22 Burst results for "Robert Califf"
"robert califf" Discussed on WTOP
"As temperatures reached 111. Currently, 85 large fires are burning, scorching more than 3 million acres in 13 states. And Britain on Tuesday shattered its record for highest temperature ever registered. More people are dying in the U.S. from overdoses than ever before. WSB radio Sabrina Cupid. More people in the U.S. are dying from overdosing than ever before. From 2019 to 2020, there was a 30% increase and that was the largest increase in U.S. history. The CDC's doctor Deb outy says deaths were up across the board. The most recent data shows over a 100,000 deaths in a year's time, most of those deaths linked to fentanyl. The FDA commissioner is asking for an outside review of the agency's food and tobacco programs. The request from FDA commissioner Robert califf comes one day before he scheduled to testify before a Senate committee about the FDA's oversight of food safety. It also follows the rash of criticism over the agency's handling of the baby formula shortage, which was triggered by concerns about contamination problems at a major formula plan in Michigan. CBS Linda canyon, the director of the bureau of alcohol, tobacco and firearms, Steve dental back, says addressing the epidemic of gun violence is a challenge because it can not be solved with the same solution in every city. He spoke to CBS evening news anchor Nora O'Donnell. Well, it certainly a national problem that is urgent. And I think everybody agrees about that. One of the things that makes this problem so hard is that it looks way different depending on where you are. President Biden has signed an executive order, focused on American citizens taken hostage abroad. National Security Council spokesman John Kirby. It authorizes agencies to impose costs and consequences including financial sanctions and Visa bans on governments and non state actors and those that provide them with the material support who are involved in hostage taking support
FDA weighs oversight changes after formula, Juul troubles
"The head of the Food and Drug Administration is asked for review of the agency's food and tobacco programs following months of criticism of the agency's handling of E cigarettes and the baby formula shortage on Norman hall FDA commissioner Robert califf says a non governmental research group will convene experts to conduct evaluations within 60 business days more than two dozen consumer groups have called for the appointment of one official to oversee all FDA food operations which are dispersed across multiple centers Parents and politicians have also expressed frustration over FDA handling of a recent decision to ban all E cigarettes from jewel a federal court quickly blocked the agency's order the FDA then backtracked and said it needed more review time Norman hall Washington
"robert califf" Discussed on Bloomberg Radio New York
"A global food crisis With Russia's war driving up inflation worldwide threatening vulnerable countries with severe food shortages we have to work together to mitigate the immediate fallout of this crisis And Biden commenting in his virtual address to the major economies forum on energy and climate The FDA has just authorized emergency use of the Pfizer and Moderna vaccines for kids as young as 6 months finding them both safe and effective Doctor Robert califf is FDA commissioner These authorizations will be further discussed by the Centers for Disease Control and prevention advisory committee on immunization practices And if the CDC gives the final thumbs up The White House estimates the shots could be administered as early as next Tuesday Hours after FDA commissioner doctor Kayla who you just heard there was grilled by senators about the response to the infant formula shortage White House press secretary Korean Jean Pierre was asked by reporters whether President Biden still has confidence in him for the job Yes yes and yes So the FDA has an important mission Is to make sure that the infant formula on the shelf isn't just available but also that it's safe And that was White House press secretary karine Jean Pierre there Global news 24 hours a day on air and on Bloomberg quicktake powered by more than 2700 journalists and analysts in more than a 120 countries In the newsroom I'm Denise Pellegrini and this is Bloomberg Progressive presents today's to do list for your dog Check front door Check window Check other window Rest your non ground look into distance Bar for no reason Check front door Check window Check other window Your pen is a very busy schedule so it's up.
"robert califf" Discussed on WLS-AM 890
"It's called the rebound to work program and employment pilot program for victims of violent crime the program includes a series of webinars that focus on writing a resume interviewing skills and more Attorney general Kwame Raoul says this will help survivors of violence who have been traumatized enough In many cases have had their employment disrupted and how we can partner with both corporate as well as community partners to respond to this very common need amongst crime victims The corporate partners include Amazon AT&T and McDonald's Time is ticking for the bipartisan Senate group to finish work on gun reform legislation They had hoped to have it wrapped by the end of this week but the lead Republican senator walked out of the latest round of talks Saying he remains hopeful Republican senator John cornyn walked away from negotiations Thursday The remaining bipartisan senators continue drafting that new gun reform Bill there's been reported disagreement on language about incentives for states that launch red flag laws to remove firearms from those deemed a danger and the boyfriend loophole which authorizes blocking abuse of partners from buying guns but does not cover unmarried intimate partners The group says the bill's final text could come soon Justin Finch ABC News Washington The FDA today authorized emergency use of the Pfizer and Moderna vaccines for kids as young as 6 months old finding them both safe and effective The White House is estimated shots will be administered as early as Tuesday Doctor Robert califf is the FDA commissioner He warned parents that young children have a higher risk of hospitalization from omicron than the delta variant Since the surge of the omicron variant children's zero to four years of age have been hospitalized at a rate approximately 5 times higher than the previous peak experience during delta variant predominance The next step is CDC approval Former Trump White House adviser Peter Navarro pleaded not guilty to contempt of Congress after he refused to cooperate with the congressional investigation into the January 6th attack on the U.S. capitol today the 72 year old appeared in federal court He's charged with one count for failing to appear for a deposition and for failing to produce documents the committee requested a trial is scheduled for November WLS news.
