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The hunt for a coronavirus vaccine – a perilous and uncertain path

The pressing need to find a solution to the pandemic means risks and shortcuts may have to be taken

The stakes could hardly be higher; the prize still tantalisingly out of reach. It is no exaggeration to say that the fate of many millions of people rests on the discovery of a vaccine for Covid-19 – the only sure escape route from the pandemic.

Yet the optimism that accompanied the launch of Oxford University’s human trials this week has to be put in context, and the hurdles facing the scientists need to be understood.

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US stays away as world leaders agree action on Covid-19 vaccine

Video meeting seen as global endorsement of WHO and sign of Trump’s isolation on world stage

Global leaders have pledged to accelerate cooperation on a coronavirus vaccine and to share research, treatment and medicines across the globe. But the United States did not take part in the World Health Organization initiative, in a sign of Donald Trump’s increasing isolation on the global stage.

The cooperation pledge, made at a virtual meeting, was designed to show that wealthy countries will not keep the results of research from developing countries.

Related: The hunt for a coronavirus vaccine – a perilous and uncertain path

Related: ‘Please don’t inject bleach’: Trump’s wild coronavirus claims prompt disbelief

Provide access to new treatments, technologies and vaccines across the world.

Commit to an unprecedented level of international partnership on research and coordinate efforts to tackle the pandemic and reduce infections.

Reach collective decisions on responding to the pandemic, recognising that the virus’s spread in one country can affect all countries.

Learn from experience and adapt the global response.

Be accountable, to the most vulnerable communities and the whole world.

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We're desperate for a coronavirus cure, but at what cost to the human guinea pigs? | Kenan Malik

Big drugs companies have long favoured outsourcing clinical trials to poor countries with lax regulations to cut costs and maximise profit

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Last week, in Oxford, the first volunteers in the first European human trial were injected with a potential coronavirus vaccine. At the same time, Pakistan’s National Institute of Health received an offer from the Chinese pharmaceutical firm Sinopharm International Corp to take part in a trial of another potential coronavirus vaccine.

Related: Africa's Covid-19 research must be tailored to its realities – by its own scientists | Monique Wasunna

In India, many poor people were recruited to HIV trials without knowing that they were taking part in experiments

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World's stock markets soar on coronavirus treatment hopes

Investors shrug off US growth gloom after promising data from remdesivir drug trial

Shares have soared on the world’s stock markets after investors shrugged off a deep slump in the US economy and pinned their hopes on a possible breakthrough in treatment for Covid-19.

Despite news that the longest expansion in US history came to an abrupt end in the first three months of 2020, financial markets were buoyed by an update from the American biopharma company Gilead Sciences on its experimental drug remdesivir.

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AstraZeneca success should prompt review of takeover rules | Nils Pratley

Firm’s recent success could have been very different had it been bought out by Pfizer in 2014

It’s perhaps not surprising that the worth of healthcare companies should emerge during a global pandemic, but we should offer thanks for the UK’s big pharma twins – AstraZeneca and GlaxoSmithKline.

The former, with its share price at all-time high, is now jostling with Shell and Unilever for the title of biggest company in the FTSE 100 index. Successful research bets, especially on cancer drugs, have transformed Astra.

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Remdesivir: early findings on experimental coronavirus drug offer 'quite good news'

Preliminary results of US government trial show patients who received drug recovered faster than others

Hopes of an effective drug treatment for coronavirus patients have risen following positive early results from a trial of remdesivir, a drug first tried in Ebola patients.

Data from the trial on more than 1,000 severely ill patients in 75 hospitals around the world show that patients put on the drug recovered 31% faster than similar patients who were given a placebo drug instead. Remdesivir cut recovery time from a median of 15 days to 11.

Related: World's stock markets soar on coronavirus treatment hopes

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Covid-19 could mark a deadly turn in Ghana's fight against fake drugs

With substandard medicines already in wide circulation, fears are growing that coronavirus could create a lethal ‘parallel crisis’

When Joana Opoku-Darko’s daughter Anna was 18 months old, she came down with malaria, a disease common in Ghana and especially deadly for children.

