Joe Biden secures landslide victory in South Carolina primary

first_imgSunday 1 March 2020 10:48 am (Getty Images) Also Read: Joe Biden secures landslide victory in South Carolina primary The businessman and former New York mayor chose not to take part in the first four state primaries. Overall, Biden secured 49 per cent of the vote while Sanders won just 20 per cent, according to official state results. Billionaire hedge fund manager Tom Steyer came third on 11 per cent, and ended his presidential campaign. Biden beat Sanders among a wide range of demographic and ideological groups, including those who said they were “very liberal”, according to exit polls by Edison Research. whatsapp Share “Win big or lose, that’s the choice. Most Americans don’t want the promise of a revolution. They want more than promises they want results.” whatsapp Joe Biden’s campaign to reach the White House has been given a new lease of life after the Democrat secured a resounding victory in the South Carolina primary yesterday. It marks the first presidential primary win ever for Biden, who is making his third bid for the White House. Biden, who has positioned himself as a moderate alternative to left-winger Bernie Sanders, immediately took aim at his socialist rival.center_img (Getty Images) Also Read: Joe Biden secures landslide victory in South Carolina primary Biden, who served as vice president under Barack Obama, emerged victorious in the vote, where Democrats decide which candidate they want to run against President Donald Trump. (Getty Images) James Warrington “Democrats want a nominee who is a Democrat,” he told supporters in Columbia, South Carolina. Pete Buttigieg, Elizabeth Warren and Amy Klobuchar, who are also competing for the Democratic candidacy, trailed in South Carolina and now face a significant challenge to mount a comeback against the frontrunners. Joe Biden secures landslide victory in South Carolina primary The South Carolina results came days ahead of so-called Super Tuesday, when primaires in 14 states will award one-third of the available national delegates. Super Tuesday will also present the first major challenge from billionaire Michael Bloomberg, who has splashed out half a billion dollars in advertising across the country. Show Comments ▼ More From Our Partners Astounding Fossil Discovery in California After Man Looks Closelygoodnewsnetwork.orgColin Kaepernick to publish book on abolishing the policethegrio.comPolice Capture Elusive Tiger Poacher After 20 Years of Pursuing the Huntergoodnewsnetwork.orgRussell Wilson, AOC among many voicing support for Naomi Osakacbsnews.comBrave 7-Year-old Boy Swims an Hour to Rescue His Dad and Little Sistergoodnewsnetwork.orgA ProPublica investigation has caused outrage in the U.S. this weekvaluewalk.comNative American Tribe Gets Back Sacred Island Taken 160 Years Agogoodnewsnetwork.orgKansas coach fired for using N-word toward Black playerthegrio.comFans call out hypocrisy as Tebow returns to NFL while Kaepernick is still outthegrio.comlast_img read more

London transport freedom passes for all – but at what cost?

