t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t Teva’s cancer drug Bendeka protected from generics until 2031, judge rules By www.pharmafile.com Published On :: Thu, 30 Apr 2020 11:20:42 +0000 A US federal judge has ruled that generic versions of the cancer treatment Bendeka infringe on four separate patents, and has delayed them from launching until 2031. Full Article Bendeka Teva Teva and Eagle Business Services
t Top Ten most popular articles on Pharmafile.com this week By www.pharmafile.com Published On :: Fri, 01 May 2020 09:27:14 +0000 The search for a COVID-19 treatment has ramped up this week, with two new studies detailing the efficacy of Gilead’s antiviral therapy remdesivir in the treatment of patients hospitalised with coronavirus, while researchers in America have been studying famotidine, the active ingredient in Pepcid, as a potential drug to help alleviate symptoms of the virus. Full Article coronaviurs COVID-19 Gilead Research and Development UK Medical Communications Sales and Marketing Business Services Manufacturing and Production
t 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
t 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
t 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
t NHS sets out plans to deal with the second phase of the pandemic By www.pharmafile.com Published On :: Fri, 01 May 2020 11:38:50 +0000 The NHS has set out plans to step up its non-COVID-19 services over the next six weeks. Full Article coronavirus COVID-19 Medical Communications
t 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
t 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
t Trump vows to reduce America’s reliance on foreign drug imports By www.pharmafile.com Published On :: Mon, 04 May 2020 11:12:58 +0000 President Donald Trump has vowed to cut the US’s reliance on foreign drugs, singling out China and Ireland as countries he wants to stop buying pharmaceuticals from. Full Article coronavirus COVID-19 Sales and Marketing
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t 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
t Coronavirus contact-tracing app trial to begin on the Isle of Wight By www.pmlive.com Published On :: Wed, 06 May 2020 12:06:00 +0100 Initial roll-out will see key workers utilise the app Full Article
t US trials of Pfizer/BioNTech coronavirus vaccine start By www.pmlive.com Published On :: Wed, 06 May 2020 12:16:48 +0100 It is hoped that the drug may prevent COVID-19 Full Article
t 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
t FTC clears AbbVie’s $63bn Allergan takeover By www.pmlive.com Published On :: Thu, 07 May 2020 15:48:00 +0100 US regulator satisfied that antitrust concerns are remediated Full Article