light Health Highlights: Aug. 23, 2010 By www.medicinenet.com Published On :: Mon, 29 Aug 2022 00:00:00 PDT Title: Health Highlights: Aug. 23, 2010Category: Health NewsCreated: 8/23/2010 12:10:00 PMLast Editorial Review: 8/24/2010 12:00:00 AM Full Article
light Health Highlights: Aug. 24, 2010 By www.medicinenet.com Published On :: Mon, 29 Aug 2022 00:00:00 PDT Title: Health Highlights: Aug. 24, 2010Category: Health NewsCreated: 8/24/2010 12:10:00 PMLast Editorial Review: 8/25/2010 12:00:00 AM Full Article
light Health Highlights: Aug. 25, 2010 By www.medicinenet.com Published On :: Mon, 29 Aug 2022 00:00:00 PDT Title: Health Highlights: Aug. 25, 2010Category: Health NewsCreated: 8/25/2010 12:10:00 PMLast Editorial Review: 8/26/2010 12:00:00 AM Full Article
light Health Highlights: Aug. 26, 2010 By www.medicinenet.com Published On :: Mon, 29 Aug 2022 00:00:00 PDT Title: Health Highlights: Aug. 26, 2010Category: Health NewsCreated: 8/26/2010 12:10:00 PMLast Editorial Review: 8/27/2010 12:00:00 AM Full Article
light Electronic Cigarettes Have Slight Impact on Heart: Study By www.medicinenet.com Published On :: Mon, 29 Aug 2022 00:00:00 PDT Title: Electronic Cigarettes Have Slight Impact on Heart: StudyCategory: Health NewsCreated: 8/27/2012 2:05:00 PMLast Editorial Review: 8/28/2012 12:00:00 AM Full Article
light Health Highlights: Aug. 30, 2013 By www.medicinenet.com Published On :: Mon, 29 Aug 2022 00:00:00 PDT Title: Health Highlights: Aug. 30, 2013Category: Health NewsCreated: 8/30/2013 9:35:00 AMLast Editorial Review: 8/30/2013 12:00:00 AM Full Article
light Health Highlights: Aug. 29, 2013 By www.medicinenet.com Published On :: Mon, 29 Aug 2022 00:00:00 PDT Title: Health Highlights: Aug. 29, 2013Category: Health NewsCreated: 8/29/2013 12:35:00 PMLast Editorial Review: 8/30/2013 12:00:00 AM Full Article
light Light Therapy a Good Option for Pre-Cancerous Skin Lesions, Study Says By www.medicinenet.com Published On :: Mon, 29 Aug 2022 00:00:00 PDT Title: Light Therapy a Good Option for Pre-Cancerous Skin Lesions, Study SaysCategory: Health NewsCreated: 8/27/2014 4:35:00 PMLast Editorial Review: 8/28/2014 12:00:00 AM Full Article
light Health Tip: Stay Safe During a Lightning Storm By www.medicinenet.com Published On :: Mon, 29 Aug 2022 00:00:00 PDT Title: Health Tip: Stay Safe During a Lightning StormCategory: Health NewsCreated: 9/1/2017 12:00:00 AMLast Editorial Review: 9/1/2017 12:00:00 AM Full Article
light Running Red Lights a Deadly Practice That's Becoming More Common By www.medicinenet.com Published On :: Mon, 29 Aug 2022 00:00:00 PDT Title: Running Red Lights a Deadly Practice That's Becoming More CommonCategory: Health NewsCreated: 8/29/2019 12:00:00 AMLast Editorial Review: 8/29/2019 12:00:00 AM Full Article
light Medical Marijuana for Pain Is Linked to Slight Rise in Heart Trouble By www.medicinenet.com Published On :: Tue, 23 Aug 2022 00:00:00 PDT Title: Medical Marijuana for Pain Is Linked to Slight Rise in Heart TroubleCategory: Health NewsCreated: 8/23/2022 12:00:00 AMLast Editorial Review: 8/23/2022 12:00:00 AM Full Article
light High-resolution reconstruction of a C. elegans ribosome sheds light on evolutionary dynamics and tissue specificity [ARTICLE] By rnajournal.cshlp.org Published On :: 2024-10-16T07:18:13-07:00 Caenorhabditis elegans is an important model organism for human health and disease, with foundational contributions to the understanding of gene expression and tissue patterning in animals. An invaluable tool in modern gene expression research is the presence of a high-resolution ribosome structure, though no such structure exists for C. elegans. Here, we present a high-resolution single-particle cryogenic electron microscopy (cryo-EM) reconstruction and molecular model of a C. elegans ribosome, revealing a significantly streamlined animal ribosome. Many facets of ribosome structure are conserved in C. elegans, including overall ribosomal architecture and the mechanism of cycloheximide, whereas other facets, such as expansion segments and eL28, are rapidly evolving. We identify uL5 and uL23 as two instances of tissue-specific ribosomal protein paralog expression conserved in Caenorhabditis, suggesting that C. elegans ribosomes vary across tissues. The C. elegans ribosome structure will provide a basis for future structural, biochemical, and genetic studies of translation in this important animal system. Full Article
