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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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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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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.




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Ousted chief of BARDA says Trump administration ignored COVID-19 warnings

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.




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

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.




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AZ's Farxiga becomes first FDA-approved SGLT2 inhibitor for heart failure with reduced ejection fraction

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.




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South Korea says Ebola drug remdesivir may not be suitable for all coronavirus patients

South Korea says that remdesivir, traditionally used in treating Ebola, may not be effective enough in treating COVID-19 patients.




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Scientists in the UK and US identify hundreds of mutations in the COVID-19 virus

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.




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UK becomes first European country to pass 30,000 deaths from COVID-19

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.




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Black people are four times more likely to die from COVID-19 than white in England and Wales, ONS report shows

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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Imperial College London to lead major coronavirus home testing programme

Aims to track the progress of the infection across the UK




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AstraZeneca partners with Oxford University on UK’s lead coronavirus vaccine

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




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EMA starts rolling review of Gilead’s COVID-19 hope remdesivir

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




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Amgen adds Otezla to the COVID-19 candidate list

Psoriasis therapy may be a potential treatment for COVID-19




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Roche’s COVID-19 antibody test approved for emergency use in the US

Ramps up capacity for testing across the country




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Alnylam and Vir plan gene-silencing attack on COVID-19 virus

Drug could be ready for clinical trials before the end of the year




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World leaders donate to COVID-19 vaccine funding drive

Experts says $20bn needed to vaccinate global population




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Coronavirus contact-tracing app trial to begin on the Isle of Wight

Initial roll-out will see key workers utilise the app




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US trials of Pfizer/BioNTech coronavirus vaccine start

It is hoped that the drug may prevent COVID-19




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Regeneron says antibody for COVID-19 could be ready this year

Two antibody cocktails for COVID-19 could be available as early as this autumn




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CBD Product - Patriot Hemp Company

The U.S. Food and Drug Administration posted a photo:

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:

CBD Product – Patriot Hemp Company: www.fda.gov/inspections-compliance-enforcement-and-crimin...

More information is available at www.fda.gov/consumers/health-fraud-scams/fraudulent-coron...

Photo by FDA's Office of Regulatory Affairs, Health Fraud Branch

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to FDA's Office of Regulatory Affairs, Health Fraud Branch is appreciated but not required.




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COVID-19 Core Formula

The U.S. Food and Drug Administration posted a photo:

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...

Photo by FDA's Office of Regulatory Affairs, Health Fraud Branch

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to FDA's Office of Regulatory Affairs, Health Fraud Branch is appreciated but not required.




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Elanco to Buy Bayer's Animal Health Business for $7.6 Billion

Click to view a price quote on ELAN.




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Lannett to Be U.S. Distributor of Posaconazole Delayed-Release Tablets

Click to view a price quote on LCI.




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Oligonucleotide Therapeutics and Delivery Conference 2020

16 - 17 September 2020, London, UK.
Oligonucleotide therapeutics - the emerging medicine class - are harnessing the therapeutic benefit of targeting genetic material via antisense, mRNA, RNAi, saRNA and siRNA. Their market growth: CAGR of 13.7% projected to reach USD 8.2 billion by 2024 is driven by their potential to provide more efficacious and less toxic alternatives to small molecules.




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Oxford COVID-19 vaccine programme opens for clinical trial recruitment

University of Oxford researchers working in an unprecedented vaccine development effort to prevent COVID-19 have started screening healthy volunteers (aged 18-55) for their upcoming ChAdOx1 nCoV-19 vaccine trial in the Thames Valley Region. The vaccine based on an adenovirus vaccine vector and the SARS-CoV-2 spike protein is already in production but won’t be ready for some weeks still.




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AstraZeneca and Saint Luke’s Mid America Heart Institute initiate Phase III DARE-19 trial with Farxiga in COVID-19 patients

AstraZeneca and Saint Luke's Mid America Heart Institute have initiated a randomised, global Phase III trial to assess the potential of Farxiga (dapagliflozin) as a treatment in patients hospitalised with COVID-19 who are at risk of developing serious complications, such as organ failure.




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Key nose cells identified as likely COVID-19 virus entry points

Two specific cell types in the nose have been identified as likely initial infection points for COVID-19 coronavirus. Scientists discovered that goblet and ciliated cells in the nose have high levels of the entry proteins that the COVID-19 virus uses to get into our cells. The identification of these cells by researchers from the




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Loss of smell associated with milder clinical course in COVID-19

Following an earlier study that validated the loss of smell and taste as indicators of SARS-CoV-2 infection, researchers at UC San Diego Health report in newly published findings that olfactory impairment suggests the resulting COVID-19 disease is more likely to be mild to moderate, a potential early indicator that could help health care providers determine which patients may require hospitalization.