first_imgSadiq Khan’s administration already has a detailed Cycling Action Plan, and Covid has given it new impetus. Private sector partners have also stepped up to the plate: Brompton Bicycles backed the Wheels for Heroes campaign which made bikes available to front-line workers for free, while an extension of cycle lanes was supported by high-profile, blue-chip firms like RBS, Deloitte and Knight Frank. There is a danger that a quick-fix, ready-cash concept like freedom passes would ignore and perhaps delay the addressing of structural issues which need to be part of an overall strategy. According to TfL, Tube figures continue to hover around one-third of pre-lockdown rates, while the use of buses is around half what it was. It is implausible that all of this decline is due to monetary issues, but making journeys free would probably overcome some people’s fears. Opinion Eliot WilsonEliot Wilson is co-founder of Pivot Point and a former House of Commons official. whatsapp whatsapp Share Friday 11 September 2020 5:37 am Commuters on the London Underground (AFP via Getty Images) Also Read: London transport freedom passes for all – but at what cost? London transport freedom passes for all – but at what cost? We should all think very carefully, then, about how the public’s money can most wisely and most effectively be deployed, for the good of our capital city. The commercial sector must understand that, while the government is there to help, it cannot be there to support indefinitely. Bluntly, some enterprises will not make it through Covid: and the government must not be expected to keep them alive indefinitely. However, like the scheme for restaurants, it could never be a permanent investment – TfL has to make money somehow – and there is not yet enough information to judge whether Rishi’s Dishes have left a legacy of eating out or were simply a temporary blip while the cash was available. A free travel scheme would be a shot in the dark, and one fired at considerable cost. Commuters on the London Underground (AFP via Getty Images) center_img The success of “Rishi’s Dishes” suggests that freedom passes would, indeed, encourage more people into town, though it is clear to anyone currently using public transport that fear of infection is still a strong disincentive.  One more caveat. The thinking behind Rishi’s Dishes and a free travel period is clear: they are short-term investments intended to inject life into the pandemic-battered economy. But they carry with them presentational and psychological risks. We have seen calls for the government-funded furlough scheme to be extended beyond its original deadline to keep supporting certain sectors, like the arts. There is a danger that the government, with the best of intentions, fosters a dependency culture which effectively cries: “Everything’s free!”  Commuters on the London Underground (AFP via Getty Images) Also Read: London transport freedom passes for all – but at what cost? There is also a question of how far a temporary spike in Tube and bus usage fits into a wider transport strategy for the city. While public transport is to be encouraged in preference to car journeys, the figures from TfL also show a dramatic increase in cycling, which would be at best unaffected (and at worst discouraged) by suspending fares. Promoting cycling and integrating it into London’s habits and infrastructure is a key part of any strategic plan, since it delivers personal wellbeing, a reduction in congestion and progress in meeting the UK’s 2050 emissions goals. We are in changing times. Many businesses will have to pivot, and re-examine the whole basis of their existence. The London Futures project is aiming to pull together this kind of thinking and create a vision for where we will be in 2050. The government is rightly expected to help, and to act as a safety net, but long-term investment has to be better than short-term solutions, and the taps will eventually be turned off.  Eliot Wilson is co-founder of Pivot Point and a former House of Commons official. Ewan Venters, CEO of Fortnum and Mason, and Simon Thomas, boss of the Hippodrome Casino, were among the big names to lend their support, which was compared to the chancellor’s popular “Eat Out to Help Out” scheme in terms of deploying government money to stimulate growth. Earlier this week it was reported that senior London business figures were pressing the mayor and Transport for London (TfL) to offer free travel on public transport to encourage the public, in their guise as potential consumers, to venture into the city and make free with their hard-earned pounds.  City A.M.’s opinion pages are a place for thought-provoking views and debate. These views are not necessarily shared by City A.M. Show Comments ▼ Tags: Transport for Londonlast_img read more

Ketchikan campus director takes interim UAS provost position

first_imgEducation | Southeast | University of AlaskaKetchikan campus director takes interim UAS provost positionJuly 24, 2015 by Leila Kheiry, KRBD Share:University of Alaska Southeast Ketchikan Campus Director Priscilla Schulte has accepted a temporary assignment as provost for UAS in Juneau. (Photo courtesy of University of Alaska)University of Alaska Southeast Ketchikan Campus Director Priscilla Schulte has accepted a temporary assignment as provost for UAS, effective Aug. 9, and will relocate to Juneau for the coming academic year.According to UAS, Schulte will continue in her role as director of the Ketchikan campus, and will return periodically to Ketchikan during her stint as interim provost.A university provost is a high-ranking administrator, in charge of academic programs. As provost, Schulte will represent UAS in leadership venues, including Board of Regents and Summit Team meetings, and Statewide Academic Council, according to the university.A search for a permanent provost is expected to commence in August, and UAS plans for the new provost to start work in early summer of 2016.Share this story:last_img read more

Dan Ortiz calls for Republican candidate Bob Sivertsen to denounce ‘dark money’

first_imgPolitics | Southeast | Southwest | State GovernmentDan Ortiz calls for Republican candidate Bob Sivertsen to denounce ‘dark money’October 20, 2016 by Aaron Bolton, KSTK-Wrangell Share:House District 36 incumbent Dan Ortiz called for Republican candidate Bob Sivertsen on Monday to denounce so-called “dark money” in this year’s campaign.He was referring to the independent expenditure group known as Southeast Voters for Bob Sivertsen, which has spent about $4,000 opposing Ortiz, some of which funded various ads.The Accountability Project, an Anchorage-based group with ties to Southeast Voters for Bob Sivertsen, has one TV ad on its Facebook page attacking Ortiz for voting with Democrats.Ortiz said he sees nothing positive coming out of these ads.“It’s not the way we’ve done things in the past. I’m concerned that groups like that might have more influence as to what happens in elections throughout the district in the future,” Ortiz said. “I think this is not just this year’s issue, it’s an issue of the future as to what our elections will look like as move forward.”Ortiz said the Accountability Project is a vessel for corporate-backed Washington DC money.State records show that a little under half the Accountability Project’s $130,000 in contributions came from Alaska-based groups and that $80,000 came from DC-based groups – and it contributed $5,000 to the Southeast Voters for Bob Sivertsen group.By state law these groups can’t have ties with or fund candidates.Sivertsen said due to their nature, he won’t denounce the money spent.“I think that the bottom line is that they are asking you to not support Dan Ortiz. You can consider that negative in the sense that they’re not asking you to support him,” Sivertsen said. “I don’t think they’re publishing stuff that I would consider non-factual.”Former District 36 Rep. Peggy Wilson chairs the Southeast Voters for Bob Sivertsen group.Wilson could not be reached in time for this story.Two groups, The Alaska Center and Working Families of Alaska, have spent about $4,500 supporting Ortiz.The Southeast Voters for Bob Sivertsen and Accountability Project groups spent about $2,400 dollars in support of Sivertsen.Share this story:last_img read more

