New data on Gilead’s remdesivir, released by accident, show no benefit for coronavirus patients. Company still sees reason for hope

first_img [email protected] Related: Senior Writer, Medicine, Editorial Director of Events Matthew covers medical innovation — both its promise and its perils. The antiviral medicine remdesivir from Gilead Sciences failed to speed the improvement of patients with Covid-19 or prevent them from dying, according to results from a long-awaited clinical trial conducted in China. Gilead, however, said the data suggest a “potential benefit.”A summary of the study results was inadvertently posted to the website of the World Health Organization and seen by STAT on Thursday, but then removed.“A draft manuscript was provided by the authors to WHO and inadvertently posted on the website and taken down as soon as the mistake was noticed. The manuscript is now undergoing peer review and we are waiting for a final version before WHO comments on it,” said WHO spokesperson Daniela Bagozzi.advertisement Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Ed Silverman @matthewherper Many studies are being run to test remdesivir, and this one will not be the final word. Results are expected soon from a Gilead-run study in severe Covid-19 patients, although that study may be difficult to interpret because the drug is not compared to patients receiving only standard treatment. Encouraging data from patients in that study at the University of Chicago were described by researchers at a virtual town hall and obtained by STAT last week. However, unlike those data, these new results are from a randomized controlled trial, the medical gold standard.Gilead is also running a study with a control group in more moderate Covid-19 patients, and the National Institute of Allergy and Infectious Diseases is running a study that compares remdesivir to placebo. There are even more studies of the drug ongoing.According to the summary of the China study, remdesivir was “not associated with a difference in time to clinical improvement” compared to a standard of care control. After one month, it appeared 13.9% of the remdesivir patients had died compared to 12.8% of patients in the control arm. The difference was not statistically significant.“In this study of hospitalized adult patients with severe COVID-19 that was terminated prematurely, remdesivir was not associated with clinical or virological benefits,” the summary states. The study was terminated prematurely because it was difficult to enroll patients in China, where the number of Covid-19 cases was decreasing.An outside researcher said that the results mean that any benefit from remdesivir is likely to be small.“If there is no benefit to remdesivir in a study this size, this suggests that the overall benefit of remdesivir in this population with advanced infection is likely to be small in the larger Gilead trial,” said Andrew Hill, senior visiting research fellow at Liverpool University.He added that the results of the study should be pooled with larger studies being conducted by Gilead using a technique called meta-analysis to allow for “a balanced view of the efficacy of remdesivir from all randomized trials.” Please enter a valid email address. Matthew Herper Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. Adam Feuerstein [email protected] Tags Coronaviruscenter_img Bottles of remdesivir in a hospital for Covid-19 patients in Wuhan, China. FeatureChina via AP Leave this field empty if you’re human: STAT contacted the lead investigator of the study but did not receive an immediate response.As originally designed, the China study was meant to enroll 453 patients. The patients were allowed to enter the study up to 12 days from the onset of Covid-19 symptoms. Once enrolled, the patients were randomized in a double-blind fashion and were treated with daily infusions of remdesivir or a placebo for 10 days.The primary goal is to show that the drug is better than placebo at improving symptoms within 28 days. That improvement is measured with a six-point scoring system ranging from hospital discharge (a score of 1) to death (a score of 6). In order to count as someone who responded to the drug, a patient must improve by at least two points. Patients can remain hospitalized at the end of the 28-day period of the clinical trial but still improve enough clinically — no longer needing intubation or supplemental oxygen, for example — to count as a responder.According to the abstract, 158 patients received remdesivir and 79 patients were in the control arm; one patient in the control arm withdrew before receiving treatment. The abstract said that for time to clinical improvement, the hazard ratio was 1.23, which would normally mean the patients on remdesivir improved more slowly than those in the control group.However, in a previous note to investors preparing them for the data, Umer Raffat, a biotech analyst at Evercore ISI, had said to expect the opposite arrangement: that a hazard ratio of 1.2 would show patients were doing better. It is not certain how the hazard ratio is being described in the abstract.Whether or not the drug benefit is trending in a positive or negative direction, the difference described in the abstract is not statistically significant, meaning that the study failed.There are differences in the enrollment criteria of Covid-19 patients and the way remdesivir is being used that make extrapolating results from this China study to the ongoing studies difficult. Flood, the Gilead spokesperson, said the company regrets that “the WHO prematurely posted information regarding the study, which has since been removed” and emphasized that the researchers running the study “did not provide permission for publication of results.” She said the data are expected to be published in a peer-reviewed journal soon.A screenshot from the WHO website. Screen capture The coronavirus pandemic could shrink some biotech startup valuations  Senior Writer, Biotech Adam is STAT’s national biotech columnist, reporting on the intersection of biotech and Wall Street. He’s also a co-host of “The Readout LOUD” podcast. Privacy Policy By Ed Silverman , Adam Feuerstein , and Matthew Herper April 23, 2020 Reprints BiotechNew data on Gilead’s remdesivir, released by accident, show no benefit for coronavirus patients. Company still sees reason for hope @adamfeuerstein [email protected] About the Authors Reprints @Pharmalot Gilead spokesperson Amy Flood said the company believes “the post included inappropriate characterization of the study.” Because the study was stopped early because it had too few patients, she said, it cannot “enable statistically meaningful conclusions.” However, she said, “trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease.”The data (for details, see screenshot below) will be closely scrutinized but are also likely imperfect. The study was terminated prematurely, which could have affected the results. The context that would be provided by a full manuscript is missing, and the data have not been reviewed as normally occurs before publication.advertisementlast_img read more

