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Dec 22, 2021
12/21
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before joining the fda, dr. califf was a professor of medicine and vice chancellor for clinical and transitional research at duke university in durham, north carolina. position of director of transitional medical institute and director of clinical research institute. he's also worked to move the promising field of transitional science forward as the director of the clinical trials transformation initiative. dr. califf currently is the head of clinical policy and strategy for verify life science and google health at alphabet, google's parent company. his experience also includes serving as vice chancellor for health data science and director of duke fortune and donald f. fortune m.d. professor of cardiology at the duke university school of medicine. dr. califf's unique perspective as fda commissioner coupled with his understand partnerships of the private sector and academia that assist in fuelling innovation will be vital if kwmpld as the next fda commissioner. dr. califf thank you for being here to answer quest
before joining the fda, dr. califf was a professor of medicine and vice chancellor for clinical and transitional research at duke university in durham, north carolina. position of director of transitional medical institute and director of clinical research institute. he's also worked to move the promising field of transitional science forward as the director of the clinical trials transformation initiative. dr. califf currently is the head of clinical policy and strategy for verify life science...
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Dec 22, 2021
12/21
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the fda can lead the way. it needs to work, as we mentioned, with senator romney in conjunction with the nih. >> absolutely. we're seeing a crisis now and i think covid has already exaggerated what already existed. trrs but as you say the misinformation that's out there in social media and the regular media as well. around not just prescription drugs, per se, but the fda's role and i think there's -- we discussed a number of the movie treatments and television episodes around obviously the opioids and the issues there with the sackler family have been well covered. but it's larger question of mistrust between fda employees going in and working for the large pharmaceutical companies and back and forth. how do you go about rebuilding people's trust in the system? >> well, you know, trust once lost is hard to regain. that's an old statement and i think it's true. we're going to have to be much more aggressively out going and work on every single aspect of transparency we can. again, if confirmed, i do think, as a
the fda can lead the way. it needs to work, as we mentioned, with senator romney in conjunction with the nih. >> absolutely. we're seeing a crisis now and i think covid has already exaggerated what already existed. trrs but as you say the misinformation that's out there in social media and the regular media as well. around not just prescription drugs, per se, but the fda's role and i think there's -- we discussed a number of the movie treatments and television episodes around obviously...
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Dec 28, 2021
12/21
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CNNW
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so what we wanted fda to hear us is to show that we wanted to show fda that depending on the viral load, the test was excellent but if you go to the tails, that test does not perform. no test can perform in those tails, either the beginning or the end of the disease. and they were not considering that. they were actually asking for just a number, a bulk number of performance, regardless of where the amount of virus was. >> so the fda declined to -- go ahead. i'm sorry. >> no, no, that was basically a huge problem. and in order to do that, there is a technique called pcr. and that pcr has actually a number, ct, cycle numbers. and you know how much virus you have. in a test like antigen tests, it's similar. you can see how much virus you have by looking at the intensity of a band. so if you look at like a band that comes up in here -- >> right. >> the more red. so basically they were not interested in that. they were interested in just like a bulk result which, by the way, you know, that's a problem because depending on where you are in your patient population, your performance will chang
so what we wanted fda to hear us is to show that we wanted to show fda that depending on the viral load, the test was excellent but if you go to the tails, that test does not perform. no test can perform in those tails, either the beginning or the end of the disease. and they were not considering that. they were actually asking for just a number, a bulk number of performance, regardless of where the amount of virus was. >> so the fda declined to -- go ahead. i'm sorry. >> no, no,...
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Dec 28, 2021
12/21
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CSPAN
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we learned what reforms need to take place within the fda. real-time review. in years past, it would take longer to bring that kind of vaccine to market and the able to distribute it as quickly as we did. it underscores the importance of american innovation when it comes to new breakthroughs and therapies and it is part of why i believe it is important we not pass the current prescription drug bill that imposes government price controls. that will be a step backward at the very time we want to make sure america is leading in innovation and breakthroughs. the university of chicago released a study on the proposal , the government price control proposal, and estimated 130 five fewer new drugs coming to market. think about the impact on als, alzheimer's, cancer, we don't know, but i am concerned about this legislation. and it gives the secretary of health and human services the ability to set the minimum price for the negotiation of drugs at zero. it raises questions as to how that would work, how it would impact janeiro -- impact generic drugs, bio similars that
we learned what reforms need to take place within the fda. real-time review. in years past, it would take longer to bring that kind of vaccine to market and the able to distribute it as quickly as we did. it underscores the importance of american innovation when it comes to new breakthroughs and therapies and it is part of why i believe it is important we not pass the current prescription drug bill that imposes government price controls. that will be a step backward at the very time we want to...
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Dec 23, 2021
12/21
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FOXNEWSW
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fda yet. it's really bizarre. 1.6 billion? >> yes, in operation warp speed. >> the army at walter reed developed a traditional vaccine i think. is this something we should keep our eye? might this move faster since it was developed within the government? >> well, it hasn't gone through the human trials yet. it's hopeful but we have to make do with what we have now as best we can. >> doctors, thank you very much. merry christmas to both of you. joe biden announced yesterday he was mobilizing the troops. are they going to the border to china? nope. >> i directed the pentagon to mobilize an additional 1,000 troops to help staff local hospitals. doctors, nurses and medics. we already started moving military medical teams. they landed in wisconsin and indiana this week. >> joining me now is a retired brigadier general. you say this will harm our troops. how so? >> well, thanks for having me on. the biden administration they mishandled covid and mishandled the omicron response. their policies are causing the shortage in the hospital
fda yet. it's really bizarre. 1.6 billion? >> yes, in operation warp speed. >> the army at walter reed developed a traditional vaccine i think. is this something we should keep our eye? might this move faster since it was developed within the government? >> well, it hasn't gone through the human trials yet. it's hopeful but we have to make do with what we have now as best we can. >> doctors, thank you very much. merry christmas to both of you. joe biden announced...
