in The hunt for a coronavirus vaccine – a perilous and uncertain path By www.theguardian.com Published On :: 2020-04-24T12:04:19Z The pressing need to find a solution to the pandemic means risks and shortcuts may have to be takenCoronavirus – latest updatesSee all our coronavirus coverageThe stakes could hardly be higher; the prize still tantalisingly out of reach. It is no exaggeration to say that the fate of many millions of people rests on the discovery of a vaccine for Covid-19 – the only sure escape route from the pandemic.Yet the optimism that accompanied the launch of Oxford University’s human trials this week has to be put in context, and the hurdles facing the scientists need to be understood. Continue reading... Full Article Coronavirus outbreak Infectious diseases Medical research Microbiology Science World news Research Pharmaceuticals industry Higher education Education Business UK news Vaccines and immunisation Health Society
in US stays away as world leaders agree action on Covid-19 vaccine By www.theguardian.com Published On :: 2020-04-24T16:55:50Z Video meeting seen as global endorsement of WHO and sign of Trump’s isolation on world stageCoronavirus – latest updatesSee all our coronavirus coverageGlobal leaders have pledged to accelerate cooperation on a coronavirus vaccine and to share research, treatment and medicines across the globe. But the United States did not take part in the World Health Organization initiative, in a sign of Donald Trump’s increasing isolation on the global stage.The cooperation pledge, made at a virtual meeting, was designed to show that wealthy countries will not keep the results of research from developing countries. Related: The hunt for a coronavirus vaccine – a perilous and uncertain path Related: ‘Please don’t inject bleach’: Trump’s wild coronavirus claims prompt disbelief Provide access to new treatments, technologies and vaccines across the world.Commit to an unprecedented level of international partnership on research and coordinate efforts to tackle the pandemic and reduce infections.Reach collective decisions on responding to the pandemic, recognising that the virus’s spread in one country can affect all countries.Learn from experience and adapt the global response.Be accountable, to the most vulnerable communities and the whole world. Continue reading... Full Article Coronavirus outbreak World Health Organization United Nations Emmanuel Macron Angela Merkel Donald Trump Health Infectious diseases Medical research Microbiology US news World news US foreign policy G20 G7 Bill Gates China UK news Pharmaceuticals industry Science
in We're desperate for a coronavirus cure, but at what cost to the human guinea pigs? | Kenan Malik By www.theguardian.com Published On :: 2020-04-26T07:00:07Z Big drugs companies have long favoured outsourcing clinical trials to poor countries with lax regulations to cut costs and maximise profit• Coronavirus latest updates• See all our coronavirus coverageLast week, in Oxford, the first volunteers in the first European human trial were injected with a potential coronavirus vaccine. At the same time, Pakistan’s National Institute of Health received an offer from the Chinese pharmaceutical firm Sinopharm International Corp to take part in a trial of another potential coronavirus vaccine. Related: Africa's Covid-19 research must be tailored to its realities – by its own scientists | Monique Wasunna In India, many poor people were recruited to HIV trials without knowing that they were taking part in experiments Continue reading... Full Article Coronavirus outbreak Medical research Pharmaceuticals industry Infectious diseases Aids and HIV Microbiology Business Biology Science World news
in Remdesivir: early findings on experimental coronavirus drug offer 'quite good news' By www.theguardian.com Published On :: 2020-04-29T21:58:54Z Preliminary results of US government trial show patients who received drug recovered faster than othersHopes of an effective drug treatment for coronavirus patients have risen following positive early results from a trial of remdesivir, a drug first tried in Ebola patients.Data from the trial on more than 1,000 severely ill patients in 75 hospitals around the world show that patients put on the drug recovered 31% faster than similar patients who were given a placebo drug instead. Remdesivir cut recovery time from a median of 15 days to 11. Related: World's stock markets soar on coronavirus treatment hopes Continue reading... Full Article Coronavirus outbreak Pharmaceuticals industry US news Infectious diseases Science Medical research World news
in Covid-19 could mark a deadly turn in Ghana's fight against fake drugs By www.theguardian.com Published On :: 2020-04-30T08:00:15Z With substandard medicines already in wide circulation, fears are growing that coronavirus could create a lethal ‘parallel crisis’When Joana Opoku-Darko’s daughter Anna was 18 months old, she came down with malaria, a disease common in Ghana and especially deadly for children.She bought medication from a pharmacy in Ghana’s capital, Accra; when Anna’s fever didn’t subside she took her to a hospital, where they ran some tests.The current focus on curbing Covid-19 spread means there is less focus on routine market surveillance Related: Fight the fakes: how to beat the $200bn medicine counterfeiters | Helen Lock Continue reading... Full Article Global health Ghana Global development Health Pharmaceuticals industry Healthcare industry Society World news Africa