light Freehand SPECT Combined with 3-Dimensional Light Detection and Ranging as Alternative Means of Specimen Scanning During Prostate Cancer Surgery By jnm.snmjournals.org Published On :: 2024-11-01T04:25:31-07:00 Full Article
light Arterial Spin-Labeling Perfusion Lightbulb Sign: An Imaging Biomarker of Pediatric Posterior Fossa Hemangioblastoma [CLINICAL PRACTICE] By www.ajnr.org Published On :: 2024-11-07T15:14:12-08:00 BACKGROUND AND PURPOSE: Hemangioblastoma is a rare vascular tumor that occurs within the central nervous system in children. Differentiating hemangioblastoma from other posterior fossa tumors can be challenging on imaging, and preoperative diagnosis can change the neurosurgical approach. We hypothesize that a "lightbulb sign" on the arterial spin-labeling (ASL) sequence (diffuse homogeneous intense hyperperfusion within the solid component of the tumor) will provide additional imaging finding to differentiate hemangioblastoma from other posterior fossa tumors. MATERIALS AND METHODS: In this retrospective comparative observational study, we only included pathology-proved cases of hemangioblastoma, while the control group consisted of other randomly selected pathology-proved posterior fossa tumors from January 2022 to January 2024. Two blinded neuroradiologists analyzed all applicable MRI sequences, including ASL sequence if available. ASL was analyzed for the lightbulb sign. Disagreements between the radiologists were resolved by a third pediatric neuroradiologist. 2 and Fisher exact test were used to analyze the data. RESULTS: Ninety-five patients were enrolled in the study; 57 (60%) were boys. The median age at diagnosis was 8 years old (interquartile range: 3–14). Of the enrolled patients, 8 had hemangioblastoma, and 87 had other posterior fossa tumors, including medulloblastoma (n = 31), pilocytic astrocytoma (n = 23), posterior fossa ependymoma type A (n = 16), and other tumors (n = 17). The comparison of hemangioblastoma versus nonhemangioblastoma showed that peripheral edema (P = .02) and T2-flow void (P = .02) favor hemangioblastoma, whereas reduced diffusion (low ADC) (P = .002) and ventricular system extension (P = .001) favor nonhemangioblastoma tumors. Forty-two cases also had ASL perfusion sequences. While high perfusion favors hemangioblastoma (P = .03), the lightbulb sign shows a complete distinction because all the ASL series of hemangioblastoma cases (n = 4) showed the lightbulb sign, whereas none of the nonhemangioblastoma cases (n = 38) showed the sign (P < .001). CONCLUSIONS: Lightbulb-like intense and homogeneous hyperperfusion patterns on ASL are helpful in diagnosing posterior fossa hemangioblastoma in children. Full Article
light Highlights from the Respiratory Failure and Mechanical Ventilation Conference 2024 By breathe.ersjournals.com Published On :: 2024-11-12T00:25:08-08:00 The Respiratory Intensive Care Assembly of the European Respiratory Society gathered in Berlin to organise the third Respiratory Failure and Mechanical Ventilation Conference in February 2024. The conference covered key points of acute and chronic respiratory failure in adults. During the 3-day conference ventilatory strategies, patient selection, diagnostic approaches, treatment and health-related quality of life topics were addressed by a panel of international experts. In this article, lectures delivered during the event have been summarised by early career members of the Assembly and take-home messages highlighted. Full Article
light Tigerair chaos as Bali flights cancelled By www.dailytelegraph.com.au Published On :: Wed, 11 Jan 2017 23:52:00 GMT HUNDREDS of travellers’ holiday plans are in disarray after all Tigerair flights in and out of Bali were cancelled again today and early tomorrow. Full Article
light Fire engine crashes with two cars while travelling under blue lights By www.heraldscotland.com Published On :: Tue, 12 Nov 2024 06:45:32 +0000 A fire engine on its way to a callout has been involved in a collision with two cars on a road junction in Edinburgh. Full Article