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Dec 9, 2021
12/21
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KPIX
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the fda recently approved a prescription eye drop which is now the first fda approved eyedrop to treat age-related blurry near vision, also known as presbyopia. doctors say the drug takes effect in about 15 minutes. >> utilizes the natural ability of the eye to reduced pupil size which expands the depth of field or the depth of focus, that allows you to focus at different ranges naturally. >> one drop in each eye provide sharper vision for about six to 10 hours, a spokesperson says the medicine will cost about $80 for a 30 day supply. it works best in people aged 40 to 55. the side effects in the three- month trial included headaches and red eyes. >>> late-night host james corden celebrating 1000 episodes, how he celebrated with cement. >>> breaking news, the fda has authorized pfizer booster shots for millions of 16 and 17-year- olds. >>> and we want to take you behind the scenes to show you how fedex claims to ship 100 million more of >>> the bay area real estate marker is getting crazier, at 5:00, house and san francisco that just went $1 million over asking price after being on the
the fda recently approved a prescription eye drop which is now the first fda approved eyedrop to treat age-related blurry near vision, also known as presbyopia. doctors say the drug takes effect in about 15 minutes. >> utilizes the natural ability of the eye to reduced pupil size which expands the depth of field or the depth of focus, that allows you to focus at different ranges naturally. >> one drop in each eye provide sharper vision for about six to 10 hours, a spokesperson says...
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Dec 18, 2021
12/21
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MSNBCW
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this is one of the drugs that the fda regulates and this drug was treated very differently. if a treatment needed to be done in person at a clinic or a doctor's office by a specially certified doctor. in spite of the fact that there are 4 million patients who have taken this drug over 20 years, the safety record is really almost unparalleled. during the period of the early breakout of covid is a lot of medical groups joined together once again to say to the fda you're putting women at an even greater risk by continuing this in-person distribution limitation by putting this drug under a very restricted distribution scheme. women are being penalized and a lot of them will not have access to their constitutional rights. so the fda made a temporary change that was then resistant by the trump administration, but when the biden administration authorized that temporary change to continue and just on thursday, on the 16th, the fda said we are lifting the restriction on this drug and a more global fashion. so it's not just pandemic related. we're going to look at this evidence. it's
this is one of the drugs that the fda regulates and this drug was treated very differently. if a treatment needed to be done in person at a clinic or a doctor's office by a specially certified doctor. in spite of the fact that there are 4 million patients who have taken this drug over 20 years, the safety record is really almost unparalleled. during the period of the early breakout of covid is a lot of medical groups joined together once again to say to the fda you're putting women at an even...
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Dec 23, 2021
12/21
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they've been authorized by the fda. the antivirals will be provided by states and jurisdictions at no charge. it is on a pro rata basis to get the supply in the field. as i mentioned in my comments as part of the administration's commitment to equity, we are also distributing antiviral pills directly to federally qualified community health centers. that is in all 50 states, and that will ensure that there is a lifesaving antiviral for those who are vulnerable in those communities, with populations across the country. over to you, dr. fauci. dr. fauci: it is a very difficult situation when you have a limited supply, and for that reason, we have asked for guidelines to put together a recommendation of when someone comes in with an acute infection in a risk group, which is what you want this for since we have a limited supply. we would have a prioritization of what the best approach would be. it will almost certainly be a physician writing a prescription for someone who was in the first three days of notable symptoms of co
they've been authorized by the fda. the antivirals will be provided by states and jurisdictions at no charge. it is on a pro rata basis to get the supply in the field. as i mentioned in my comments as part of the administration's commitment to equity, we are also distributing antiviral pills directly to federally qualified community health centers. that is in all 50 states, and that will ensure that there is a lifesaving antiviral for those who are vulnerable in those communities, with...
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Dec 24, 2021
12/21
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KDTV
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la fda autorizÓ hoy molnupiravir, de merck, o un
la fda autorizÓ hoy molnupiravir, de merck, o un
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Dec 1, 2021
12/21
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CNBC
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this as the spread of a new strain omicron and what he sees ahead close but a big day for merck as the fda narrowly backed its covid treatment. and a c-suite shake-up something unusual this way comes as apple stock pops in the middle of all the volatility it is wednesday, december 1. >>> good morning, good evening wherever you might be watching welcome to this first day of september. dow futures up 300 points. s&p and nasdaq are doing better. nasdaq futures soaring the dow and s&p seeing their second losing month in the past three. small caps even worse coming off their worst month from when the waend began in march of 2020 as of this morning, 10% off the high even worse, 120 of those are 20 or more below their peaks. big ones discovery, gap, las vegas sands, twitter, disney, even boeing maybe there is better news the s&p hit a lower low. higher volume. that may be a good sign of the washout coming up, we'll show you something of stocks. just below 1.5%. yesterday, markets had a double whammy jay powell talking about a so-called faster pace of a taper. >> economy is strong and pressures ar
this as the spread of a new strain omicron and what he sees ahead close but a big day for merck as the fda narrowly backed its covid treatment. and a c-suite shake-up something unusual this way comes as apple stock pops in the middle of all the volatility it is wednesday, december 1. >>> good morning, good evening wherever you might be watching welcome to this first day of september. dow futures up 300 points. s&p and nasdaq are doing better. nasdaq futures soaring the dow and...
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Dec 1, 2021
12/21
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KNTV
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>> reporter: well, lester, it now will go before the full fda in the coming days. now, the advisory panel's vote was very close, 13 to 10, and many of the panelists said they only wanted the pill used by high-risk patients and not pregnant women, lester >> gabe gutierrez starting us from new york >>> across the country this evening medical detectives are searching for the new variant, analyzing positive covid tests in dozens of labs. erin mclaughlin got access to one of them in san diego. >> reporter: tonight, the cdc and scientists at nearly 70 state and local health labs are on the hunt for omicron, sequencing 40,000 to 80,000 specimens each week. >> given what we have seen in southern africa and certainly in europe, we do expect that it is here. >> reporter: like all viruses, covid mutates. that's normal. but what has experts concerned is the high number of mutations in the omicron variant, which attaches to human cells, making it more transmissible to others we were invited inside the labs at uc san diego where scientists are sequencing positive covid tests to
>> reporter: well, lester, it now will go before the full fda in the coming days. now, the advisory panel's vote was very close, 13 to 10, and many of the panelists said they only wanted the pill used by high-risk patients and not pregnant women, lester >> gabe gutierrez starting us from new york >>> across the country this evening medical detectives are searching for the new variant, analyzing positive covid tests in dozens of labs. erin mclaughlin got access to one of...