She bought medication from a pharmacy in Ghana’s capital, Accra; when Anna’s fever didn’t subside she took her to a hospital, where they ran some tests.

The current focus on curbing Covid-19 spread means there is less focus on routine market surveillance

Related: Fight the fakes: how to beat the $200bn medicine counterfeiters | Helen Lock

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Promising drug against Covid-19 unlikely to be available in UK soon

Trial of remdesivir shows fewer deaths and shorter hospital stays

The first drug against Covid-19 to show promise in trials, reducing the time seriously ill people take to recover in hospital, is unlikely to be available widely in the UK soon, it has emerged.

Forty-six people in the UK have received remdesivir as part of the European arm of an international trial. Researchers would like to have given the drug to more patients but did not have the supplies.

Related: Coronavirus: what do scientists know about Covid-19 so far?

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AstraZeneca partners with Oxford University to produce Covid-19 vaccine

Drugmaker will manufacture and distribute vaccine if human trials are successful

AstraZeneca, the Cambridge-based pharmaceutical group, is teaming up with Oxford University to manufacture and distribute a coronavirus vaccine if clinical trials currently under way show it is effective.

News of the partnership boosted AstraZeneca’s share price, helping it to become Britain’s most valuable company by market capitalisation.

Related: The hunt for a coronavirus vaccine – a perilous and uncertain path

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Remdesivir: five Australian hospitals to receive experimental coronavirus drug

Exclusive: St Vincent’s in Sydney is the only confirmed location so far, as NSW Health negotiates with US pharmaceutical giant Gilead

The US pharmaceutical company Gilead is finalising the location of five hospitals in Australia to receive the highly sought-after experimental coronavirus drug remdesivir.

The only confirmed location is St Vincent’s hospital in Sydney, a major tertiary hospital and the centre of many of the New South Wales outbreak areas. A NSW Health spokeswoman confirmed the health department “has been engaging with Gilead on gaining access to the drug for Covid-19 patients”.

Related: Remdesivir: the antiviral drug is being touted as a possible coronavirus treatment – but will it work?

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The promise of an Oxford vaccine reveals how a new Britain could thrive | Will Hutton

The partnership between AstraZeneca and the Jenner Institute should jolt our industry and banks


There was some good news last week. Oxford University’s Jenner Institute announced it was teaming up with AstraZeneca to take a promising prototype of coronavirus vaccine into volume production by the autumn. Of course there are caveats – the institute’s confidence in its vaccine may not be validated by the trials that began last week.

Still it was heartening, after so much tragic incompetence, that a British university and a British company could forge a relationship of such potential national importance.

The piping through which emergency credit must flow is atrophied and weak

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Leading COVID-19 hope remdesivir fails to provide clinical benefit in first randomised trial

Gilead’s remdesivir, which has been hailed as one of the few truly promising treatments for COVID-19 at this early stage of the ongoing pandemic, has failed in its first randomised clinical trial, leaked data has revealed.




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European Medicines Agency’s review of Picato finds its risks outweigh its benefits

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the risks from using Picato are too high to end its suspension.




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FDA urges close monitoring of COVID-19 patients treated with hydroxychloroquine

The FDA has released a safety communication reiterating the need for doctors to closely monitor COVID-19 patients who are treated with either hydroxychloroquine or chloroquine.




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‘Excess deaths’ in England among the highest in Europe

English excess deaths from the coronavirus are comparable to the worst hit countries in Europe, according to a Sky News analysis.




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Researchers studying heartburn drug as potential coronavirus treatment

Researchers in America have been studying famotidine, the active ingredient in Pepcid, as a potential treatment for COVID-19.




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Italy to relax COVID-19 lockdown in early May

Italy has outlined its plans to ease the lockdown restrictions that were implemented across the country 7 weeks ago to combat the COVID-19 coronavirus pandemic.




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Sanofi's Meningococcal Conjugate Vaccine secures FDA approval in patients aged two and up

Sanofi’s MedQuadfi Meningococcal Conjugate Vaccine has scored FDA approval for the prevention of invasive meningococcal disease, becoming the first and only product available in the US for this indication in patients of at least two years old.




