9 Positive CHMP opinion for BMS and Acceleron's Reblozyl in transfusion-dependent anaemia sub-populations By www.pharmafile.com Published On :: Fri, 01 May 2020 11:32:10 +0000 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. Full Article Acceleron Bristol-Myers Squibb EU Reblozyl Medical Communications Sales and Marketing
9 Mike Pompeo says there is evidence COVID-19 was made in a lab, despite US intelligence saying it occurred naturally By www.pharmafile.com Published On :: Mon, 04 May 2020 09:20:26 +0000 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. Full Article coronavirus COVID-19 lab pandemic Wuhan Institute of virology Sales and Marketing
9 UK testing experimental treatment for use in COVID-19 patients By www.pharmafile.com Published On :: Mon, 04 May 2020 10:06:21 +0000 British scientists are testing an experimental drug to help some of society’s most vulnerable fight off the COVID-19 coronavirus. Full Article coronavirus coronavirus treatment COVID-19 Sales and Marketing
9 FDA approves emergency use of Gilead's remdesivir for hospitalised COVID-19 patients By www.pharmafile.com Published On :: Mon, 04 May 2020 11:31:55 +0000 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. Full Article coronavirus COVID-19 FDA Gilead remdesivir Sales and Marketing
9 Sanofi and Regeneron's Libtayo shows durable responses in world's most common skin cancer By www.pharmafile.com Published On :: Tue, 05 May 2020 09:23:27 +0000 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. Full Article cancer Libtayo Regeneron Research and Development Sanofi Manufacturing and Production
9 MHRA launches new pharmacovigilance reporting platform for COVID-19 treatments By www.pharmafile.com Published On :: Tue, 05 May 2020 10:27:13 +0000 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. Full Article coronavirus COVID-19 MHRA pharma Research and Development UK Manufacturing and Production
9 First French case of COVID-19 occurred in December, a month earlier than previously thought By www.pharmafile.com Published On :: Tue, 05 May 2020 11:46:00 +0000 A French patient who suffered from pneumonia in December actually had COVID-19, it has been revealed. Full Article coronavirus COVID-19 Manufacturing and Production
9 Ousted chief of BARDA says Trump administration ignored COVID-19 warnings By www.pharmafile.com Published On :: Wed, 06 May 2020 09:33:46 +0000 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. Full Article BARDA chloroquine coronavirus COVID-19 hydroxychloroquine Research and Development
9 Pharmafile.com's weekly COVID-19 news round-up By www.pharmafile.com Published On :: Wed, 06 May 2020 10:17:43 +0000 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. Full Article coronavirus COVID-19 Research and Development
9 AZ's Farxiga becomes first FDA-approved SGLT2 inhibitor for heart failure with reduced ejection fraction By www.pharmafile.com Published On :: Wed, 06 May 2020 11:28:32 +0000 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. Full Article AstraZeneca farxiga FDA heart failure Research and Development Sales and Marketing
9 Scientists in the UK and US identify hundreds of mutations in the COVID-19 virus By www.pharmafile.com Published On :: Thu, 07 May 2020 09:42:57 +0000 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. Full Article coronavirus COVID-19 Protein virus Business Services
9 UK becomes first European country to pass 30,000 deaths from COVID-19 By www.pharmafile.com Published On :: Thu, 07 May 2020 10:31:27 +0000 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. Full Article coronavirus COVID-19 Business Services
9 Black people are four times more likely to die from COVID-19 than white in England and Wales, ONS report shows By www.pharmafile.com Published On :: Thu, 07 May 2020 11:53:35 +0000 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. Full Article coronavirus COVID-19 Business Services
9 NICE gives thumbs-up to Roche's Kadcyla in HER2+ breast cancer sub-population By www.pharmafile.com Published On :: Thu, 07 May 2020 12:00:39 +0000 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. Full Article breast cancer cancer Kadcyla NHS NICE Roche UK Sales and Marketing
9 EMA starts rolling review of Gilead’s COVID-19 hope remdesivir By www.pmlive.com Published On :: Fri, 01 May 2020 13:01:24 +0100 New crop of data suggests drug can speed recovery from COVID-19 Full Article
9 Amgen adds Otezla to the COVID-19 candidate list By www.pmlive.com Published On :: Mon, 04 May 2020 12:18:21 +0100 Psoriasis therapy may be a potential treatment for COVID-19 Full Article
