m Working Life Interview: Kim Stratton, CEO, Orphazyme By www.pharmafile.com Published On :: Mon, 04 May 2020 12:02:08 +0000 "Every professional faces challenges. As a woman in industry, particularly in leadership, it adds another dimension to those challenges in how you present yourself." Full Article Interview Orphazyme Research and Development Working Life Medical Communications Sales and Marketing Business Services Manufacturing and Production
m 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
m 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
m Scientists in Kenya discover microbe that could stop transmission of malaria By www.pharmafile.com Published On :: Tue, 05 May 2020 10:46:01 +0000 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. Full Article malaria mosquitoes Manufacturing and Production
m 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
m 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
m 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
m Portola Pharmaceuticals to merge with Alexion in $1.41bn cash deal By www.pharmafile.com Published On :: Wed, 06 May 2020 10:36:40 +0000 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. Full Article Alexion pharma Portola Pharmaceuticals Research and Development Sales and Marketing
m 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
m South Korea says Ebola drug remdesivir may not be suitable for all coronavirus patients By www.pharmafile.com Published On :: Wed, 06 May 2020 11:29:32 +0000 South Korea says that remdesivir, traditionally used in treating Ebola, may not be effective enough in treating COVID-19 patients. Full Article coronavirus COVID-19 Research and Development south korea
m 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
m 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
m FDA approval for Tabrecta in metastatic non-small cell lung cancer with METex14 By www.pharmafile.com Published On :: Thu, 07 May 2020 11:35:49 +0000 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. Full Article Incyte Novartis pharma Tabrecta Sales and Marketing
m 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
m 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
m Imperial College London to lead major coronavirus home testing programme By www.pmlive.com Published On :: Fri, 01 May 2020 12:39:45 +0100 Aims to track the progress of the infection across the UK Full Article
m 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
m 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
m 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
m US clears emergency use of Gilead’s remdesivir By www.pmlive.com Published On :: Mon, 04 May 2020 12:32:39 +0100 Move comes after drug showed preliminary efficacy in clinical trial in late April Full Article
m Novartis’ asthma triple heads CHMP’s latest meeting By www.pmlive.com Published On :: Tue, 05 May 2020 12:50:48 +0100 Eight new medicines recommended for approval Full Article
m 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
m Novo Nordisk trumpets NASH data with semaglutide By www.pmlive.com Published On :: Thu, 07 May 2020 15:39:49 +0100 Results could unlock another big market for the company’s star drug Full Article
m NMN Sublingual Gel By www.flickr.com Published On :: Thu, 07 May 2020 08:13:38 -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
m CBD Product - Patriot Hemp Company 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: 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. Full Article
m 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
m Immunity Blend 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
m Endo, Allergan Nearing Deals to Limit Ohio Litigation Over Opioids - Report By www.thestreet.com Published On :: Tue, 20 Aug 2019 07:23:05 EDT Click to view a price quote on AGN. Full Article
m 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
m Rick Simpson Oil (RSO): Benefits, Effects and Research By www.thestreet.com Published On :: Tue, 18 Feb 2020 10:42:15 EST Click to view a price quote on TLRY. Full Article
m 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
m 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
m 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
m 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
m 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
m 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
m 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
m Supercomputer simulations present potential active substances against coronavirus By www.pharmanews.eu Published On :: Tue, 05 May 2020 10:00:00 +0200 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, Full Article Featured Research Research & Development
m 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
m 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
m Vitamin D linked to low virus death rate By www.pharmanews.eu Published On :: Fri, 08 May 2020 10:00:00 +0200 A new study has found an association between low average levels of vitamin D and high numbers of COVID-19 cases and mortality rates across 20 European countries. The research, led by Dr Lee Smith of Anglia Ruskin University (ARU) and Mr Petre Cristian Ilie, lead urologist of Queen Elizabeth Hospital King's Lynn NHS Foundation Trust, is published in the journal Aging Clinical and Experimental Research. Full Article Featured Research Research & Development
m India remains on USTR list of IP problem countries By www.thepharmaletter.com Published On :: Mon, 04 May 2020 16:58:00 +0100 India continues to be on the 'Priority Watch List' of the US Trade Representative (USTR) for lack of… Full Article Focus On/Generics/India/Intellectual property law/Legal/Patents & Trademarks/USA
m US-Swiss partnership takes aim at rare heart condition By www.thepharmaletter.com Published On :: Mon, 04 May 2020 17:15:00 +0100 A new collaboration targeting rare heart diseases has been formed between California’s BioMarin Pharmaceutical… Full Article BioMarin Pharmaceutical/Biotechnology/Cardio-vascular/Deals/DiNA-001/DiNAQOR/Licensing/Rare diseases/Research/Switzerland/USA
m Mallinckrodt’s INOmax successful in trial of neonates with pulmonary hypertension By www.thepharmaletter.com Published On :: Mon, 04 May 2020 17:20:00 +0100 UK-based Mallinckrodt Pharmaceuticals has ended a trial of INOmax (nitric oxide) gas early due to positive… Full Article Drug Trial/Inomax/Mallinckrodt/Nitric Oxide/Pharmaceutical/Research/Respiratory and Pulmonary/UK
m European progress in long path for Lokelma By www.thepharmaletter.com Published On :: Tue, 05 May 2020 10:08:00 +0100 The European medicines regulator has OK’d a label update for AstraZeneca’s Lokelma (sodium zirconium… Full Article AstraZeneca/Biotechnology/Cardio-vascular/Drug Trial/Europe/European Medicines Agency/Focus On/Lokelma/Regulation/Research/UK
m 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
m Positive Phase III data for Lupin’s trichomoniasis candidate By www.thepharmaletter.com Published On :: Tue, 05 May 2020 11:03:00 +0100 India’s Lupin has announced positive top-line results from its pivotal Phase III clinical trial to… Full Article Antibiotics and Infectious diseases/Drug Trial/India/Lupin/Pharmaceutical/Research/Solosec/Symbiomix Therapeutics/Women's health
m Menarini nabs hematologic malignancy drug along with buy of Stemline By www.thepharmaletter.com Published On :: Tue, 05 May 2020 12:32:00 +0100 Privately-held pharma and diagnostics firm Menarini Group has announced a definitive agreement to acquire… Full Article Biotechnology/Companies mergers and acquisitions/Elzonris/Hematology/Italy/Menarini Group/Oncology/One to Watch Companies/Rare diseases/Stemline Therapeutics/USA
m 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
m EU brings production home amid supply chain worries By www.thepharmaletter.com Published On :: Tue, 05 May 2020 14:37:00 +0100 Specialty chemicals company Evonik has kicked off a major expansion project at two German facilities,… Full Article Europe/Evonik/Generics/Germany/Production