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Reinventing the value equation

There is a duty to ensure access to innovative treatments for patients with unmet need, but a health service gatekeeper must commit to efficient use of limited resources. Matt Fellows looks at how real-world evidence could be the key to reassessing how we determine the value of these drugs and ensure their swift availability.




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12 British children hospitalised with rare condition linked to COVID-19

12 children have fallen ill across the UK with a new and potentially fatal combination of symptoms linked to COVID-19.




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South Korean researchers start testing pancreatitis drug in COVID-19 patients

The South Korean Ministry of Food and Drug Safety have approved a local trial to evaluate nafamostat’s effectiveness in COVID-19 patients.




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NICE backtracks to approve Janssen's Stelara in ulcerative colitis

NICE has recommended Janssen’s Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis (UC), a move which rows back on the Institute’s decision to reject the drug last year.




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The May 2020 issue of Pharmafocus is available to read free online now!

COVID-19 continues to dominate the news cycle as we all try to maintain business as usual under the shadow of the pandemic. Just about every area of society and business has been hit and Life Sciences is no exception; the impact of the virus has been felt in every corner of the industry and our monthly issues aim to cut through the confusion to shed a light on that impact.




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Nearly half of Americans believe COVID-19 was created in a lab, according to a new survey

Almost half of Americans believe that the coronavirus was created in a lab, according to an April survey of 6,300 people.




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EU approval for Novartis' Cosentyx in active non-radiographic axial spondyloarthritis

Novartis has revealed that the European Commission has moved to approve Cosentyx (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients.




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Pharmafile.com's weekly COVID-19 news round-up

Hydroxychloroquine continues to feature in coronavirus news. Rick Bright, the Director of BARDA, alleges he was pushed out of his position due to his pushback to the administration focusing on the use of hydroxychloroquine in COVID-19 patients. This came after the National Institutes of Health said coronavirus patients should not take the drug due to potential “toxicities.”




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Australia calls for investigation into China’s coronavirus response

Scott Morrison, the Australian Prime Minister, has called for an investigation into the origins of the COVID-19 coronavirus, as Australia becomes one of China’s most vocal critics of its response to the pandemic.




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Phase 3 Libtayo monotherapy trial halted early due to strong benefit in advanced non-small cell lung cancer

A Phase 3 study of Sanofi and Regeneron’s Libtayo (cemiplimab) as a monotherapy for advanced or metastatic non-small cell lung cancer (NSCLC) has been stopped early after showing strong overall survival benefit, it has emerged.




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Arizona GOP lawmakers and AAPS say hydroxychloroquine has 90% chance of helping COVID-19 patients, but data is not based on clinical trials

The Association of American Physicians and Surgeons (AAPS) wrote a letter to Republican Arizona Governor Doug Ducey urging the wider use of hydroxychloroquine, based on data they have collected.




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Men most likely to exhibit the worst COVID-19 symptoms, according to a new study

Research into coronavirus cases in Shenzhen, China found that men were 2.5 times as likely to exhibit severe symptoms.




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Two studies reveal "positive" data for Gilead's remdesivir in hospitalised COVID-19 patients

The first findings of two new studies have been revealed detailing the efficacy of Gilead’s antiviral therapy remdesivir in the treatment of patients hospitalised with COVID-19.




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More than half of US states will relax lockdowns by the end of the week

Nearly half of US states will have their ‘stay-at-home’ orders expire this week, paving the way for much of the US to relax its lockdowns.




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AstraZeneca joins forces with University of Oxford to develop and manufacture potential coronavirus vaccine

A “landmark” partnership has been struck between AstraZeneca and the University of Oxford in the ongoing battle against COVID-19, with the former agreeing to aid in the development and large-scale manufacture of the latter’s potential recombinant adenovirus vaccine for the prevention of novel coronavirus infection.



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  • Manufacturing and Production

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Teva’s cancer drug Bendeka protected from generics until 2031, judge rules

A US federal judge has ruled that generic versions of the cancer treatment Bendeka infringe on four separate patents, and has delayed them from launching until 2031.