Strengthening demand for workers is fuelling sharp salary increases

first_img Share Tags: NULL Show Comments ▼ Strengthening demand for workers is fuelling sharp salary increases Thursday 7 May 2015 9:16 pm whatsapp Express KCS RAPIDLY rising demand for workers and reduced jobseeker availability is causing pay to climb, according to survey figures released today by consultants KPMG and the Recruitment and Employment Confederation. An index representing the growth of permanent hiring rose to a score of 60.6 in April from March’s 59.5. An index score above 50 signifies growth, with higher numbers pointing to faster growth.It puts the rate of permanent hiring at an eight-month high and marks a 31st consecutive month of hiring growth.Climbing demand for workers is pushing up pay, with pay growth accelerating to a nine-month high in April. An index representing pay growth increased to 65.8 in April. It is the fastest growth in salaries for newly placed workers since July 2014. A shorter supply of workers is also helping to lift pay. An index for growth in permanent candidate supply posted a score of 34.3. Because it is below 50, it implies the pool of available workers is shrinking. “The declining pool of available labour continues to force pay up. With two in five recruiters in the UK reporting falling candidate availability, spiralling salary growth remains a concern as businesses bid against each other to secure skilled staff,” said Bernard Brown, partner and head of business services at KPMG. Brown added: “There has been a resurgence of recruitment into Britain’s boardrooms, with businesses poaching top talent to drive their companies forward. This surge of executive hires is a strong indication of underlying business sentiment and their ambitions for the future.” Read This NextRicky Schroder Calls Foo Fighters’ Dave Grohl ‘Ignorant Punk’ forThe Wrap’Drake & Josh’ Star Drake Bell Arrested in Ohio on Attempted ChildThe WrapCNN’s Brian Stelter Draws Criticism for Asking Jen Psaki: ‘What Does theThe WrapDid Donald Trump Wear His Pants Backwards? Kriss Kross Memes Have AlreadyThe WrapHarvey Weinstein to Be Extradited to California to Face Sexual AssaultThe WrapPink Floyd’s Roger Waters Denies Zuckerberg’s Request to Use Song in Ad:The Wrap’Black Widow’ First Reactions: ‘This Is Like the MCU’s Bond Movie’The Wrap’Kevin Can F**k Himself’ TV Review: Annie Murphy Blows Up the Idea of aThe WrapKatt Williams Explains Why He Believes There ‘Is No Cancel Culture’ inThe Wrap whatsapplast_img read more

