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Oct 31, 2017
10/17
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a blog on the site accuses the fda of being in the pocket of the drug industry.hose 14 companies just a drop in the bucket. even though it is illegal to claim that they treat or cure cancer without the fda's approval. listen to what 7 on your side when we went into six different shops undercover. recommendations range from vitamins to tea, from marijuana to miracles. they've given up on those treatments. they have taken this and the cancer is gone. i think it is a miracle. >> it's much more hope. it is heartbreaking. she encourages a combination of alternative and conventional medicines for cancer care. >> when you say the scary c-word, that will cure them. >> eventually it's a risk. there are no guarantees. kimberly: as much as they would like to believe, they know there is no bottled cure. >> it's your body. it's your life. you have to take charge and do the research and listen to your inner voice. the powerthe fda has to seize products and prosecute, but they have not taken further action against any of the 14 companies given warning letters. 7 on your side as
a blog on the site accuses the fda of being in the pocket of the drug industry.hose 14 companies just a drop in the bucket. even though it is illegal to claim that they treat or cure cancer without the fda's approval. listen to what 7 on your side when we went into six different shops undercover. recommendations range from vitamins to tea, from marijuana to miracles. they've given up on those treatments. they have taken this and the cancer is gone. i think it is a miracle. >> it's much...
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Oct 30, 2017
10/17
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they have the legal authority to do it. fda needs to figure out the very difficult criteria so that we can get drugs that will be substitutable. the big gain that we have in lower prices from generic, traditional generic drugs, is that when they were the same drug as the original one, that was an immediate competition,, especially when there was a substitutable generic. and most states allow the substitutable, substitution of a generic drug for a brand-name drug. right now we have the brand-name companies in the biotech area going to the states and making it more difficult for the states to allow went fda figures out the criteria, how to substitute generic biologic. i think that, that we have to overcome that as we look at reforms in this area. >> i do want to get back to the orphan drug act, that's incredibly long list of various things we could do and it also i think points to the fact it's going to take interventions for people at every level, not just federal legislatures to its state legislators, regulators, physicians and
they have the legal authority to do it. fda needs to figure out the very difficult criteria so that we can get drugs that will be substitutable. the big gain that we have in lower prices from generic, traditional generic drugs, is that when they were the same drug as the original one, that was an immediate competition,, especially when there was a substitutable generic. and most states allow the substitutable, substitution of a generic drug for a brand-name drug. right now we have the...
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Oct 5, 2017
10/17
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and it may be part of the fda's plan to try to lower the cost of medicine. >>> muny mayhem? municipal bond investors woke up to a big surprise after president trump said that puerto rico's debt could be wiped out. those stories and more tonight on "nightly business report" for this wednesday, october the 4th. >>> good evening, everybody. i'm bill griffeth in tonight for tyler mathisen, coming to you once again from the new york stock exchange, hi, sue. >> good to see you, bill. i'm sue herera. a record close for stocks. but we begin tonight with the job market. and the potentially unprecedented impact that hurricanes irma and harvey could have on the labor market, at least in the short term. today we learned that american employers created fewer jobs in september than they had in any single month in nearly a year, primarily because of hurricanes harvey and irma. as hampton pearson reports, the disruptions are expected to show up in the monthly government jobs r >> reporter: today's private sector hiring survey is the first indicator of just how much of an impact hurricanes h
and it may be part of the fda's plan to try to lower the cost of medicine. >>> muny mayhem? municipal bond investors woke up to a big surprise after president trump said that puerto rico's debt could be wiped out. those stories and more tonight on "nightly business report" for this wednesday, october the 4th. >>> good evening, everybody. i'm bill griffeth in tonight for tyler mathisen, coming to you once again from the new york stock exchange, hi, sue. >> good...
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Oct 28, 2017
10/17
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we need the fda to be much more involved. so we need more bio-similars that can compete with each other. that is one of the ways we have seen the price drop we did it a generic so very, very carefully. >> but i would second that as the biologic drugs there are dozens out there on the market that they need to be concerned about that there are mechanisms to make sure we are adequately addressing this issue but even though the fda has approved these bio-similars drugs they're only a couple on the market for those that have prevented these products from being approved. i know when to say a paper delay settlement but they will not market that through 2023. and then with those very old 35 that they could use in europe. >> one of these presentations a senator stood up and said competition sets the price there is a monopoly to regulate. so with an unusual situation of pharmaceuticals there is no easy answer because we have to have a petition -- competition with the public is put in a position. with the new miracles. then that the cong
we need the fda to be much more involved. so we need more bio-similars that can compete with each other. that is one of the ways we have seen the price drop we did it a generic so very, very carefully. >> but i would second that as the biologic drugs there are dozens out there on the market that they need to be concerned about that there are mechanisms to make sure we are adequately addressing this issue but even though the fda has approved these bio-similars drugs they're only a couple...
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Oct 27, 2017
10/17
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they have the authority to do that. we need fda to be much more involved. nd insofar as we don't get clear substitutable generics, we need more biosimilars that can compete with each other. in fact, i think that's one of the ways we have seen the price drop for dealing with the hepatitis d epidemic that we didn't get a generic but we got a competing biotech drugs. we need to look at all this area very, very carefully and maybe the fda can be the leader in helping this. >> again i would also second that and add follow-on biologic drugs are being used and have been used in europe for the last decade. or are dozens as on the market that it venues safely. i think we need to be concerned about the safety of these products but that there are mechanisms we can use to try to get products out and be able to then use them and follow them and make sure that we are adequately addressing the safety issue. but right now even though the fda has approved something like seven or eight biosimilar drugs we'll have one or two out of the park because of litigation over patents a
they have the authority to do that. we need fda to be much more involved. nd insofar as we don't get clear substitutable generics, we need more biosimilars that can compete with each other. in fact, i think that's one of the ways we have seen the price drop for dealing with the hepatitis d epidemic that we didn't get a generic but we got a competing biotech drugs. we need to look at all this area very, very carefully and maybe the fda can be the leader in helping this. >> again i would...