9 Roche’s COVID-19 antibody test approved for emergency use in the US By www.pmlive.com Published On :: Mon, 04 May 2020 12:25:11 +0100 Ramps up capacity for testing across the country Full Article
9 Alnylam and Vir plan gene-silencing attack on COVID-19 virus By www.pmlive.com Published On :: Tue, 05 May 2020 12:59:41 +0100 Drug could be ready for clinical trials before the end of the year Full Article
9 World leaders donate to COVID-19 vaccine funding drive By www.pmlive.com Published On :: Tue, 05 May 2020 13:08:40 +0100 Experts says $20bn needed to vaccinate global population Full Article
9 Regeneron says antibody for COVID-19 could be ready this year By www.pmlive.com Published On :: Thu, 07 May 2020 15:59:05 +0100 Two antibody cocktails for COVID-19 could be available as early as this autumn Full Article
9 FDA Works - 24937541436 By www.flickr.com Published On :: Thu, 30 Apr 2020 13:40:49 -0700 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. Full Article
9 FDA Works - 24938398436 By www.flickr.com Published On :: Thu, 30 Apr 2020 13:40:50 -0700 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. Full Article
9 FDA Works - 24963817515 By www.flickr.com Published On :: Thu, 30 Apr 2020 13:40:51 -0700 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. Full Article
9 FDA Works - 24963850865 By www.flickr.com Published On :: Thu, 30 Apr 2020 13:40:51 -0700 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. Full Article
9 FDA Works - 24964138315 By www.flickr.com Published On :: Thu, 30 Apr 2020 13:40:52 -0700 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. Full Article
9 FDA Works - 24964391365 By www.flickr.com Published On :: Thu, 30 Apr 2020 13:40:52 -0700 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. Full Article
9 FDA Works - 24964489645 By www.flickr.com Published On :: Thu, 30 Apr 2020 13:40:52 -0700 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. Full Article
9 COVID-19 Core Formula By www.flickr.com Published On :: Fri, 08 May 2020 11:07:04 -0700 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. Full Article
9 Elanco to Buy Bayer's Animal Health Business for $7.6 Billion By www.thestreet.com Published On :: Tue, 20 Aug 2019 09:35:13 EDT Click to view a price quote on ELAN. Full Article
9 Oxford COVID-19 vaccine programme opens for clinical trial recruitment By www.pharmanews.eu Published On :: Thu, 23 Apr 2020 10:00:00 +0200 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. Full Article Featured Research Research & Development
9 AstraZeneca and Saint Luke’s Mid America Heart Institute initiate Phase III DARE-19 trial with Farxiga in COVID-19 patients By www.pharmanews.eu Published On :: Fri, 24 Apr 2020 10:00:00 +0200 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. Full Article Featured AstraZeneca Business
9 Key nose cells identified as likely COVID-19 virus entry points By www.pharmanews.eu Published On :: Mon, 27 Apr 2020 10:00:00 +0200 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 Full Article Featured Research Research & Development
9 Loss of smell associated with milder clinical course in COVID-19 By www.pharmanews.eu Published On :: Tue, 28 Apr 2020 10:00:00 +0200 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. Full Article Featured Research Research & Development
9 Novartis announces plan to initiate clinical trial of canakinumab for patients with COVID-19 pneumonia By www.pharmanews.eu Published On :: Wed, 29 Apr 2020 10:00:00 +0200 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. Full Article Featured Novartis Business
9 AstraZeneca and Oxford University announce landmark agreement for COVID-19 vaccine By www.pharmanews.eu Published On :: Thu, 30 Apr 2020 10:00:00 +0200 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. Full Article Featured AstraZeneca Business
9 Antibodies from llamas could help in fight against COVID-19 By www.pharmanews.eu Published On :: Fri, 01 May 2020 10:00:00 +0200 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. Full Article Featured Research Research & Development
9 Researchers identify four possible treatments for COVID-19 By www.pharmanews.eu Published On :: Mon, 04 May 2020 10:00:00 +0200 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. Full Article Featured Research Research & Development
9 Study reveals most critically ill patients with COVID-19 survive with standard treatment By www.pharmanews.eu Published On :: Wed, 06 May 2020 10:00:00 +0200 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. Full Article Featured Research Research & Development
