english Remdesivir, check. Now, analysts are looking ahead to 'several' COVID-19 drugs to come By fiercepharma.com Published On :: Mon, 04 May 2020 15:22:41 +0000 Gilead made waves on Friday with its emergency FDA approval for remdesivir quickly on the heels of a controlled trial data release. But while it’s an important first step, other COVID-19 medicines will likely be coming down the line, analysts wrote. Full Article
english Fair price for Gilead's COVID-19 med remdesivir? $4,460, cost watchdog says By fiercepharma.com Published On :: Mon, 04 May 2020 15:09:09 +0000 While Gilead has yet to present a marketing plan for remdesivir—much less a price—ICER figures the COVID-19 drug could be cost-effective at up to $4,460 per patient. That means it could easily rake in blockbuster sales this year, at least theoretically. Full Article
english With the world waiting, Roche socks $459M into COVID-19 antibody test production By fiercepharma.com Published On :: Mon, 04 May 2020 15:05:01 +0000 Roche scored a major win with the FDA's backing for its COVID-19 antibody tests last week in a field marked by products of questionable quality. Now, to cover its booming production goals, Roche plans to infuse nearly half-a-billion dollars into its German manufacturing facility. Full Article
english Novartis taps real-life Cosentyx patients to thank healthcare workers, pledge patient support By fiercepharma.com Published On :: Sat, 02 May 2020 21:13:54 +0000 Novartis is using familiar faces—real patients from its Cosentyx TV commercials—to thank healthcare workers and promise support for patients. It’s a shift away from product-centered TV ads as Novartis adjusts its Cosentyx DTC effort during the COVID-19 crisis to highlight resources for patients, the drugmaker said. Full Article
english Gilead's remdesivir scores emergency FDA nod in COVID-19 days after big data reveal By fiercepharma.com Published On :: Fri, 01 May 2020 20:01:17 +0000 Days after U.S. officials reported the first positive controlled data for Gilead's remdesivir in COVID-19, the FDA has given the drug an emergency use authorization. Full Article
english AbbVie CEO: Don't worry, Allergan's aesthetics clients still have money—and 'strong desire' for treatment By fiercepharma.com Published On :: Fri, 01 May 2020 15:20:40 +0000 AbbVie may be working through COVID-19, but it's pressing ahead with its Allergan merger, too—and taking stock of products hit by pandemic lockdowns. That puts Allergan’s aesthetics business top of mind, but AbbVie CEO Rick Gonzalez figures customers are ready and able to return quickly for treatment. Full Article
english Gilead in talks to expand COVID-19 hopeful remdesivir supply chains with outside partner By 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
english NICE gives thumbs-up to Roche's Kadcyla in HER2+ breast cancer sub-population By 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
english Black people are four times more likely to die from COVID-19 than white in England and Wales, ONS report shows By 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
english FDA approval for Tabrecta in metastatic non-small cell lung cancer with METex14 By 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
english UK becomes first European country to pass 30,000 deaths from COVID-19 By 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
english Scientists in the UK and US identify hundreds of mutations in the COVID-19 virus By 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
english South Korea says Ebola drug remdesivir may not be suitable for all coronavirus patients By 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
english AZ's Farxiga becomes first FDA-approved SGLT2 inhibitor for heart failure with reduced ejection fraction By 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
english Portola Pharmaceuticals to merge with Alexion in $1.41bn cash deal By 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
english Pharmafile.com's weekly COVID-19 news round-up By 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
english Ousted chief of BARDA says Trump administration ignored COVID-19 warnings By 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
english Jonathan Freve joins Galecto as Chief Financial Officer By 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
english First French case of COVID-19 occurred in December, a month earlier than previously thought By 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
english Scientists in Kenya discover microbe that could stop transmission of malaria By 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
english MHRA launches new pharmacovigilance reporting platform for COVID-19 treatments By 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
english UK contact-tracing app being tested on the Isle of Wight By 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
english Sanofi and Regeneron's Libtayo shows durable responses in world's most common skin cancer By 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
english Working Life Interview: Kim Stratton, CEO, Orphazyme By 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
english Lonza and Moderna enter agreement to mass produce coronavirus vaccine By 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
english FDA approves emergency use of Gilead's remdesivir for hospitalised COVID-19 patients By 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
english Trump vows to reduce America’s reliance on foreign drug imports By 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
english UK testing experimental treatment for use in COVID-19 patients By 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
english Mike Pompeo says there is evidence COVID-19 was made in a lab, despite US intelligence saying it occurred naturally By 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
english NHS sets out plans to deal with the second phase of the pandemic By 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
english Positive CHMP opinion for BMS and Acceleron's Reblozyl in transfusion-dependent anaemia sub-populations By 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
english COVID-19 pandemic likely to last two years, study says By 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
english Vertex's Kalydeco seizes EU CHMP recommendation for Kalydeco in R117H+ cystic fibrosis By 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
english Top Ten most popular articles on Pharmafile.com this week By 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
english Teva’s cancer drug Bendeka protected from generics until 2031, judge rules By 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
english AstraZeneca joins forces with University of Oxford to develop and manufacture potential coronavirus vaccine By 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
english More than half of US states will relax lockdowns by the end of the week By 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
english Two studies reveal "positive" data for Gilead's remdesivir in hospitalised COVID-19 patients By 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
english Men most likely to exhibit the worst COVID-19 symptoms, according to a new study By 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
english Arizona GOP lawmakers and AAPS say hydroxychloroquine has 90% chance of helping COVID-19 patients, but data is not based on clinical trials By 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
english Phase 3 Libtayo monotherapy trial halted early due to strong benefit in advanced non-small cell lung cancer By 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
english Australia calls for investigation into China’s coronavirus response By 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
english Pharmafile.com's weekly COVID-19 news round-up By 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
english EU approval for Novartis' Cosentyx in active non-radiographic axial spondyloarthritis By 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
english Nearly half of Americans believe COVID-19 was created in a lab, according to a new survey By 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
english The May 2020 issue of Pharmafocus is available to read free online now! By 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
english NICE backtracks to approve Janssen's Stelara in ulcerative colitis By 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
english South Korean researchers start testing pancreatitis drug in COVID-19 patients By 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
english 12 British children hospitalised with rare condition linked to COVID-19 By 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
english Reinventing the value equation By 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