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Oct 30, 2017
10/17
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the fda, and i'm going to highlight this in the next slide, the fda has actually in certain ways created artificial monopolies for drugs that are off patent. the famous example is the martin shkreli drug in the news. that was actually a really old drug that had been off patent for a while, but because of an artificial monopoly the fda helped create, that drug was no longer a monopoly and shkreli could raise the price. there are a number of ways in which the fda regulations have created prices and there should be more competition. biosimilars are a very important emerging area for more competition. as many of you know, but maybe not everyone, there's a difference in fda regulation between small molecules which are pills you could synthesize in a high school chemistry lab, like aspirin, like tlipitor, versus other big proteins which come out of the dna revolution of the last several decades. those larger proteins have to be manufactured much more carefully and much more specialized ways. and they're not so easy to replicate. and as a result, the fda has been much tougher on and has created
the fda, and i'm going to highlight this in the next slide, the fda has actually in certain ways created artificial monopolies for drugs that are off patent. the famous example is the martin shkreli drug in the news. that was actually a really old drug that had been off patent for a while, but because of an artificial monopoly the fda helped create, that drug was no longer a monopoly and shkreli could raise the price. there are a number of ways in which the fda regulations have created prices...
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Oct 31, 2017
10/17
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today the fda said it wants to remove a health claim on labels of hundreds of soy protein products. labels that say the products can reduce the risk of heart disease by lowering cholesterol. >> that science is somewhat inconsistent and does not rate the standard that we would allow for an authorized health claim. >> reporter: it's stunning because 18 years ago the fda said the opposite, but tonight cardiologists agree, studies since then no longer show strong proof. >> no one is saying that soy protein is unhealthy. we're just not -- we're saying you can't expect some special benefits from the soy protein. >> reporter: the multibillion dollar soy industry is pushing back. in a statement saying, they're disappointed and soy protein can be an important part of a heart-healthy diet. for michelle hendricks, it's all very confusing. >> the trouble at the grocery store is that nothing is really clear when i'm trying to make a choice for my family. >> reporter: the fda's final decision expected next year, making sure health claims on food labels are true. rehema ellis, nbc news, new york. >
today the fda said it wants to remove a health claim on labels of hundreds of soy protein products. labels that say the products can reduce the risk of heart disease by lowering cholesterol. >> that science is somewhat inconsistent and does not rate the standard that we would allow for an authorized health claim. >> reporter: it's stunning because 18 years ago the fda said the opposite, but tonight cardiologists agree, studies since then no longer show strong proof. >> no one...
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Oct 11, 2017
10/17
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has put in place to ensure that the opioid alternatives submitted to the fda are prioritized and get the attention they ought to. i have heard from numerous skps who either submitted to the fda or who have products for pain or development. and i want to make sure they have clear guidance on when the fda will review them in a tombly way. if traditional path wes do not fit these products i would like to hear how we can provide the help fda may need. prescription monitoring programs, state run electronic databases that can help track prescribed entities are an important and innovative tool. like forward to hearing today how we can help states integrate prescription drug monitoring programs with electronic health records to help inform physicians practices while protecting patient privacy. congress has accomplished a hot in a bipartisan way to provide funding and update programs to assist states and help combat this public health crisis. i look forward to hearing how the administration is moving forward in this important work. senator murray. >> thank you very much chairman land land.
has put in place to ensure that the opioid alternatives submitted to the fda are prioritized and get the attention they ought to. i have heard from numerous skps who either submitted to the fda or who have products for pain or development. and i want to make sure they have clear guidance on when the fda will review them in a tombly way. if traditional path wes do not fit these products i would like to hear how we can provide the help fda may need. prescription monitoring programs, state run...
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Oct 30, 2017
10/17
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for the first time ever the fda says it wants to revoke a health claim the agency once approved thataid drinking soy protein milk or eating other soy foods can keep your heart healthy. nbc's rehema ellis explains why they're taking a second look at that. >> reporter: for millions of americans who from tru t consuming soy is good for their heart, this is a surprise. today the fda said it wants to remove a health claim on labels of hundreds of soy protein products, labels that say the products can reduce the risk of heart disease by lowering cholesterol. >> that science is somewhat inconsistent and does not rate the standard that we would allow for an authorized health claim. >> reporter: it's stunning because 18 years ago the fda said the opposite, but tonight cardiologists agree, studies since then no longer show strong proof. >> no one is saying that soy protein is unhealthy. we're just not -- we're saying you can't expect some special benefits from the soy protein. >> reporter: the multibillion dollar soy industry is pushing back in a statement saying they're disappointed and soy p
for the first time ever the fda says it wants to revoke a health claim the agency once approved thataid drinking soy protein milk or eating other soy foods can keep your heart healthy. nbc's rehema ellis explains why they're taking a second look at that. >> reporter: for millions of americans who from tru t consuming soy is good for their heart, this is a surprise. today the fda said it wants to remove a health claim on labels of hundreds of soy protein products, labels that say the...
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Oct 31, 2017
10/17
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KGO
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the fda is issuing an alert about this popular candy. >>> and meet the other george papadopoulos, the man who shares a now famous name tries to explain himself to the internet. >>> a good tuesday morning. we begin with reports of a furious president trump after the first indictments in the russia investigation. >> ex-campaign chair paul manafort and his former deputy now under house arrest after pleading not guilty to charges connected to their business dealings. but the first evidence of possible collusion is coming from another former trump adviser who apparently cut a deal after lying to the fbi about russia. we're now just learning about it. abc's janai norman is joining us from washington where things are pretty busy this morning. good morning, janai. >> reporter: absolutely, kendis and diane. so special counsel robert mueller handed up the first indictments in the russia investigation. we expected that, but then came the unexpected news, that guilty plea from a former adviser to the trump campaign. >> did you commit a crime? >> reporter: former trump campaign chairman paul manaf
the fda is issuing an alert about this popular candy. >>> and meet the other george papadopoulos, the man who shares a now famous name tries to explain himself to the internet. >>> a good tuesday morning. we begin with reports of a furious president trump after the first indictments in the russia investigation. >> ex-campaign chair paul manafort and his former deputy now under house arrest after pleading not guilty to charges connected to their business dealings. but the...