Ofcom fines EE £1m over customer complaints failings

first_img Show Comments ▼ whatsapp Tags: EE Catherine Neilan Ofcom has fined EE £1m for failures over how the telecoms group handled customer complaints. The investigation into EE – which includes when it was trading as 4GEE, Orange and T-Mobile – found that between July 2011 and April 2014 the company did not provide certain customers with accurate or adequate information about their right to take their complaint to an alternative dispute resolution scheme.  Specifically, EE failed to send out written notifications to “a number of customers” that should have detailed their right to take a complaint to ADR eight weeks after the matter was first raised.  EE also failed to state in its customer complaints code that customers could access its ADR scheme by requesting a so-called ‘deadlock letter’. But several of those who did request this letter were not sent them – and in some cases, told by EE that letters of this type did not exist.   Ofcom, which carrying out wider monitoring of the sector’s complaints handling procedures, said: “ADR is an important part of consumer protection. It allows customers to refer complaints that cannot be resolved with their provider to an independent body which can reach an impartial judgment.”  As a result of the investigation, EE has amended its customer complaints code and the information provided on its paper bills and in its written notifications to make sure customers are informed that they may use ADR for free.  The £1m fine, which is due in the next 20 days, will be passed on tothe Treasury.   Claudio Pollack, Ofcom’s consumer and content group director, said: “It’s vital that customers can access all the information they need when they’re pursuing a complaint. “Ofcom imposes strict rules on how providers must handle complaints and treats any breach of these rules very seriously. The fine imposed against EE takes account of the serious failings that occurred in the company’s complaints handling, and the extended period over which these took place.”  Ofcom fines EE £1m over customer complaints failings Sharecenter_img More From Our Partners White House Again Downplays Fourth Possible Coronvirus Checkvaluewalk.comKiller drone ‘hunted down a human target’ without being told tonypost.comNative American Tribe Gets Back Sacred Island Taken 160 Years Agogoodnewsnetwork.orgInstitutional Investors Turn To Options to Bet Against AMCvaluewalk.comPolice Capture Elusive Tiger Poacher After 20 Years of Pursuing the Huntergoodnewsnetwork.orgFlorida woman allegedly crashes children’s birthday party, rapes teennypost.comAstounding Fossil Discovery in California After Man Looks Closelygoodnewsnetwork.orgRussell Wilson, AOC among many voicing support for Naomi Osakacbsnews.comBrave 7-Year-old Boy Swims an Hour to Rescue His Dad and Little by Taboolaby TaboolaSponsored LinksSponsored LinksPromoted LinksPromoted LinksYou May LikeInvestment GuruRemember Cote De Pablo? Take A Deep Breath Before You See Her NowInvestment GuruMaternity WeekA Letter From The Devil Written By A Possessed Nun In 1676 Has Been TranslatedMaternity WeekPost FunKate & Meghan Are Very Different Mothers, These Photos Prove ItPost Funzenherald.comMeghan Markle Changed This Major Detail On Archies Birth Certificatezenherald.comEquity MirrorThey Drained Niagara Falls — They Weren’t Prepared For This Sickening DiscoveryEquity MirrorEliteSinglesThe Dating Site for Highly-Educated Singles in ScottsdaleEliteSinglesTotal Battle – Tactical Game OnlineThe Most Addictive Strategy Game of 2021Total Battle – Tactical Game OnlineTele Health DaveRemember Pierce Brosnan’s Wife? Take A Deep Breath Before You See What She Looks Like NowTele Health DaveLivestlyThe Best Redhead Actresses, RankedLivestly Friday 3 July 2015 2:27 am whatsapp last_img read more

News / Vietnam ‘has bitten off more than it can chew’ as it struggles with growth

