- Halol, Gujarat plant listed under import alert
- Halol supply to U.S. accounted for 3% of Sun revenue in FY22
- Sun says not cutting rev guidance
- Shares end down 3.6%, worst day since May 2021
This story was originally published by Chalkbeat. Sign up for their newsletters at ckbe.at/newsletters
Arizbeth Cortez felt confident college would be just like high school and she’d ace all her classes. After all, she’d never received anything less than an A grade at Denver’s Bruce Randolph School.
On her first test at the University of Northern Colorado, however, she got a B. It brought a flood of tears and worries that she didn’t have the skills to meet her expectations.
“I ended up with anxiety about exams because I didn’t know how to study very well,” said Cortez, 18, a freshman.
The challenge of college can be an eye opening experience for even the brightest student. But Cortez realized she didn’t know how to manage her time or know how to prepare for a test.
They’re skills she missed while attending high school during the pandemic, when she took her classes virtually for more than a year, rarely had homework, and most of the tests she took were open book. Most of her junior year was spent learning from home and she saw her mom and sister more than peers and teachers.
Cortez isn’t alone in her first semester struggles, which at times left her rattled. College leaders have encountered many more freshmen like her this year — students who don’t have the base of skills that will make them successful in college. And they all agree about the cause: nearly five high school semesters upended by the pandemic, and less accountability placed on students because of it.
Educators say students entering college this fall have fewer study and test-taking skills, such as simple tactics like preparing note cards or the value of study groups. They’re less communicative with professors when they need extra time to complete assignments, have difficulty staying on task, and have fewer coping mechanisms when adversity strikes.
University of Northern Colorado administrators say they have had to double down on efforts to help freshmen succeed, teaching basic skills to help them adjust and navigate the new environment.
EATING 60 grapes a day can help stop people from getting sunburn, a study found.
People who ate the fruits every day for two weeks were better protected against skin damage from ultraviolet light.
Natural components found in grapes, called polyphenols, are thought to be responsible.
US scientists fed 29 participants grape powder.
Around a third of the group had some resistance to ultraviolet light after eating the powder.
Ten per cent still had resistance four weeks after they had stopped eating it, the study in journal Antioxidants said.
More than 210,000 cases of non-melanoma skin cancer and around 16,000 cases of the more deadly melanoma are diagnosed in Britain each year.
Rates of skin cancer are increasing faster than any other cancer in the UK, with figures doubling every 10 to 20 years.
Most skin cancer cases are linked to ultraviolet radiation from the sun and around 90 per cent of skin ageing is caused by the sun.
The US Department of Energy is set to make an announcement on Tuesday about a “major scientific breakthrough” following media reports that a major milestone in nuclear fusion research has been achieved.
The Financial Times reported on Monday that the Lawrence Livermore National Laboratory in California achieved the significant breakthrough of achieving a net energy gain from nuclear fusion.
This would be the first time scientists have successfully produced more energy in a fusion reaction than was required to sustain it – an advance that may potentially lead to a climate-friendly, renewable energy source.
While the laboratory confirmed to FT that it had recently conducted a “successful” experiment, it did not share further details, citing the preliminary nature of the study data.
“US Secretary of Energy Jennifer M Granholm and Under Secretary for Nuclear Security and National Nuclear Security Administration (NNSA) Administrator Jill Hruby will announce a major scientific breakthrough accomplished by researchers at DOE’s Lawrence Livermore National Laboratory (LLNL),” the Department of Energy noted.
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In the test, scientists bombarded a pellet of hydrogen plasma with the world’s largest laser to trigger a nuclear fusion reaction – a process similar to the one that takes place in the Sun.
In nuclear fusion, hydrogen atoms are forced into each other and combined into helium in a process that releases enormous amounts of heat and energy.
To achieve this, scientists reportedly used the world’s biggest laser to bombard a small quantity of hydrogen plasma that produced super heated electron-free hydrogen nuclei.
These nuclei then fuse and release energy when it leaves the bonded nuclei as they carry less mass than before.
Researchers could reportedly produce 2.5 megajoules of energy, which is 120 per cent of the 2.1 megajoules that was used to power the experiment.
The findings are not yet backed up by peer-reviewed published research.
Net energy gain has been difficult to achieve until now because the ignition for fusion happens at very high temperatures and pressures that are difficult to control.
“However, the exact yield is still being determined and we can’t confirm that it is over the threshold at this time,” the laboratory reportedly said.
An LLNL spokesperson told FT that “analysis is still ongoing”, adding that more information would be shared on Tuesday “when that process is complete”.
Proponents of nuclear power say fusion can one day lead to nearly limitless, carbon-free energy and may help displace fossil fuels.
While a net gain nuclear fusion reaction is significant, experts also explained that using the process to produce sustainable electricity for homes and cities is likely decades away.