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Oct 13, 2017
10/17
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s e will their numbers set the tone for the rest of the economy? >>> an fda panel gives its stamp of approval for a gene therapy treatment here in the u.s. all that and more on "nightly .usiness repor >>> good evening, everyone, and welcome. it's been quite a few weeks for credit reporting agency equifax. last month the company revealed it had been hacked, potentially compromising the data of 145 million people. since then, the ceo stepped down and apologized. several other executives also left. there are investigations by federal and state agencies includg the department of justice. now today the company said it was looking into a possible second breach but later in the day reversed course, kind of, instead of putting the issue on a third party vendor. andrea day explains. >> reporter: it comes just one month after the credit giant disclosed a hack that compromised sensitive information of more than 145 million people. then today equifax, taking one of its consumer web pages offline, the same page people use to dispute issues in their credit report. this is
s e will their numbers set the tone for the rest of the economy? >>> an fda panel gives its stamp of approval for a gene therapy treatment here in the u.s. all that and more on "nightly .usiness repor >>> good evening, everyone, and welcome. it's been quite a few weeks for credit reporting agency equifax. last month the company revealed it had been hacked, potentially compromising the data of 145 million people. since then, the ceo stepped down and apologized. several...
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Oct 5, 2017
10/17
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the fda says it's a violation. the bakery says it has been 20 years, butor they will call operate with the fda. jonathan: after 20 years they there is no love in that story. an incredible story ahead. alison: the couple born on the same day in the same place now getting married? jonathan: this is love. alison: i just saved a bunch of money on my car insurhuh. with geico. i should take a closer look at geico... geico can help with way more than car insurance. boats, homes, motorcycles... even umbrella coverage. rought his umbrella. fire at will! how'd you know the guy's name is will? yeah? it's an expression, ya know? fire at will? you never heard of that? oh, there goes will! bye, will! that's not his name! take a closer look at geico. great savings. and a whole lot more. jonathan: there is an incredible coincidence playing out in massachusetts. this couple figured they were born at the same hospital, on the same day. look at those heads of hair. alison: they look alike. jonathan: the plot thick
the fda says it's a violation. the bakery says it has been 20 years, butor they will call operate with the fda. jonathan: after 20 years they there is no love in that story. an incredible story ahead. alison: the couple born on the same day in the same place now getting married? jonathan: this is love. alison: i just saved a bunch of money on my car insurhuh. with geico. i should take a closer look at geico... geico can help with way more than car insurance. boats, homes, motorcycles... even...
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Oct 1, 2017
10/17
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however, the fda has an admitted agenda to foster biotechnology. and when it issues its policy in may of 1992 after having received all that input, it claimed that it was the not aware of any information showing that foods derived by genetic engineering differ from any other foods in uniform or meaningful way. it also asserted there was overwhelming consensus among scientists that g.e. foods are so safe they don't need to be tested at all even though it knew no such consensus existed. accordingly, the fda's not required even a midge john of -- smidgen of safety testing. if the fda had disclosed the extensive concerns of its own experts, the subsequent history of the gm e. venture would surely have been very different and might well have been very short. at the least, every -- any g.e. food that did reach the market would have been subjected to much more rigorous testing than regulators anywhere in the world have yet required. so that's one claim. what about the oft-repeated claim that no ingestible product of genetic engineering has ever been linked
however, the fda has an admitted agenda to foster biotechnology. and when it issues its policy in may of 1992 after having received all that input, it claimed that it was the not aware of any information showing that foods derived by genetic engineering differ from any other foods in uniform or meaningful way. it also asserted there was overwhelming consensus among scientists that g.e. foods are so safe they don't need to be tested at all even though it knew no such consensus existed....
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Oct 28, 2017
10/17
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the way fda regulations created monopolies and there should be more competition. and as many of you know there is the difference of fda regulations between small molecule's like aspirin or cholesterol or of the tort verses antibodies are proteins with that dna revolution but those larger proteins have to be much more carefully manufactured better not so easy to replicate and as a result they have been much tougher with much higher regulatory barriers for generic competition. so to have much longer runways. >> lecter is that intellectual and cultural bias that we have to have innovative drugs not a the me too drugs under similar and profile and structure guess what that means? if they are competing for that group of patients then prices go down. we have a bias against me too drugs because it is an innovative but economically it is important to encourage the development of me too drugs that means lower prices for every american. so let's focus on these three areas in particular but first i will talk about one of these ideas. this is an example. and basically to stimu
the way fda regulations created monopolies and there should be more competition. and as many of you know there is the difference of fda regulations between small molecule's like aspirin or cholesterol or of the tort verses antibodies are proteins with that dna revolution but those larger proteins have to be much more carefully manufactured better not so easy to replicate and as a result they have been much tougher with much higher regulatory barriers for generic competition. so to have much...
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Oct 10, 2017
10/17
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scott gotlieb, commissioner of the fda confirmed in may of this year. dr. mccantz, we'll begin with you, and please summarize your comments in about five minutes. >> thank you, senator alexander. chairman alexander, ranking member murray and members of the senate health education and pensions committee thank you for inviting me to testify at this important hearing. i'm honored to testify today along with my colleagues from the department of health and human services on the federal response to the opioid crisis. over the past 15 years communities across our nation have been devastated by increasing prescription and illicit opioid adistribution, overdose. in 2016 over 11 million americans misused prescription opioids. nearly 1 million used heroin and 2 .1 had an opioid use disorder due to prescription opioids. most alarming are the increase in overdose deaths especially the increase in deaths involving illicitly made feintal and other drugs. we are committed to bringing everything the federal government has to bare on this health crisis. we have identified fiv
scott gotlieb, commissioner of the fda confirmed in may of this year. dr. mccantz, we'll begin with you, and please summarize your comments in about five minutes. >> thank you, senator alexander. chairman alexander, ranking member murray and members of the senate health education and pensions committee thank you for inviting me to testify at this important hearing. i'm honored to testify today along with my colleagues from the department of health and human services on the federal...