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Dec 23, 2021
12/21
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FOXNEWSW
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the fda has given the nod to a new covid drug. you've been hearing about it all day but why do some pink it could cause mutations? are medicine cabinet investigates biden is calling out the troops against covid. former leader general don baldock hits back at the white house's new deployments, don't go anywhere. .. hey, angie! you forgot your phone! hey lou! angie forget her phone again? yep. lou! mom said she could save up to $400 on her wireless bill by switching to xfinity internet and mobile. with nationwide 5g at no extra cost. and lou! on the most reliable network, lou! smart kid, bill. oh oh so true. and now, the moon christmas special. gotta go! take the savings challenge at xfinitymobile.com/mysavings or visit an xfinity store to learn how our switch squad makes switching fast and easy this holiday season. >> ♪ ♪ >> welcome back to "the ingraham angle." in the early days of covid, it show was the first to tell you raymond: welcome back to the in the agreement. emily early days of covid this show was the first to tell y
the fda has given the nod to a new covid drug. you've been hearing about it all day but why do some pink it could cause mutations? are medicine cabinet investigates biden is calling out the troops against covid. former leader general don baldock hits back at the white house's new deployments, don't go anywhere. .. hey, angie! you forgot your phone! hey lou! angie forget her phone again? yep. lou! mom said she could save up to $400 on her wireless bill by switching to xfinity internet and...
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60
Dec 10, 2021
12/21
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the fda claims it needs it 75 years to fully release the data on the fda that it itself took 108 days to go through before authorizing pfizer's covid-19 vaccine. cannot be right right? the attorney behind the lawsuit challenging back claim joins us live, next. get more with neutrogena® retinol pro plus. a powerful .05% retinol that's also gentle on skin. for wrinkles results in one week. neutrogena®. for people with skin. >> man: what's my safelite story? for wrinkles results in one week. my truck...is my livelihood. so when my windshield cracked... the experts at safelite autoglass came right to me... with service i could trust. right, girl? >> singers: ♪ safelite repair, safelite replace. ♪ [uplifting music playing] ♪ i had a dream that someday ♪ ♪ i would just fly, fly away ♪ when it comes to autism, finding the right words can be tough. finding understanding doesn't have to be. together, we can create a kinder, more inclusive world for the millions of people on the autism spectrum. go to autismspeaks.org hi. i'm shannon storms bador. when we started selling my health
the fda claims it needs it 75 years to fully release the data on the fda that it itself took 108 days to go through before authorizing pfizer's covid-19 vaccine. cannot be right right? the attorney behind the lawsuit challenging back claim joins us live, next. get more with neutrogena® retinol pro plus. a powerful .05% retinol that's also gentle on skin. for wrinkles results in one week. neutrogena®. for people with skin. >> man: what's my safelite story? for wrinkles results in one...
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Dec 30, 2021
12/21
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CNNW
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the fda is expected to green light covid boosters for 12 to 15-year-olds soon. also breaking, we're now getting the first word from the white house about president biden's high stakes call with vladimir putin. did it ease or escalate tensions over ukraine? as the u.s. nears one year since the capitol attack, the january 6th committee is asking the supreme court to not thwart the investigation. welcome to our viewers here in the united states and around the world. i'm jim acosta and you're in the "situation room." >>> this is cnn breaking news. >> and we do begin with breaking news on the record shattering onslaught of the omicron variant. more children are being hospitalized with covid-19 than at any time during the pandemic. let's go to cnn's tom foreman. the covid cases are skyrocketing, but the fda is scrambling to get 12 to 15-year-olds greater protection. that's a very important development. >> they're trying to pull out all of the stops and they're saying that something has to slow this onslaught and even though hospitalizations as a percentage have not sh
the fda is expected to green light covid boosters for 12 to 15-year-olds soon. also breaking, we're now getting the first word from the white house about president biden's high stakes call with vladimir putin. did it ease or escalate tensions over ukraine? as the u.s. nears one year since the capitol attack, the january 6th committee is asking the supreme court to not thwart the investigation. welcome to our viewers here in the united states and around the world. i'm jim acosta and you're in...
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7.0
Dec 24, 2021
12/21
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KSTS
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. >> la fda (food and drug administration) a prueba una segunda pÍldora anticovid-19, pero la propagaciÓn de esta variante no frena a viajeros que reva aeropuertos y carreteras. >> expertos recomiendan hacerse la prueba antes de viajar algo en difÍcil de cumplir ante una multitud quespera por horas. >> creÍa en la inocencia en su pastor, pero cuando perdiÓ la fe en Él y su iglesia, fue amenazada. >> fui perseguida y amenazada por miembros de la luz del mundo por eso fue que el gobierno del paÍs me dio asilo polÍtico. >> noticias telemundo investiga nos revela el drama de esta mexicana perseguida por miembros de la luz del mundo tras negarse a aportar por la fianza de su lÍder. >> un jurado encuentra culpable a un oficial. >> la primera dama abre las puertas a noticias telemundo nos muestra las decoraciones que rinden homenaje a los trabajos esenciales de la pandemia, muchos de ellos latinos comenzamos con lo Último sobre el avance de Ómicron y quÉ hace el paÍs para frenarlo, la fda (food and drug administration) autorizÓ el uso de emergencia de merck un dÍa despuÉs de a prob
. >> la fda (food and drug administration) a prueba una segunda pÍldora anticovid-19, pero la propagaciÓn de esta variante no frena a viajeros que reva aeropuertos y carreteras. >> expertos recomiendan hacerse la prueba antes de viajar algo en difÍcil de cumplir ante una multitud quespera por horas. >> creÍa en la inocencia en su pastor, pero cuando perdiÓ la fe en Él y su iglesia, fue amenazada. >> fui perseguida y amenazada por miembros de la luz del mundo por...
