recap The Eddy Recap: The Low End By feedproxy.google.com Published On :: Sat, 09 May 2020 08:00:09 -0400 An overlooked member of The Eddy band steps into the spotlight for a bittersweet—mostly bitter—story about his troubled past and uncertain future. Full Article tv tv recaps overnights recaps the eddy
recap Brown bear recaptured in northern Italy after months on the loose following escape from enclosure By www.standard.co.uk Published On :: 2020-05-01T11:31:03Z Forest rangers snare bear in the Dolomites in a move that also unleashes row over animal rights Full Article
recap Correction: Humanized bone facilitates prostate cancer metastasis and recapitulates therapeutic effects of Zoledronic acid in vivo By feeds.nature.com Published On :: 2020-04-03 Full Article
recap Event recap: Lessons learned from two years of breakthrough therapy designation By webfeeds.brookings.edu Published On :: Thu, 14 May 2015 10:05:00 -0400 The breakthrough therapy designation (BTD) program was initiated by the U.S. Food and Drug Administration (FDA) in 2012 to expedite the development of treatments for serious or life-threatening illness that demonstrate “substantial improvement” over existing therapies. The program has since become a widely supported mechanism for accelerating patient access to new drugs. As of March 2015, FDA has received a total of 293 requests for BTD. However, it has granted just 82 (28%), which indicates an ongoing lack of clarity over what exactly meets the criteria for the designation. On April 24, the Center for Health Policy at Brookings convened a public meeting to explore the designation’s qualifying criteria and how FDA applies those criteria across therapeutic areas. Panelists used real-world and hypothetical case studies to frame the discussion, and highlighted major considerations for the application process, the FDA’s evaluation of the evidence, and the key factors for acceptance or rejection. The discussion also identified strategies to ensure that qualifying criteria are well understood. Here are the five big takeaways: 1. The BTD program is viewed positively by drug companies, researchers, advocates, and others Across the board, participants expressed enthusiasm for the BTD program. Industry representatives noted that their experience had been extremely positive, and that the increased cooperation with and guidance from FDA were very helpful in streamlining their development programs. Receiving the designation can also raise a drug company’s profile, which can facilitate additional investment as well as clinical trial patient recruitment; this is particularly important for smaller companies with limited resources. Patient and disease advocates were likewise supportive, and expressed hope that the early lessons learned from successful breakthrough therapy approvals (which have been mostly concentrated in the oncology and antiviral fields) could be translated to other disease areas with less success. However, while BTD is an important tool in expediting the development of new drugs, it is just one piece of broader scientific and regulatory policy landscape. Accelerating the pace of discovery and development of truly innovative new drugs will depend on a range of other factors, such as developing and validating new biomarkers that can be used to measure treatment effects at an earlier stage, as well as establishing networks that can streamline the clinical trial process. It will also be important to develop effective new approaches to collecting, analyzing, and communicating information about these treatments once they are on the market, as this information can potentially be used by FDA, providers, and patients to further improve prescription drug policy and medical decision-making. 2. BTD requests far outnumber those that actually meet the qualifying criteria Since the program began, less than 30 percent of requests have received BTD designation. A substantial majority were denied at least in part due to either a lack of data or problems with the quality of the data, or some combination of the two. For example, some sponsors requested the designation before they had any clinical data, or submitted the request using clinical data that was incomplete or based on flawed study designs. Many requests also failed to meet the Agency’s bar for “substantial improvement” over existing therapies. One reason for the high denial rate may be a lack of a clear regulatory or statutory bar that could be used as a definitive guide for sponsors to know what is needed to qualify for the designation. BTD denials are also confidential, which means that sponsors effectively have nothing to lose by submitting a request. Going forward, manufacturers may need to exercise more discretion in deciding to request the designation, as the process can be resource- and time-intensive for both sides. 