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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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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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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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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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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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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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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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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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NICE gives thumbs-up to Roche's Kadcyla in HER2+ breast cancer sub-population

NICE has revealed that it has recommended the NHS use of Roche’s Kadcyla (trastuzumab emtansine) for HER2+ breast cancer in patients who have residual invasive disease in the breast or lymph nodes after receiving neoadjuvant treatment including a HER2-targeted agent.




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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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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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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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US clears emergency use of Gilead’s remdesivir

Move comes after drug showed preliminary efficacy in clinical trial in late April




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Novartis’ asthma triple heads CHMP’s latest meeting

Eight new medicines recommended for approval




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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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Rick Simpson Oil (RSO): Benefits, Effects and Research

Click to view a price quote on TLRY.




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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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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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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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Mallinckrodt’s INOmax successful in trial of neonates with pulmonary hypertension

UK-based Mallinckrodt Pharmaceuticals has ended a trial of INOmax (nitric oxide) gas early due to positive…



  • Drug Trial/Inomax/Mallinckrodt/Nitric Oxide/Pharmaceutical/Research/Respiratory and Pulmonary/UK

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European progress in long path for Lokelma

The European medicines regulator has OK’d a label update for AstraZeneca’s Lokelma (sodium zirconium…



  • AstraZeneca/Biotechnology/Cardio-vascular/Drug Trial/Europe/European Medicines Agency/Focus On/Lokelma/Regulation/Research/UK

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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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EU brings production home amid supply chain worries

Specialty chemicals company Evonik has kicked off a major expansion project at two German facilities,…



  • Europe/Evonik/Generics/Germany/Production

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China and COVID-19 offer test case for blockchain

The COVID-19 pandemic did not stop China from launching its national blockchain-based service network…



  • China/Coronavirus/Digital Pharma/Focus On/GlobalData/Pharmaceutical

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Latest data show Libtayo beneficial in BCC trial

Positive top-line data for a pivotal, single-arm, open-label trial of PD-1 inhibitor Libtayo (cemiplimab)…



  • Biotechnology/Drug Trial/France/Immuno-oncology/Libtayo/Oncology/Regeneron Pharmaceuticals/Research/Sanofi/USA

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Regeneron rockets as financial results provide perfect picture of growth

Investors in Regeneron could afford a rare smile in these difficult times, as the company’s first quarter…



  • Anti-virals/Biotechnology/Dermatologicals/Dupixent/Eylea/Financial/Immuno-oncology/Inflammatory diseases/Libtayo/Management/Oncology/Ophthalmics/Regeneron/REGN-COV2/USA

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Akebia soars on positive Ph III trial results for vadadustat

Shares of US biotech Akebia Therapeutics were up more than 35% at $11.72 by early afternoon today, after…



  • Akebia Therapeutics/Biotechnology/Drug Trial/Nephrology and Hepatology/Research/USA/vadadustat

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US FTC clears AbbVie’s buy of Allergan, but with divestments

Almost a year after the original announcement, the US Federal Trade Commission (FTC) has accepted the…



  • AbbVie/Allergan/Companies
  • mergers and acquisitions/Endocrinology/Federal Trade Commission/Ireland/Legal/Management/Pancrelipase/Pharmaceutical/USA/Viokace/Zenpep

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Gilead plans to meet rising tide of remdesivir demand

California’s Gilead Sciences has outlined a plan to ramp up production of newly USA-approved COVID-19…



  • Anti-virals/Coronavirus/Focus On/Gilead Sciences/Pharmaceutical/Production/Public health/Remdesivir/USA

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Portola agrees to takeover bid from Alexion

Following a couple of active M&A years, USA-based Alexion Pharmaceuticals has now reached a definitive…



  • Alexion Pharmaceuticals/AndexXa/Anticoagulants/Biotechnology/Cardio-vascular/Companies
  • mergers and acquisitions/Hematology/Ondexxya/Portola Pharmaceuticals/USA

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BRIEF—Key appointments at Denmark’s Acesion Pharma

Danish drugmaker Acesion Pharma, which is focused on novel treatments for atrial fibrillation (AF), has…



  • Acesion Pharma/Boardroom/Cardio-vascular/Denmark/Management/Pharmaceutical

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Stockpiling spurs sales at Novo Nordisk in first quarter

Pandemic-based stockpiling among people with diabetes helped lift revenues beyond analysts’ expectations…



  • Biotechnology/Denmark/Diabetes/Financial/Management/Novo Nordisk/Ozempic/Research/Rybelsus/Tresiba/USA/Victoza

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Alexion exceeds earnings estimates but drops guidance

US drugmaker Alexion Pharmaceuticals fared better in its revenue and adjusted earnings figures in the…



  • Alexion Pharmaceuticals/Autoimmune Disorders/Biotechnology/Financial/Immunologicals/Management/Rare diseases/Soliris/Strensiq/Ultomiris/USA

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BRIEF—Merck invests in AI chip start-up SynSense

Germany’s science and technology company Merck KGaA today announced its investment in SynSense (formerly…



  • China/Companies
  • mergers and acquisitions/Digital Pharma/Germany/Merck KGaA/Pharmaceutical/Switzerland/SynSense

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Bausch + Lomb licenses Stada and Xbrane’s Lucentis biosimilar

Eye health specialist Bausch + Lomb, part Bausch Health Companies, has entered into an exclusive licensing…



  • Bausch & Lomb/Bausch Health Companies/Biosimilars/Canada/Deals/Germany/Licensing/Lucentis/Ophthalmics/STADA Arzneimittel/Sweden/USA/Xbrane Biopharma AB/Xlucane