light RPG Cast – Episode 740: “Truck-Kun in the Background Is Slightly Less Blurry” By rpgamer.com Published On :: Sat, 14 Sep 2024 20:26:56 +0000 Chris saw a wizard in Tokyo in Trader Vic's, his robe and wizard hat were perfect. Kelley got tired of Alf memes. Josh shoved his Steam Link in a closet somewhere. Gamers suck, tune in next week for monitor cast. The post RPG Cast – Episode 740: “Truck-Kun in the Background Is Slightly Less Blurry” appeared first on RPGamer. Full Article News Podcasts RPG Cast Castlevania: Portrait of Ruin The Legend of Heroes: Trails through Daybreak Visions of Mana World of Warcraft: The War Within
light Hideaki Itsuno to Lead New AAA Developer LightSpeed Japan Studio By www.vgchartz.com Published On :: Tue, 12 Nov 2024 03:37:22 GMT Tencent Games subsidiary LightSpeed Studios has announced Hideaki Itsuno, who recently left Capcom after 30 years working for the company, will be leading a new video game studio called LightSpeed Japan Studio. LightSpeed Japan Studio will have two locations in Tokyo and Osaka and is focused on developing original AAA games. "Joining LightSpeed Studios is an exciting new chapter for me," said Hideaki Itsuno. "With LightSpeed’s strong development capability and global network, I look forward to creating original AAA action game titles together with the amazing team and building aesthetic and innovative experiences for the global player community. We welcome all talented and passionate game creators from the world over to join our vision." LightSpeed Studios president Jerry Chen added, "It is our great honor to have Hideaki Itsuno join LightSpeed Studios. The establishment of LightSpeed Japan Studio is a significant step in LightSpeed Studios’ expansion and demonstrates our commitment to bringing the best possible games to our players." Itsuno directed entries in the Rival Schools, Power Stone, Capcom VS. SNK, Devil May Cry, and Dragon’s Dogma franchises. A life-long and avid gamer, William D'Angelo was first introduced to VGChartz in 2007. After years of supporting the site, he was brought on in 2010 as a junior analyst, working his way up to lead analyst in 2012 and taking over the hardware estimates in 2017. He has expanded his involvement in the gaming community by producing content on his own YouTube channel and Twitch channel. You can contact the author on Twitter @TrunksWD.Full Article - https://www.vgchartz.com/article/463041/hideaki-itsuno-to-lead-new-aaa-developer-lightspeed-japan-studio/ Full Article Analysis Charts Industry
light Liam Payne’s Snapchat Story Seemingly Sheds Light on Singer’s Final Hours By www.thedailybeast.com Published On :: Thu, 17 Oct 2024 02:50:30 GMT Ryan Pierse/Getty ImagesLiam Payne was seemingly having a “lovely day in Argentina” just hours before his death on Wednesday, according to what appear to be a series of final posts made to his Snapchat account.The former One Direction member was found dead in the courtyard of a Buenos Aires hotel, having apparently plunged 13 to 14 meters from his balcony, according to local police. A cause of death has not officially been determined, and it was unclear whether the fall was accidental or intentional.On his Snapchat Story, however, it would have appeared to any fan that Payne was having a relaxing vacation. In since-deleted posts in the hours before his death, he posted a front-facing video in which he told followers, “It’s a lovely day here in Argentina. This is the breakfast table. Just enjoying coffee and breakfast even though it’s 1 p.m.” Read more at The Daily Beast. Full Article Entertainment
light Grand Theft Auto: The Definitive Edition trilogy on PC gets a classic lighting update from the mobile version By www.rockpapershotgun.com Published On :: Tue, 12 Nov 2024 13:44:27 +0000 My strongest and most enduring memory of Grand Theft Auto will always be creasing into complete hysterics watching my mate pile into a crumpled police officer with a wooden baseball bat in GTA 3 after school one time. Young’uns these days just don’t appreciate how revolutionary it was to be able to hit a cop with a thing after he’d already fallen over. Suffice it to say I’ve got good memories of the open world series’ nascent forays into 3D, though never enough to tempt me into revisiting