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Dec 15, 2021
12/21
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CNBC
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>> shep, pfizer says potentially this month, depending on how quickly the fda acts the company's ceo, albert bourla, told us last week the agency was waiting on this week specifically before potentially clearing the drug because another covid pill from merck showed dramatically different results between an interim look and the final one. it wasn't the same for pfizer's pill even the president weighed in on it saying, quote, if this treatment is indeed authorized and once the pills are widely available, it will mark a significant step forward in our path out of the pandemic the u.s. has purchased 10 million courses of the drug for more than $5 billion a key question is how widely the fda will clear it just for people with risk factors for severe disease, like age and health conditions or more broadly. pfizer presented results from a second study in lower risk people who weren't vaccinated and in some high-risk folks who were and showed a 70% reduction in hospitalization for them. the key for the drug's success will be getting it early, within three to five days of symptoms that means r
>> shep, pfizer says potentially this month, depending on how quickly the fda acts the company's ceo, albert bourla, told us last week the agency was waiting on this week specifically before potentially clearing the drug because another covid pill from merck showed dramatically different results between an interim look and the final one. it wasn't the same for pfizer's pill even the president weighed in on it saying, quote, if this treatment is indeed authorized and once the pills are...
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Dec 22, 2021
12/21
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KGO
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>> you know, i'm not going to get ahead of the fda. what i will say is, this is going to be a really -- both of these will be really important tools to address this virus. but importantly, all of those tools work to address it once you have it, and what we really want to do is prevent it. and you prevent it by getting vaccinated, getting boosted, and wearing your mask. >> all right, cdc director dr. rochelle walensky with us tonight. dr. walensky, thank you. >>> and with omicron now sweeping across the country and this new warning today from the president, i'll be sitting down one-on-one with president biden for an exclusive interview on it all. the interview is at the white house tomorrow, we'll have it tomorrow night right here on "world news tonight" and on "nightline." >>> but we move on now and to the millions traveling across this country, and with just four days until christmas, we're tracking storms on both costs tonight. in the east, an ef-1 tornado with 95-mile-an-hour winds in fort myers, florida, damaging homes and taking d
>> you know, i'm not going to get ahead of the fda. what i will say is, this is going to be a really -- both of these will be really important tools to address this virus. but importantly, all of those tools work to address it once you have it, and what we really want to do is prevent it. and you prevent it by getting vaccinated, getting boosted, and wearing your mask. >> all right, cdc director dr. rochelle walensky with us tonight. dr. walensky, thank you. >>> and with...
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Dec 17, 2021
12/21
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MSNBCW
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those laws are not going to be changed by this fda ruling. but as a general matter in the country in states that don't ban it or block it, the fda now says women can get these pills in the mail in the privacy of their own home and handle the end of their pregnancy on their own terms without unnecessary costs, without unnecessary trips, without unnecessary hoops to jump through. the fda's decision on this tonight may mean that states that have blocked access to abortion pills, they're going to get those laws challenged in court. this may create sort of a new legal environment, a new sort of legal playing field on which those challenges could be heard. we'll see. but at a time when a large majority of the population in this country wants roe versus wade to stay intact and republican elected officials and republican elected justices are going to get rid of it anyway, this decision by the fda is one of the only things that has gone in the other direction. this is one of the only things that has happened recently in terms of expanding access to ab
those laws are not going to be changed by this fda ruling. but as a general matter in the country in states that don't ban it or block it, the fda now says women can get these pills in the mail in the privacy of their own home and handle the end of their pregnancy on their own terms without unnecessary costs, without unnecessary trips, without unnecessary hoops to jump through. the fda's decision on this tonight may mean that states that have blocked access to abortion pills, they're going to...
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9.0
Dec 22, 2021
12/21
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CNBC
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we're still wading from the fda. jim, it's interesting as well, your point you have tested negative now, and there is this growing chorus of people saying, maybe ten days is too much. delta air lines saying, make it five days, we know healthcare workers, concerns, hospitals and the like, that's where we could see a significant impact in certain areas of the economy where we need people there's the delta ceo saying, you know, ten days is an awful lot. it will impact our workforce and operations and it gets back to the idea if you're vaccinated with three shots, perhaps you should be able to get back out there sooner, certainly if you're going to be surrounded by people who are also vaccinated what kind of cockamamie country are we that delta's ceo is the leader david, you're a healthcare worker, you have to be out ten days and we have a wave of omicron that goes to mostly unvaccinated they get mad at calling these unvaccinated you want to saint them i thought the president was pretty strong about this the thing is it'
we're still wading from the fda. jim, it's interesting as well, your point you have tested negative now, and there is this growing chorus of people saying, maybe ten days is too much. delta air lines saying, make it five days, we know healthcare workers, concerns, hospitals and the like, that's where we could see a significant impact in certain areas of the economy where we need people there's the delta ceo saying, you know, ten days is an awful lot. it will impact our workforce and operations...
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Dec 30, 2021
12/21
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KRON
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fda's give you a different statistic. but, you know, you'd like the thing to perform a little bit better. but given the. >> relatively low rate of disease. it's you know, that's performing like well, however. >> doctor rutherford reiterate what we already know about the at-home tests that timing is crucial in the pcr molecular tests are the most accurate option. there's some timing issues with it. >> if you do it too early, it's not going to pick it up. that's not fault of the test. it's it's just the timing of it. if using the at-home rapid tests. doctor rutherford says you can count on accurate results as long as you test twice a couple days apart. >> i'm taylor bisacky reporting kron 4 news. happening tomorrow. san francisco will bring back the mask mandate for all public indoor places. this time everyone has to wear a mask even if you're vaccinated. >> and have been boosted. no exceptions here. the rule will last through january starting february 1st the city will require health workers and people working in high-risk
fda's give you a different statistic. but, you know, you'd like the thing to perform a little bit better. but given the. >> relatively low rate of disease. it's you know, that's performing like well, however. >> doctor rutherford reiterate what we already know about the at-home tests that timing is crucial in the pcr molecular tests are the most accurate option. there's some timing issues with it. >> if you do it too early, it's not going to pick it up. that's not fault of the...