3. There is no single threshold for determining what defines a breakthrough therapy About 53 percent of the 109 total BTD denials were due at least in part to the fact that the drug did not represent a substantial improvement over existing therapies. During the day’s discussion, FDA and sponsors both noted that this is likely because the criteria for BTD are inherently subjective. In practice, this means there is no clear threshold for determining when a new therapy represents a “substantial improvement” over existing therapies. Designation decisions are complex and highly dependent on the context, including the disease or condition being targeted, the availability of other treatments, the patient population, the outcomes being studied, and the overall reliability of the data submitted. Given the multiple factors at play, it can be difficult in some cases to determine when a new product is potentially “transformational” as opposed to “better,” especially for conditions that are poorly understood or have few or no existing treatments. In making its determinations, FDA considers the totality of the evidence submitted, rather than focusing on specific evidentiary requirements. 4. Early communication with FDA is strongly recommended for BTD applicants Roughly 72 percent of the BTD denials related at least in part to trial design or analysis problems, which led several people to suggest that sponsors engage with FDA prior to submitting their request. Though there are several formal mechanisms for interacting with the agency, informal consultations with the relevant review division could help sponsors to get a better and much earlier sense of what kind of data FDA might need. This early communication could both strengthen viable BTD requests and reduce the number of frivolous requests. 5. FDA may need more resources for implementing the BTD program Drugs that receive breakthrough designation are subject to much more intensive FDA guidance and review. However, when the program was established in 2012, Congress did not allocate funding to cover its costs. There have been ongoing concerns that the program is exacting a significant toll on FDA’s already limited resources, and potentially affecting the timeline for other drug application reviews. These concerns were reiterated during the day’s discussion, and some suggested that Congress consider attaching a user fee to the BTD program when the Prescription Drug User Fee Act comes up for reauthorization in 2017. Authors Gregory W. DanielElizabeth RichardsonCraig Streit Full Article
recap Climate News Recap: Climate Scientists Get A Legal Defense Fund; Warming to Both Help & Hurt UK; More By www.treehugger.com Published On :: Fri, 27 Jan 2012 10:41:00 -0500 Plus, spewing sulfate into sky to stop warming won't fully work (redux); what Singapore's doing to make sure sea level rise doesn't swamp their city. Here's what caught our eye this morning. Full Article Science
recap Energy News Recap: Illegal Nuclear Power Subsidies, Geothermal Power From Volcanoes, More By www.treehugger.com Published On :: Mon, 23 Jan 2012 14:10:00 -0500 Energy policy and energy use are not forces of nature beyond our control. It's all about choices; different choices set us off on different paths, but don't prevent us from switching course. Full Article Energy
recap Energy News Recap: Hurricanes Versus Wind Farms; Nuclear Power & Childhood Leukemia; More By www.treehugger.com Published On :: Wed, 15 Feb 2012 11:25:00 -0500 Beyond the headline, a really great overview of how globalization may well be entirely reshaped by energy constraints, for the betterment of local economies in places where manufacturing has been outsourced for years. Full Article Energy
recap Energy News Recap: Record Energy Efficiency Investments In 2011, Chevron Still Must Pay $18bn Rainforest Destruction Fine By www.treehugger.com Published On :: Thu, 05 Jan 2012 15:16:00 -0500 From record investments in energy investments made by US states, to East Africa's largest wind power project, Chicago's smart gridization, to Chevron's huge fine being upheld, here's what we're reading today. Full Article Energy
