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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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Nearly half of Americans believe COVID-19 was created in a lab, according to a new survey

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




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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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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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COVID-19 pandemic likely to last two years, study says

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.




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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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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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Trump vows to reduce America’s reliance on foreign drug imports

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.




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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.




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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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Jonathan Freve joins Galecto as Chief Financial Officer

The biotech company Galecto Inc have appointed Jonathan Freve as its Chief Financial Officer, and in his role he will lead financial operations including overseeing investor relations and fundraising efforts.  

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  • Manufacturing and Production

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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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FDA approval for Tabrecta in metastatic non-small cell lung cancer with METex14

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.




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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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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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Sanofi, Regeneron set up another niche use for PD-1 drug Libtayo

Drug has shown “clinically meaningful responses” for basal cell carcinoma




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FTC clears AbbVie’s $63bn Allergan takeover

US regulator satisfied that antitrust concerns are remediated




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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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Endo, Allergan Nearing Deals to Limit Ohio Litigation Over Opioids - Report

Click to view a price quote on AGN.




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

Click to view a price quote on TLRY.




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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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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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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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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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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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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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Positive Phase III data for Lupin’s trichomoniasis candidate

India’s Lupin has announced positive top-line results from its pivotal Phase III clinical trial to…



  • Antibiotics and Infectious diseases/Drug Trial/India/Lupin/Pharmaceutical/Research/Solosec/Symbiomix Therapeutics/Women's health

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Menarini nabs hematologic malignancy drug along with buy of Stemline

Privately-held pharma and diagnostics firm Menarini Group has announced a definitive agreement to acquire…



  • Biotechnology/Companies
  • mergers and acquisitions/Elzonris/Hematology/Italy/Menarini Group/Oncology/One to Watch Companies/Rare diseases/Stemline Therapeutics/USA

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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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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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Pfizer and BioNTech move on COVID-19 vaccine work apace

As with other companies, US drug giant Pfizer and its German partner BioNTech are moving forward their…



  • BioNTech/BNT162/Coronavirus/Drug Trial/Focus On/Pfizer/Pharmaceutical/Research/USA/Vaccines

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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