first_imgThe news is welcome to forwarders who have been clamouring for more lift out of Vietnam.Equally welcome is the arrival of the first of eight B787-10 aircraft for Vietnam Airlines three days after the Ethiopian freighter had taken off. The national carrier is going to use them on major international routes and on the Hanoi-Ho Chi Minh City sector.Vietnam’s economy is enjoying blistering growth. It expanded by 8.2% in 2018. Exports are going strong, up 9.3% in July, led by electronics, computers and components shipments, which surged 19% year on year. Footwear, textiles and machinery also registered double-digit increases, while Vietnam’s container traffic was up 3% in the first half.The country is seemingly one of the major beneficiaries of the trade conflict between the US and China, which is in line with trade flows. US imports from Vietnam were up 36.7% for the first six months of this year.“Vietnam is showing strong growth in its import and export markets,” said John Driscoll, maritime director of the port of Oakland. Last year the southeast Asian country was the Californian gateway’s third-largest import market and fifth-largest on the export side.Carriers are responding to Vietnam’s rising exports. Asian airlines like EVA Air have boosted their capacity in the market. Over the past year several freighter operators, including AirBridgeCargo, FedEx and Cargolux have upped their presence in the market.On the maritime side, Pacific International Lines has launched a transpacific service from Haiphong, via Nansha, Hong Kong and Yantian, to Long Beach and Oakland. The operation, in partnership with Cosco and Wan Hai, uses an 11,900 teu vessel.According to forwarders, more carrier capacity would be helpful, but the bigger issue is infrastructure capacity: airports can barely cope.This year the government in Hanoi gave the green light for a new airport for Ho Chi Minh City at Long Thanh, which is set to become the nation’s largest. The development, which will be built in three phases, has an estimated price tag of US$5.4bn, but this is expected to increase substantially.The project has been delayed for years and further setbacks would come as no surprise. Ultimately, Long Thanh will have annual capacity for 100 million passengers and five million tons of cargo.Ocean capacity is another headache. Last year, Haiphong opened its first deepwater container terminal and capacity is set to increase with the completion of the second phase of the port’s expansion, scheduled for next year. The government aims to bring port capacity up to 200 million tons by 2020 and 400 million tons ten years later.Theoretically it is already there: Vietnam’s ports have an estimated total capacity of over 450 million tons. However, as much as 80% of the nation’s traffic moves through small feeder ports to regional gateways like Singapore. This can add up to a week in transit times.“It’s a challenge. They do not have the big ship infrastructure,” said Jon Slangerup, CEO of American Global Logistics.He does not think the country can readily cope with the shift of production from China that has been accelerated by the mounting tension between Washington and Beijing.“They have taken on far more than they could handle. They don’t have the skill sets, labour, manufacturing facilities in place, and they haven’t got the transport infrastructure in place yet. Vietnam has serious infrastructure problems,” he explained.The World Bank estimates that Vietnam needs $25bn-worth of investment every year  for sustainable infrastructure development, but pointed out in a blog that the government does not have deep enough pockets for this.Private investors have taken note of the rapid pace of development, but they will also be aware of recent rhetoric from the Trump administration, claiming Vietnam has taken advantage of the US-China dispute and threatening tariffs. By Ian Putzger 27/08/2019 Air cargo capacity serving Vietnam is on the rise.Last week, Ethiopian Airlines started a weekly B777F service to Bangkok and Hanoi, and in line with the carrier’s triangular strategy, the flight is routed from its home base via Europe to Asia.“These flights make Ethiopian the first African carrier to operate cargo flights from Bangkok, and will also create better opportunities for Thai and Vietnamese exporters to have a one-stop access to the 60 plus African destinations that Ethiopian serves.“The freighter flight will also link Bangkok and Hanoi to Europe, Asia, Middle East and the Americas,” said Ethiopian Group CEO Tewolde GebreMariam.center_img © Alexey Novikov last_img read more