"robert califf" Discussed on WTOP
"23 the commissioner of the Food and Drug Administration Robert califf is back before Congress today He'll testify before a Senate committee about the baby formula shortage yesterday caliph was criticized by House lawmakers after months of delays investigating problems at the nation's largest baby formula plant Caleb says a COVID outbreak at the plant delayed the investigation there and he admitted that a whistleblower complaint didn't reach FDA leadership because it was apparently lost in the mail The nation's first federally backed test to treat site for COVID-19 opens today in Rhode Island patients will get immediate access to the antiviral COVID treatment pax lovid if they test positive more of the sites will open in the coming weeks in Massachusetts and New York City both places have recorded increases in infections across the nation infections have quadrupled since late March jumping from about 25,000 a day to more than 100,000 However deaths in the nation have plateaued at fewer than 300 a day Passengers on a cruise ship carnival magic have become ill after reporting a chemical smell on the ship The coast guard says it received reports that passengers were nauseous and vomiting from the fumes The ship is in transit to Norfolk Virginia from The Bahamas members of the coast guard will board the ship to investigate when it arrives there today carnival magic can carry about 4000 passengers It's the largest cruise ship to ever sail out of Virginia A lot of folks moved out of America's big cities during the first year of the pandemic The Census Bureau says 8 of the nation's ten largest cities lost population from 2020 to 2021 only Phoenix in San Antonio grew New York losing the most residents about three and a half percent of its 2020 population.
"robert califf" Discussed on WTOP
"The top stories we're following for you on WTO the sad task of arranging funerals has begun for the families of the 19 students and two teachers killed in a shooting at an elementary school in Texas Tuesday The bodies of 9 victims were released to funeral homes last night The Senate will vote today on a bill designed to fight domestic terrorism that bill passed the house last week after the mass shooting at a supermarket in Buffalo the bill is not expected to get through the Senate however because of Republican opposition Only one Republican representative Adam kinzinger of Illinois voted for the bill in the house Stay with WTO for more on these stories in just minutes The commissioner of the Food and Drug Administration Robert califf will be back on the congressional hot seat today He'll testify before a Senate committee about the baby formula shortage Yesterday caliph was criticized by Republicans and Democrats alike during a House committee hearing over months of delays investigating problems at the nation's largest baby formula planned Caleb said a COVID-19 outbreak at the plant delayed the investigation and he admitted that a whistleblower complaint didn't reach FDA leadership because it was apparently lost in the mail Alexandria city high school will offer virtual classes only for the rest of the week That's a decision follows the deadly stabbing of a student this week in a letter to the school community the principal said that when students return to classrooms on Tuesday there will be staggered dismissals and a change to the lunch block He said those changes will remain in effect for the rest of the school year It's 8 18 Traffic.
FDA chief struggles to explain slow response on baby formula
"Over months of delays investigating problems at the nation's largest baby formula plant that prompted an ongoing shortage FDA commissioner Robert califf told Congress the coronavirus slowed down efforts to investigate problems at the abbot plant We knew that ceasing plant operations would create supply problems but we had no choice given the insanitary conditions The ranking Republican on the committee Virginia's Morgan Griffith quickly zeroed in on the slow response Why did it take an onslaught of national media attention for the Biden administration to act with the sense of urgency that is required to adequately address an infant formula shortage Formula had to be airlifted from Europe to help ease the shortage Abbott and the FDA have reached an agreement to reopen the plant next
"robert califf" Discussed on WTOP
"Baby formula here in the U.S. in prepared remarks commissioner Robert califf will tell lawmakers that a COVID-19 outbreak at Abbott's formula plant led regulators to delay a scheduled inspection at Abbott manufacturing for nearly two months A whistleblower alleged serious violations at the plant last October It's 5 18 Jack Taylor and the traffic center are right Jack how we looking Well we've got our work zones that should be in the clearing stages I believe in mug and prince George's county inner loop there's still some activity on the interlude between Pennsylvania avenue and joint base Andrews off the roadway to the right side unclear if they're blocking any lanes the camera's far enough away we can't really tell but hopefully that's pretty much wrapped up and may only be along the right side as a gathering spot for everybody to now go home You'll find otherwise through Montgomery county you're looking good Topside out of loop no worries yet 95 over toward Georgia avenue two 70 is a good start Frederick south to the lane divide without delay should find nothing in your way Interloop down near the Wilson bridge no delay saint Barnabas road passing two ten headed toward the bridge itself Nice ride downtown freeways looking good D.C. two 95 I two 95 off to a good start ongoing utility work in northeast had closed 19th street between D and E streets also E street closed between 18th and 19th Now where there is a delay early horrible in manassas going 66 out of Gainesville you've got the work zone still in place between the manassas rest area and 29 centerville just the right lane is getting by 95 north good out of falmouth through woodbridge headed into Springfield north on to three 95 all the way up toward the 14th street bridge without issue or delay Four 95 looking good right now all lanes are open between Alexandria and McLean both inner and outer loop Jack Taylor WTO P traffic Storm team fours Mike still deferred looks like we get a slight upgrade over yesterday Which I guess isn't all that hard to get really The only good thing about yesterday we're right a whole lot.