in Promising drug against Covid-19 unlikely to be available in UK soon By www.theguardian.com Published On :: 2020-04-30T16:50:55Z Trial of remdesivir shows fewer deaths and shorter hospital staysCoronavirus – latest updatesSee all our coronavirus coverageThe first drug against Covid-19 to show promise in trials, reducing the time seriously ill people take to recover in hospital, is unlikely to be available widely in the UK soon, it has emerged.Forty-six people in the UK have received remdesivir as part of the European arm of an international trial. Researchers would like to have given the drug to more patients but did not have the supplies. Related: Coronavirus: what do scientists know about Covid-19 so far? Continue reading... Full Article Medical research Health Pharmaceuticals industry Coronavirus outbreak Science UK news Society
in AstraZeneca partners with Oxford University to produce Covid-19 vaccine By www.theguardian.com Published On :: 2020-04-30T16:50:57Z Drugmaker will manufacture and distribute vaccine if human trials are successfulCoronavirus – latest updatesSee all our coronavirus coverageAstraZeneca, the Cambridge-based pharmaceutical group, is teaming up with Oxford University to manufacture and distribute a coronavirus vaccine if clinical trials currently under way show it is effective.News of the partnership boosted AstraZeneca’s share price, helping it to become Britain’s most valuable company by market capitalisation. Related: The hunt for a coronavirus vaccine – a perilous and uncertain path Continue reading... Full Article AstraZeneca Pharmaceuticals industry Vaccines and immunisation Coronavirus outbreak UK news Business University of Oxford Research Medical research
in The promise of an Oxford vaccine reveals how a new Britain could thrive | Will Hutton By www.theguardian.com Published On :: 2020-05-03T06:45:44Z The partnership between AstraZeneca and the Jenner Institute should jolt our industry and banksCoronavirus latest updatesSee all our coronavirus coverageThere was some good news last week. Oxford University’s Jenner Institute announced it was teaming up with AstraZeneca to take a promising prototype of coronavirus vaccine into volume production by the autumn. Of course there are caveats – the institute’s confidence in its vaccine may not be validated by the trials that began last week.Still it was heartening, after so much tragic incompetence, that a British university and a British company could forge a relationship of such potential national importance.The piping through which emergency credit must flow is atrophied and weak Continue reading... Full Article Coronavirus outbreak Infectious diseases Medical research Microbiology Biology Science AstraZeneca University of Oxford Pharmaceuticals industry Banking Business UK news
in Leading COVID-19 hope remdesivir fails to provide clinical benefit in first randomised trial By www.pharmafile.com Published On :: Fri, 24 Apr 2020 11:29:51 +0000 Gilead’s remdesivir, which has been hailed as one of the few truly promising treatments for COVID-19 at this early stage of the ongoing pandemic, has failed in its first randomised clinical trial, leaked data has revealed. Full Article coronavirus COVID-19 Gilead pharma remdesivir Research and Development Medical Communications
in European Medicines Agency’s review of Picato finds its risks outweigh its benefits By www.pharmafile.com Published On :: Fri, 24 Apr 2020 12:12:33 +0000 The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the risks from using Picato are too high to end its suspension. Full Article Medical Communications Sales and Marketing
in FDA urges close monitoring of COVID-19 patients treated with hydroxychloroquine By www.pharmafile.com Published On :: Mon, 27 Apr 2020 08:37:56 +0000 The FDA has released a safety communication reiterating the need for doctors to closely monitor COVID-19 patients who are treated with either hydroxychloroquine or chloroquine. Full Article chloroquine coronavirus COVID-19 FDA hydroxychloroquine Sales and Marketing
in ‘Excess deaths’ in England among the highest in Europe By www.pharmafile.com Published On :: Mon, 27 Apr 2020 09:51:21 +0000 English excess deaths from the coronavirus are comparable to the worst hit countries in Europe, according to a Sky News analysis. Full Article coronavirus COVID-19 deaths pandemic Sales and Marketing
in Researchers studying heartburn drug as potential coronavirus treatment By www.pharmafile.com Published On :: Mon, 27 Apr 2020 10:42:23 +0000 Researchers in America have been studying famotidine, the active ingredient in Pepcid, as a potential treatment for COVID-19. Full Article coronavirus COVID-19 pandemic Pepcid Sales and Marketing
