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Remdesivir, check. Now, analysts are looking ahead to 'several' COVID-19 drugs to come

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.




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Fair price for Gilead's COVID-19 med remdesivir? $4,460, cost watchdog says

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.




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With the world waiting, Roche socks $459M into COVID-19 antibody test production

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. 




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Novartis taps real-life Cosentyx patients to thank healthcare workers, pledge patient support

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.




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Gilead's remdesivir scores emergency FDA nod in COVID-19 days after big data reveal

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.




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AbbVie CEO: Don't worry, Allergan's aesthetics clients still have money—and 'strong desire' for treatment

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.




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Gilead in talks to expand COVID-19 hopeful remdesivir supply chains with outside partner

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. 




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NICE gives thumbs-up to Roche's Kadcyla in HER2+ breast cancer sub-population

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.




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Black people are four times more likely to die from COVID-19 than white in England and Wales, ONS report shows

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.




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FDA approval for Tabrecta in metastatic non-small cell lung cancer with METex14

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.




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UK becomes first European country to pass 30,000 deaths from COVID-19

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.




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Scientists in the UK and US identify hundreds of mutations in the COVID-19 virus

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.




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South Korea says Ebola drug remdesivir may not be suitable for all coronavirus patients

South Korea says that remdesivir, traditionally used in treating Ebola, may not be effective enough in treating COVID-19 patients.




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AZ's Farxiga becomes first FDA-approved SGLT2 inhibitor for heart failure with reduced ejection fraction

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.




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Portola Pharmaceuticals to merge with Alexion in $1.41bn cash deal

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.




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Pharmafile.com's weekly COVID-19 news round-up

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.




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Ousted chief of BARDA says Trump administration ignored COVID-19 warnings

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.




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Jonathan Freve joins Galecto as Chief Financial Officer

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.  

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  • Manufacturing and Production

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First French case of COVID-19 occurred in December, a month earlier than previously thought

A French patient who suffered from pneumonia in December actually had COVID-19, it has been revealed.




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Scientists in Kenya discover microbe that could stop transmission of malaria

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.




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MHRA launches new pharmacovigilance reporting platform for COVID-19 treatments

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.




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UK contact-tracing app being tested on the Isle of Wight

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.




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Sanofi and Regeneron's Libtayo shows durable responses in world's most common skin cancer

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.




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Working Life Interview: Kim Stratton, CEO, Orphazyme

"Every professional faces challenges. As a woman in industry, particularly in leadership, it adds another dimension to those challenges in how you present yourself."




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Lonza and Moderna enter agreement to mass produce coronavirus vaccine

Lonza Group AG and Moderna Inc have entered a deal to develop 1 billion doses of coronavirus vaccines a year.




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FDA approves emergency use of Gilead's remdesivir for hospitalised COVID-19 patients

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.




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Trump vows to reduce America’s reliance on foreign drug imports

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.




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UK testing experimental treatment for use in COVID-19 patients

British scientists are testing an experimental drug to help some of society’s most vulnerable fight off the COVID-19 coronavirus.




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Mike Pompeo says there is evidence COVID-19 was made in a lab, despite US intelligence saying it occurred naturally

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.




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NHS sets out plans to deal with the second phase of the pandemic

The NHS has set out plans to step up its non-COVID-19 services over the next six weeks.




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Positive CHMP opinion for BMS and Acceleron's Reblozyl in transfusion-dependent anaemia sub-populations

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.




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COVID-19 pandemic likely to last two years, study says

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.




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Vertex's Kalydeco seizes EU CHMP recommendation for Kalydeco in R117H+ cystic fibrosis

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.




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Top Ten most popular articles on Pharmafile.com this week

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.




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Teva’s cancer drug Bendeka protected from generics until 2031, judge rules

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.




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AstraZeneca joins forces with University of Oxford to develop and manufacture potential coronavirus vaccine

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.



  • Research and Development
  • Manufacturing and Production

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More than half of US states will relax lockdowns by the end of the week

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.




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Two studies reveal "positive" data for Gilead's remdesivir in hospitalised COVID-19 patients

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.




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Men most likely to exhibit the worst COVID-19 symptoms, according to a new study

Research into coronavirus cases in Shenzhen, China found that men were 2.5 times as likely to exhibit severe symptoms.




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Arizona GOP lawmakers and AAPS say hydroxychloroquine has 90% chance of helping COVID-19 patients, but data is not based on clinical trials

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.




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Phase 3 Libtayo monotherapy trial halted early due to strong benefit in advanced non-small cell lung cancer

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.




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Australia calls for investigation into China’s coronavirus response

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.




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Pharmafile.com's weekly COVID-19 news round-up

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.”




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EU approval for Novartis' Cosentyx in active non-radiographic axial spondyloarthritis

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.




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Nearly half of Americans believe COVID-19 was created in a lab, according to a new survey

Almost half of Americans believe that the coronavirus was created in a lab, according to an April survey of 6,300 people.




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The May 2020 issue of Pharmafocus is available to read free online now!

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.




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NICE backtracks to approve Janssen's Stelara in ulcerative colitis

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.




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South Korean researchers start testing pancreatitis drug in COVID-19 patients

The South Korean Ministry of Food and Drug Safety have approved a local trial to evaluate nafamostat’s effectiveness in COVID-19 patients.




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12 British children hospitalised with rare condition linked to COVID-19

12 children have fallen ill across the UK with a new and potentially fatal combination of symptoms linked to COVID-19.




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Reinventing the value equation

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.