“This is a key step on a possible pathway to commercial fusion. It demonstrates and underpins our basic understanding of the physics, and is an engineering triumph,” said Professor Sir Robin Grimes, of Imperial College London.
“Nevertheless, extracting this energy in a way that it can be harnessed, and developing the materials that can stand up to continuous operation, are massive challenges,” Dr Grimes said.
From news to politics, travel to sport, culture to climate – The Independent has a host of free newsletters to suit your interests. To find the stories you want to read, and more, in your inbox, click here.
BENGALURU, Dec 8 (Reuters) - Sun Pharmaceutical Industries Ltd's (SUN.NS) drug shipments from its Gujarat plant could be refused entry in its key U.S. market after the drug regulator slapped an import alert on the facility, the drugmaker said on Thursday.
The Food and Drug Administration's (FDA) import alert implies all future shipments of products made at the plant in Halol, Gujarat could be refused admission to the U.S. market until the facility becomes compliant with the regulator's Current Good Manufacturing Practice standards.
"The company continues to cooperate with the U.S. FDA and will undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with the company's remedial action," Sun Pharma said.
Shares of Sun Pharma slid 3.6% on their worst day since May 28, 2021, and were the top loser on the blue-chip Nifty 50 (.NSEI) index.
The drug maker is not revising its revenue forecast for this fiscal year due to the FDA action, it said in a separate filing after market close.
The FDA has excluded 14 products from the import alert, subject to conditions, which Sun Pharma said were confidential.
It was not immediately clear what remedial action the FDA had asked the company to take. Sun Pharma did not immediately respond to Reuters' request for further comment. The company also said it was evaluating whether it would incur any additional costs for remediation.
"Import alerts are very tough to remove, and several companies are still not able to get their facilities back in compliance after 7-10 years," said Shrikant Akolkar of Asian Markets Securities. The house cut Sun Pharma's revenue and earnings outlook, and lowered target price by 4.5% to 1,156 rupees.
The focus would now move to Sun's Mohali facility, Akolkar added. The plant was classified as "official action indicated" after an inspection in November, which means the FDA would recommend regulatory or administrative actions.
The Halol plant had received the same inspection classification in August after the FDA made 10 observations.
Transferring products made at Halol to other sites would be a complex and time-consuming process, so product transfers would be evaluated on a case-to-case basis, Sun said.
Reporting by Navamya Ganesh Acharya in Bengaluru; Editing by Subhranshu Sahu, Savio D'Souza and Dhanya Ann Thoppil
Our Standards: The Thomson Reuters Trust Principles.
IS THE cost-of-living crisis making it harder for working-class staff to make progress in their chosen job?
A new report from the Social Mobility Foundation shows an annual 25 per cent fall in employers publicising their schemes to help promote employees from lower socio-economic backgrounds.
Another study, from Samsung, reveals one in four working-class adults believe they are overlooked for jobs due to their societal status.
Official figures show working-class people face a class pay gap of £6,718 per year.
But half the nation consider themselves working-class, so companies urgently need to concentrate on hiring and developing lower- income staff to fill the skills gap.
As a result, the SMF is urging firms to “double down” on their commitment to social mobility as more people are hit by soaring bills, tax rises and Government spending cuts.
Leading campaigner Joe Seddon, founder of social mobility mentorship platform zerogravity.co.uk, believes schools need to support working-class talent before youngsters enter the workplace.
The site helps working-class students build a network to help find work experience and top jobs.
He said: “There is a widely accepted but rarely spoken-about truth that who you know often matters more than what you know.
“With nearly half of state-educated pupils unable to name a single Russell Group university compared to just one in six students at private schools, we’re faced with a situation where both universities and businesses are missing out on the next generation of talent.”
BEING made redundant can hit working- class staff hardest, as they typically have fewer savings and less experience in networking to find a new role.
Here Dr Lynda Folan, inset, from inspireddevelopment.net shares her tips to bounce back from losing your job.
LAW FIRM Browne Jacobson has been named the UK’s top employer for social mobility for the second consecutive year.
The company was praised for actively hiring new trainees from non-selective state schools and encouraging applications from pupils on free school meals.
Almost a million employees entered the annual Social Mobility Employer Index, with other big-name firms, including Clifford Chance, KPMG and PwC, making progress on closing their class pay gap.
Alan Milburn, chair of the Social Mobility Foundation said: “Young people are on the front line of this great divide which is why employer-led social mobility efforts are so vital to creating opportunity based on merit and not social class.”
APPLICATIONS for the SUTTON TRUST’S United States University programme are now open.
Students have all fees and living costs paid. See us.suttontrust.com.
SOCIAL mobility charity Speakers For Schools is calling on the Govern- ment to make work experience a universal right for state-educated students.