"robert califf" Discussed on WTOP
"Empty at the store FDA commissioner Robert califf was grilled by members of both parties during a House subcommittee hearing where he tried to reassure them that the agency is taking steps to address the situation I can assure you FDA has been working tirelessly to address this issue We've set up a mechanism that streamlines the ability for companies that do not normally sell infant formula in this country to do so and provides other flexibilities to domestic distributors who can help increase availability The shortage was largely brought about when the FDA shut down an Abbott plant in Michigan in February due to a contamination problem The plant under federal guidance is now going to gradually be allowed to resume production Caliph was asked about that as well as new efforts to fly in formula from overseas by Louisiana congresswoman Julia letlow How much formula do you expect will be imported and what is the real timeline of seeing those products on our store shelves Well the way we're thinking about is we're pulling a bunch of levers at the same time The other formula manufacturers in the U.S. have reved up there supply to 24 by 7 It's increased considerably We're going to start out to start this plant We have the importation that you're referring to And I think the combination of all three we should begin to see improvement within days And I do want to point out that right now in the last week we have had more infant formula bond by between 11 and 19% than what was bought in the month before the closure of the plan So I can kill my kids safety and within a matter of days they'll be able to find formula on the shelves It will gradually get better The big problem we have right now is distribution You can hear Mitchell Miller's entire the week on the hill podcast on the podcast D.C. app or wherever you get your podcasts Sports is next It's four 43 Here's Ashish khat the chief executive officer a techno mile on the discussion leading voices in federal contract management sponsored by techno mile And we provide an end to end solution to manage the entire life cycle of a government contract And we are purpose built for the unique needs of government contractors present depends organization and any business that is doing business with the government Listen to the entire discussion on federal news network search techno mile Techno mile provides transformative cloud solutions purpose built to help federal contractors find pursue win and retain more business with the government Techno miles growth suite empowers BD and capture teams to efficiently manage opportunities Gain actionable market and contact intelligence and focus resources on the.
"robert califf" Discussed on WTOP
"Safe Christy king WTO P news It was just last month the drugmaker reported that in children those ages a third child sized dose of its vaccine actually generated antibodies against both the omicron variant and the original version of the coronavirus Three 34 Several developments in Congress this week related to two major but very different issues The baby formula shortage an aid for Ukraine This morning WTO Capitol Hill correspondent Mitchell Miller first on the formula shortage and what the head of the FDA Food and Drug Administration said to lawmakers this week during the hearing on Capitol Hill One headline from this house hearing where he testified is that FDA commissioner Robert califf said that a Michigan baby formula producer that's been effectively closed could start running next week still that does not mean that avid labs in Michigan will actually get baby formula on the shelves next week as well In fact Caleb said it could be a matter of a couple of months before the formula starts to get onto those shelves He really came under a lot of grilling as you can expect this is such a sensitive issue for a lot of people Both from Republicans and Democrats and what really frustrated a lot of lawmakers during this hearing is that Caleb said well there is an investigation by the FDA internally going on and he couldn't comment on why they delayed so long lawmakers pointing out that the FDA knew about this problem really going back to last fall and they feel that the agency just slow walked it up to this point And what's the Senate doing when it comes to this baby formula crisis There was action in the Senate a unanimous consent vote just basically a voice vote in the Senate This was related to the issue involving low income women getting access to baby formula through the so called wick program That's the women's infants and children program This was a second piece of legislation that the House passed basically what it says is that women who are under this program don't have to only go to one producer of baby formula that it will open it up to others normally they have to only go through one USDA approved a producer However on the other issue the $28 million for the FDA that the house has already approved the Senate does not appear ready to approve that right now That is on hold Now after a bit of delay over the past week the Senate has approved that huge aid package for Ukraine That's right As we talked about we had a delay over the last week in connection with Kentucky senator Rand Paul eventually they grinded through all the procedural activities that they had to do Eventually to get to really two votes first the cloture vote they had to get more than 60 votes just to end debate and then to get to this final vote which was 86 to 11 approving nearly $40 billion in aid for Ukraine This is something that Democrats and Republicans on the hill have been talking about really over the last several weeks wanting to make sure to get this through And of course the Senate this week approving the ambassador to Ukraine So a lot of activity there was 11 Republicans including Rand Paul who voted against this aid They say it needs to be better counted for that there should be more scrutiny of the money going out the door But nonetheless this is one of the few issues.