them, especially given the poor reception to Grand Theft Auto: The Trilogy - The Definitive Edition. I can sympathise. I’m annoyed just having to type a semicolon and a dash in the same game name. If you’re in a similarly non-fussed position (I will never not be annoyed that ‘nonplussed’ doesn’t mean what it sounds like it should mean) I can’t imagine a lighting update that’s been available on the mobile versions for a while is enough to tempt you back. But what is a reporter's job if not pathetically treading water between chunklets of Grand Theft Auto news, upon the publishing of which Graham presses the button to release the nutritious pellets on which we all wholly subsist? I hope he doesn’t read that last sentence. I don’t get my pellet if the syntax becomes too convoluted. Moving swiftly on. Read more Full Article iOS Android Grand Theft Auto: The Trilogy - The Definitive Edition Nintendo Switch Rockstar Games Third person PS5 PC Simulation RPG Shooter Action Adventure Xbox Series X/S Single Player Xbox One Racing PS4
light Lightning can make energy waves that travel shockingly far into space By www.newscientist.com Published On :: Fri, 16 Aug 2024 20:00:52 +0100 Lightning strikes near Earth give rise to electromagnetic waves called “whistlers” that can carry energy high enough above our planet to pose a risk to satellites and astronauts Full Article
light Planet spotted orbiting Barnard's star just 6 light years away By www.newscientist.com Published On :: Tue, 01 Oct 2024 14:00:09 +0100 Astronomers have detected an exoplanet around Barnard’s star, one of the sun’s closest neighbours, but it is too hot for liquid water or life Full Article
light New Scientist recommends astronomy exhibition Borrowed Light in Berlin By www.newscientist.com Published On :: Wed, 02 Oct 2024 19:00:00 +0100 The books, TV, games and more that New Scientist staff have enjoyed this week Full Article
light New Scientist recommends HowTheLightGetsIn festival in London By www.newscientist.com Published On :: Wed, 09 Oct 2024 19:00:00 +0100 The books, TV, games and more that New Scientist staff have enjoyed this week Full Article
light Starship: When will SpaceX's next 'chopstick' test flight go ahead? By www.newscientist.com Published On :: Fri, 11 Oct 2024 13:30:26 +0100 SpaceX claims the fifth test flight of its Starship rocket will happen “within days”, but the Federal Aviation Administration has not yet approved the launch Full Article
light SpaceX targets Starship flight next week – just a month after last one By www.newscientist.com Published On :: Tue, 12 Nov 2024 14:00:27 +0000 SpaceX is preparing for the sixth test flight of Starship, the world's most powerful rocket. Next week's launch – if successful – will be the fastest turnaround yet Full Article
light Microscopic gears powered by light could be used to make tiny machines By www.newscientist.com Published On :: Tue, 08 Oct 2024 14:00:47 +0100 Gears just a few micrometres wide can be carved from silicon using a beam of electrons, enabling tiny robots or machines that could interact with human cells Full Article
light 3D printing with light and sound could let us copy human organs By www.newscientist.com Published On :: Tue, 05 Nov 2024 14:00:07 +0000 One day, doctors might be able to 3D print copies of your organs in order to test a variety of drugs, thanks to a new technique that uses light and sound for rapid printing Full Article
light AI-powered attack drones take flight By www.foxnews.com Published On :: Fri, 08 Nov 2024 06:00:13 -0500 A company announced the launch of two new advanced drones designed to improve military operations with the use of cutting-edge technology. Full Article 97a2b755-bfab-510d-a277-d25af8648fd8 fnc Fox News fox-news/tech fox-news/tech/artificial-intelligence fox-news/tech/topics/innovation fox-news/tech/technologies/drones fox-news/us fox-news/us/military fox-news/science fox-news/tech article
light Momodora: Reverie Under the Moonlight By www.tigsource.com Published On :: Fri, 08 Jul 2016 05:38:41 +0000 It’s become a joke to talk about Cave Story and Dark Souls when describing other games, but in the case of Momodora: Reverie Under the Moonlight, I’d be remiss not to: the series has never been shy about its influences. In Reverie, the fourth game of the Momodora series, rdein has done a fantastic job […] Full Article Highly Recommended Metroidvanias Platformers Steam Windows rdein