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Dec 24, 2021
12/21
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FOXNEWSW
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what is happening at the fda? >> there has been this concern because they give the drug in high dose in mice and look for some forms of mutation. even though that is not a does that is recommended it raises questions. the drug should not be given to children or pregnant women in my opinion. it can be lifesaving so there could be a risk-benefit analysis there but we got pfizer, the cut covid of 20, we just need more of the drug. raymond: we will talk to you in the new year. in just two weeks the supreme court will hear oral arguments regarding the vaccine mandates as well as masks. despite some early setbacks in lower courts the biden administration is confident there mandates will prevail, joining me now, harmeet dhillon, civil rights attorney and managing partner of the dhillon law group. the circuit courts were split on the constitutionality of these mandates. you petitioned the supreme court to hear this case. what are they looking for? >> the mandates of met with pretty harsh responses from the courts of appea
what is happening at the fda? >> there has been this concern because they give the drug in high dose in mice and look for some forms of mutation. even though that is not a does that is recommended it raises questions. the drug should not be given to children or pregnant women in my opinion. it can be lifesaving so there could be a risk-benefit analysis there but we got pfizer, the cut covid of 20, we just need more of the drug. raymond: we will talk to you in the new year. in just two...
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11
Dec 2, 2021
12/21
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CSPAN3
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eye 11
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the fda supports this proposal in its current form. we believe it achieves that important balance that's mention ed here today already, the balance between placing these products under appropriate control, recognizing their deadly potential while also providing a rapid mechanism, science-based mechanism to support additional research, which, as dr. volkow has said, is necessary. we believe losing control would be -- >> and you think the administration's proposal accomplishes that? >> i think in its entirety, with control of the class within a possibility of rapid decontrol based on further science and research, it does achieve that goal, yes. >> all right. i'll ask dr. volkow the same question, keeping in mind that, you know, we are getting those that say they are opposed to the administration's proposal and the class 1 scheduling. >> thanks for the question, because indeed, we have been getting a lot of concerns from scientists, and that's why we are very supportive of these new proposals that will actually allow us not only to addres
the fda supports this proposal in its current form. we believe it achieves that important balance that's mention ed here today already, the balance between placing these products under appropriate control, recognizing their deadly potential while also providing a rapid mechanism, science-based mechanism to support additional research, which, as dr. volkow has said, is necessary. we believe losing control would be -- >> and you think the administration's proposal accomplishes that?...
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Dec 22, 2021
12/21
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CNBC
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for its covid antiviral pill up next, pfizer board member former fda commissioner dr. scott gottlieb on that news and when he thinks the omicron surge could come to eannd -aflac! -i love my gold jacket, but that aflac blue feels so right. when you feel right, you coach right. i know that's right! prime never believed in double coverage, but health insurance and aflac...is money. ♪ must be the money ♪ and i know how coach prime feels about money. -aflaaaac. -♪ aaahhhh ♪ now that is what this jacket needs. ♪ must be the money ♪ get help with the expenses health insurance doesn't cover. at aaflac.com >>> tonight, pfizer's covid pill authorized, but will there be enough supply? >>> plus, a 3-year-old girl vanishes in texas. now the fbi joining the case the facts, >>> time for a cnbc news update with contessa brewer >> congress will investigate the astroworld festival tragedy. the house oversight committee announced a bipartisan probe to focus on the concert promoter livenation ten people were killed and hundreds injured in that crowd surge during travis scott's
for its covid antiviral pill up next, pfizer board member former fda commissioner dr. scott gottlieb on that news and when he thinks the omicron surge could come to eannd -aflac! -i love my gold jacket, but that aflac blue feels so right. when you feel right, you coach right. i know that's right! prime never believed in double coverage, but health insurance and aflac...is money. ♪ must be the money ♪ and i know how coach prime feels about money. -aflaaaac. -♪ aaahhhh ♪ now that is what...
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2.0
Dec 5, 2021
12/21
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CSPAN
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the fda supports this proposal in its current form. we believe it achieves that important balance that's mention ed here today already, the balance between placing these products under appropriate control, recognizing their deadly potential while also providing a rapid mechanism, science-based mechanism to support additional research, which, as dr. volkow has said, is necessary. we believe losing control would be -- >> and you think the administration's proposal accomplishes that? >> i think in its entirety, with control of the class within a possibility of rapid decontrol based on further science and research, it does achieve that goal, yes. >> all right. i'll ask dr. volkow the same question, keeping in mind that, you know, we are getting those that say they are opposed to the administration's proposal and the class 1 scheduling. >> thanks for the question, because indeed, we have been getting a lot of concerns from scientists, and that's why we are very supportive of these new proposals that will actually allow us not only to addres
the fda supports this proposal in its current form. we believe it achieves that important balance that's mention ed here today already, the balance between placing these products under appropriate control, recognizing their deadly potential while also providing a rapid mechanism, science-based mechanism to support additional research, which, as dr. volkow has said, is necessary. we believe losing control would be -- >> and you think the administration's proposal accomplishes that?...
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Dec 17, 2021
12/21
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CSPAN
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he said the fda has worked independently. is this the same fda that changed the wording that allowed big pharma to do what they did with the opiates, which ultimately -- hello? did you -- host: i think we lost can but you got part of your question. can you answer for her? guest: i think she said something about opiates and changing language. i'm not familiar with that. i apologize. i was not part of the federal government during that time, so i did not follow that closely. host: let's go to joe calling from new jersey on the republican line. joe, good morning. caller: hey, doctor, good morning. i think you did a wonderful job with the vaccine. you took away the bureaucracy. it was the greatest example of entrepreneurship. using the private industry to innovate and make our country work the way it is supposed to be. people are always throwing stones at one side or the other. they sent out information beginning when the vaccine came out, they said they would not take it if it was a trump vaccine and then joe took credit when he
he said the fda has worked independently. is this the same fda that changed the wording that allowed big pharma to do what they did with the opiates, which ultimately -- hello? did you -- host: i think we lost can but you got part of your question. can you answer for her? guest: i think she said something about opiates and changing language. i'm not familiar with that. i apologize. i was not part of the federal government during that time, so i did not follow that closely. host: let's go to joe...
