitivity of greater than 99% 14 days or more after symptoms started.

The test adds to Abbott’s existing COVID-19 tests in the UK that are already being used on its m2000 molecular laboratory system, which is already in use across NHS laboratories.

“We are proud to be able to provide our antibody tests immediately as they will help understand who has had the virus, leading to greater confidence as we get back to living life,” commented Mike Clayton, managing director Northern Europe diagnostics, Abbott.

“We are collaborating with the NHS, Public Health bodies and private laboratories across the UK to enable this test to be used here.”

Elsevier expands free resources for COVID-19 researchers

30th April 2020

The research hub includes a biomedical database, scientific and clinical content, COVID-19-specific datasets, and more

As of this morning – Thursday April 30 – the current recorded case count for COVID-19 (coronavirus) in the UK has hit 165,221 with 26,097 deaths.

Elsevier is offering free access to a unique set of biomedical research tools and content to help researchers and life science companies accelerate the fight against COVID-19.

The new Elsevier Coronavirus Research Hub currently includes a biomedical database, scientific and clinical content, COVID-19-specific datasets, a biomedically-focused text mining solution and several research collaboration tools, with more tools coming soon, the firm said.

“Since January, Elsevier has been making its content, data analytical tools and expertise, from clinicians to data scientists, freely available to support the global health and scientific communities in their fight against COVID-19.

“Working with colleagues across the company, we are pleased to expand our contribution, by providing free access to an even broader array of products and tools, which we hope will help researchers achieve their goals faster and hopefully help stem the pandemic,” said John Danaher, president, Global Clinical Solutions, Elsevier.

“Researchers all over the world are working hard to repurpose existing drugs in order to rapidly develop vaccines and therapies,” said Cameron Ross, managing director, Life Sciences Solutions, Elsevier. “During this emergency, we want to do all we can to make sure that researchers have the tools and content they need to enable discoveries that stem this global pandemic.”

ILC seeks £4m to help advance COVID-19 trials

30th April 2020

The two treatments could ‘constitute an early stage and late stage treatment option for all COVID-19 patients’

As of this morning – Thursday April 30 – the current recorded case count for COVID-19 (coronavirus) in the UK has hit 165,221 with 26,097 deaths.

Glasgow, UK-based ILC Therapeutics is on the hunt for funding of £4 million to help advance studies of two separate novel treatment for COVID-19 patients discovered in-house.

The company said it has patented a new Interferon-Alpha subtype, called Interferon Alpha 14, which can be administered to patients through injection or inhalation.

This natural human molecule treatment could prevent COVID-19 induced Acute Respiratory Distress Syndrome (ARDS), “which would mean that a considerable number of patients may no longer need to be on a ventilator”.

It could also treat novel coronavirus by boosting the body’s Natural Killer cells (NK cells) which fight the virus and prevent an immune overreaction that can cause fatal damage to the lungs, known as a Cytokine Storm, the firm added.

In addition to its interferon project, the ILC is also working with Professor Shoumo Bhattacharya at the University of Oxford to develop therapeutic Evasins, which are molecules derived from ticks that can extinguish a Cytokine Storm in the body once it has already advanced.

This, the firm notes, would give COVID-19 patients who have already developed ARDS a much higher chance of survival and recovery.

“The two treatments could constitute an early stage and late stage treatment option for all COVID-19 patients and offers the prospect of many severe cases of COVID-19 making a good recovery,” according to ILC.

Source: http://www.pharmatimes.com/coronavirus_timeline

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