Inside the sci-fi world of growing human tissue and organs in the lab

first_img The fledgling veins and arteries are delicate in other ways, too: “We need to feed them vitamin C all the time, or they get scurvy,” Niklason said.The cells grow around a scaffold made of a synthetic polymer that disintegrates over the two-month incubation period. All the while, the cells are producing collagen, a sturdy substance that grows into a new, organic structure in the shape of a blood vessel.Growing a ‘stealth implant’At the end of the incubation, technicians wash away the cells, leaving just the lab-grown blood vessel. Niklason describes it as a “stealth implant” because it contains no foreign DNA that might prompt the patient’s body to reject it. Instead, the patient’s own cells wrap around the implant, filling in any gaps and strengthening the new vein or artery.These lab-grown blood vessels are currently being studied in hemodialysis, a procedure that uses implanted veins as a conduit to remove waste from the blood of patients with kidney failure. Last month, promising results from a 60-patient midstage trial of Humacyte’s product were published in The Lancet.Humacyte is now kicking off a Phase 3 study of its engineered vessels in 35 sites with 350 patients. It expects to submit data in 2018.As for the future of tissue engineering, Langer said some applications will be more practical than others.“Tissues that are more structural in nature will be easier to create than those that are more functional in nature,” Langer said. “I think we’ll see engineered skin, cartilage, and blood vessels on a commercial scale before we see things like the liver, pancreas, heart, or brain.”As the potential becomes more clear, Elisseef said she’s beginning to see more interest from regulators and doctors, as well as research scientists.“People are sniffing out that tissue engineering is at a unique stage,” Elisseef said. “You’re seeing a convergence of the science, clinical, regulatory, and manufacturing, all sort of combining and connecting together.” About the Author Reprints Related: Inside a North Carolina lab, row upon row of plastic bioreactor bags pulsate gently to the beat of an artificial heart. Within each bag, a lab-forged blood vessel slowly expands, feeding off a primordial cocktail of vitamins and proteins.The blood vessels start as individual cells, placed inside a sinewy scaffold. Weeks later, they’ve grown into full-fledged arteries and veins that surgeons can use for transplants.Welcome to the age of tissue engineering.advertisement For decades, scientists and doctors have been seeking a way to manufacture human tissue — including entire organs — in a lab, hoping to make grafts and transplants easier and safer than they are now. The goal has proved elusive, because it’s hard to replicate the complexity of human tissue outside the body. But those in the trenches say the industry could be on the verge of a breakthrough.“In the past two years, we’ve seen a real evolution in thinking — both in the science and in the practical aspect of tissue engineering,” said Jennifer Elisseef, the director of the Translational Tissue Engineering Center at Johns Hopkins University.advertisement Meghana Keshavan A dogged quest to fix broken spinal cords pays off with new hope for the paralyzed By Meghana Keshavan June 8, 2016 Reprints Name a tissue in the body, and you can be sure work’s being done — somewhere — to try and replicate it in the lab, said Robert Langer of the Massachusetts Institute of Technology, a bioengineer who pioneered some of this work in the 1980s.Jennifer Lewis of Harvard University is using a 3-D bioprinter to layer a mix of cells, as if they were ink, in the form of blood vessels. Australia-based Mesoblast is developing lab-grown tissues, made from stem cells, that could be used for organ repair or new blood vessel formation. In San Diego, a startup called Organovo is trying to using 3-D printing to build livers and kidneys for transplant.And in North Carolina, a richly funded biotech startup called Humacyte — which has links to the ever-prolific entrepreneur Langer — is moving into late-stage clinical trials on artificial blood vessels.The work is still fraught with risks, both scientific and commercial.One cautionary tale: the San Diego startup Advanced BioHealing, which created a promising lab-grown replacement for human skin, to be used in wound care. Anticipating a billion-dollar market, the Irish drug giant Shire bought out Advanced BioHealing in 2011 for $750 million. But insurers such as Medicare were reluctant to cover the skin replacement. Three years later, Shire shed that unit at a loss. BiotechInside the sci-fi world of growing human tissue and organs in the lab Related: Privacy Policy @megkesh The dream of 3-D-printed organs rests on keeping cells alive. A new advance could help Biotech Correspondent Meghana covers biotech and contributes to The Readout newsletter. [email protected] Shawn Rocco/Duke Medicine Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. Please enter a valid email address. Leave this field empty if you’re human: “Tissue engineering has to mature a bit as a market,” said Keith Murphy, the CEO of Organovo. Pharma companies haven’t been rushing to invest in the field, in part because of flops like the skin replacement technology. But Murphy is optimistic: “The science is finally getting to the point where it’s becoming attractive to do these things.”A ‘barbaric’ procedureIt was a heart bypass surgery that first got Dr. Laura Niklason interested in growing human tissue.During her anesthesiology residency at Massachusetts General Hospital in the 1990s, Niklason stood by a patient’s bed and watched as surgeons hacked into his legs to find usable veins to replace the clogged arteries in his heart. When that failed, they looked in the patient’s arms, then his abdomen, where they finally found suitable blood vessels for grafting.“It really was a barbaric thing to watch, to be perfectly honest,” she said.“At the time, I remember thinking: We know a lot about how blood vessels grow, heal, and develop,” she said. “Why can’t we take that into the lab, and grow them for patients who need them?”Niklason began working on that problem in Langer’s lab. She founded Humacyte in 2004; Langer sits on the board of directors.Humacyte, which raised $150 million in venture funding last year, grows each graft individually in its own little plastic sack, which serves as a sort of womb for the vessel as it grows. Each bag’s connected to a central bioreactor tank that pumps out all the nutrients it needs — a carefully crafted “soup” of vitamins, amino acids, and chemicals called cytokines that feed cells directions about how they’re supposed to grow.“We set up a little miniature, simplified human body where we’ve got a pulse that mimics the beat of a heart,” Niklason said. After all, if these cells aren’t stretched in a way that mimics how arteries expand and contract every time a heart beats, then the resulting tissue will be too weak to function in the body. Tags organ transplantRobert Langertissue engineeringlast_img read more