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Dec 3, 2021
12/21
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CNBC
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also, we have this new fda i don't want to call it a morass, but they put dr. fauci out. he seems to agree or disagree with others. i wish the government would speak softly and give everybody tests, so we can find out where we are when we get the antiviral from pfizer, the conversation will be totally different. i think we're going to say, all we care about is whether the hospitals are are too full or not and will bring us into a new world that's better than where we are you think the pfizer drug, you think that's a march, april, may event? >> i've been saying pfizer 1, government 0 more or less an unsung hero. i feel as positive about him as i feel negative about all the people who are at the cdc, fda and nih. >> jim cramer, we'll see you in just a couple minutes. have a great weekend if i don't get to talk to you before then. >>> and as always, check out the cnbc investing club. will many in real time, it ends up in my inbox point your phone at the screen to get it. "squawk box" returns right after this >>> the jobs report for november showing a gain of just 210,000 job
also, we have this new fda i don't want to call it a morass, but they put dr. fauci out. he seems to agree or disagree with others. i wish the government would speak softly and give everybody tests, so we can find out where we are when we get the antiviral from pfizer, the conversation will be totally different. i think we're going to say, all we care about is whether the hospitals are are too full or not and will bring us into a new world that's better than where we are you think the pfizer...
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9.0
Dec 23, 2021
12/21
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KSTS
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la administración de alimentos y medicamentos de los estados unidos (fda) anunció hoy la aprobación de emergencia de una segunda píldora contra los síntomas leves y moderados contra el coronavirus. esta pastilla es producida por farmacéutica merck, y estará disponible para mayores de 18 años y con receta del médico. no sustituye a las vacunas ni a sus dosis de refuerzo. otra píldora es por parte de la farmacéutica pfizer y fue aprobada por la administración de alimentos y medicamentos de los estados unidos (fda), es una combinación antiviral similar al tratamiento para las personas con vih. con un porcentaje de efectividad de 89% en pacientes contagiados con el virus de covid-19. ayuda únicamente a evitar síntomas graves y hasta la muerte. la doctora nos dice cómo funciona. >> hay que tener síntomas por menos de cinco días, no es para prevenir, es para tratar la covid-19. >> tendrá que ser recetada por un médico especialista, son tres tabletas que se toman de manera oral dos veces al día. un estudio en el reino unido sugiere que el número de hospitalizaciones ha dism
la administración de alimentos y medicamentos de los estados unidos (fda) anunció hoy la aprobación de emergencia de una segunda píldora contra los síntomas leves y moderados contra el coronavirus. esta pastilla es producida por farmacéutica merck, y estará disponible para mayores de 18 años y con receta del médico. no sustituye a las vacunas ni a sus dosis de refuerzo. otra píldora es por parte de la farmacéutica pfizer y fue aprobada por la administración de alimentos y...
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Dec 22, 2021
12/21
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MSNBCW
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due to convoluted fda standards, it never got approval. dr. ebony hilton is back with us. irene, thanks for being with us. when was your test ready and why was it not approved? >> yeah. well, thank you. thank you for the opportunity. so yeah, indeed, we had very early in march and indeed was the first submission to the fda back then as a clinical study in three hospitals in florida. so basically the test is just, as you know, a very simple test. it's an antigen test so it actually detects the virus. and what we found out, that indeed the first three to four days it's absolutely accurate. this test can even reach the same as pcr, but then it actually goes down in the sensitivity and performance as you progress in the disease. so fda was not able to accept this test because they want an overall one that basically takes into account about seven days of disease. when you do that, the average of that performance goes a little bit down and they didn't like that. so the way they do it is they compare it to pcr and it didn't reach that threshold. >> what would having these tests a
due to convoluted fda standards, it never got approval. dr. ebony hilton is back with us. irene, thanks for being with us. when was your test ready and why was it not approved? >> yeah. well, thank you. thank you for the opportunity. so yeah, indeed, we had very early in march and indeed was the first submission to the fda back then as a clinical study in three hospitals in florida. so basically the test is just, as you know, a very simple test. it's an antigen test so it actually detects...
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Dec 31, 2021
12/21
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FOXNEWSW
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it looks like the fda might improve the pfizer booster 12-15-year-olds. what science is there behind that for booster in young and healthy people? >> the science on boosters for young and healthy people points to the recommendation that young and healthy people should not get a booster. that's where the data lives right now, and that's why the fda a posthumous experts, they sit on an advisory committee and its routinely convened with any authorization decision the fda does. that's why the advisors voted against boosters for young people and then the fda made a second internal push and simply circumvented those experts, they decided not to convene the meeting and rumor is now "the new york times" is reporting that they are about to authorize boosters for 12 through 15-year-olds, again without convening their experts. that's unconscionable and if we have any journalism left in the united states, they should ask how are they getting away with this. >> lisa: how do you think they are getting away with this? >> this has been the modus operandi of the cdc and t
it looks like the fda might improve the pfizer booster 12-15-year-olds. what science is there behind that for booster in young and healthy people? >> the science on boosters for young and healthy people points to the recommendation that young and healthy people should not get a booster. that's where the data lives right now, and that's why the fda a posthumous experts, they sit on an advisory committee and its routinely convened with any authorization decision the fda does. that's why the...
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Dec 31, 2021
12/21
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CSPAN2
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determined to be safe and he felt comfortable to be protected and this was coming up now, from the fda advisory committee and then on tuesday the money to consider several thousand child study five - 11 -year-olds so i'mi' getting to that in this context and so,wa he was happy anything about it and eureka, got it. but then he wanted to beat do a big study we did not want to do that a broke his heart, and this vaccine entering polio season but nonetheless, that was what was on andhe so we had four and 20000 children who got vaccines into hundredcc thousand children god - the vaccine was declared by the president headed that trial safe put in ten effective in those three words were in the headliness of every newspaper in the united states, church bells rang out in synagogues held prayer meetings and they announced that over the loudspeaker, the call of europe, and at last polio can be conquered ahead we know it was affected but we do it because 16 children died of polio that study and all the placebo group. and it paralyzed the study, and amigos were first and second graders in the 1950s
determined to be safe and he felt comfortable to be protected and this was coming up now, from the fda advisory committee and then on tuesday the money to consider several thousand child study five - 11 -year-olds so i'mi' getting to that in this context and so,wa he was happy anything about it and eureka, got it. but then he wanted to beat do a big study we did not want to do that a broke his heart, and this vaccine entering polio season but nonetheless, that was what was on andhe so we had...