Two thirds of young people aged 18 to 30 cannot recall doing work experience while in education.
But a third of those who did work experience said it boosted their confidence.
And each period of work experience also saw a 3.4 per cent average wage boost.
Andrew Law, chair of Speakers For Schools, said: “Work experience is a fundamental right for students of all backgrounds, not just those attending prestigious schools or lucky enough to have parental connections.
“Young people should be able to learn about multiple types of jobs across different sectors before leaving school.”
Find out more at speakersforschools.org/work-experience-for-all.
PUPILS seeking in-depth social mobility-led work experience can apply for a placement with top charity THE TALENT TAP.
You can find further details on its website thetalenttap.com/students.
One of the first things Nicole Frost asked the Isabella County board of commissioners to do when she took over as county administrator at the start of 2021 was to commission a study about the future of the recycling center.
It’s expected that study will get presented to commissioners almost exactly a year later.
Finishing touches are wrapping up a study commissioned by the board last spring. They provided some preliminary findings to the Materials Recovery Facility’s advisory board and expected to make a full presentation sometime in January.
The MRF, built in the early 1990s, is as it stands is out-of-date and a drag on county finances. This year, the county commission expects to subsidize it to the tune of $450,000.
County officials want to move that liability off the county’s general fund and turn it into what it’s always supposed to have been, a self-sustaining operation.
One question the study was hoped to answer was whether it’s financially feasible to upgrade the equipment so haulers wouldn’t need to pre-sort it. While that would be expensive, it’s also possible that new revenue raised because it would make it more attractive to haulers who otherwise spend extra trucking their materials to Grand Rapids and Lansing.
Frost told commissioners in January that addressing the MRF’s future wasn’t just a priority for the facility. It’s also a priority created by the county’s financial picture.
The county’s financial picture is rather tight in the near- and mid-term with additional expenses from increasing employee wages, paying for the new jail and sheriff’s facility from the county’s general fund and also with unfunded pension liabilities.
Ending the MRF subsidy is one area that the county is looking at to wring savings out of its current expenditures to address those financial challenges.
BENGALURU, Dec 8 (Reuters) - Sun Pharmaceutical Industries Ltd's (SUN.NS) drug shipments from its Gujarat plant could be refused entry in its key U.S. market after the drug regulator slapped an import alert on the facility, the drugmaker said on Thursday.
The Food and Drug Administration's (FDA) import alert implies all future shipments of products made at the plant in Halol, Gujarat could be refused admission to the U.S. market until the facility becomes compliant with the regulator's Current Good Manufacturing Practice standards.
"The company continues to cooperate with the U.S. FDA and will undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with the company's remedial action," Sun Pharma said.
Shares of Sun Pharma slid 3.6% on their worst day since May 28, 2021, and were the top loser on the blue-chip Nifty 50 (.NSEI) index.
The drug maker is not revising its revenue forecast for this fiscal year due to the FDA action, it said in a separate filing after market close.
The FDA has excluded 14 products from the import alert, subject to conditions, which Sun Pharma said were confidential.
It was not immediately clear what remedial action the FDA had asked the company to take. Sun Pharma did not immediately respond to Reuters' request for further comment. The company also said it was evaluating whether it would incur any additional costs for remediation.
"Import alerts are very tough to remove, and several companies are still not able to get their facilities back in compliance after 7-10 years," said Shrikant Akolkar of Asian Markets Securities. The house cut Sun Pharma's revenue and earnings outlook, and lowered target price by 4.5% to 1,156 rupees.
The focus would now move to Sun's Mohali facility, Akolkar added. The plant was classified as "official action indicated" after an inspection in November, which means the FDA would recommend regulatory or administrative actions.
The Halol plant had received the same inspection classification in August after the FDA made 10 observations.
Transferring products made at Halol to other sites would be a complex and time-consuming process, so product transfers would be evaluated on a case-to-case basis, Sun said.
Reporting by Navamya Ganesh Acharya in Bengaluru; Editing by Subhranshu Sahu, Savio D'Souza and Dhanya Ann Thoppil
Our Standards: The Thomson Reuters Trust Principles.
Consider this a serious, possibly deadly side effect of the great pandemic: Only 91.7% of Florida kindergarteners received their mandatory vaccination regimes last school year.
In an era when social media quackery and the Florida Department of Health have sabotaged trust in medical science, an alarming number of parents now contend their children need religious or medical exemptions. (I suppose in Florida “mandatory” has become an elastic term.)
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Mind you, these compulsory kindergarten inoculations don’t include mRNA immunizations against COVID-19, which are available for kids but not required. The American Academy of Pediatrics (which recommends COVID shots for all children six months and older) reported last month that only 38% of U.S. children ages 5-11 have been vaccinated against a coronavirus that, so far, has killed 1,089,845 Americans. Obviously, there’s a considerable trust gap between kids’ parents and kids’ docs.