How key decisions slowed FDA’s review of a Covid-19 vaccine — but also gave it important data

first_img Why is the review of the data taking so long? The FDA takes the raw data that companies provide and reanalyzes them, often picking apart statistical calculations made by manufacturers. Among regulators the world over, there is no similar direct check on the data produced by pharmaceutical manufacturers. This type of analysis, routine for new drug approvals at the FDA, is not legally necessary for emergency use authorizations during a pandemic. But given that Covid-19 vaccines could be given to hundreds of millions of people, the agency decided a thorough review was needed. In an interview with the Wall Street Journal, Hahn, the FDA commissioner, said staffers are working long hours in parallel seeking to prepare.To insiders at the FDA, even the current timeline seems insanely compressed; one insider said that when Marks, the center director, first stated it publicly regulators were shocked. “Our folks nearly fainted at the start of this when Peter [Marks] stood up in public and said when we get an EUA application we can turn it around in a few weeks,” the staffer said. “That itself was a heart-stopping moment. Now people are motivated to do that because the vaccine is looking like it has serious efficacy and it’s a public health crisis, but it doesn’t mean that there’s a fast way to do that.”The EUA process, which allows for clearances based on far less data than a traditional approval, does not have a provision for rolling applications.What’s more, the FDA said in a statement, “rolling review” does not have the same meaning at the European Medicines Agency as in the U.S. “The EMA does not have access to the same scope of data for an investigational product that the FDA has while the product is under development,” the statement said. The FDA said it has “tremendous insight” into the manufacturing processes and preclinical and clinical research that the EMA rolling review would provide.Another point of delay was Pfizer’s decision to drop its initial interim analysis, which would likely have occurred in late November. This would have allowed an outside committee to peek at the efficacy results when there were 32 cases of symptomatic Covid. Instead, the company decided to conduct the analysis after 62 cases; by the time that plan was formalized, there had actually been 94 cases. But many experts believe it would have been a mistake to analyze the data after 32 cases. It could have been clear a vaccine was effective, but not clear whether its efficacy was 60% or 90% — and there would have been little safety data.“If an EUA had been issued by some regulatory authority based on 30 cases, we would not know much about that vaccine,” said Jesse Goodman, a former FDA chief scientist and a professor at Georgetown University.Even when Pfizer had much more data — and evidence of greater than 90% efficacy — the drug giant still couldn’t file. That’s because of the FDA’s decision, announced quietly on Oct. 6 in the prelude to an earlier FDA advisory committee, to tell vaccine makers not to ask for an EUA until half the patients in their studies had been followed for two months. Setting the threshold slightly lower would have saved time, but meant less safety data.At an FDA advisory panel held on Oct. 22, experts convened by the FDA said resoundingly that they would favor conducting the studies for longer, and collecting more data. At the time of the Oct. 6 decision, that approach was met with resistance from the White House, which was pushing for a faster approval.The debate was shaped, in part, by widespread worries that even lower standards might hold the day. In May, Scott Gottlieb, who was the FDA commissioner early in the Trump administration, and Luciana Borio, whose name is being floated as a potential FDA commissioner in a Biden administration, co-authored a Wall Street Journal op-ed saying that immune response data alone should not be used as the basis of an approval. (Almost all experts agree, and it wasn’t.) In August, 400 vaccine experts signed a letter cautioning the FDA to make sure sufficient data were collected. Wherever the FDA landed, it was going to draw fire. And by any account, the process has been far faster than normal.“During a pandemic and an emergency, the passion and concern about public health and our patients is admirable, but it’s kind of like the heat of battle and people can lose their perspective,” said Goodman, the former FDA chief scientist. “And I think that’s why a strong science-based regulatory agency is so important.” About the Authors Reprints Raging at the pandemic, a VC raises $800M for a company that aims to transform biotech manufacturing Nicholas Florko On Wednesday, the United Kingdom became the first country to clear the Pfizer vaccine. Over the past week, FDA Commissioner Stephen Hahn has been called to the White House twice to explain why the vaccine could not be authorized more quickly. Those urging speed point to the two-dose vaccine’s incredibly strong short-term efficacy — it prevents 95% of symptomatic Covid-19 cases, at least based on a few months’ data — and that it appears safe overall. With more than 2,000 Americans dying from Covid-19 daily, they argue, what was the risk of trying it sooner?The FDA has said in multiple public forums that it could not have moved any faster. The agency’s staff “were eating turkey sandwiches on Thanksgiving while reviewing documents,” Peter Marks, who heads the FDA center conducting the vaccine reviews, said on a Thursday webcast run by the Journal of the American Medical Association. Additionally, members of an FDA advisory committee that will convene Thursday to review the data and issue its recommendations, have expressed no desire to meet sooner. STAT spoke to four members of the panel and all said the agency should not try to move any faster. “It takes a few months usually to review these kinds of data, and now this has been shortened to a few weeks,” said Hana El Sahly, a researcher at the Baylor College of Medicine who normally chairs the FDA’s vaccine advisory committee, but who is recused this time because of her involvement with a vaccine developed by Moderna, expected to be before the panel on Dec. 17. “I just can’t see this amount of work being compressed significantly much more than it’s already been compressed.”Cody Meissner, a Tufts Children’s Hospital vaccinologist who serves on the committee, said his concern is that “the process is too fast, not that it’s not fast enough.” “I understand completely why people want a vaccine sooner, but they wouldn’t want a vaccine sooner if it wasn’t safe,” he said.A STAT review of the process of vaccine development reveals only three ways it could have been further sped up. The first, and biggest, revolves around an FDA decision to require two months of safety data for half the patients in a study before a company asked for authorization. Had it settled for less data, a vaccine likely would have been authorized quicker.The FDA might have also been able to save some time if it evaluated data on the vaccines on a rolling basis, instead of getting all of the information — in Pfizer’s case, tens of thousands of pages — at once. (Regulators in the U.K. accepted Pfizer’s data on a rolling basis, but the FDA argues that the processes were simply very different.)Lastly — and perhaps least consequently — the FDA could have turned around the data for its advisory committee more rapidly, holding the meetings on, say, Dec. 3 and Dec. 10, instead of Dec. 10 and Dec. 17.  Nanotechnology in Medicine Related: In September, as Pfizer and partner BioNTech were quickly advancing a study of their Covid-19 vaccine, dozens of well-known academics sent an open letter to Pfizer’s CEO with a simple plea: Please slow down and collect more data.It was not until Nov. 20 that the data were submitted to the Food and Drug Administration.Now, as the FDA prepares to convene a group of outside advisers on Thursday to review the data, and recommend whether the vaccine should be broadly used, many experts are voicing the opposite opinion. What, they ask, is taking so long?advertisement Washington Correspondent Nicholas Florko reports on the the intersection of politics and health policy. He is the author the newsletter “D.C. Diagnosis.” STAT Reports: @matthewherper “I would hope the EUA is 75% written at this point,” he said, referring to the emergency use authorization the agency is widely expected to issue.center_img By Matthew Herper and Nicholas Florko Dec. 4, 2020 Reprints Matthew Herper Senior Writer, Medicine, Editorial Director of Events Matthew covers medical innovation — both its promise and its perils. [email protected] Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, said the process has been halting and hesitant.“The next two months are going to be bad,” Gellad said. “A vaccine that is highly likely to be effective and highly likely to be safe could have an impact.” advertisement HealthHow key decisions slowed FDA’s review of a Covid-19 vaccine — but also gave it important data Laboratory technicians in Anagni, Italy, handle capped vials as part of filling and packaging tests for the large-scale production and supply of the AstraZeneca/University of Oxford Covid-19 vaccine candidate. VINCENZO PINTO/AFP via Getty Images [email protected] @NicholasFlorko Tags Coronaviruslast_img read more