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Oct 18, 2017
10/17
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set a good example of bipartisan success in the fda user agreement. this committee worked with our counterparts in the house to update and past user fee agreements. it included agreements for many senators on both sides of the including additional staff and resources to the fda. generic drugs provide more competition and lower drug costs. committee worked together on 21st century cures, to spur the development of new drugs and treatments. ingoal is to continue these a bipartisan way to learn the facts about what goes into the price patients pay when picking up prescriptions and what steps we can agree on to lower the prices. we are at the middle of a remarkable time in producing amazing discoveries for patients. we have drugs that can cure hepatitis c, keep cancer at bay, and stop a stroke. with this innovation comes new challenges. we need to make sure all patients can benefit. the cost of new drugs are often too much for them to afford. we need to make sure any action we take does not jeopardize the innovation and the breakthroughs. the prescription
set a good example of bipartisan success in the fda user agreement. this committee worked with our counterparts in the house to update and past user fee agreements. it included agreements for many senators on both sides of the including additional staff and resources to the fda. generic drugs provide more competition and lower drug costs. committee worked together on 21st century cures, to spur the development of new drugs and treatments. ingoal is to continue these a bipartisan way to learn...
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Oct 27, 2017
10/17
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they were on the market before the fda existed. they have been on the market legally for many years. the fda said, we don't like that. we're going to try to get those unapproved drugs off the market. manufacturersage to do clinical trials of the drugs. we will give them time. they jack up the price by 60,000%. the fda had certain good intentions. we want to make sure these drugs that have been around for hundreds of years have a certain kind of regulatory safety that we can certify. but they didn't think ahead and say we are creatingbut they di'd say we are creating this incentive for exploitation of pricing. -- exploitative pricing. another thing that fda commissioner scott gottlieb has , it's the issue of generic drugs when there is a delivery. a specialized delivery technology associated with it. epinephrine, the drug in epipen has been around for 100 years. but the injector thatepinephrins to administer epinephrine has a patent around it. what stymied competition in this area is that if you want to be a generic manufacturer of a
they were on the market before the fda existed. they have been on the market legally for many years. the fda said, we don't like that. we're going to try to get those unapproved drugs off the market. manufacturersage to do clinical trials of the drugs. we will give them time. they jack up the price by 60,000%. the fda had certain good intentions. we want to make sure these drugs that have been around for hundreds of years have a certain kind of regulatory safety that we can certify. but they...
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Oct 19, 2017
10/17
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we call that the fda gold standard. there are 4.4 billion prescriptions a year, most of us when we go into our local pharmacy or the doctor's office don't really worry about the safety of those prescriptions, because we rely on the fda gold standard. sometimes when the cost of drugs comes up, there are proposals that we should import drugs from other countries. and sidestep the careful fda review and approval of each drug sold in the united states. i would like to ask each of you, starting with mr. managen and then going across whether you agree that we should allow drugs approved by other countries to be sold in the united states without careful review and approval of each drug by the food and drug administration. >> the short answer is absolutely not. while hapa appreciates the effort to combat drug costs, we don't believe importation of the drugs would help, it conflicts with the efforts to increase the integrity and the security of the drug supply chain and disrupts value of care and payment and delivery. we're conce
we call that the fda gold standard. there are 4.4 billion prescriptions a year, most of us when we go into our local pharmacy or the doctor's office don't really worry about the safety of those prescriptions, because we rely on the fda gold standard. sometimes when the cost of drugs comes up, there are proposals that we should import drugs from other countries. and sidestep the careful fda review and approval of each drug sold in the united states. i would like to ask each of you, starting with...
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Oct 31, 2017
10/17
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the fda says not so fast. what it wants to remove from a certain food label. >>> an i-team investigation surrounding the iphone. the spike in violent attacks you want to know about if you m mark herring, candidate for attorney general, and i sponsored this ad. female narrator: what would john adams do to women's health? adams argued before the supreme court to give employers control over your access to birth control. block access to affordable contraception for 1.6 million virginia women. and adams opposes abortion even in cases of rape, or incest. john adams: wrong for women's health. wrong for virginia. . >>> we know the odds of hitting a mega jackpot are pretty slim. but 180 tickets were sold statewide last week that had zero chance of winning. so the virginia lottery had technical difficulties and it has upgraded its gaming system. that's a lot of wasted money. >> some of the tickets produced according to the previous rules of the game basically made them worthless for the big jackpot. i don't know what rep
the fda says not so fast. what it wants to remove from a certain food label. >>> an i-team investigation surrounding the iphone. the spike in violent attacks you want to know about if you m mark herring, candidate for attorney general, and i sponsored this ad. female narrator: what would john adams do to women's health? adams argued before the supreme court to give employers control over your access to birth control. block access to affordable contraception for 1.6 million virginia...
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Oct 6, 2017
10/17
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one of the places where fda can have an outside impact and we all have different roles to play, trying to reduce the rate of new addiction by trying to decrease the overall exposure to opioids. it comes down to math. a certain percentage of patients exposed to opioids will become addicted and the key is to reduce exposure. we will do that by changing prescribing among physicians. most people become addicted become medically addicted and a drug like percocet and then low cost alternatives, which is street drugs. we have taken steps in recent months to increase provider interjection. we've been looking at dispensing and we're asking what we can do with respect to mandatory education. the key for us is to try to reduce overall exposure. >> i think you're absolutely right that we have to put more effort at the front end of this problem, and reduce access by changing prescribing habits, particularly by allowing partial cells, by allowing physicians, by training physicians, that they should only give 10 pills, not 50, that sort of thing. dr. collins, do you have anything to add? >> totally a
one of the places where fda can have an outside impact and we all have different roles to play, trying to reduce the rate of new addiction by trying to decrease the overall exposure to opioids. it comes down to math. a certain percentage of patients exposed to opioids will become addicted and the key is to reduce exposure. we will do that by changing prescribing among physicians. most people become addicted become medically addicted and a drug like percocet and then low cost alternatives, which...
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Oct 17, 2017
10/17
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>> to the credit of the fda commissioner, he's doing what he can. does he have all the authorities to dress that in and of himself, no. >> i would say companies like in the instance of daraprim, took advantage of regulatory arbitrage to increase the price. >> because there was no direct regulator on the beat whose responsibility was to look at a clear de facto monopoly and address the excess price extraction. >> to chip's point, i think there's -- >> right? i just want to make sure i heard you. your answer. >> i would say in the case, in that particular case, and we have seen a handful of others that mimic the same pattern, is exactly right. i think the fda is trying to do, but more could be done. we have lots of ideas on how you could address that. >> thanks for letting me go over, chairman franken. >> i went way over. and i'm even going to ask one more question just to mr. merritt real quick. pay for delay. because we're talking about monopolies. pay for delay. drug company has a patent, and then a generic comes up, the patent runs out. generic has
>> to the credit of the fda commissioner, he's doing what he can. does he have all the authorities to dress that in and of himself, no. >> i would say companies like in the instance of daraprim, took advantage of regulatory arbitrage to increase the price. >> because there was no direct regulator on the beat whose responsibility was to look at a clear de facto monopoly and address the excess price extraction. >> to chip's point, i think there's -- >> right? i just...