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Top Ten most popular articles on Pharmafile.com this week

The search for a COVID-19 treatment has ramped up this week, with two new studies detailing the efficacy of Gilead’s antiviral therapy remdesivir in the treatment of patients hospitalised with coronavirus, while researchers in America have been studying famotidine, the active ingredient in Pepcid, as a potential drug to help alleviate symptoms of the virus.




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Vertex's Kalydeco seizes EU CHMP recommendation for Kalydeco in R117H+ cystic fibrosis

The European Medicines Agency’s Committee for Medicinal Products for Human Use has given its recommendation for the approval of Kalydeco for the treatment of children and adolescents with cystic fibrosis in a new indication, Vertex has revealed.




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COVID-19 pandemic likely to last two years, study says

The coronavirus pandemic is likely to last as long as two years and will not be properly controlled until two-thirds of the world’s populations have become immune.




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Positive CHMP opinion for BMS and Acceleron's Reblozyl in transfusion-dependent anaemia sub-populations

Bristol Myers Squibb and Acceleron Pharma’s Reblozyl (luspatercept) has secured a positivr opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for use in the treatment of transfusion-dependent anaemia in two adult patient populations.




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NHS sets out plans to deal with the second phase of the pandemic

The NHS has set out plans to step up its non-COVID-19 services over the next six weeks.




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Mike Pompeo says there is evidence COVID-19 was made in a lab, despite US intelligence saying it occurred naturally

US Secretary of State Mike Pompeo claimed that there is evidence the COVID-19 coronavirus was created in a lab, despite US intelligence officials stating it probably occurred naturally.




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UK testing experimental treatment for use in COVID-19 patients

British scientists are testing an experimental drug to help some of society’s most vulnerable fight off the COVID-19 coronavirus.




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Trump vows to reduce America’s reliance on foreign drug imports

President Donald Trump has vowed to cut the US’s reliance on foreign drugs, singling out China and Ireland as countries he wants to stop buying pharmaceuticals from.




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FDA approves emergency use of Gilead's remdesivir for hospitalised COVID-19 patients

Gilead’s antiviral therapy remdesivir has shown tentatively promising efficacy in the race to find an effective treatment for COVID-19, one of the only therapies to do so at this early stage of the pandemic. Now, the FDA has invoked its Emergency Use Authorization powers to approve the drug for the treatment of patients hospitalised with the novel coronavirus.




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Lonza and Moderna enter agreement to mass produce coronavirus vaccine

Lonza Group AG and Moderna Inc have entered a deal to develop 1 billion doses of coronavirus vaccines a year.




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Working Life Interview: Kim Stratton, CEO, Orphazyme

"Every professional faces challenges. As a woman in industry, particularly in leadership, it adds another dimension to those challenges in how you present yourself."




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Sanofi and Regeneron's Libtayo shows durable responses in world's most common skin cancer

Sanofi and Regeneron’s have lifted the lid on new topline data on their PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced basal cell carcinoma (BCC), the most common skin cancer in the world, with around two million new cases diagnosed each year in the US alone.




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UK contact-tracing app being tested on the Isle of Wight

The NHS’s coronavirus contract tracing app has been published to Apple and Google’s app stores with council staff and healthcare workers being invited to download it on the Isle of Wight today.




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MHRA launches new pharmacovigilance reporting platform for COVID-19 treatments

A new online reporting site has been launched by the Medicines and Healthcare products Regulatory Agency’s (MHRA) to track potential side-effects arising from the use of any therapies used to treat COVID-19, in a bid to build a knowledge base around safe treatment of the pandemic disease.




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Scientists in Kenya discover microbe that could stop transmission of malaria

Researchers studying malaria in Kenya have discovered a microbe that blocks transmission of malaria from mosquitoes which could pave the way to eradicating the disease.




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First French case of COVID-19 occurred in December, a month earlier than previously thought

A French patient who suffered from pneumonia in December actually had COVID-19, it has been revealed.