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The Geosciences Community Needs to Be More Diverse and Inclusive

It’s essential if we’re going to protect our planet

-- Read more on ScientificAmerican.com




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Majority of Americans Open to Clinical Trial Participation If Recommended by a Doctor, New Study Finds

WASHINGTON–(BUSINESS WIRE)–The Association of Clinical Research Organizations (ACRO) applauds Research!America for a recently released survey on the public’s perception of clinical trials....




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British MP Benn talks Brexit challenges and the future of UK clinical research industry

The Association of Clinical Research Organizations (ACRO) highlights contributions to health and economy (Leeds, UK) – Facing unprecedented challenges associated with Brexit,...




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ACRO members talk UK competitiveness and enabling post-Brexit success

What happens to clinical research when the UK leaves the EU’s common market and regulatory structure? When public perceptions seem locked onto...




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UK Government focus on strengthening clinical research amidst unique challenges of Brexit

The Association of Clinical Research Organizations (ACRO) convenes discussion series that seeks to advance an industry with important health and economic impacts...




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ACRO testifies before IRS and Treasury Department on proposed Base Erosion and Anti-Abuse Tax (BEAT) regulation

On Monday, March 25, 2019 ACRO provided testimony at a public hearing held by the Internal Revenue Service (IRS) and Treasury Department...




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New ACRO Report Quantifies Benefits of RBM for Quality Reviews

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




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A Consistent Approach to Risk Based Quality Management: Collaboration is Key

Developing, executing and overseeing clinical trials is a complex process. Yet it is essential to gain reliable evidence from clinical trials to...




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ACRO hosts Congressional Briefing on clinical research advancements

On Wednesday, October 23, 2019, ACRO hosted a Congressional Briefing on Capitol Hill. With the help of the Congressional Research & Development...




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2020 Officers and New Member Announcement

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




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ACRO Members Heed the UK Government’s Call for Volunteers in Response to the COVID-19 Pandemic

May 6, 2020 – (Washington, DC) – In an effort to fight the global COVID-19 pandemic, over 150 employees from clinical research...




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Bayer donates 8 million chloroquine tablets to the German Federal Government

Additional donations of chloroquine sent to governments in numerous other countries / Various clinical and preclinical studies investigate the efficacy and adverse effects in COVID-19 infections / Bayer plans considerable expansion of production capacities in the event that the efficacy of chloroquine is proven for COVID-19




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Bayer partners with Population Health Research Institute (PHRI) on global clinical research evaluating COVID-19 treatments

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




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We'll find a treatment for coronavirus – but drug companies will decide who gets it

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

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

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FTSE 100 boosted amid optimism over potential coronavirus drug

Stock index up more than 3% in early trading on the back of hopes for remdesivir treatment

Optimism about a potential treatment for Covid-19 gave a shot in the arm to stock markets around the world, amid claims that a drug called remdesivir has spurred rapid recovery in 113 patients.

A University of Chicago hospital participating in a study of the antiviral medication, made by US firm Gilead Sciences, found that nearly all patients suffering severe fever and respiratory symptoms were discharged within a week. A report of the study, issued by specialist healthcare publication Stat News shortly after Wall Street closed on Thursday night, spurred hopes among investors that lockdowns around the world could soon be eased.

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Roche to commence rollout of coronavirus antibody test in UK

Pharmaceutical company says it can produce tests in the high tens of millions by June

The pharmaceutical giant Roche has devised a new coronavirus antibody test, which it is aiming to launch in the UK next month.

Antibody testing, which has already been utilised in Germany, South Korea and Finland, is seen as a way for countries to exit lockdown by showing who has already had Covid-19 and could therefore have a degree of immunity.

Related: Antibody tests aren't perfect, but they may be Britain's way out of the lockdown | Eleanor Riley

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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

• Coronavirus latest updates

• See all our coronavirus coverage

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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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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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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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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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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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.



  • Research and Development
  • 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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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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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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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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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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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.