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Novartis announces plan to initiate clinical trial of canakinumab for patients with COVID-19 pneumonia

Novartis announced plans to initiate a Phase III clinical trial to study canakinumab in patients with COVID-19 pneumonia. The CAN-COVID trial will examine the efficacy of utilizing canakinumab, an interleukin (IL)-1β blocker, to treat a type of severe immune overreaction called cytokine release syndrome (CRS) in people with COVID-19 pneumonia.




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AstraZeneca and Oxford University announce landmark agreement for COVID-19 vaccine

AstraZeneca and the University of Oxford announced an agreement for the global development and distribution of the University’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection from SARS-CoV-2.

The collaboration aims to bring to patients the potential vaccine known as ChAdOx1 nCoV-19, being developed by the Jenner Institute and Oxford Vaccine Group, at the University of Oxford.




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Antibodies from llamas could help in fight against COVID-19

The hunt for an effective treatment for COVID-19 has led one team of researchers to find an improbable ally for their work: a llama named Winter. The team - from The University of Texas at Austin, the National Institutes of Health and Ghent University in Belgium - reports their findings about a potential avenue for a coronavirus treatment involving llamas on May 5 in the journal Cell.




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Researchers identify four possible treatments for COVID-19

While COVID-19 has infected millions of people worldwide and killed hundreds of thousands, there is currently no vaccine. In response, researchers have been evaluating the effectiveness of various antiviral drugs as possible COVID-19 treatments.




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Supercomputer simulations present potential active substances against coronavirus

Several drugs approved for treating hepatitis C viral infection were identified as potential candidates against COVID-19, a new disease caused by the SARS-CoV-2 coronavirus. This is the result of research based on extensive calculations using the MOGON II supercomputer at Johannes Gutenberg University Mainz (JGU). One of the most powerful computers in the world,




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Pre-filled Syringes San Francisco Conference 2020

14 - 15 September 2020, San Francisco, USA.
The global pre-filled syringes market was valued at $4.9 billion in 2018 and with the rapid growth of the industry, is expected to exceed $9.7 billion by 2025. With that in mind, this event will bring together specialists within the industry to provide an exclusive insight into the sphere of regulation, new digital technology trends, human studies and innovative design and delivery systems within the prefilled syringe industry.




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Study reveals most critically ill patients with COVID-19 survive with standard treatment

Clinicians from two hospitals in Boston report that the majority of even the sickest patients with COVID-19 - those who require ventilators in intensive care units - get better when they receive existing guideline-supported treatment for respiratory failure. The clinicians, who are from Massachusetts General Hospital (MGH) and Beth Israel Deaconess Medical Center, published their findings in the American Journal of Respiratory and Critical Care Medicine.




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Repurposing existing drugs for COVID-19 offers a more rapid alternative to a vaccine

Repurposing existing medicines focused on known drug targets is likely to offer a more rapid hope of tackling COVID-19 than developing and manufacturing a vaccine, argue an international team of scientists in the British Journal of Pharmacology today.

Since the emergence of the SARS-CoV-2 virus in late 2019, more than 3.5 million people are known to have been infected, leading to over 240,000 deaths worldwide from COVID-19, the disease caused by the novel coronavirus.




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India remains on USTR list of IP problem countries

India continues to be on the 'Priority Watch List' of the US Trade Representative (USTR) for lack of…



  • Focus On/Generics/India/Intellectual property law/Legal/Patents & Trademarks/USA

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US-Swiss partnership takes aim at rare heart condition

A new collaboration targeting rare heart diseases has been formed between California’s BioMarin Pharmaceutical…



  • BioMarin Pharmaceutical/Biotechnology/Cardio-vascular/Deals/DiNA-001/DiNAQOR/Licensing/Rare diseases/Research/Switzerland/USA

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COVID-19 leading to shortage of orphan drugs in Russia

The ongoing spread of COVID-19 in Russia is leading to shortages of drugs against orphan diseases in…



  • Anti-virals/Coronavirus/Focus On/From our correspondent/Hydroxychloroquine/In Depth/Pharmaceutical/Public health/Rare diseases/Russia/Russian market

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Firms ready RNAi candidate for COVID-19 development

A collaboration in COVID-19 between immunology specialist Vir Biotechnology and Alnylam Pharmaceuticals…



  • Alnylam Pharmaceuticals/Anti-virals/Biotechnology/Cell and Gene Therapy/Coronavirus/Focus On/Public health/Research/USA/Vir Biotechnology/VIR-2703

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Clinical tests imminent for Junshi's COVID-19 antibody

A new collaboration between Shanghai’s Junshi Biosciences and Eli Lilly will seek to develop novel…



  • Anti-virals/Biotechnology/China/Coronavirus/Drug Trial/Eli Lilly & Company/Focus On/JS016/Junshi Biosciences/Research/USA

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BRIEF—US court upholds Amgen Kyprolis patent

The US District Court in Delaware issued a decision upholding the validity of patent claims from three…



  • Amgen/Biotechnology/Cipla/Focus On/Kyprolis/Legal/Oncology/Patents & Trademarks/USA