A new report based on a survey of ACRO members reveals that Risk-Based Monitoring (RBM) makes clinical trial quality review more efficient...

Washington DC – The Association of Clinical Research Organizations (ACRO) is pleased to announce that its Board of Directors has elected Alistair...

Investigation of combination therapies including Bayer’s chloroquine and interferon beta-1b to foster much needed solutions for patients in fight against coronavirus pandemic / Bayer Canada to make CAD 1.5 million (approximately 1 million euros) financial commitment and to supply products in support of the research / Plans to include more than 60 contributing research locations involving 6.000 patients

Coronavirus crisis: Employee safety at the top of the agenda / First DAX company to hold virtual stockholders’ meeting / Strategic and operational targets attained in 2019 / Dividend of 2.80 euros per share proposed / Good start to fiscal 2020 / Winkeljohann to succeed Wenning as Supervisory Board Chairman

Pharmacists will be allowed to give out medication to patients who have already been receiving it

Pharmacists are to be allowed to hand out a range of super-strength medicines, including the heroin substitute methadone, without prescription during the Covid-19 crisis, under emergency measures that official drug policy advisers have warned could trigger a spike in drug misuse.

The Advisory Council for Misuse of Drugs (ACMD), which makes recommendations to the government on the control of dangerous drugs, was asked by the home secretary to consider the risks of lifting restrictions on certain substances controlled under the Misuse of Drugs Act.

Two companies jointly have capacity to manufacture hundreds of millions of doses

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Two of the world’s biggest vaccine companies have joined forces in an “unprecedented” collaboration to develop a Covid-19 vaccine.

GlaxoSmithKline and Sanofi, which combined have the largest vaccine manufacturing capability in the world, are working together on a hi-tech vaccine they say could be in human trials within months.

What is Covid-19?

Pharmaceutical giants will bury treatments in a thicket of patents, making them unaffordable to the world’s poorest

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How will the Covid-19 pandemic end? According to conventional wisdom, the crisis may ease in a few months, when some of the antiviral medicines on trial succeed. In a few years’ time, when a vaccine becomes available, we may eradicate the virus altogether.

Yet it’s unlikely that this is how the pandemic will actually play out. Although there is every indication that treatments for coronavirus may soon emerge, the mere fact of their existence is no guarantee that people will be able to access them. In fact, Covid-19 is more likely to end in the same way that every pandemic ends: treatments and vaccines will be buried in a thicket of patents – and pharmaceutical companies will ultimately make the decisions about who lives and who dies.

Related: The race to find a coronavirus treatment has one major obstacle: big pharma | Ara Darzi

Government bodies, industry and charities to collaborate in research efforts

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• Coronavirus vaccine – when will we have one?

The government has announced a new vaccines taskforce to help the development of a vaccine for Covid-19 and ensure its rapid production and rollout if one arrives.

The business secretary, Alok Sharma, also gave details of cash grants for work into both vaccines and potential treatments. Among the projects receiving cash is one led by Public Health England (PHE), which hopes to develop an antibody drug, something that has the potential to work as both a prophylactic and a treatment for those infected.

Related: The hunt for a coronavirus vaccine

Hydroxychloroquine, also known by its brand name, Plaquenil, is a drug used to treat malaria. It is a less toxic version of chloroquine, another malaria drug, which itself is related to quinine, an ingredient in tonic water.

Patients were used as guinea pigs but denied access to resulting therapies. This time, Big Pharma must be held to account

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The year I turned 11, my uncle Josiah Ssesanga was admitted to a hospital in Uganda with meningitis. It was 1994, and he was HIV positive. Between him and death stood a tattered post-civil war health system.

Treatments for HIV and Aids existed in other parts of the world, but in Uganda they were mostly limited to those used in clinical trials. For my uncle’s particular infection – cryptococcal meningitis – there was a drug called Fluconazole. But he didn’t know it existed; regardless, he wouldn’t have been able to afford it. and even among patients who took it, only 12% survived beyond six months.

Related: Macron calls for clinical trials of controversial coronavirus 'cure'

Related: Fear, bigotry and misinformation – this reminds me of the 1980s Aids pandemic | Edmund White

Any vaccine has to work, but it also has to be safe. Making it happen is one of the government’s biggest priorities

• Patrick Vallance is the UK government chief scientific adviser

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Covid-19 has made fundamental and long-lasting changes to the way we live our lives, not just in the UK, but across the world.

As we continue with social-distancing measures and deal with the most immediate issue of reducing the number of cases to protect the NHS and save lives, and keeping R, which is the average infection rate per person, below one, we also need to progress ways to tackle the disease in the longer term.

The vaccines taskforce will be working in lockstep with the public and private sector

Related: New UK taskforce to help develop and roll out coronavirus vaccine

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

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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.

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

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

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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.

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.

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

Drugmaker will manufacture and distribute vaccine if human trials are successful

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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

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

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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

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.

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.

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.

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.

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

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.

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

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.”

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.

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

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.

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.

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.

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.

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.

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

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.

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.

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

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.

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.

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.

Ousted Director of the Biomedical Advanced Research and Development Authority (BARDA), Dr Rick Bright, alleges the Trump administration ignored warnings about the severity of the coronavirus.

Vaccines and treatments for COVID-19 continue to dominate the news, as two studies reveal "positive" data for Gilead's remdesivir in hospitalised coronavirus patients while Lonza and Moderna have entered an agreement to mass produce a vaccine.

Alexion has announced it is to acquire Boston-based blood disorder specialist Portola Pharmaceuticals in a transaction to the value of $1.41 billion in cash.

The FDA has moved to approve an oral tablet formulation of AstraZeneca’s Farxiga (dapagliflozin) to reduce the risk of cardiovascular death and hospitalisation in adult patients with New York Heart Association’s functional class II-IV heart failure with reduced ejection fraction.

The FDA has awarded marketing authorisation to Novartis for the Oral MET inhibitor Tabrecta for the first-line treatment of metastatic non-small cell lung cancer in patients whose tumors have a mutation that leads to MET exon 14 skipping (METex14), regardless of whether they have previously received any type of treatment.

A recent report from the Office of National Statistics (ONS) has shown that black people in Britain are four times more likely to die from the COVID-19 coronavirus than white Britons.

AZ has pledged to make the vaccine at cost for the duration of the pandemic

New crop of data suggests drug can speed recovery from COVID-19

Experts says $20bn needed to vaccinate global population

Initial roll-out will see key workers utilise the app

Results could unlock another big market for the company’s star drug