light DevLog Spotlight: Leilani’s Island By www.tigsource.com Published On :: Fri, 29 Jul 2016 05:35:30 +0000 I started work on it around a year ago on a whim because I was reading a lot of game design articles and couldn’t resist the idea of a small platform game. It’s really expanded a lot beyond that though! I’d like to start showing it to and discussing it with more people as I […] Full Article DevLogs Platformers Previews Ishisoft
light Sport's 'crown jewels' told to ramp up crowd numbers after Government gives green light By www.telegraph.co.uk Published On :: Tue, 11 May 2021 12:32:27 GMT Full Article structure:racing topics:organisations/england-rugby-union-team structure:rugby-union topics:events/wimbledon-tennis structure:tennis topics:events/royal-ascot structure:sport topics:in-the-news/coronavirus structure:football storytype:standard
light Orionid meteor shower to light up night sky through most of November By www.foxnews.com Published On :: Mon, 21 Oct 2024 16:59:06 -0400 The Orionids meteor shower peaks on Monday, but will continue to light up the sky through Nov. 22, as debris from Halley's Comet enters Earth's atmosphere. Full Article 3d0d5aa2-d6f1-54b6-b1ad-d6745df3f642 fnc Fox News fox-news/science/air-and-space/astronomy fox-news/science/air-and-space/nasa fox-news/science/air-and-space fox-news/science article
light 15,800-Year-Old Engraved Plaquettes Shed Light on Paleolithic Fishing Techniques By www.sci.news Published On :: Mon, 11 Nov 2024 14:28:30 +0000 Scientists from the Leibniz Zentrum für Archäologie and Durham University have examined a collection of 406 engraved schist plaquettes found at the Magdalenian site of Gönnersdorf in Germany. The post 15,800-Year-Old Engraved Plaquettes Shed Light on Paleolithic Fishing Techniques appeared first on Sci.News: Breaking Science News. Full Article Anthropology Archaeology Paleoanthropology Abstract art Art Engraving Europe Fishing Fishing net Fishing traps Germany Gönnersdorf Homo sapiens Human Hunter-gatherer Ice Age Magdalenian Paleolithic Plaquette Schist
light Dinosaurs Evolved Feathers for Far More Than Flight By www.smithsonianmag.com Published On :: Fri, 20 Sep 2024 13:18:27 +0000 Fluff and fuzz helped the creatures keep warm, blend in and communicate Full Article
light Delight in These 15 Photos That Capture the Exotic Undersea Lives of Jellyfish By www.smithsonianmag.com Published On :: Fri, 27 Sep 2024 10:00:00 +0000 Despite their often dangerous stings, these creatures create serene scenes as they float through the deep sea Full Article
light From Prolonging Wallaby Pregnancies to Disorienting Hatchling Turtles, 11 Ways Artificial Lights Affect Animals By www.smithsonianmag.com Published On :: Mon, 28 Oct 2024 16:00:00 +0000 From the busy cities to ocean waters, our need to illuminate the world has had some strange and tragic consequences Full Article
light How Sharda Sinha turned the spotlight on Bihar’s folk music By www.thehindu.com Published On :: Tue, 12 Nov 2024 14:50:53 +0530 The singer conveyed the richness of Bhojpuri and Maithili languages through her wide repertoire of songs Full Article Music
light ‘Disney Dreamlight Valley’ Dapper Delights Update Now Available for Apple Arcade, Consoles, and PC By toucharcade.com Published On :: Wed, 21 Aug 2024 14:33:23 +0000 Last week, Gameloft announced the next major and free Disney Dreamlight Valley update for PC and consoles alongside Disney Dreamlight … Continue reading "‘Disney Dreamlight Valley’ Dapper Delights Update Now Available for Apple Arcade, Consoles, and PC" Full Article Apple Arcade Featured Games iPad Games iPhone games News Universal
light SwitchArcade Round-Up: Reviews Featuring ‘Bakeru’ & ‘Peglin’, Plus Highlights From Nintendo’s Blockbuster Sale By toucharcade.com Published On :: Tue, 03 Sep 2024 02:54:38 +0000 Hello gentle readers, and welcome to the SwitchArcade Round-Up for September 2nd, 2024. I think it’s a holiday today in … Continue reading "SwitchArcade Round-Up: Reviews Featuring ‘Bakeru’ & ‘Peglin’, Plus Highlights From Nintendo’s Blockbuster Sale" Full Article Featured Games News SwitchArcade