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Oct 10, 2017
10/17
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now that tlegislation has given the authorization, what steps have the fda taken? >> thank you for the question, senator. we set out probably about three weeks ago, four weeks ago, so undertake a formal study of the lexicon we use in describing the abuse deterrent formulations to make sure we're not conveying to providers and patients that a drug that has abuse deterrent features is less prone to addiction. it's not. the abuse features make them less prone to manipulation. they still can cause addiction. and so we are looking at this scientifically. we should have that information back in a reasonable time frame. i'd be happy to come in and talk to you about it. >> i would appreciate that. we are giving you tools to get information out there. these drugs were approved without a full understanding of this potential impact, and i think just the more quickly you can move, the better off we will be even as you're gathering there? >> i agree. i want to make sure we're science based, but we'll move quickly. >> thank you. and we've talked a lot about the two-year opioid re
now that tlegislation has given the authorization, what steps have the fda taken? >> thank you for the question, senator. we set out probably about three weeks ago, four weeks ago, so undertake a formal study of the lexicon we use in describing the abuse deterrent formulations to make sure we're not conveying to providers and patients that a drug that has abuse deterrent features is less prone to addiction. it's not. the abuse features make them less prone to manipulation. they still can...
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Oct 31, 2017
10/17
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WRC
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reach the standard that we would allow for a claim. >> reporter: it's stunning because 18 years ago the fda said the opposite. but tonight cardiologist agree. studies since then no longer show strong proof. >> no one is saying that soy protein is unhealthy. we are just saying you can't expect some special benefits from the soy protein. >> reporter: the multi billion dollar soy industry is pushing back and say it can be an important part of a heart healthy diet. for her it's all very confusing. >> the trouble at the grocery store is nothing is really clear when i'm trying to make a choice for my family. >> reporter: the fda final decision expected next year. making sure a health claims on food labels are true. nbc news new york. > parents. hear one thing is safe, then years later another study comes out, and, yeah, struggling. >> which is it? >>> all right. welcoming up after the break, jimmy fallon has fun with a popular treat this time of year. >>> and looks ahead to the warm-up at the end of the week and whe we could see that ranin at 11:40. you know it's halloween. tonight jimmy fallon w
reach the standard that we would allow for a claim. >> reporter: it's stunning because 18 years ago the fda said the opposite. but tonight cardiologist agree. studies since then no longer show strong proof. >> no one is saying that soy protein is unhealthy. we are just saying you can't expect some special benefits from the soy protein. >> reporter: the multi billion dollar soy industry is pushing back and say it can be an important part of a heart healthy diet. for her it's...
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Oct 12, 2017
10/17
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CNBC
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meg tirrell, give us the details. >> it was 16-0 unanimously in favor from the outside panel of fda advisers on the sparks gene therapy trial. this is for a rare inherited form of blindness that affects few people this would be a landmark moment in medicine if the fda does approve this drug this would be the first gene therapy on the market in the united states. gene therapy is aimed to be a one-time treatment where you deliver a healthy copy of a gene to fix an underlying genetic problem. spark therapeutics has the drug at fda shares have one up significantly into today people were expecting a positive handling here at the fda, that's what we saw. we don't know when spark share also reopen. i want to introduce you to a couple patients we talked to last year. karen and cole carpenter listen to how she described her vision before. brfrnlgt, >> before, i couldn't see snow, the little snowflakes, and then i went outside when it was snowing, and i was like, oh, i can see the snowflakes what is that like? >> it's cool, to see something i haven't seen in my life before. >> both caroline an
meg tirrell, give us the details. >> it was 16-0 unanimously in favor from the outside panel of fda advisers on the sparks gene therapy trial. this is for a rare inherited form of blindness that affects few people this would be a landmark moment in medicine if the fda does approve this drug this would be the first gene therapy on the market in the united states. gene therapy is aimed to be a one-time treatment where you deliver a healthy copy of a gene to fix an underlying genetic...
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Oct 6, 2017
10/17
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WPVI
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a massachusetts bakery found out the hard way that the fda is not feeling the love.s the bakery has been putting the word "love" on its ingredient list on all of its granola packages but the fda is demanding it be removed saying love is not a common or unusual name of an ingredient. the owners say come on. have a little heart. >> i thought of george orwell. the idea we can't use the word "love" on an ingredient label feels like the government is getting a little too involved. >> even though love is no longer listed on their products, it's still baked into every loaf of bread and it is still in every bag of granola. so take that, fda. >>> finally a grandma goes to barnes and noble and picks up a book. it's called if animals can talk. cute, right? when they started flipping through the book, they realized this was not meant for a 6-year-old to be read at bedtime. and what those animals had to say was kind of x-rated. this chicken was not cluck cluck. it was saying that rhymes with it and is not suitable for tv audiences. yes, animals saying dirty words, adult themes. t
a massachusetts bakery found out the hard way that the fda is not feeling the love.s the bakery has been putting the word "love" on its ingredient list on all of its granola packages but the fda is demanding it be removed saying love is not a common or unusual name of an ingredient. the owners say come on. have a little heart. >> i thought of george orwell. the idea we can't use the word "love" on an ingredient label feels like the government is getting a little too...