Fort Myers police report 35 car break-ins, thefts in past two weeks

first_imgShut off & lock your cars… or face a fine May 19, 2021 Gateway neighborhood break-ins caught on camera June 3, 2021 Property manager accused of multiple Fort Myers apartment thefts May 21, 2021 Advertisement AdvertisementDC Young Fly knocks out heckler (video) – Rolling OutRead more6 comments’Mortal Kombat’ Exceeded Expectations Says WarnerMedia ExecutiveRead more2 commentsDo You Remember Bob’s Big Boy?Read more1 commentsKISS Front Man Paul Stanley Reveals This Is The End Of KISS As A Touring Band, For RealRead more1 comments AdvertisementRecommended ArticlesBrie Larson Reportedly Replacing Robert Downey Jr. As The Face Of The MCURead more81 commentsGal Gadot Reportedly Being Recast As Wonder Woman For The FlashRead more29 comments Family discovers their car was stolen from a North Fort Myers Walmart parking lot June 5, 2021center_img AdvertisementTags: car burglaryFort Myers Police RELATEDTOPICS AdvertisementPolice said you can park your car in a garage to keep thieves away. Sgt. Thompson said people will check door handles on cars and if they are locked, they will move on.FMPD has not arrested anyone at this point. FORT MYERS, Fla. – Fort Myers police are reminding people to lock their doors after they’ve reported 35 car break-ins or thefts in the past two weeks.Sgt. Glenn Thompson said thieves are targeting unlocked cars in driveways, and they’ve seen an increase since November 6. FMPD said to always lock your car doors. Many communities have front gates, but that is not enough protection for your car. Some people have stolen cars altogether, or items from cars. Advertisementlast_img read more