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Dec 4, 2021
12/21
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CSPAN2
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with regard to the regulatory issues i would have to d for that to the fda but in general it could and i say could fall under the same situation as we do with the strain change for influenza but i would have to leave that determination to the fda. >> to build on that the fda has laid out guidance for the manufacturers to understand how the agency will evaluate the potential impacts of a variant on the vaccines and the fda will move quickly and maintain its rigorous scientific studies. next question. >> last question, to nate wax so. >> thanks for doing this. curious about the timeline on the travel restrictions. it seems like there is community spread right now in the us, some of these cases, the restrictions, is there a timeline for lifting them? is there a next step? >> as we talked about throughout today's briefing we are actively monitoring the new variant, addressing questions about transmissibility, severity and vaccine effectiveness. as we learn more about the variant over the coming days on all these fronts, decisions, changes to travel policy will be based on the advice as the
with regard to the regulatory issues i would have to d for that to the fda but in general it could and i say could fall under the same situation as we do with the strain change for influenza but i would have to leave that determination to the fda. >> to build on that the fda has laid out guidance for the manufacturers to understand how the agency will evaluate the potential impacts of a variant on the vaccines and the fda will move quickly and maintain its rigorous scientific studies....
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Dec 24, 2021
12/21
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KDTV
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la fda autorizÓ hoy molnupiravir, de merck, o un mes despuÉs de aprobar la pÍldora de pfizer. >> si medicina para controlar esta pandemia, yo lo tomarÍa. presentadora: la actriz mexicana silvia pinal fue hospitalizada en la ciudad de mÉxico. sus hijas hicieron declaraciones. un jurado declara culpable de homicidio involuntario a una policÍa que disparÓ a un hombre. presentadora: bienvenidos. todo indica que a los estadounidenses que tenÍa planeado viajar esos dÍas festivos no les asusta el aumento de casos, principalmente por la nueva variante de covid—19 . "la triple" estima que viajarÁn cientos —— 110 millones de personas dejando. reportero: hacia tiempo que los aeropuertos no estaban tan ocupados. >> la gente ya estÁ tirado en los pisos. reportero: la agencia de seguridad en el transporte dice haber inspeccionado ayer a mÁs de 2 millones de viajeros. hoy espero nÚmero mÁs grande, el pronÓstico es que mÁs de 20 millones viajarÁn en aviÓn entre navidad y aÑo nuevo, son muchos los que piensen que le incomodidad y el riesgo de no —— de vacunarse valen la pena. >> son
la fda autorizÓ hoy molnupiravir, de merck, o un mes despuÉs de aprobar la pÍldora de pfizer. >> si medicina para controlar esta pandemia, yo lo tomarÍa. presentadora: la actriz mexicana silvia pinal fue hospitalizada en la ciudad de mÉxico. sus hijas hicieron declaraciones. un jurado declara culpable de homicidio involuntario a una policÍa que disparÓ a un hombre. presentadora: bienvenidos. todo indica que a los estadounidenses que tenÍa planeado viajar esos dÍas festivos no les...
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Dec 30, 2021
12/21
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CNNW
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we had to wait for the fda approval process. they had to step up the manufacturing. could have the defense production act been utilized more quickly? i don't know the answer to that question. i'm dealing in the reality of what we face at this particular moment, trying to look ahead to the future. i'm looking ahead to hospital space, taking the steps we might need in the event we run short on that but right now we're addressing the need of testing. i know they're working on it from a federal perspective but i don't know that 500 million at the federal level is as good a solution as the states having sufficient to get them out and get them where they're needed more quickly. >> a judge in arkansas struck down your state's ban on mask mandates in schools. this is an issue where you changed your position on whether school districts should be allowed to impose mask mandates if they want to. why do you now think that schools should be able to if they want to? >> that's an example of where you just don't know the future when it comes to the pandemic. at the time i signed tha
we had to wait for the fda approval process. they had to step up the manufacturing. could have the defense production act been utilized more quickly? i don't know the answer to that question. i'm dealing in the reality of what we face at this particular moment, trying to look ahead to the future. i'm looking ahead to hospital space, taking the steps we might need in the event we run short on that but right now we're addressing the need of testing. i know they're working on it from a federal...
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9.0
Dec 30, 2021
12/21
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KRON
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the fda has a warning for people who have bagged salads in their refrigerators. dole is voluntarily recalling all of its packaged salads. they were processed at its facilities in north carolina and arizona after a potential listeria common contamination products are part of the recall have the letter n or y in the upper right-hand corner of the package and they'll have a best if used by dates between november 30th 2021 and january 8th 2022 a surprising reason. some of you like your coffee black and that you probably like dark bitter chocolate. it could be in your genetics researchers at northwestern university say people who drink 3 to 5 cups of coffee a day have a lower risk of certain diseases. they're talking about parkinson's heart disease type 2 diabetes and several types of cancer. so that includes you. you're a lucky winner of a nice genetic trait. as for bitter chocolate studies show it boost mental awareness. enjoy the chocolate folks and you can enjoy some good health. >> in just a couple of days. corks will be popping to celebrate the new year. but sup
the fda has a warning for people who have bagged salads in their refrigerators. dole is voluntarily recalling all of its packaged salads. they were processed at its facilities in north carolina and arizona after a potential listeria common contamination products are part of the recall have the letter n or y in the upper right-hand corner of the package and they'll have a best if used by dates between november 30th 2021 and january 8th 2022 a surprising reason. some of you like your coffee black...