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Oct 5, 2017
10/17
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CNBC
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the fda will expedite drugs for serious conditions where there are few or no treatment options. >>> shares of zumiez are up today. the clothing same-store sales rose 9% and raising the outlook for third quarter earnings, revenue and same-store sales shares up 8% >>> is gold starting to lose ets shin its shine? >>> and later, piling on just when you think theresa may's speech yesterday couldn't get worse, it just did wel llou'lte y how when "worldwide exchange" returns ins, causing a lack of sharpness, or even trouble with recall. thankfully, the breakthrough in prevagen helps your brain and actually improves memory. the secret is an ingredient originally discovered... in jellyfish. in clinical trials, prevagen has been shown to improve short-term memory. prevagen. the name to remember. throughout history, the one meal when we come together, break bread, share our day and connect as a family. [ bloop, clicking ] and connect, as a family. just, uh one second voice guy. [ bloop ] huh? hey? i paused it. bam, family time. so how is everyone? find your awesome with xfinity xfi and cha
the fda will expedite drugs for serious conditions where there are few or no treatment options. >>> shares of zumiez are up today. the clothing same-store sales rose 9% and raising the outlook for third quarter earnings, revenue and same-store sales shares up 8% >>> is gold starting to lose ets shin its shine? >>> and later, piling on just when you think theresa may's speech yesterday couldn't get worse, it just did wel llou'lte y how when "worldwide...
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Oct 2, 2017
10/17
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CSPAN2
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eye 55
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and so on track but i got to tell you the pharmaceutical industry and its cozy relationship with the fda, cms and that's a red herring. those are red hearings. those are not good and they're not laudable and there many cases prosecutable but that is not the central for the biggest problems and we will get to that in a few minutes, in the course of the questions i laid out to ask you. i wanted to interject to say you are on the track of this and we will get you a pulitzer prize one of these days for exposing the whole thing but i want to say that from the standpoint of marketing schemes closing up to researchers in relationships with the fda cms not having price restrictions off label use that is not where the actions and it's the deep throat follows the money or whatever the term was and i'm going to tell you how to do that -- >> guest: i'm a reporter and i go where the facts go and i'm open-minded to learn new things. i'm glad to hear what you have to tell me. >> host: getting back to more substance issues you break down the mental health system into three coexisting systems of public s
and so on track but i got to tell you the pharmaceutical industry and its cozy relationship with the fda, cms and that's a red herring. those are red hearings. those are not good and they're not laudable and there many cases prosecutable but that is not the central for the biggest problems and we will get to that in a few minutes, in the course of the questions i laid out to ask you. i wanted to interject to say you are on the track of this and we will get you a pulitzer prize one of these days...
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Oct 19, 2017
10/17
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WUSA
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. >>> and the fda approves a second gene-altering treatment for cancer. this is the "cbs morning news." the toothpaste that helps prevent bleeding gums. if you spit blood when you brush or floss you may have gum problems and could be on the journey to much worse. help stop the journey of gum disease. try parodontax toothpaste. it's clinically proven to remove plaque, the main cause of bleeding gums. for healthy gums, and strong teeth. leave bleeding gums behind. with parodontax toothpaste. ♪ i'm lucky to get through a shift without a disaster. my bargain detergent couldn't keep up. so, i switched to tide pods. they're super concentrated, so i get a better clean. number one trusted. number one awarded. it's got to be tide trust #1 doctor recommended dulcolax. use dulcolax tablets for gentle dependable relief. suppositories for relief in minutes. and dulcoease for comfortable relief of hard stools. dulcolax. designed for dependable relief. yourwrong car.ady. oh, i'm so sorry about that. you guys want to check it out? it's someone else's car. what is this? it
. >>> and the fda approves a second gene-altering treatment for cancer. this is the "cbs morning news." the toothpaste that helps prevent bleeding gums. if you spit blood when you brush or floss you may have gum problems and could be on the journey to much worse. help stop the journey of gum disease. try parodontax toothpaste. it's clinically proven to remove plaque, the main cause of bleeding gums. for healthy gums, and strong teeth. leave bleeding gums behind. with...
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Oct 8, 2017
10/17
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CSPAN2
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eye 57
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so on track, but i've got to tell you, the pharmaceutical industry, its cordial relationship with the fda, cms, that's a red herring. those are red herrings. those are not good. they are not laudable. they are in many cases prosecutable, but that's not the central, the biggest problem. we're going to get to that in a few minutes, in the course of the way i have laid out the questions i would ask you. i just want to interject to say you are on the track of this and will get you a pulitzer prize one of these days for sort of exposing the whole thing, but i just want to say that from the standpoint of pharma marketing schemes, cozying up to researchers, relationships with the fda, cms not having price restrictions, off-label use, that's not where the actions, it's like the deep throat,, follow the money or follow whatever, the term was hit on going to have to do that and -- >> guest: okay. one thing is i'm a report and aye where the facts go and an open-minded to learn new things. -- i go. >> host: good. just getting back to the more substantive issues, you break down the mental health syste
so on track, but i've got to tell you, the pharmaceutical industry, its cordial relationship with the fda, cms, that's a red herring. those are red herrings. those are not good. they are not laudable. they are in many cases prosecutable, but that's not the central, the biggest problem. we're going to get to that in a few minutes, in the course of the way i have laid out the questions i would ask you. i just want to interject to say you are on the track of this and will get you a pulitzer prize...
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Oct 3, 2017
10/17
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KQED
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the medicine was approved by the fda on august 30th. marketed by novartis. r the johnsons, it was a joyful moment. >> breathtaking for me, just, you know, thinking, wow, we are a part of this to help hundreds of thousands of kids. i'm always thinking -- i almost chose not to do this. more work is under way to extend the reach to more patients, who like caitlyn, had tried everything that medicine had to offer. for "nightly business report," i'm meg tirrell. >>> coming up tole, an historic approval and an historic price tag. a look into the business of this way of fighting cancer. >>> a wonderful way to end a broadcast on a tough day. >> yeah. >>> lovely story. >> that does it for us on "nightly business report i'm sue herera. thanks for joining us. >> and i'm tyler mathisen. have a great evening, everybody. see you you >> this is "bbc world news america." funding of this presentation is made possible by the freeman foundation, and kovler foundation, pursuing solutions for america's neglected needs. >> planning a vacation escape that is relaxing, inviting, and
the medicine was approved by the fda on august 30th. marketed by novartis. r the johnsons, it was a joyful moment. >> breathtaking for me, just, you know, thinking, wow, we are a part of this to help hundreds of thousands of kids. i'm always thinking -- i almost chose not to do this. more work is under way to extend the reach to more patients, who like caitlyn, had tried everything that medicine had to offer. for "nightly business report," i'm meg tirrell. >>> coming up...