"robert califf" Discussed on WTOP
"As they can if not to perform the procedure take it link people with support and resources child advocates also say they hope lawmakers support all children after they're born The suspect in the buffalo supermarket shootings has had his murder indictment read in court He's already pled not guilty surviving family members like Veronica white or pleading for racial violence to stop This is so simple I can not believe somebody would give some child a gun and let him think that it's okay and coming somebody Hometown of this shoot it up Her nephew was one of the ten black people killed he had gone to tops to pick up a birthday cake for his son The head of the FDA says the abbot baby formula plant that was shut down could be back in action next week More from CBS's Debra alfaro They are understandably frustrated and anxious Commissioner Robert califf told a House panel the FDA is working on a number of solutions that should gradually ease the situation and return formula supply levels to normal in weeks It's never soon enough to have food for crying baby Investigators are trying to learn what caused an explosion at a construction company and eagle Wisconsin Three firefighters among the 6 people hurt Matt harder is with southeastern Wisconsin incident management The structure of the building has collapsed significantly and trapped a lot of the combustibles that are burning underneath a very thick metal roof There's been a controlled explosion at cape canaveral Three Two And liftoff Boeing's starliner spacecraft is on its way to the International Space Station the uncrewed flight is the third try at a test before astronauts fly it for real Boeing says two thruster rockets have failed but others have made up for that This is CBS News.
"robert califf" Discussed on WTOP
"Dot com and schedule your free estimate today 6 11 several developments in Congress tonight related to two major but very different issues the baby formula shortage and aid for Ukraine Capitol Hill correspondent Mitchell Miller joined us earlier starting with the formula shortage and what the FDA boss said to lawmakers during a hearing One headline from this house hearing where he testified is that FDA commissioner Robert califf said that a Michigan baby formula producer that's been effectively closed could start running next week still that does not mean that avid labs in Michigan will actually get baby formula on the shelves next week as well In fact Caleb said it could be a matter of a couple of months before the formula starts to get onto those shelves He really came under a lot of grilling as you can expect this is such a sensitive issue for a lot of people Both from Republicans and Democrats and what really frustrated a lot of lawmakers during this hearing is that caliph said well there is an investigation by the FDA internally going on and he couldn't comment on why they delayed so long lawmakers pointing out that the FDA knew about this problem really going back to last fall and they feel that the agency just slow walked it up to this point And what's the Senate doing when it comes to this baby formula crisis Well it's interesting just a short time ago there was action in the Senate a unanimous consent vote just basically a voice vote in the Senate This was related to the issue involving low income women getting access to baby formula through the so called wick program That's the women's infants and children program This was a second piece of legislation that the House passed yesterday Basically what it says is that women who are under this program don't have to only go to one producer of baby formula that it will open it up to others normally they have to only go through one USDA approved a producer However on the other issue the $28 million for the FDA that the house has already approved the Senate does not appear ready to approve that right now so that is on hold Now after a bit of delay over the past week the Senate has approved that huge aid package for Ukraine That's right As we talked about we had a delay over the last week in connection with Kentucky senator Rand Paul eventually they grinded through all the procedural activities that they had to do Eventually to get to really two votes today first the cloture vote they had to get more than 60 votes just to end debate and then to get to this final vote which was 86 to 11 approving nearly $40 billion in aid for Ukraine This is something that Democrats and Republicans on the hill have been talking about really over the last several weeks wanting to make sure to get this through And of course the Senate this week approving the ambassador to Ukraine So a lot of activity there was 11 Republicans including Rand Paul who voted against this aid They say it needs to be better counted for That's Capitol Hill correspondent Mitchell Miller Sports next Hi it's Jonathan cotton with a good feed store in springtime can bring a new season of change in growth There are so many things to look forward to whether it's walking your dog taking a stroll through.