recap The TreeHugger Recap: Thursday, July 28, 2011 By www.treehugger.com Published On :: Fri, 29 Jul 2011 11:11:13 -0400 With ~30+ new posts on TreeHugger.com each weekday, we understand if you miss a post here and there. To keep you up-to-date, here's what we covered on Thursday, July 28, 2011.Animals David explained the difficulties of GPS Full Article TreeHugger Exclusives
recap The Weekend Recap: Friday-Sunday, July 29, 30 & 31, 2011 By www.treehugger.com Published On :: Mon, 01 Aug 2011 12:17:00 -0400 With ~30+ new posts on TreeHugger.com each weekday, we understand if you miss a post here and there. To keep you up-to-date, here's what we covered over the weekend, July 29, 30, and 31, 2011.Animals Jaymi told us that Full Article TreeHugger Exclusives
recap The TreeHugger Recap: Monday, August 1, 2011 By www.treehugger.com Published On :: Tue, 02 Aug 2011 11:35:00 -0400 With ~30+ new posts on TreeHugger.com each weekday, we understand if you miss a post here and there. To keep you up-to-date, here's what we covered on Monday, August 1, 2011.Animals Alex Davies informed us that New York dairy Full Article TreeHugger Exclusives
recap The TreeHugger Recap: Tuesday, August 2, 2011 By www.treehugger.com Published On :: Wed, 03 Aug 2011 13:58:00 -0400 With ~30+ new posts on TreeHugger.com each weekday, we understand if you miss a post here and there. To keep you up-to-date, here's what we covered on Tuesday, August 2, 2011.Animals Lloyd asked is urban chickens are a gateway Full Article TreeHugger Exclusives
recap The TreeHugger Recap: Wednesday, August 3, 2011 By www.treehugger.com Published On :: Thu, 04 Aug 2011 11:07:00 -0400 With ~30+ new posts on TreeHugger.com each weekday, we understand if you miss a post here and there. To keep you up-to-date, here's what we covered on Wednesday, August 3, Full Article TreeHugger Exclusives
recap Virus hits Trump's inner circle, unemployment rivals Great Depression: This week's recap and our best reads By www.cnbc.com Published On :: Sat, 09 May 2020 14:37:36 GMT The U.S. shed a record number of jobs in April, Trump's personal valet tests positive for virus: This weeks news recap and our best reads. Full Article
recap Traders recap scary week on Wall Street and see more wild times ahead By www.cnbc.com Published On :: Fri, 28 Feb 2020 22:57:08 GMT Traders on the floor of the New York Stock Exchange swapped stories all week about the extreme trading conditions they witnessed. Full Article
recap Here's a full recap of Warren Buffett's newsmaking comments at Berkshire Hathaway's annual meeting By www.cnbc.com Published On :: Mon, 04 May 2020 11:42:34 GMT Buffett made a lot of news at Berkshire's first virtual annual meeting on Saturday, including revealing that he sold all his airline stocks. Full Article
recap Married At First Sight episode 2 RECAP: ALEX MICHAEL exposes sneaky production tricks By www.dailymail.co.uk Published On :: Wed, 05 Feb 2020 06:23:49 GMT Married At First Sight was equal parts Jerry Springer and Downton Abbey in an uneven, scripted affair on Tuesday night. Full Article
recap Borussia Dortmund vs PSG - Champions League last-16: RECAP By www.dailymail.co.uk Published On :: Tue, 18 Feb 2020 21:52:02 GMT Borussia Dortmund host Paris Saint-Germain in their first Champions League last-16 encounter at Westfalenstadion this evening. Join Sportsmail for live updates of every kick from tonight's game. Full Article
recap Big Little Lies Season 2 premiere recap By www.dailymail.co.uk Published On :: Mon, 10 Jun 2019 05:57:42 GMT More than two years after its debut season, which earned eight Emmys including Outstanding Limited Series, Big Little Lies returns for a second season on HBO Sunday night. Full Article
recap Rafael Nadal set to recapture world No 1 spot following Novak Djokovic's shock defeat By www.dailymail.co.uk Published On :: Fri, 11 Oct 2019 23:01:28 GMT Rafael Nadal has been absent from the Shanghai Masters but is guaranteed to recapture the world No 1 spot next month after Novak Djokovic went down to a shock quarter final defeat in China . Full Article
recap Six Nations 2019, RECAP - Scotland 11-18 Wales: Gatland's men survive fight-back to earn win By www.dailymail.co.uk Published On :: Sat, 09 Mar 2019 16:25:29 GMT Wales hung on to beat Scotland and edge closer to Six Nations glory at Murrayfield on Saturday. Full Article
recap World Cup 2018: Senegal 0-1 Colombia RECAP - as it happened By www.dailymail.co.uk Published On :: Thu, 28 Jun 2018 16:04:19 GMT Colombia went through courtesy of a Yerry Mina header that saw them pick up three points and top Group H. It was a moment of rare quality in a match lacking in clear-cut chances. Full Article