Portuguese trains again with Levski – BG Football – efbet League

first_imgPortuguese right-back Claudio Tavares made a second training session with the team of Levski, which is preparing for its visit to Montana in a match of the 4th round of the efbet League. Tavares has been rehearsing for several days at Gerena.Valeri Bozhinov, Atanas Kurdov, Alex Petkov and Borislav Tsonev continue to train with the team of the “blues”. They have no contracts with the team.Today Simeon Slavchev leads independent activities, and Nigel Roberta was out of the group. Follow us anywhere and anytime with the mobile application of Gong.bg. You can download it from Google Play, App Store and AppGallery.last_img read more

Revealed: The 25 clubs with the most expensive squads in Europe

first_img 25 25 25 Premier League clubs have set a new spending record in 2017/18, after the £430m outlay in the recent January window followed the staggering £1.4bn spent last summer. It should come as little surprise then that so many English sides feature in the top 25 list of the the most expensively-assembled squads in European football.So vast are the riches in the Premier League that the findings – released by the CIES Football Observatory – reveal that relegation-threatened Crystal Palace’s squad cost more than Serie A high-fliers Napoli.Everton, meanwhile, have incredibly outspent German giants Bayern Munich to fund their new-look team.Check out the top 25 most expensive squads in Europe, and find out who has spent the most, by clicking through the gallery above. 23. Wolfsburg (Bundesliga) – £144m has been spent on their squad. 25 7. Liverpool (Premier League) £408m has been spent on their squad. 2. Paris Saint-Germain (Ligue 1) – £713m has been spent on their squad. 22. West Ham (Premier League) – £157m has been spent on their squad. 25 25 17. Roma (Serie A) – £231m has been spent on their squad. 9. Arsenal (Premier League) – £356m has been spent on their squad. 4. Barcelona (LaLiga) – £641m has been spent on their squad. 18. Southampton (Premier League) – £202m has been spent on their squad. 11. Bayern Munich (Bundesliga) – £321m has been spent on their squad. 3. Manchester United (Premier League) – £661m has been spent on their squad. 25 25 25 25 5. Chelsea (Premier League) – £524m has been spent on their squad. 25 16. Borussia Dortmund (Bundesliga) – £237m has been spent on their squad. 14. Atletico Madrid (LaLiga) – £263m has been spent on their squad. 8. Juventus (Serie A) – £396m has been spent on their squad. 13. AC Milan (Serie A) – £269m has been spent on their squad. 25 25 25. Sevilla (LaLiga) – £141m has been spent on their squad, making it the 25th most expensively-assembled in European football. Click right to find out who is next in the list. 25 25 10. Everton (Premier League) – £323m has been spent on their squad. 25 15. Monaco (Ligue 1) – £253m has been spent on their squad. 20. Inter Milan (Serie A) – £192m has been spent on their squad. 25 19. Crystal Palace (Premier League) – £199m has been spent on their squad. 25 1. Manchester City (Premier League) – £777m has been spent on their squad. 21. Napoli (Serie A) – £180m has been spent on their squad. 25 25 24. Leicester City (Premier League) – £143m has been spent on their squad. 25 6. Real Madrid (LaLiga) – £439m has been spent on their squad. 25 25 25 25 12. Tottenham (Premier League) – £316m has been spent on their squad. last_img read more