in Italy to relax COVID-19 lockdown in early May By www.pharmafile.com Published On :: Mon, 27 Apr 2020 11:35:23 +0000 Italy has outlined its plans to ease the lockdown restrictions that were implemented across the country 7 weeks ago to combat the COVID-19 coronavirus pandemic. Full Article coronavirus COVID-19 COVID-19 coronavirus Italy Sales and Marketing
in Sanofi's Meningococcal Conjugate Vaccine secures FDA approval in patients aged two and up By www.pharmafile.com Published On :: Mon, 27 Apr 2020 11:58:57 +0000 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. Full Article FDA meningococcal disease MenQuadfi pharma Sanofi US Sales and Marketing
in Reinventing the value equation By www.pharmafile.com Published On :: Mon, 27 Apr 2020 12:06:41 +0000 There is a duty to ensure access to innovative treatments for patients with unmet need, but a health service gatekeeper must commit to efficient use of limited resources. Matt Fellows looks at how real-world evidence could be the key to reassessing how we determine the value of these drugs and ensure their swift availability. Full Article Drug pricing feature real-world data real-world evidence Research and Development Medical Communications Sales and Marketing Business Services Manufacturing and Production
in 12 British children hospitalised with rare condition linked to COVID-19 By www.pharmafile.com Published On :: Tue, 28 Apr 2020 09:25:30 +0000 12 children have fallen ill across the UK with a new and potentially fatal combination of symptoms linked to COVID-19. Full Article coronavirus COVID-19 NHS NHS UK Manufacturing and Production
in South Korean researchers start testing pancreatitis drug in COVID-19 patients By www.pharmafile.com Published On :: Tue, 28 Apr 2020 10:19:05 +0000 The South Korean Ministry of Food and Drug Safety have approved a local trial to evaluate nafamostat’s effectiveness in COVID-19 patients. Full Article coronavirus COVID-19 Pancreas Pancreatitis Manufacturing and Production
in NICE backtracks to approve Janssen's Stelara in ulcerative colitis By www.pharmafile.com Published On :: Tue, 28 Apr 2020 10:20:00 +0000 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. Full Article Janssen NICE Research and Development Stelara ulcerative colitis Manufacturing and Production
in 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
in 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
in 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
in Australia calls for investigation into China’s coronavirus response By www.pharmafile.com Published On :: Wed, 29 Apr 2020 11:24:41 +0000 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. Full Article Australia China coronavirus COVID-19 Research and Development
in 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
in 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
in 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
in Two studies reveal "positive" data for Gilead's remdesivir in hospitalised COVID-19 patients By www.pharmafile.com Published On :: Thu, 30 Apr 2020 10:12:25 +0000 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. Full Article coronavirus COVID-19 Gilead remdesivir Research and Development
in 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
in 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
in 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
in 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
in 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
in Lonza and Moderna enter agreement to mass produce coronavirus vaccine By www.pharmafile.com Published On :: Mon, 04 May 2020 11:43:10 +0000 Lonza Group AG and Moderna Inc have entered a deal to develop 1 billion doses of coronavirus vaccines a year. Full Article coronavirus COVID-19 Sales and Marketing
in 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
in 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
in UK contact-tracing app being tested on the Isle of Wight By www.pharmafile.com Published On :: Tue, 05 May 2020 09:58:21 +0000 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. Full Article coronavirus COVID-19 Manufacturing and Production
in 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
in 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
in 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
in Jonathan Freve joins Galecto as Chief Financial Officer By www.pharmafile.com Published On :: Tue, 05 May 2020 16:50:41 +0000 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. read more Full Article Manufacturing and Production
in 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
in 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
in 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
in 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
in 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
in 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
in 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
in 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
in 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
in 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