recap Married At First Sight RECAP: Alex Michael reveals the TRUTH about Stacey Hampton's age By www.dailymail.co.uk Published On :: Tue, 11 Feb 2020 09:31:28 GMT A service station ice dealer cops the Jim Carrey edit, a 48-year-old woman invents a verb for menopause and the internet goes Sherlock Holmes on a woman's age. Full Article
recap World Cup 2018, Sweden 1-0 Switzerland RECAP - as it happened By www.dailymail.co.uk Published On :: Tue, 03 Jul 2018 15:58:26 GMT Join Sportsmail's ANTHONY HAY with all the live action from the 3pm (BST) kick-off, with IAN LADYMAN providing all the updates from St Petersburg. Full Article
recap Sweden 0-2 England, RECAP - World Cup quarter-final as it happened By www.dailymail.co.uk Published On :: Sat, 07 Jul 2018 16:42:23 GMT In the Samara Arena, situated on the banks of the River Volga in a far-flung corner of the sprawling Russian Motherland, an England team made history. Full Article
recap New Zealand vs Ireland RECAP - Rugby World Cup Quarter-Final 2019: As it happened By www.dailymail.co.uk Published On :: Sat, 19 Oct 2019 12:24:33 GMT All Blacks take on Ireland in their Rugby World Cup quarter-final clash in Japan as they look to progress to the semi-final to take on either England or Australia. Follow LIVE ACTION RIGHT HERE. Full Article
recap World Cup 2018 Draw RECAP: Russia open with Saudi Arabia By www.dailymail.co.uk Published On :: Fri, 01 Dec 2017 16:13:34 GMT Spain are paired in the same group as Portugal for the World Cup next summer, while Russia host Saudi Arabia in the tournament's opening game as England are handed favourable draw. Full Article
recap World Cup 2018: Japan 0-1 Poland RECAP - as it happened By www.dailymail.co.uk Published On :: Thu, 28 Jun 2018 16:13:01 GMT Surprise Group H leaders Japan know that a draw will be enough to take them through to the knockout stages of the tournament in Russia. Poland have already been knocked out. Full Article
recap Frozen II review: It's a sequel that never recaptures the magic of the original By Published On :: Sat, 23 Nov 2019 22:03:32 +0000 Six years ago, when the original Frozen film was released, I was one of many, many adults who absolutely loved it. Full Article
recap Transfer News RECAP: Deadline Day for Manchester United, Chelsea, Tottenham, Arsenal and the rest By Published On :: Fri, 31 Jan 2020 07:01:06 +0000 Deadline day has arrived for the January transfer window as Premier League clubs have their last chance to make any signings for the second-half of the season. Follow LIVE news right here. Full Article
recap Carabao Cup third round draw RECAP - Manchester Utd, Man City, Chelsea, Arsenal and more By Published On :: Thu, 30 Aug 2018 17:58:29 +0100 Thirty-two teams will entered the Carabao Cup third round draw as the competition heated up with the addition of top-flight clubs. Relive Sportsmail's coverage Full Article
recap Carabao Cup RECAP - Relive the third round action from Man Utd vs Derby and the rest By Published On :: Tue, 25 Sep 2018 17:45:27 +0100 Manchester United take on Derby County in the Carabao Cup third round as Jose Mourinho takes on a player he used to manage in Frank Lampard. Follow all the matches with Sportsmail. Full Article
recap Blackpool 0-3 Arsenal, RECAP- Joe Willock nets two in easy FA Cup win By Published On :: Sat, 05 Jan 2019 16:09:46 +0000 Arsenal's trip to League One side Blackpool on Saturday evening heads the list of late kick-offs in the third round of the FA Cup. Join ROB SUMMERSCALES for all the live action. Full Article
recap Serena Williams vs Simona Halep - Women's Wimbledon final recap at SW19 By www.dailymail.co.uk Published On :: Sat, 13 Jul 2019 14:24:16 GMT Seven-time Wimbledon champion Serena Williams takes on Simona Halep in the women's singles final today. Sportsmail's Jordan Seward will provide live coverage of the Williams vs Halep's final clash. Full Article
recap Real Madrid vs Atletico Madrid RECAP as it happened - La Liga By www.dailymail.co.uk Published On :: Sun, 08 Apr 2018 16:08:16 GMT Real Madrid and Atletico Madrid lock horns at the Bernabeu on Sunday afternoon with plenty of local pride at stake. Join ADAM SHERGOLD for all the action as it unfolds. Full Article
recap Tottenham 1-0 Inter Milan, RECAP - Christian Eriksen keeps Champions League hopes alive By www.dailymail.co.uk Published On :: Wed, 28 Nov 2018 22:11:50 GMT Tottenham face a must-win home tie against Inter Milan as they bid to keep their hopes of reaching the Champions League knockout stages alive. Follow all of the action with NATHAN SALT. Full Article