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Dec 22, 2021
12/21
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CNNW
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on the fda's authorization of the first pill to treat covid-19. let's go straight to our athena jones in new york. top health officials say this could be a game changer as the omicron variant rips through the country right now. >> reporter: that is right. a potential game-changer in this new pill that is highly effective against hospitalization and death. the key thing here is that you have to take it within the first five days of having symptoms so ma means focusing on tests and getting tests back to people. in a season of setbacks, a glimmer of hope. >> the pfizer team has a v promising and now authorized tempe treatment for those at risk. >> reporter: the fda granting pfizer's new anti-viral pill paxlovid. >> folks who tax paxlovid early, within three days of symptom on set had a 90% reduction in hospitalization or death compared to those that took placebo. so this is very potent agent. >> reporter: one problem, the treatment has to be administered within the first five days of symptoms making it hard to come by tests all the more important. ev
on the fda's authorization of the first pill to treat covid-19. let's go straight to our athena jones in new york. top health officials say this could be a game changer as the omicron variant rips through the country right now. >> reporter: that is right. a potential game-changer in this new pill that is highly effective against hospitalization and death. the key thing here is that you have to take it within the first five days of having symptoms so ma means focusing on tests and getting...
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Dec 31, 2021
12/21
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KDTV
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la fda se prepara para aprobar el refuerzo para jÓvenes de 12—15 aÑos. los estudios indican que puede evitar hospitalizaciones y casos graves de niÑos. en hayward se ofrecerÁ una tarjeta de regalo electrÓnica para aquellos que se vacunen. la tarjeta se puede usar en cualquiera de los 39 negocios participantes y tienen una validez de 90 dÍas. la informaciÓn la tiene en pantalla. veamos algunas recomendaciones para mejorar su finanza el prÓximo aÑo. reportera: oscar Ávila es electricista y dice que uno de sus propÓsito es trabajar menos el prÓximo aÑo. >> ahorita estoy bien, pero el aÑo que viene... quiero descansar mÁs. estoy muy agotado y duermo poco. trabajo mucho. quiero estar mÁs tranquilo. reportera: oscar reconoce que 2021 ha sido difÍcil y tuvo que conseguir tres trabajos. algÚn propÓsito para aÑo nuevo? >> trabajar un poco mÁs. este aÑo se recortÓ el tiempo de trabajo. si dios quiere, tendrÉ mÁs tiempo. >> el aÑo que viene quiero hacer crecer mi negocios. reportera: hay consejos bÁsicos para mejorar sus finanzas en 2022. >
la fda se prepara para aprobar el refuerzo para jÓvenes de 12—15 aÑos. los estudios indican que puede evitar hospitalizaciones y casos graves de niÑos. en hayward se ofrecerÁ una tarjeta de regalo electrÓnica para aquellos que se vacunen. la tarjeta se puede usar en cualquiera de los 39 negocios participantes y tienen una validez de 90 dÍas. la informaciÓn la tiene en pantalla. veamos algunas recomendaciones para mejorar su finanza el prÓximo aÑo. reportera: oscar Ávila es...
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2.0
Dec 23, 2021
12/21
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CNBC
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that's who the fda cleared the drug for initially patients will take three pills twice a day for five days and early on supplies will be limited. only enough for 265,000 people in january overall the u.s. has purchased 10 million courses for $5 billion. supply will grow throughout the year globally it expects to supply 120 million treatment courses up from 80 million it projected previously this drug has some interactions with intermedicines. health care providers will have to work through those with patients one may be to use another antiviral pill from merck which is expected to be cleared by the fda soon it was a 30% reduction we saw there in the risk of hospitalization or death there will be more supply. 3 million treatment courses by the end of january that drug also has some safety concerns so its use may be more limited. meanwhile, some doctors are urging the fda to consider authorizing a commonly used drug for depression and fluvoxamine for covid. it has shown a benefit along the same magnitude of merck's drug it costs $1 a day. merck's and pfizer's more than $500 per course.
that's who the fda cleared the drug for initially patients will take three pills twice a day for five days and early on supplies will be limited. only enough for 265,000 people in january overall the u.s. has purchased 10 million courses for $5 billion. supply will grow throughout the year globally it expects to supply 120 million treatment courses up from 80 million it projected previously this drug has some interactions with intermedicines. health care providers will have to work through...
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Dec 23, 2021
12/21
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CNBC
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their drug comes up for fda approval next year while we're hitting the shame. can i say that mo, larry, curley are the cdc, fda and the nih even when they're right they're doing damage they have divg messages or no messages some shoot from the hip, others say nothing. i know the biden administration wanted to defer to the scientists but they've taken that way too far finally, let's not forget about att wrecked by management. company destroyed one of the most pristine balance sheets in the industry it had to cut the one thing investors wanted from the company, shameless just shameless bottom line, look, i don't want to be a grinch 'tis the season to be jolly so let's just say that with the averages up nicely it's certain that santa claus has been hanging around town. let's take some questions. let's go to steve in california. steve. >> caller: boo-yah, jim, and major props for playing kirk >> thank you >> caller: you're welcome. as an employee i can purchase shares pretax with a 15% discount what do you think of loeds >> take as much as you can i think lowe's is
their drug comes up for fda approval next year while we're hitting the shame. can i say that mo, larry, curley are the cdc, fda and the nih even when they're right they're doing damage they have divg messages or no messages some shoot from the hip, others say nothing. i know the biden administration wanted to defer to the scientists but they've taken that way too far finally, let's not forget about att wrecked by management. company destroyed one of the most pristine balance sheets in the...
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110
Dec 31, 2021
12/21
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FOXNEWSW
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for young people and the fda made a second internal push and circumvented those experts, they decided not to convene the meeting and rumor is now the new york times is reporting it as well that they are about to authorize boosters for 12 through 15-year-olds again without convening their experts, that is unconscionable and if we have any journalism left in the united states they should ask how are they getting away with this? lisa: how do you think they are getting away with this? >> this has been the modus operandi of the cdc and fda for the last few years that the review committee of doctor corcoran were boarded with pharma, 18 of the 54 in the first can become a letter 20, this is all been orchestrated from the top of nih and pharma. lisa: what therapeutics are using, is there anything promising you have been looking at so we should be embracing now that we know the vaccines aren't stopping the spread of covid? >> there is a bunch of them and immediately when omicron emerged our public health officials started talking about additional vaccine boosters, 10 weeks after your boosted t
for young people and the fda made a second internal push and circumvented those experts, they decided not to convene the meeting and rumor is now the new york times is reporting it as well that they are about to authorize boosters for 12 through 15-year-olds again without convening their experts, that is unconscionable and if we have any journalism left in the united states they should ask how are they getting away with this? lisa: how do you think they are getting away with this? >> this...