FDA head: Baby formula factory could reopen by next week
"The Food and Drug Administration's chief says the shuttered baby formula factory at the heart of a national shortage could reopen as soon as next week The abbot plant in Michigan has been closed since February due to contamination issues FDA commissioner Robert califf faced tough questions from a house panel about why it took months for the agency to investigate whistleblower warnings in the fall about safety violations Why did the FDA not spring into action Caleb told Connecticut's rosa de lauro and others he can't say much for now We have an ongoing investigation about the details Wisconsin's Mark pocan says that's unacceptable You can talk about it honestly You should talk about it Abbott says it could take about two months for a new formula to hit store shelves once production resumes
"robert califf" Discussed on KOMO
"It is 8 30 New steps aimed at easing the nationwide shortage of baby formula The FDA expects the fly to continue to improve over the next couple of months Food and Drug Administration commissioner Robert califf announcing a settlement with avid laboratories to reopen the manufacturing facility that's been closed the last two months because of bacterial contamination Under the consent decree Abbott has a great to take actions that would be expected to ultimately result in an increase of infant formula products and ensure safe powered infant formula is produced at the facility The government will also allow more imports from overseas The top FBI agent in Buffalo says they're looking at Peyton gendron's online activity detailed entries show he wrote as early as November about staging a live stream attack on black people He's pleaded not guilty to murder charges Doing away with another left over of his predecessors President Biden is lifting restrictions on remittances Cuban immigrants can send the family on the island It's also allowing non family remittances Richard cantu ABC News Stay connected stay informed with the northwest's only all news station Northwest news radio Good evening I'm Kelly blyler and here's what's happening Doctors as well as patients will be safe in Washington state of roe versus wade is overturned says the state's attorney general Jeff pojo has more Bob Ferguson says Washington will become a haven for abortion providers if the Supreme Court rules as expected He sent a letter to various medical boards and commissions saying they should not withhold a license if a doctor is charged with a crime for providing service in an anti abortion state Typically when you provide a license you look for someone's criminal history If roe V wade is overturned several conservative states including neighboring Idaho seek to criminalize.
"robert califf" Discussed on WTOP
"Manufacturers and retailers some transportation and logistic support in an effort to increase supply The administration is also working to bring the largest domestic plant back online after it was shut down earlier this year because of safety issues Meantime this week Congress is set to take action The measures of the house will consider this week aim to fill the void on store shelves lawmakers are working on a bill that would enable the U.S. to buy more formula from other countries like Mexico and Ireland to increase supply they'll also consider a bill that would loosen restrictions for parents in the wick program which aids low income families despite recent calls for The White House to use the defense production act to produce more formula House speaker Nancy Pelosi argues it's not legally possible this week FDA commissioner Robert califf will appear before a congressional committee where he's expected to face questions on the shortage and the federal response House oversight panel has also requested information from some of the major manufacturers of infant formula to find out what they're doing to ramp up production CBS News congressional correspondent Nicole Killian A missing family heirloom NBC four Susan Hogan has a preview of the story she's working for news for Businesses come and go in some go without any warning to customers A local woman called NBC four response after bringing a family heirloom and for reupholstering But when months went by with no word from the company she drove there herself only to find the business closed the building empty and her chair gone We're working for you and her when things like this happen and how to get your property back coming up today on news four at four.
"robert califf" Discussed on AP News
"Congress approved last month as the war enters its third month Sagar Meghani at The White House The Food and Drug Administration will reveal its plan to ban menthol cigarettes and flavored cigars FDA commissioner Robert califf says the proposal would reduce disease and deaths by helping current smokers quit and preventing younger people from starting He previewed the agency's announcement in congressional testimony Menthol accounts for more than a third of U.S. cigarette sales the mint flavor it's very popular among black smokers and young people The FDA has attempted several times to get rid of menthol but has always faced pushback from big tobacco members of Congress and competing political interests Mike Hempen Washington President Biden is asking Congress to provide billions more in aid to Ukraine as Russia's bloody war enters its third month It's a $33 billion request for military economic and humanitarian aid more than double a package Congress approved last month This one is meant to show the U.S. is not growing weary of backing Kyiv The cost of this fight is not cheap But KV new aggression is going to be more costly if we allow it to happen He's urging fast action in Congress where there's wide support for giving Ukraine all it needs But the president's also asking lawmakers to approve billions more to battle the COVID-19 pandemic I don't care how they tie how they do it I'm sending them both up I mean they can do it separately or together but we need them both Sagar Meghani at The White House The number of Americans applying for unemployment benefits fell again last week with numbers holding at historically low levels The Labor Department says there were 5000 fewer jobless claims last week than the week before at 180,000 The four week average which smooths out weekly ups and downs rose by more than 2000 claims but in mid April there were just over 1.4 million people getting unemployment the lowest number in more than 50 years hiring remains robust despite the pandemic slowdowns which at one point had unemployment at 14.7% two years ago Now it's a low 3.6% I'm Jackie Quinn AP.