Enterprise Software: Analysts Predict Enterprise Software business will Skid Lower

first_imgThe same day that Oracle is touting itself as the world’s largest Enterprise Software company, Merrill Lynch gave the enterprise software space thumbs down.After factoring in the overall economic outlook and slow growth performance from the first quarter, Merrill Lynch predicted lower sales for the industry in the coming quarter. The report terms enterprise software as an area of ‘discretionary’ spending that businesses would seek to minimize if the economy takes a turn for the worse.The report cited Oracle and Microsoft as two companies that they see vulnerable to this trend. Merrill Lynch lowered their rating on both companies from a “buy”.Merrill saw the financial industry as a key sales target for many Enterprise Companies, and after a few troubling weeks in the financial industry, the pain could trickle down to vendors who serve these markets.Oracle has strong ties into the financial industry, so this could cause them a problem. Merrill also worried that Oracle has been beating estimates so consistently that they may have become overvalued and put onto an unsustainable path. Merrill also sees Microsoft’s heavily exposed to consumer spending — and the worry now is that this Christmas season may be slow time for spending.Along with Microsoft and Oracle, Merrill also downgraded Red Hat, Sybase, Taleo, and Concur Technologies. Software companies that Merrill continues to value include VMWare, Salesforce.com, BladeLogic, and Lawson.Big internet companies aren’t feeling the same pain as enterprise software vendors. Another report shows that in Q3 2007 that the four internet giants Amazon, Yahoo!, Google and eBay collectively added 5600 jobs.last_img read more

Referee Uniform Update

first_imgTouch Football Australia (TFA) has been working toward the redevelopment of our community and elite referee uniforms for implementation this year.Consultation has now been worked through with a cross section of the referee community to which we are extremely grateful for their contribution.The uniform design has been developed with the consideration for current requirements of the community as well as looking to streamline the costs associated with participation at various levels. To that end there will be alignment between the social level and elite so that there is no requirement for multiple purchases therefore alleviating a level of expense.We recognise the time, energy and effort of our referee base therefore we hope this assists.With any change process there will be complications and TFA is mindful of how this is managed so current stock or purchases are not seen as an extra expense.  TFA will be placing the order for community level in the near future and will compliment this with specials on the outgoing uniform.We understand this may have some issues over the next few months as stock runs down and therefore ask for your understanding as we are looking to manage this effectively and in the most cost efficient manner.We hope you like the upgrade and look forward to seeing you on the park soon.To view the new uniform, please visit the TFA Facebook page – www.facebook.com/touchfootballaustralia. This article was first placed on the TFA website on Monday, 6 August 2012.Related Filestfa_community_referee_uniforms_-jpgRelated LinksReferee Uniformlast_img read more

