y The May 2020 issue of Pharmafocus is available to read free online now! By www.pharmafile.com Published On :: Tue, 28 Apr 2020 11:30:43 +0000 COVID-19 continues to dominate the news cycle as we all try to maintain business as usual under the shadow of the pandemic. Just about every area of society and business has been hit and Life Sciences is no exception; the impact of the virus has been felt in every corner of the industry and our monthly issues aim to cut through the confusion to shed a light on that impact. Full Article coronavirus COVID-19 pharma Research and Development Medical Communications Sales and Marketing Business Services Manufacturing and Production
y Nearly half of Americans believe COVID-19 was created in a lab, according to a new survey By www.pharmafile.com Published On :: Tue, 28 Apr 2020 11:31:39 +0000 Almost half of Americans believe that the coronavirus was created in a lab, according to an April survey of 6,300 people. Full Article coronavirus COVID-19 survey Manufacturing and Production
y EU approval for Novartis' Cosentyx in active non-radiographic axial spondyloarthritis By www.pharmafile.com Published On :: Wed, 29 Apr 2020 09:28:04 +0000 Novartis has revealed that the European Commission has moved to approve Cosentyx (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients. Full Article axial spondyloarthritis Cosentyx EU Novartis pharma Research and Development Sales and Marketing
y Pharmafile.com's weekly COVID-19 news round-up By www.pharmafile.com Published On :: Wed, 29 Apr 2020 10:54:33 +0000 Hydroxychloroquine continues to feature in coronavirus news. Rick Bright, the Director of BARDA, alleges he was pushed out of his position due to his pushback to the administration focusing on the use of hydroxychloroquine in COVID-19 patients. This came after the National Institutes of Health said coronavirus patients should not take the drug due to potential “toxicities.” Full Article BARDA coronavirus COVID-19 hydroxychloroquine Research and Development
y Phase 3 Libtayo monotherapy trial halted early due to strong benefit in advanced non-small cell lung cancer By www.pharmafile.com Published On :: Wed, 29 Apr 2020 11:49:31 +0000 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. Full Article cancer Libtayo lung cancer Regeneron Research and Development Sanofi
y Arizona GOP lawmakers and AAPS say hydroxychloroquine has 90% chance of helping COVID-19 patients, but data is not based on clinical trials By www.pharmafile.com Published On :: Wed, 29 Apr 2020 11:58:38 +0000 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. Full Article chloroquine hydroxychloroquine Research and Development
y Men most likely to exhibit the worst COVID-19 symptoms, according to a new study By www.pharmafile.com Published On :: Thu, 30 Apr 2020 09:24:33 +0000 Research into coronavirus cases in Shenzhen, China found that men were 2.5 times as likely to exhibit severe symptoms. Full Article coronavirus COVID-19 Business Services
y More than half of US states will relax lockdowns by the end of the week By www.pharmafile.com Published On :: Thu, 30 Apr 2020 10:35:35 +0000 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. Full Article coronavirus COVID-19 Lockdown quaratine Business Services
y AstraZeneca joins forces with University of Oxford to develop and manufacture potential coronavirus vaccine By www.pharmafile.com Published On :: Thu, 30 Apr 2020 11:05:49 +0000 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. Full Article Research and Development Manufacturing and Production
y Vertex's Kalydeco seizes EU CHMP recommendation for Kalydeco in R117H+ cystic fibrosis By www.pharmafile.com Published On :: Fri, 01 May 2020 09:50:30 +0000 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. Full Article cystic fibrosis Europe Kalydeco Vertex Medical Communications Sales and Marketing
y COVID-19 pandemic likely to last two years, study says By www.pharmafile.com Published On :: Fri, 01 May 2020 10:53:09 +0000 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. Full Article coronavirus COVID-19 pandemic Medical Communications
y 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
y 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
y 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
y 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
y 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
y 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
y 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
y 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
y 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
y 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
y 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
y 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
y 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
y 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
y AstraZeneca partners with Oxford University on UK’s lead coronavirus vaccine By www.pmlive.com Published On :: Fri, 01 May 2020 12:50:48 +0100 AZ has pledged to make the vaccine at cost for the duration of the pandemic Full Article
y 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
y 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
y 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
y Sanofi, Regeneron set up another niche use for PD-1 drug Libtayo By www.pmlive.com Published On :: Wed, 06 May 2020 11:57:45 +0100 Drug has shown “clinically meaningful responses” for basal cell carcinoma Full Article
y 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
y 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
y 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
y 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
y Lannett to Be U.S. Distributor of Posaconazole Delayed-Release Tablets By www.thestreet.com Published On :: Wed, 28 Aug 2019 08:18:15 EDT Click to view a price quote on LCI. Full Article
y Oligonucleotide Therapeutics and Delivery Conference 2020 By www.pharmanews.eu Published On :: Wed, 22 Apr 2020 10:00:00 +0200 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. Full Article Featured Events
y 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
y 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
y 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
y Pre-filled Syringes San Francisco Conference 2020 By www.pharmanews.eu Published On :: Tue, 05 May 2020 12:00:00 +0200 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. Full Article Featured Events
y 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
y 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
y 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
y 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
y 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
y 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
y BRIEF—US court upholds Amgen Kyprolis patent By www.thepharmaletter.com Published On :: Tue, 05 May 2020 14:43:00 +0100 The US District Court in Delaware issued a decision upholding the validity of patent claims from three… Full Article Amgen/Biotechnology/Cipla/Focus On/Kyprolis/Legal/Oncology/Patents & Trademarks/USA
y Latest data show Libtayo beneficial in BCC trial By www.thepharmaletter.com Published On :: Tue, 05 May 2020 16:32:00 +0100 Positive top-line data for a pivotal, single-arm, open-label trial of PD-1 inhibitor Libtayo (cemiplimab)… Full Article Biotechnology/Drug Trial/France/Immuno-oncology/Libtayo/Oncology/Regeneron Pharmaceuticals/Research/Sanofi/USA
y US FTC clears AbbVie’s buy of Allergan, but with divestments By www.thepharmaletter.com Published On :: Wed, 06 May 2020 10:05:00 +0100 Almost a year after the original announcement, the US Federal Trade Commission (FTC) has accepted the… Full Article AbbVie/Allergan/Companies mergers and acquisitions/Endocrinology/Federal Trade Commission/Ireland/Legal/Management/Pancrelipase/Pharmaceutical/USA/Viokace/Zenpep
y BRIEF—Key appointments at Denmark’s Acesion Pharma By www.thepharmaletter.com Published On :: Wed, 06 May 2020 13:57:00 +0100 Danish drugmaker Acesion Pharma, which is focused on novel treatments for atrial fibrillation (AF), has… Full Article Acesion Pharma/Boardroom/Cardio-vascular/Denmark/Management/Pharmaceutical