"robert califf" Discussed on The Readout Loud
"A lot of cash on its books right now. So I don't know, it's interesting. It's like watching a guy who's had a lot of opinions from the peanut gallery now getting a seat at the table at this massive drunk company. I have to say when I heard about this, I was really bummed out just for personal reasons because Ronnie, as you said, is one of those few people who will say the thing that most people won't say about what the industry is doing, he'll just sort of baldly state, you know, the drug companies are doing this to raise prices and it'll be good for the stock and most people won't really say that or they'll sort of couch it in language that isn't as plain spoken and Ronnie has just been like an incredible person to put on camera to say the things that the industry does. And now there's one fewer person like that. And I mean, I think David Maris was another sort of different vibe, but he was an analyst for a long time. Who very much criticized the drug industry for a lot of the things they did. And he's not in that kind of role anymore either. And so these guys are kind of moving on into other things. I'm very interested to see what Ronnie does at Novartis. But I'm sad that I won't get to use them as a source in the same way. So Meg, let's have another chat about COVID vaccines. Where are we? Particularly when it comes to kids. Yeah. Exactly. Where are COVID vaccines for kids under 5? But that question, you know, which we've talked about in the last couple podcasts, I think has really been snowballing. This week we saw representative James Clyburn send a letter to FDA commissioner, doctor Robert califf, asking for a staff briefing about what is going on with the vaccines because of the reporting that we saw last week started by Politico, which essentially put out there this idea that the FDA may hold off on reviewing Moderna's vaccine, so it can do it in parallel with Pfizer's vaccine. Doctor Fauci kind of added some fuel to the fire and interview with Casey hunt on CNN plus. Last week, unfortunately, I guess we won't be having CNN plus around for a much longer, but that was a very impactful interview in this space. Where he essentially said, you know, they didn't want to cause confusion by putting out two different vaccines at the same time, but not adding a whole lot more clarity onto that. And so there's just a big question, which is also getting fueled by intense and coordinated advocacy from parents of kids under 5. We talked about how they dominated the public comment period at the CDC's ACIP meeting last week. Clearly, it sounds like they are having an impact with Congress. They are calling Congress people's offices, trying to get them to take action. And now we are starting to see these kinds of letters. So the FDA has essentially said we should perhaps get a road map of the timing for the review over the next week or two. But the FDA does need to take time to actually review the applications. That's what they do. And so that could end up working out around the same time. But there is just, there's a lot of frustration, understandably. This has been delayed for so long for a number of reasons expanding trials, but also the data not coming in where regulators wanted to see it. And guys, there's also speculation that when this goes to an outside advisory committee, it's not going to necessarily be a unanimous vote based on what we've seen of Moderna's data so far because it was under the 50% vaccine efficacy threshold with two doses. It was about 40% effective in preventing cases of COVID and the trial. In an age of omicron, that's essentially what we can expect with two doses. But it's not going to be a clear path forward. And so parents are going to keep watching this really, really closely, but we all want a vaccine. As soon as we can, but we want it to be safe and to work. So the other stalwart topic of this segment of the podcast beyond the COVID-19 pediatric vaccine saga is BioTech stocks and specifically how they are bad and seem to just get worse at them, they industry crossed a threshold this week. Tell us about it. Yeah, before I get to that, I'll tell you, maybe I'm maybe I'm sharing confidence this year, but I think we all know Brad lon Carr by tech investor and a guy on Twitter, who's usually this man in BioTech. Nicest man in BioTech fairly sunny optimistic. He actually DMed me the other day, you know, like that sort of the vomit sad vomiting emoji character. He DMed me that the other day just after another relentless day of selling in BioTech. And I think if it's getting to a guy like Brad lon car, it's getting to everybody. And you can kind of see that. I mean, the selling, as you mentioned, Damien has been unrelenting. We follow the index called the XBI, and it did, it sort of hit this kind of bad milestone this week, where it essentially it got down to the level of April last seen April 2020. So basically what that's saying is like all of the kind of enthusiasm and exuberance in BioTech in the early days of the COVID pandemic where, you know, BioTech and farm where we're going to sort of save the world, that's all been erased out of the sector. And now we're sort of trading back as if COVID didn't happen. I don't want to be completely depressing here. I will say that and we are going to be talking about NK cells, therapy later on in the podcast, and we'll be talking specifically about a company called encarta. You know, they had some encouraging data this week for their NK cell therapy, and the stock actually went up. Which we are not seeing very much of these days, you know, like good clinical data leads to a rise in the stock price. They actually even, they raise money, but the stock kind of stayed up there. So maybe that's a sign that, you know, that's a hopeful sign. That we're not just seeing selling even when the clinical news is positive. Yeah, and we are expecting another pretty big catalyst from a much bigger company fairly soon alnylam's data in a disease called TTR amyloidosis. I saw one LS note that said the stock could go up 40% or down 50% based on these phase three results expected sometime around midyear. So whether or not that'll be a big catalyst for the space or not, remains to be seen, but it seems to be we need clinical data. We need to see stocks reacting, well, when clinical trials succeed, and we might need to see M and a before sentiment really turns around for BioTech, right? Yeah, exactly. And so far, each aspect of that equation hasn't quite come together. Moving into 2022, BioTech stocks were already down relative to where they had been, and there was this expectation that the combination of cash on the books of major pharma companies, BioTech companies with promising assets who were slipping below maybe fair valuations was a recipe for a.