light LED lights on underside of surfboards may deter shark attacks! By www.theguardian.com Published On :: 2024-11-13T06:19:38Z LED lights on underside of surfboards may deter shark attacks! (Third column, 13th story, link) Drudge Report Feed needs your support! Become a Patron Full Article
light UPDATE: FAA grounds flights to Haiti after two planes struck by gunfire... By www.cnn.com Published On :: 2024-11-13T06:19:37Z UPDATE: FAA grounds flights to Haiti after two planes struck by gunfire... (Second column, 13th story, link) Full Article
light From 'Little Marco' to 'Mr Secretary': Rubio In Spotlight... By www.yahoo.com Published On :: 2024-11-13T06:19:36Z From 'Little Marco' to 'Mr Secretary': Rubio In Spotlight... (Top headline, 3rd story, link) Related stories:Republican Euphoria Punctured by Tough Math in House...WILL WHITE HOUSE RESULTS STAY ABOVER 50%? DEVELOPING... Full Article
light Video highlights new evidence to support treating HIV early By www.starobserver.com.au Published On :: Tue, 14 Apr 2015 07:41:08 +0000 ACON last week released a short video to highlight new evidence in the fight to end HIV by 2020. As part of the ENDING HIV platform, the [TREAT EARLY] campaign was ... The post Video highlights new evidence to support treating HIV early appeared first on Star Observer. Full Article Healthy Living National News
light Indian capital plans drone flights to combat smog crisis By www.spacewar.com Published On :: Wed, 13 Nov 2024 05:57:03 GMT New Delhi (AFP) Nov 8, 2024 India's capital unveiled plans Friday to fly special drones to clear pollution from its smog-choked skies - a plan derided by experts as another "band-aid" solution to a public health crisis. New Delhi and the surrounding metropolitan area, home to more than 30 million people, consistently tops world rankings for air pollution in winter. The smog is blamed for thousands of premature de Full Article
light H5N1 Detected in Pig Highlights the Risk of Bird Flu Mixing with Seasonal Flu By www.scientificamerican.com Published On :: Thu, 31 Oct 2024 15:15:00 +0000 Humans and pigs could both serve as mixing vessels for a bird flu–seasonal flu hybrid, posing a risk of wider spread Full Article
light There Are Three Types of Twilight By www.scientificamerican.com Published On :: Fri, 01 Nov 2024 10:45:00 +0000 At dusk and dawn, the sky dances with three phases of in-between light Full Article
light The Streetlight Effect and 505(b)(2) approvals By www.placebocontrol.com Published On :: Sat, 18 Mar 2017 20:35:00 +0000 It is a surprisingly common peril among analysts: we don’t have the data to answer the question we’re interested in, so we answer a related question where we do have data. Unfortunately, the new answer turns out to shed no light on the original interesting question. This is sometimes referred to as the Streetlight Effect – a phenomenon aptly illustrated by Mutt and Jeff over half a century ago: This is the situation that the Tufts Center for the Study of Drug Development seems to have gotten itself into in its latest "Impact Report". It’s worth walking through the process of how an interesting question ends up in an uninteresting answer. So, here’s an interesting question: My company owns a drug that may be approvable through FDA’s 505(b)(2) pathway. What is the estimated time and cost difference between pursuing 505(b)(2) approval and conventional approval? That’s "interesting", I suppose I should add, for a certain subset of folks working in drug development and commercialization. It’s only interesting to that peculiar niche, but for those people I suspect it’s extremely interesting - because it is a real situation that a drug company may find itself in, and there are concrete consequences to the decision. Unfortunately, this is also a really difficult question to answer. As phrased, you'd almost need a randomized trial to answer it. Let’s create a version which is less interesting but easier to answer: What are the overall development time and cost differences between drugs seeking approval via 505(b)(2) and conventional pathways? This is much easier to answer, as pharmaceutical companies could look back on development times and costs of all their compounds, and directly