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#FDA says tazemetostat (Tazverik), for epithelioid sarcoma (#cancer), had no beneficial effect for 85% of patients; "complete response" (CR) rate: 1.6% (1 of 62); relevance of CR to survival not discussed. No randomized control grp. 1 trial.https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-tazverik?utm_campaign=CDER%20New%2002%2F05%2F2020&utm_medium=email&utm_source=Eloqua&elqTrackId=3b5b991f05744fc881a07cde5ac043bc&elq=8a0382b15fce4cd9970b9a0dee1f78d5&elqaid=11137&elqat=1&elqCampaignId=9350 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
New
#FDA policy on Priority ANDAs (under previous policy "roughly half of all ANDA submissions were designated as priority," said FDA) https://www.fda.gov/media/89061/download …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
When it comes to colon
#cancer screening, legislators should be aware that there is more than meets the eye (e.g., conflicts of interest): https://blog.petrieflom.law.harvard.edu/2014/03/04/capsule-endoscopy-instead-of-colonoscopy-the-fda-approves-the-pillcam-colon/ …https://twitter.com/KimiChernoby/status/1222595910728912896 …
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#FDA list of 2019 novel new drugs: https://www.fda.gov/media/133911/download …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
Jonathan J Darrow proslijedio/la je Tweet
US has been on an accelerating "reversal of fortunes" public health trajectory since the 1980s https://twitter.com/JStein_WaPo/status/1190714809102348288 …pic.twitter.com/K79ZXZTWFa
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When discussing high
#drug spending, the contribution of volume (vs price) is often downplayed. Our study, just published, found increased volume contributed 90% of public sector spending growth on oncology drugs in Chile. https://ascopubs.org/doi/pdf/10.1200/JGO.19.00223 …#drugprices#cancer#oncologypic.twitter.com/RacJr2Rjl0
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A 4-minute history of
#PBMs (pharmacy benefit managers) from NPR/Kaiser:#drugs#pharmacy#drugpriceshttps://lnkd.in/efkaYmwHvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
Acetominophen/paracetamol (Tylenol) kills ~150 in US per year; 55,000+/year hospitalized. Generally from liver toxicity / inadvertent overdose. https://www.theatlantic.com/national/archive/2013/09/150-americans-die-each-year-from-tylenols-most-active-ingredient/310814/ …
#drugs#safetyHvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
2nd trastuzumab (Herceptin)
#biosimilar (Mylan) launched in US. No price info yet, but Mylan's pegfilgrastim (Fulphila/Neulasta) launched in 2018 at a 33% discount:https://www.centerforbiosimilars.com/news/mylan-and-biocon-launch-biosimilar-trastuzumab-ogivri-in-the-united-states …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
Can drug efficacy be so tiny that the excipient (inactive ingredient) is responsible for a substantial portion of perceived benefit? Some evidence suggests this may be the case for certain gold-containing arthritis medicines: https://www.ncbi.nlm.nih.gov/pubmed/26059394
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Higher
#eBay prices to come? How is it that sellers from some countries (eg#China) can sell *& ship* a product for less than the cost of US shipping alone? Part of the answer: a postal treaty that will be revised in July after a threatened US withdrawal:https://www.bbc.com/news/world-europe-49833914 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
CDC releases 2019
#antibiotic resistance report: 35k US deaths, 1/3 of which are from C dif.....and the major cause of C dif?? --> The use of#antibiotics (p39 of the CDC report) https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
Dear
#patient: Your#appendectomy may cost you $1,500 or $180,000 (a factor difference of >100)...and we won't tell you which until after you have had the procedure (PS: no refunds or returns allowed). Please sign to indicate your#consent...https://www.cbsnews.com/news/cost-of-an-appendectomy-reddit-user-posts-55000-bill/ …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
New TB
#vaccine (just 50% effective) for adults already infected with#tuberculosis begs the Q: Why not expand use of time-tested (~$3) BCG vaccine (used in 180 countries, and 70% effective (CDC est.)? FDA approved BCG, but it is not recommended in US.https://www.newscientist.com/article/2221405-experimental-tuberculosis-vaccine-could-save-millions-of-lives/ …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
How effective is Trikafta in treating
#CysticFibrosis? -->#FDA reports the key figure is a 10% to 13.8% improvement in ppFEV (lung capacity measurement obtained by blowing into a hollow tube). Cost: $311,000/yr https://lnkd.in/efC9cZT#drughttps://lnkd.in/ea4KBerHvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
More priority review vouchers should mean lower price per voucher (supply goes up --> price comes down (ceteris paribus)). This is in fact what we see: https://www.raps.org/regulatory-focus/news-articles/2017/12/regulatory-explainer-everything-you-need-to-know-about-fdas-priority-review-vouchers …https://twitter.com/ZacharyBrennan/status/1186360605726400512 …
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For a terrific (and classic) book examining the history of the business of
#medicine, see: The Social Transformation of American Medicine, by Paul Starr, https://www.amazon.com/Social-Transformation-American-Medicine-Profession/dp/0465093027 …https://twitter.com/JohnArnoldFndtn/status/1181938083505360896 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
California "physician lobbying group" opposed state efforts to facilitate access to drugs. Not against drugs per se, ...but in their view patients should first pay the prescriber for advice, whether the patient wants it or not.https://www.sfchronicle.com/politics/article/Gavin-Newsom-signs-bill-to-make-anti-HIV-drug-14499337.php?utm_campaign=CMS%20Sharing%20Tools%20(Premium)&utm_source=t.co&utm_medium=referral …
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No such thing as an "international patent"? ARIPO comes close for 18 countries in Africa: Uganda says no
#patents will issue on#pharmaceutical products until 2033 (a permitted exclusion under a#WTO#TRIPS council decision).https://www.managingip.com/Article/3894809/Africa-Uganda-exercisesTRIPS-flexibilities-for-pharmaceutical-products.html?ArticleId=3894809&LS=EMS1552607&utm_medium=email+alerts&utm_campaign=MIP+US+Free+email&utm_content=2019_10_07&utm_source=ems+email …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
New paper from
@Lietzan + Acri finds "generally no relationship" between a#drug's therapeutic category and "effective#patent life" (w/ some caveats). The paper also offers a lesson in why magnitude is more important than statistical significance. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3458588 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi
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