"robert califf" Discussed on The Readout Loud
"So I don't think you'd offer someone a job like that just as a symbolic gesture if you knew that it could jeopardize you getting confirmed. And I mean, if we look at the past and the role that she's playing, I mean, Janet took on a pretty large role, like you said, Damien, it's basically the FDA's second in command. And the last person that had that job, Amy Abernathy took on things like charting a path for the FDA to regulate CBD and revamping the agency's IT structures. These sort of sweeping initiatives that touch all parts of the agency. And so we don't know what Janet will take on yet, but she's not being given a small role. I mean, that's for sure. Nick as she wrote in the story this week, you know, Kali's confirmation was the narrowest in FDA history. Do you think that comes back to haunt him as the FDA takes positions on some controversial upcoming decisions and topics? I mean, it's complicated. So I bet senators do chew him out for some decisions. I mean, especially folks like Joe Manchin, who made clear that they really don't think that caliph can do anything right, quite frankly. But I don't think that the thin margin of him being confirmed will actually impact the FDA's ability to navigate Congress to sort of pass major must pass legislation. I mean, to give you an example, Congress has to pass new user fee agreements that basically keep the FDA's doors open. But the lawmakers that actually play a major role in that process, those that are on the committee with oversight over the FDA, they love Caleb. And they were the driving force behind wrangling votes to get him confirmed. So they're definitely not going to hold up that process. But I mean, Caleb will have to deal with some nasty letters and some nasty things said about him on the Senate floor. I mean, there's definitely going to be that because he was confirmed by such a narrow margin and people have such strong opinions about him. But I do think that now that he's in the chair, he should be able to largely go about his work. Because frankly, those people don't matter as much now that he's in the chair. So back in November, when The White House first nominated caliph, you wrote that caliph had unfinished business at the FDA after his brief initial tenure. So what might he have planned now that he's back do you think? So the big one that always stands out with rob caliph is revamping how the FDA collects the evidence, evidence on the products that it regulates. I mean, Caleb was pretty explicit about this during his confirmation hearing. He said, now is the time to develop a systematic approach to evidence generation. And as one of the world's top clinical trial experts, he's always talking about this idea. I mean, during his last confirmation hearing during the Obama administration, he called it his one true professional love. But who knows really what that looks like in practice? I mean, caliph pitched a pretty vague idea of this evidence generation collaborative during his first time at the FDA, but it never really got off the ground. I wouldn't be surprised if we see Caleb pitch the same sort of big idea amorphous idea on data collection. That sort of his calling card. The other piece of unfinished business that I think is really important to note is just the FDA's work on tobacco. Caleb has been pretty vocal since leaving the FDA about how he thinks that the FDA should handle tobacco issues. I mean, he even called for a ban on over the counter vaping products. And the FDA still has a lot of decisions to make on vaping. I mean, it said it's promised that it's going to ban menthol cigarettes. It has to decide on joules application. For vapes, it has to deal with this issue of synthetic nicotine that's popping up. These are all issues that caliph is going to play a role in he's made it very clear that he thinks the FDA should take a more forceful stance on tobacco. So that's definitely one that I'm going to be watching. And Nick for a second, I just want to go back to the ALS drug and particularly the advisory panel that's going to be held on March 30th because our body Billy Dunn, who runs the neuroscience division at FDA, is the guy who's in charge of that review as everyone knows he also was in charge of the agile home review. So it'll be interesting to see how Billy handles this ALS drug contrasting it or maybe seeing how it may differ or be similar to how he dealt with the Alzheimer's situation with adjacent. Yeah, I'm really interested to see that too because I mean, when we listeners might remember that stat wrote a big profile on Billy Dunn after the agile home decision. And I talked to a lot of ALS advocates for that story. Folks that had met with Billy Don and they had very strong opinions about him. Let's just put it that way. One advocate who was a real driving force of the right to try law, back during the Trump administration. I mean, he was making Facebook posts criticizing Billy Dunn demanding that he apologized to him. So it's going to be really interesting to see the tone of that meeting and how Billy Dunn navigates what is likely to be some vitriol from advocates who felt that he's wronged them before. Nick, thanks as always for joining us. Thanks for having me..