compare the different types. It is, however, a much less useful question. Many new drugs are simply not eligible for 505(b)(2) approval. If those drugs Extreme qualitative differences of 505(b)(2) drugs. Source: Thomson Reuters analysis via RAPS are substantially different in any way (riskier, more novel, etc.), then they will change the comparison in highly non-useful ways. In fact, in 2014, only 1 drug classified as a New Molecular Entity (NME) went through 505(b)(2) approval, versus 32 that went through conventional approval. And in fact, there are many qualities that set 505(b)(2) drugs apart. So we’re likely to get a lot of confounding factors in our comparison, and it’s unclear how the answer would (or should) guide us if we were truly trying to decide which route to take for a particular new drug. It might help us if we were trying to evaluate a large-scale shift to prioritizing 505(b)(2) eligible drugs, however. Unfortunately, even this question is apparently too difficult to answer. Instead, the Tufts CSDD chose to ask and answer yet another variant: What is the difference in time that it takes the FDA for its internal review process between 505(b)(2) and conventionally-approved drugs? This question has the supreme virtue of being answerable. In fact, I believe that all of the data you’d need is contained within the approval letter that FDA posts publishes for each new approved drug. But at the same time, it isn’t a particularly interesting question anymore. The promise of the 505(b)(2) pathway is that it should reduce total development time and cost, but on both those dimensions, the report appears to fall flat. Cost: This analysis says nothing about reduced costs – those savings would mostly come in the form of fewer clinical trials, and this focuses entirely on the FDA review process. Time: FDA review and approval is only a fraction of a drug’s journey from patent to market. In fact, it often takes up less than 10% of the time from initial IND to approval. So any differences in approval times will likely easily be overshadowed by differences in time spent in development. But even more fundamentally, the problem here is that this study gives the appearance of providing an answer to our original question, but in fact is entirely uninformative in this regard. The accompanying press release states: The 505(b)(2) approval pathway for new drug applications in the United States, aimed at avoiding unnecessary duplication of studies performed on a previously approved drug, has not led to shorter approval times. This is more than a bit misleading. The 505(b)(2) statute does not in any way address approval timelines – that’s not it’s intent. So showing that it hasn’t led to shorter approval times is less of an insight than it is a natural consequence of the law as written. Most importantly, showing that 505(b)(2) drugs had a longer average approval time than conventionally-approved drugs in no way should be interpreted as adding any evidence to the idea that those drugs were slowed down by the 505(b)(2) process itself. Because 505(b)(2) drugs are qualitatively different from other new molecules, this study can’t claim that they would have been developed faster had their owners initially chosen to go the route of conventional approval. In fact, such a decision might have resulted in both increased time in trials and increased approval time. This study simply is not designed to provide an answer to the truly interesting underlying question. [Disclosure: the above review is based entirely on a CSDD press release and summary page. The actual report costs $125, which is well in excess of this blog’s expense limit. It is entirely possible that the report itself contains more-informative insights, and I’ll happily update that post if that should come to my attention.] Full Article 505(b)(2) drug development FDA metrics trial costs Tufts CSDD
light For good sleep and good health, regulate your exposure to light By www.npr.org Published On :: Sat, 09 Nov 2024 07:58:39 -0500 Your daily light exposure impacts your health. A new study finds that too much light at night and not enough natural light during the day can be harmful. This story first aired on Morning Edition on Nov. 4, 2024. Full Article