recap Atletico Madrid 1-0 Liverpool - Champions League last-16 RECAP By www.dailymail.co.uk Published On :: Tue, 18 Feb 2020 21:56:41 GMT Jurgen Klopp's Liverpool side return to the scene of last season's Champions League triumph for the first time, where they beat fellow Premier League outfit Tottenham 2-0. Full Article
recap The Great British Bake Off: The latest episode is recapped by Jim Shelley By Published On :: Wed, 09 Oct 2019 13:34:10 +0100 The bookies' favourite to win The Great British Bake Off, Steph Blackwell, narrowly failed to make history and become Star Baker for a remarkable four weeks running. Full Article
recap Homeland finale series recap: Carrie and Saul go head-to-head in nail-biting climax By www.dailymail.co.uk Published On :: Mon, 27 Apr 2020 18:07:16 GMT After eight seasons and 95 episodes, Showtime's flagship drama Homeland finally came to a close last night Full Article
recap Transfer News RECAP: Deadline Day for Manchester United, Chelsea, Tottenham, Arsenal and the rest By www.dailymail.co.uk Published On :: Sat, 01 Feb 2020 00:53:00 GMT Deadline day has arrived for the January transfer window as Premier League clubs have their last chance to make any signings for the second-half of the season. Follow LIVE news right here. Full Article
recap FA Cup draw RECAP: Date, time and channel of fifth round draw plus your team's ball numbers By Published On :: Sun, 26 Jan 2020 11:49:26 +0000 Sportsmail will provide live coverage of the FA Cup fifth round draw and reveal who your team will be facing in the next stage of the English competition right here. Full Article
recap Norwich City vs Liverpool Premier League RECAP: Follow all the action here By Published On :: Sat, 15 Feb 2020 16:00:13 +0000 It's top versus bottom as Liverpool travel to Norwich City in the Premier League on Saturday evening. Follow all the action from Carrow Road as it happens with Sportsmail's KISHAN VAGHELA. Full Article
recap Transfer News RECAP: Chelsea, Tottenham, Manchester Unired, Real Madrid and more By Published On :: Fri, 10 Jan 2020 09:21:04 +0000 The January transfer window is in full swing with Olivier Giroud drawing closer to a move to Antonio Conte's Inter Milan, and Christian Eriksen's exit from Tottenham developing. Full Article
recap Big Little Lies Season 2 Episode 2 recap: The Monterey Five return By www.dailymail.co.uk Published On :: Mon, 17 Jun 2019 06:11:19 GMT The Monterey Five return in the second episode of Big Little Lies' second season, as these women all face new challenges. Full Article
recap Big Little Lies Season 2 Episode 3 recap: The Monterey Five is tested in new ways By www.dailymail.co.uk Published On :: Mon, 24 Jun 2019 09:02:45 GMT The sudden death of Perry Wright (Alexander Skarsgard) continues to haunt The Monterey Five in Sunday night's new episode of Big Little Lies. Full Article
recap Transfer News RECAP: January window open for business! Man Utd, Arsenal, Chelsea, Liverpool and more By Published On :: Wed, 01 Jan 2020 08:56:43 +0000 Follow Sportsmail's live runner for all the latest permanent and loan deals and signings in the Premier League and across Europe on day one of the January transfer window. Full Article
recap Transfer news RECAP: January window opens for Real Madrid, Barcelona, Juventus and the rest By Published On :: Thu, 02 Jan 2020 09:28:19 +0000 Premier League and Championship clubs come into the second day of the January transfer window as the hunt to bolster their squad continues. Join Sportsmail for all the latest news. Full Article
recap Transfer news RECAP: Premier League and European clubs look to kick-start January business By Published On :: Fri, 03 Jan 2020 08:54:36 +0000 Premier League and Championship clubs are poised to enhance their squads as the January transfer window creates a hive of comings and goings around Europe. Full Article
recap Transfer news RECAP: Arsenal, Manchester United, Man City, Chelsea and more By Published On :: Mon, 06 Jan 2020 08:30:33 +0000 David Alaba, Christian Eriksen and Wilfried Zaha are just some of the names who could be on the move this January as clubs look to do the business to strengthen their ranks. Full Article
recap FA Cup fourth round draw RECAP: Date, time and channel plus BALL NUMBERS By Published On :: Mon, 06 Jan 2020 11:55:39 +0000 Scroll through Sportsmail's live feed of the draw to find out who each side will be playing in the fourth round of the FA Cup. Full Article