9 Repurposing existing drugs for COVID-19 offers a more rapid alternative to a vaccine By www.pharmanews.eu Published On :: Thu, 07 May 2020 10:00:00 +0200 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. Full Article Featured Research Research & Development
9 COVID-19 leading to shortage of orphan drugs in Russia By www.thepharmaletter.com Published On :: Tue, 05 May 2020 10:09:00 +0100 The ongoing spread of COVID-19 in Russia is leading to shortages of drugs against orphan diseases in… Full Article Anti-virals/Coronavirus/Focus On/From our correspondent/Hydroxychloroquine/In Depth/Pharmaceutical/Public health/Rare diseases/Russia/Russian market
9 Firms ready RNAi candidate for COVID-19 development By www.thepharmaletter.com Published On :: Tue, 05 May 2020 10:27:00 +0100 A collaboration in COVID-19 between immunology specialist Vir Biotechnology and Alnylam Pharmaceuticals… Full Article Alnylam Pharmaceuticals/Anti-virals/Biotechnology/Cell and Gene Therapy/Coronavirus/Focus On/Public health/Research/USA/Vir Biotechnology/VIR-2703
9 Clinical tests imminent for Junshi's COVID-19 antibody By www.thepharmaletter.com Published On :: Tue, 05 May 2020 13:11:00 +0100 A new collaboration between Shanghai’s Junshi Biosciences and Eli Lilly will seek to develop novel… Full Article Anti-virals/Biotechnology/China/Coronavirus/Drug Trial/Eli Lilly & Company/Focus On/JS016/Junshi Biosciences/Research/USA
9 China and COVID-19 offer test case for blockchain By www.thepharmaletter.com Published On :: Tue, 05 May 2020 15:25:00 +0100 The COVID-19 pandemic did not stop China from launching its national blockchain-based service network… Full Article China/Coronavirus/Digital Pharma/Focus On/GlobalData/Pharmaceutical
9 Pfizer and BioNTech move on COVID-19 vaccine work apace By www.thepharmaletter.com Published On :: Tue, 05 May 2020 16:43:00 +0100 As with other companies, US drug giant Pfizer and its German partner BioNTech are moving forward their… Full Article BioNTech/BNT162/Coronavirus/Drug Trial/Focus On/Pfizer/Pharmaceutical/Research/USA/Vaccines
9 Bristol-Myers' CAR-T cell therapy meets with FDA delay By www.thepharmaletter.com Published On :: Wed, 06 May 2020 15:23:00 +0100 The submission of additional information, upon the request of the US regulator, has delayed the action… Full Article Biotechnology/Bristol-Myers Squibb/Focus On/Immuno-oncology/lisocabtagene maraleucel/Regulation/Research/US FDA/USA
9 Global pharma and biotech’s fight against COVID-19: an investment perspective By www.thepharmaletter.com Published On :: Wed, 06 May 2020 18:01:00 +0100 Mark Brewer, who heads up the life sciences team at UK broker and M&A advisory company, finnCap, gives… Full Article Actemra/Anti-virals/Avacta/Avigan/Biotechnology/Business Financing/Chloroquine/Coronavirus/Cytiva/Expert View/Faron Pharmaceuticals/favipiravir/Focus On/Fujifilm/Gilead Sciences/Hydroxychloroquine/In Depth/Medical Devices and Diagnostics/Novacyt/Remdesivir/Roche/SNG001/Synairgen/UK
9 Assessing the long-term impact of COVID-19 on clinical research By www.thepharmaletter.com Published On :: Thu, 07 May 2020 10:15:00 +0100 The fallout from the COVID-19 pandemic has been challenging for many life sciences companies due to a… Full Article Anti-virals/Cell and Gene Therapy/Coronavirus/CRA/Feature/Focus On/Global/In Depth/Pharmaceutical/Regulation/Research/Vaccines
9 Dr Reddy's gets FDA nod for migraine drug Elyxyb By www.thepharmaletter.com Published On :: Thu, 07 May 2020 16:10:00 +0100 Shares of Dr Reddy’s Laboratories rose more than 2% to 3,936.35 rupees, after the Indian drugmaker… Full Article Analgesia/celecoxib/Dr Reddy's Laboratories/Elyxyb/Focus On/India/Migraine/Neurological/Pharmaceutical/Regulation/US FDA/USA
9 Japan grants ‘exceptional’ approval for remdesivir in COVID-19 By www.thepharmaletter.com Published On :: Fri, 08 May 2020 14:53:00 +0100 As had been widely expected, Gilead Sciences on Thursday announced that the Japanese Ministry of Health,… Full Article Anti-virals/Asia Pacific/Coronavirus/Focus On/Gilead Sciences/Japan/Pharmaceutical/Regulation/Remdesivir/USA/Veklury
9 Gilead in talks to expand COVID-19 hopeful remdesivir supply chains with outside partner By www.fiercepharma.com Published On :: Fri, 01 May 2020 14:30:25 +0000 Gilead Sciences scored a massive win earlier this week with its first positive data readout for investigational candidate remdesivir in treating patients with severe COVID-19. Gilead already has its own supply of the drug humming in anticipation of high demand, but opportunities are out there for a partner to join in. Full Article