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Oct 16, 2017
10/17
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FBC
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eye 70
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i would love to see them blow up the fda structure and put that back together. se stocks so far back, that was the era of blockbuster drugs. there is a limited amount of time tuck make cash on those things. why not extended the period of exclusivity, instead make it a 1-year process, make it a 2-year process and get a capitalistic solution. if the government tries to tell drug companies what to charge, how is that different than single payer in europe. >> it takes about 10 years for a drug company to develop something and finally get out to market. if you think about it you are talking about the price very often being passed on to the consumer. you will have democrats saying we are going to have these price control that have to be put on to medicare part d. so watch for that in the upcoming legislation. charles: i love the fact that president trump is looking at the political contributions for pharmacy companies. thank you very much, appreciate it. next, president trump trying to turn back the clock and the obama era. piece by piece he's dismanning it executive o
i would love to see them blow up the fda structure and put that back together. se stocks so far back, that was the era of blockbuster drugs. there is a limited amount of time tuck make cash on those things. why not extended the period of exclusivity, instead make it a 1-year process, make it a 2-year process and get a capitalistic solution. if the government tries to tell drug companies what to charge, how is that different than single payer in europe. >> it takes about 10 years for a...
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Oct 11, 2017
10/17
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CNBC
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we wanted to get rid of one of the old drugs and add a new targeted therapy our data is strong and the fdaed us break-through designation. we're planning to submit for approval later this year and hopefully in 2018. >> how big is that market? >> it's being 8,500 patient diagnosed in the u.s. with hostage kin lymphoma the advanced patients will certainly get this drug first. which is probe about 6,000 of them >> if you worked for 5.5 years this drug must have cost you a lot of money to develop. >> yes it is expensive to develop we are working with a partner, and we discovered and developed the drug and we partnered with de-katie that. we sell and market it in the usa and canada, they market it outside of the usa and canada and now approved in 67 countries. >> now you've got something going on for bladder cancer, again these are difficult cancers and apparently you're having some success. >> yeah in bladder cancer we had a drug targeted to something called neck tin four we're doing this in collaboration with atell lus we each own half in this one we're developing a drug we call it ev. ev has
we wanted to get rid of one of the old drugs and add a new targeted therapy our data is strong and the fdaed us break-through designation. we're planning to submit for approval later this year and hopefully in 2018. >> how big is that market? >> it's being 8,500 patient diagnosed in the u.s. with hostage kin lymphoma the advanced patients will certainly get this drug first. which is probe about 6,000 of them >> if you worked for 5.5 years this drug must have cost you a lot of...
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Oct 27, 2017
10/17
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KTVU
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the fda reviewed research on peanut allergies and approved language for certain food manufacturers to use on their labels. a study from the national institutes of health found that babies at risk of developing a food allergy could benefit if they are introduced to peanuts early in life. the fda does not recommend young children consume whole peanuts. 2% of american children are allergic to peanuts. >>> walmart took a futuristic approach to make sure their shells are replenished all the time. walmart said it will test shell scanning robots in stores in california, pennsylvania and arkansas. the robots will be roaming the aisles checking for stock levels, pricing and missed placed items. will contact a human employee with that information. walmart is stressing the robots are there to supplement humans, not replace them. the robots will be available and 50 stores nationwide at the end of january. >>> the word is the wine country is open for business. two weeks after the wildfires. we will show you some of the efforts to bring tourists back. >>> a break in the case of a bay area musician
the fda reviewed research on peanut allergies and approved language for certain food manufacturers to use on their labels. a study from the national institutes of health found that babies at risk of developing a food allergy could benefit if they are introduced to peanuts early in life. the fda does not recommend young children consume whole peanuts. 2% of american children are allergic to peanuts. >>> walmart took a futuristic approach to make sure their shells are replenished all the...
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Oct 19, 2017
10/17
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CNBC
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everybody is talking about how wonderful the airports are and colleges are >>> other stocks to watch, the fdapproving a gilead cancer therapy six weeks ahead of schedule the treatment for adults with advanced lymphoma. >>> blue apron is cutting about 6% of its total work force the meal kit delivery company's valuation dropped by more than 50% since it went public four months ago it's been dealing with rising costs, declining customers and the threat of competition from rivals like amazon that stock lower bay half percent. >>> adobe shares are rising this morning. the company offering upbeat full-year earnings and revenue guidance at its analyst's day yesterday. >>> china's q3 gdp growth came in in line with expectations yu eunice yoon has more on that nks t n >> the q3 gdp numbers were at 6.8% this is slightly slower, because they had been reigning in the property market and managing debt risk. that number supports the chatter we've been hearing at the party congress which is going on behind me at the great hall of the people we've been hearing from president xi and other officials about how
everybody is talking about how wonderful the airports are and colleges are >>> other stocks to watch, the fdapproving a gilead cancer therapy six weeks ahead of schedule the treatment for adults with advanced lymphoma. >>> blue apron is cutting about 6% of its total work force the meal kit delivery company's valuation dropped by more than 50% since it went public four months ago it's been dealing with rising costs, declining customers and the threat of competition from rivals...
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Oct 27, 2017
10/17
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KTVU
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. >>> the fda approved new labels aimed at helping babies reduce the risk of developing a peanut allergy. we have the details next. ♪ that one. this. that one. ♪ ♪ >>> twitter is cutting ties with two russian media outlets. they will not do business with russia today or sputnik. twitter said u.s. intelligence investigation show those companies interfered in the presidential election. russian officials say twitter is banning the companies because of pressure from the u.s. government and are warning russia will retaliate. >>> uber is adding a new feature. the introduced the, add a stop feature. it lets you add up to three stops to your route. riders will be able to make changes in the middle of the route. the new feature is on ios and android for users around the world if they have the latest version of the uber app. >>> a new report backs the theory that many bay area tech workers are moving to seattle. the real estate group zillow said home prices in seattle are going up faster than in silicon valley. home prices in seattle are up 12.4% compared to a year ago while home prices in san jos
. >>> the fda approved new labels aimed at helping babies reduce the risk of developing a peanut allergy. we have the details next. ♪ that one. this. that one. ♪ ♪ >>> twitter is cutting ties with two russian media outlets. they will not do business with russia today or sputnik. twitter said u.s. intelligence investigation show those companies interfered in the presidential election. russian officials say twitter is banning the companies because of pressure from the u.s....