Jim Harbaugh Bends NCAA Rules During High School Visit

first_imgHead coach Jim Harbaugh of the Michigan Wolverines blows whistle before start of the game.EAST LANSING, MI – OCTOBER 29: Head coach Jim Harbaugh of the Michigan Wolverines looks on during warm ups prior to playing the Michigan State Spartans at Spartan Stadium on October 29, 2016 in East Lansing, Michigan. (Photo by Gregory Shamus/Getty Images)High school juniors aren’t allowed to take photos with college football coaches, per NCAA rules. Michigan’s Jim Harbaugh appears to have found a way around that.In the below photo, taken at Detroit Jesuit, four students (we’re not sure if any are even recruits) lined up in the background while Harbaugh stared in another direction. Technically, they aren’t posing with Harbaugh.NCAA rules states that juniors can’t take photos with college coaches. So we got in the back ground @CoachJim4UM pic.twitter.com/nkgHGHqxJO— Nacho Libre (@jackrobruce) January 14, 2016Harbaugh appears to be hitting the recruiting trail hard. Look out, Big Ten.last_img read more

Canfor extends curtailment at Taylor mill

first_imgCombined, the summer curtailments will reduce third-quarter pulp production by an estimated 75,000 tonnes of NBSK pulp and 50,000 tonnes of BCTMP, respectively.Canfor believes global inventories will move towards a more balanced range at the end of 2019.  “Towards the end of 2019 and into 2020, global inventory levels are forecast to move towards a more balanced range reflecting a gradual drawdown of inventory that will include the anticipated impact of the conversion to dissolving pulp of two large NBSK pulp mills outside of North America by the end of 2019, as well as production curtailments.”Maintenance outages are also scheduled at the Prince George NBSK pulp mill and at the company’s paper mill in September 2019, with a projected 6,000 tonnes of reduced NBSK pulp production and 4,000 tonnes of reduced paper production, respectively. TAYLOR, B.C. – Canfor has extended the curtailment at it’s Taylor bleached chemi-thermomechanical pulp (BCTMP) mill by another five weeks.In June the company announced a curtailment from June 29 through to August 5, 2019, due to a combination of weaker market conditions and short-term fibre constraints resulting from industry-wide sawmill curtailments in the BC Interior.The new extended curtailment will last until September 9, 2019.  Canfor also announced a further reduction at it’s Northwood northern bleached softwood kraft (NBSK) mill in Prince George, B.C.last_img read more

Man wanted on Canada-wide warrant could be in Dawson Creek

first_imgDAWSON CREEK, B.C. – The RCMP is trying to find a wanted man from Kelowna that is believed to be in Dawson Creek.The RCMP is asking for the public’s help to find 45-year-old Jeremiah James Miller from Kelowna. Miller is wanted on a Canada-wide arrest warrant for suspension of statutory release.Police believe Miller is in the Dawson Creek area. Jeremiah Miller is described as a First Nations male, he stands 5 ft 9 in (175 cm) tall, weighs approximately 196 lbs (89 kg), and has black hair and brown eyes.Anyone with information on the current whereabouts of Jeremiah Miller is asked to contact their local police immediately or if necessary dial 911. The public can also share their tip information anonymously by calling Crime Stoppers at 1-800-222-8477.last_img read more

Sweet Faraali PancakesSweet Faraali Pancakes

first_imgIngredients Sanwa Millet 1 cup Buckwheat 1/2 cup Grated Coconut 1 cup Grated Jaggery 1/2 cup Mashed Banana 1/2 cup Rock Salt a pinch Cardamom Powder 1/4 tsp Ghee as requiredPreparation Clean, wash and soak the sanwa millet and buckwheat separately in enough water for atleast 1 hour. Drain and keep aside. Blend the sanwa millet along with ¼ cup of water in a mixer and blend till smooth. Blend the buckwheat by adding 2 tbsp of water in a mixer till smooth. Combine the samwa paste, buckwheat paste, coconut, jaggery, banana, rock salt and cardamom powder in a deep bowl and mix very well with your hands. Heat a non-stick tava (griddle), grease it with little ghee, pour a ladleful of the batter and spread it in a circular motion to make a 100 mm (4″) diameter thin pancake. Cook, using little ghee, till it turns golden brown in colour from both sides. Repeat with the remaining batter to make 12 more pancakes. Serve immediately. (Courtesy: Chef Ramesh, 1 Oak Cafe & Bar, New Delhi)last_img read more