On Monday, March 25, 2019 ACRO provided testimony at a public hearing held by the Internal Revenue Service (IRS) and Treasury Department...
May 6, 2020 – (Washington, DC) – In an effort to fight the global COVID-19 pandemic, over 150 employees from clinical research...
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
Employee safety and business continuity are top priorities / Wide-ranging humanitarian and social engagement / Group sales increase by 6.0 percent (Fx & portfolio adj.) to 12.845 billion euros / EBITDA before special items up by 10.2 percent to 4.391 billion euros / All divisions report higher sales and earnings – strong demand at Consumer Health / Net income advances by 20.0 percent to 1.489 billion euros / Core earnings per share increase by 9.9 percent to 2.67 euros / Outlook for 2020: impact of COVID-19 not yet reliably quantifiable
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.
Continue reading...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.
Continue reading...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.
Continue reading...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
Continue reading...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?
Continue reading...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
Continue reading...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.
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.
12 children have fallen ill across the UK with a new and potentially fatal combination of symptoms linked to COVID-19.
The South Korean Ministry of Food and Drug Safety have approved a local trial to evaluate nafamostat’s effectiveness in COVID-19 patients.
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.
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.
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.
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.
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.
British scientists are testing an experimental drug to help some of society’s most vulnerable fight off the COVID-19 coronavirus.
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.
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.
A French patient who suffered from pneumonia in December actually had COVID-19, it has been revealed.
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.
Two studies from the UK and US have identified hundreds of mutations in COVID-19, which could cause problems for the development of a vaccine.
Britain has become the first European nation to pass 30,000 deaths from the coronavirus, putting it only behind the US as the worst hit country in the world in terms of fatalities.
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.
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The U.S. Food and Drug Administration (FDA) is a science-based regulatory agency working to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required.
The U.S. Food and Drug Administration posted a photo:
The U.S. Food and Drug Administration (FDA) is a science-based regulatory agency working to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required.
The U.S. Food and Drug Administration posted a photo:
The U.S. Food and Drug Administration (FDA) is a science-based regulatory agency working to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required.
The U.S. Food and Drug Administration posted a photo:
The U.S. Food and Drug Administration (FDA) is a science-based regulatory agency working to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required.
The U.S. Food and Drug Administration posted a photo:
The U.S. Food and Drug Administration (FDA) is a science-based regulatory agency working to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required.
The U.S. Food and Drug Administration posted a photo:
The U.S. Food and Drug Administration (FDA) is a science-based regulatory agency working to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
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This product is promoted with unapproved claims to prevent, treat, mitigate, or cure COVID-19. FDA warns consumers to avoid unproven and potentially unsafe products. See the Warning Letter for more information:
www.fda.gov/inspections-compliance-enforcement-and-crimin...
More information is available at www.fda.gov/consumers/health-fraud-scams/fraudulent-coron...
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