"robert califf" Discussed on KOMO
"Indoors health experts say many factors are to blame for rising cases like the number of Americans who remain unvaccinated and potentially waning immunity from those who are vaccinated months ago We've seen a considerable increase in our hospital COVID numbers On Friday after being heavily criticized for not having a permanent head of the Food and Drug Administration to fight the pandemic The White House finally announcing its nominating cardiologist doctor Robert califf to be the new FDA commissioner The department plays a critical role in the approval of vaccines If confirmed by the Senate California would take on the role just as President Biden's controversial corporate vaccine mandate deadline is taking effect in January That mandate would require companies with more than a hundred employees to require the vaccine the workers are already pushing back No I will not get the vaccine I will unfortunately retire earlier than I wanted to The president also has a separate COVID-19 mandate for the nation's 2 million federal employees which is due to come into effect on November 22nd But the Biden administration tells ABC they aren't expecting a big employee exodus ahead of that deadline because they haven't said when they would enforce it which poses another question about when employees will have to make a decision This will require a more certainty for companies and that they will know their workplace is safe that people will feel safe going to their workplace President Biden is urging the Senate to swiftly confirm doctor caliph Caliph was previously confirmed under the Obama administration by an overwhelming vote of 89 to four M1 ABC News Washington Come on news time 6 28 What goes well.
Biden picks ex-FDA chief Robert Califf to again lead agency
"President Biden has picked an old hand to again lead the food and drug administration the president's nominee the doctor Robert Calif for FDA commissioner a post he held in the Obama administration's final year the agency's been without a permanent chief for months the president says it's mission critical to have a steady hand guiding the FDA as it deals with cold in nineteen backseat authorization and all other issues noting Calif is a leading clinical trial specialist but his first into the FDA was dominated by controversies including surging opioid addiction West Virginia senator Joe Manchin says keyless nomination is an insult to families in his state whose lives have been ravaged by addiction and says he will not vote for Calif Sager or may god he at the White House
Biden picks ex-FDA chief Robert Califf to again lead agency
"President Biden is tapping a familiar name to head the food and drug administration Robert Calif was the FDA's chief at the Obama administrations and and a person familiar with the decision says the president's naming him to reprise the role now caliphs nomination comes amid months of concern that an agency near the center of the federal code nineteen response does not have a prominent leader Janet woodcock's been acting commissioner for ten months if the Senate confirms same Calif would oversee not just FDA decisions on Kobe Bryant team vaccines but
"robert califf" Discussed on WCPT 820
"And fueling outbreaks in the north The AP's Jackie Quinn Health officials are lamenting how many people are no longer wearing masks and how many people chose not to get vaccinated Doctor Donald Milton at the university of Maryland says we're going to see a lot of outbreaks in unvaccinated people that will result in serious illness and will be tragic I'm Jackie Quinn President Biden's reportedly chosen former FDA commissioner Robert califf to again lead that agency The FDA of course is the agency that's pretty much at the heart of the government's COVID response She's tussled with former president Trump now Republican senator Lisa Murkowski has an announcement She's running for reelection The AP's Mike Hempen has this The Alaska lawmaker repeatedly is bumped heads with former president Trump and even voted to convict Trump in his second impeachment trial Trump endorsed one of Murkowski's leading opponents Kelly Chewbacca in June And in July the Alaska Republican state central committee endorsed Chewbacca after Murkowski's impeachment vote The Murkowski reelection bid will be closely watched nationally as Trump has focused his political efforts on punishing his political opponents Mike Hempen Washington The jury isn't there today but prosecutors and defense attorneys and Kyle rittenhouse's murdered trial are discussing how jurors will be instructed when they get the case next week and begin to liberating Rittenhouse is charged with murder after shooting two men dead and wounding a third at a protest last year in Kenosha Wisconsin This is a P news Activists are asking sponsors of the Beijing Winter Olympics to defend their sponsorship The AP's Mike gracias got this Human Rights Watch has asked the leading sponsors of the Beijing literal Olympics to explain why they remain largely silent about alleged human rights abuses in China In an online briefing the rights group said it reached out to all but one of the IOC's so called top sponsors in lengthy letters almost 6 months ago The only reply came from aliens last month saying we stand behind the Olympic movement Earlier this week the international trade union confederation issued a scathing report alleging genocide and crimes against humanity in the Xinjiang region of northwest China The Beijing games opened February 4th I'm Mike Gracia The U.S. is urging Americans to leave Haiti because of deepening insecurity there and the severe shortage of fuel That's the fact that hospitals schools and banks I'm Rita foley AP news This is a 20 a.m. willow springs and streaming worldwide at 8 20 dot com We are Chicago's progressive talk where facts matter Now your 8 20 Chicago traffic update In vowed Kennedy traffic is heavy Fullerton to the burned circle There is a crash at Ogden and the right lane travel time oh here today downtown is 27 minutes 18 from montrose ten of the express lanes from montrose to Ohio now found its 20 minutes downtown to O'Hare They have eyes and how are mild delays start around St. Charles It's 33 minutes three 90 to downtown 21 from wool How about 24 minutes downtown to three 90 The braidwood area north about I 55 is still packed Reed road to one 13 or traffic to earth's off than back on the interstate due to an earlier crash inbound Stevenson from the veterans memorial to do solve a lakeshore drive is 23 minutes The Brian from 95th to downtown 15 I'm Japan During.