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Oct 27, 2017
10/17
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CSPAN2
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eye 60
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i appreciate the invitation to discuss the fda's response to hurricanes hear have i, irma and maria, e remarks are fork cutsed on the impact of puerto rico because of the unique role and the enormous magnitude. our commitment is to the people of puerto rico, that's begin the long recovery from the overwhelming devastation. but fda also has a broader mission in puerto rico, a substantial portion of the island's economic base is comprised of facilities that manufacture medical products. this includes many critical medical products. there are currently more than 50 medical device manufacturing plants in puerto rico. they produce more than 1,000 different kinds of devices. to date we're especially focused on 50 types of medical do is manufactured by ten firms in puerto rico. these devices are critically important to patient care because they may be life sustaining or police officer supporting or -- life supporting ore the eye handed may be the only manufacturing site for the do ises. we have medically important drugs and biologics that are primarily manufactured on the island. 14 of these
i appreciate the invitation to discuss the fda's response to hurricanes hear have i, irma and maria, e remarks are fork cutsed on the impact of puerto rico because of the unique role and the enormous magnitude. our commitment is to the people of puerto rico, that's begin the long recovery from the overwhelming devastation. but fda also has a broader mission in puerto rico, a substantial portion of the island's economic base is comprised of facilities that manufacture medical products. this...
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Oct 4, 2017
10/17
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CNBC
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eye 160
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there's only so much the fda can do by setting price. they can't go out and tell people what to price drugs but they can speed up approvals. here's a good example. in the ms markets there are no generic competitors. this is the first one. this will really reset the pricing for other things but what he gives with one he can take away with another. so one thing to keep in mind, a complex generic like epipen there's no ab rated nonmylan generic out there. that could be one of the things he targets next. we caution that what you get with one you may get with another. >> i was going to ask you about that because people are saying there could be more upside from mylan here and teva if complex generics are sped through the fda approval process and mylan has also been delayed on generic advair. what do you think the potential is for an epipen competitor getting approved >> based on our conversations with teva the fda is active dialogue, almost daily dialogue trying to help the applicant get a product approved. i think that's going to happen. i th
there's only so much the fda can do by setting price. they can't go out and tell people what to price drugs but they can speed up approvals. here's a good example. in the ms markets there are no generic competitors. this is the first one. this will really reset the pricing for other things but what he gives with one he can take away with another. so one thing to keep in mind, a complex generic like epipen there's no ab rated nonmylan generic out there. that could be one of the things he targets...
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Oct 5, 2017
10/17
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WTTG
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. >>> coming up on fox5 news morning the fda approves a familiar treatment to help get rid of foreheadmajor changes to the district parking zone and it will ick wholy impact d.c. night life. >> another live look across the d.c. region, people getting up and going on this thursday morning. 5:27 is the time right now. we're at a very pleasant 60 degrees. you're watching fox5 news morning. >> ♪ ♪♪ ♪♪ ♪♪ ♪♪ with the company trusted for more than 75 years, you have the compassion and strength of a name, giving you the courage to enjoy the ride. carefirst blue cross blue shield. live fearless. what can you do wi t acon, eggfor $5 from dunkin'?es settle a debt. make a friend. save the day. or keep 'em both for this handsome devil. with two bacon, egg and cheese sandwiches for $5 the future is in your hands. america runs on dunkin'. >> ♪ >> today on fox5 news morning, las vegas massacre. investigators are revealing more information about the shootings including the suspect's plan to survive and escape. >>> tillerson's future. the
. >>> coming up on fox5 news morning the fda approves a familiar treatment to help get rid of foreheadmajor changes to the district parking zone and it will ick wholy impact d.c. night life. >> another live look across the d.c. region, people getting up and going on this thursday morning. 5:27 is the time right now. we're at a very pleasant 60 degrees. you're watching fox5 news morning. >> ♪ ♪♪ ♪♪ ♪♪ ♪♪ with the company trusted for more than 75 years, you...
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Oct 6, 2017
10/17
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BBCNEWS
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in 2010, the fda advised people not to buy them following reports of 12 infant deaths linked to the products nhs recommends that babies sleep in cots, considered to be the safest place. new figures out today show productivity in the british labour force has fallen in the second quarter of the year. the office for national statistics says productivity is lagging behind the uk's international competitors, and there's a warning from some 0ur economics correspondent andy verityjoins me now to go through the figures. andy, low productivity a persistent problem in the british economy and it seems to be getting worse? yes, it's about as persistent as the problem of low wages and that may be no coincidence t used to be post—war, right up until the global financial crisis, that you could ta ke financial crisis, that you could take it for granted that productivity would improve. by that imean productivity would improve. by that i mean each worker will produce a little bit more per hour each year because employers were investing in new technology, you can do more with a computer than a typewriter, for
in 2010, the fda advised people not to buy them following reports of 12 infant deaths linked to the products nhs recommends that babies sleep in cots, considered to be the safest place. new figures out today show productivity in the british labour force has fallen in the second quarter of the year. the office for national statistics says productivity is lagging behind the uk's international competitors, and there's a warning from some 0ur economics correspondent andy verityjoins me now to go...
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Oct 25, 2017
10/17
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CSPAN
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eye 79
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they can be compounded by pharmacies and they are put on the fda shortage list? >> we do not physically look at the opportunity to compound as an alternative forced solution for drug shortages. our staff would typically try to work to get the approved product packages apply and it might look to source the same product, overseas manufacturers, inspected by fda. it is the case in certain situations you might see practitioners go to approved compounding facilities within the confines of the statute to source certain tax. >> ok. so you are actually increasing access to alternate vacations? and that when you're trying to do? >> thanks to the new authorities our ability tos, identify shortages is further out from the actual shortage. we have been taking steps to try to mitigate the shortages that have occurred but also situations where we see the potential for products to tip into shortages. we are looking at approximately 1-2 months for what we think that potentially happen of production does not resume. move temporarily certain manufacturing out of facilities that mig
they can be compounded by pharmacies and they are put on the fda shortage list? >> we do not physically look at the opportunity to compound as an alternative forced solution for drug shortages. our staff would typically try to work to get the approved product packages apply and it might look to source the same product, overseas manufacturers, inspected by fda. it is the case in certain situations you might see practitioners go to approved compounding facilities within the confines of the...