But state law demands kindergarteners (excepting those with religious or medical excuses) receive vaccinations against polio, tetanus, diphtheria, measles, mumps, rubella, influenza B and hepatitis B — frightening communicative diseases that, according to medical historians, once caused “significant mortality and morbidity” among children.
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Vaccines that suppressed these once-common contagions were 20th Century medical miracles. A resurgence of any of these preventable diseases because of misinformation — an inadequate word for the rampant mendacity infesting social media — would be a tragedy of the 21st.
If 91.7% of children being vaccinated sounds like a lot, that finding actually constitutes the lowest vaccination rate among Florida kindergarteners in the last 10 years. The rate falls below the 95% benchmark epidemiologists call the minimum necessary for herd immunity. Last year, only 18 of Florida’s 67 counties, none of them in South Florida, reached or exceeded the 95% threshold for kindergarteners.
Nine counties (Palm Beach, Orange, Duval, Escambia, Gadsden, Indian River, Osceola, Putnam and Sarasota) reported that less than 90% of their kindergarteners were vaccinated — a dismal rate that epidemiologists warn escalates the risk of a serious outbreak. (The real rates may be even lower. The surveys don’t include home-schooled students or those enrolled in virtual, online classes — categories that tend to have lower vaccination rates than conventional students.)
No doubt, distrust of school kid immunizations has been exacerbated by loud, militant and misinformed opposition to COVID-19 vaccines. And because anti-vaxxer parents are too young to remember the polio epidemic that loomed over my own childhood.
In 1952 alone, 60,000 Americans — most of them young children — were stricken by a poliovirus. Three thousand died that year. Thousands were crippled. But polio vaccines licensed in 1955 and 1961 were so effective that the dread afflicting that era has finally diminished to an old man’s nightmare.
But mostly, the declining vaccination rates are a by-product of the lying reprobates who’ve managed to entangled COVID-19 and mRNA technology in toxic politics and QAnon conspiracy theories. Naturally, if someone believes that Big Pharm and deep state powermongers are conspiring to inject us with mind-control microchips, their paranoia begins to undermine all vaccines.
In Florida, anti-vaxxers feel validated by Gov. Ron DeSantis, who uses ad hominin attacks on the CDC and Anthony Fauci to poach MAGA devotees away from Donald Trump. (Who expressed more enthusiasm for anti-malarial drugs and horse dewormer as COVID treatments than his own administration’s breakthrough vaccines.)
DeSantis’s appointment of vaccine-skeptic Joseph Ladapo as Florida surgeon general further eroded trust in medical science hereabouts. Ladapo was on Twitter Dec. 2 claiming “mRNA COVID-19 vaccines are far less safe than any vaccines widely used.”
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In October, Ladapo claimed a Florida study found that COVID vaccines expose young men to an “abnormally high risk” of fatal heart reactions. But the study was an unattributed, unpublished, eight-page analysis. Medical experts told the Washington Post that the study had “severe methodological problems” and would not stand up to peer review.
H. Holden Thorp, editor-in-chief of the medical journals Science and Science Immunology, called it a “bogus study” and in a Science editorial said Ladapo continues to spread “dangerous misinformation” about COVID-19.
Even the unknown author of the study warned that the observations are “preliminary” and “should be interpreted with caution.”
But Florida’s surgeon general was undeterred, just as he flouted medical expert consensus when he opposed mask mandates and gender dysphoria treatments for juveniles — positions that, while outside those of the mainstream medical field, just happened to coincide with Gov. DeSantis’ reactionary politics.
Ladapo’s crusade against mRNA vaccines for kids and young men (with the unflagging support of his boss in the governor’s mansion) was bound to affect parental support for other childhood vaccines.
After more than 83,000 COVID deaths, what Florida sorely needs is a vaccination against medical misinformation. In that regard, we’re a long damn way from herd immunity.
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Fred Grimm, a longtime resident of Fort Lauderdale, has worked as a journalist in South Florida since 1976. Reach him by email at leogrimm@gmail.com or on Twitter: @grimm_fred.
Dear Doctors: Our daughter, 24, struggled with her health for years before being diagnosed with lupus. I have seen a study with a potential cure called CAR T-cell therapy. How does it work?
Answer: Lupus is an autoimmune disease. That means the immune system mistakenly identifies the body’s own tissues as foreign invaders and attacks them.
This results in damaging inflammation that, over time, leads to a wide range of symptoms. These can include fatigue, fever, stiffness or pain in the joints or muscles, skin problems, sensitivity to sunlight, headache, dry eyes, hair loss and mouth sores.
Lupus also can cause damage to organs, particularly the lungs and kidneys, and can affect the nervous system and heart. There’s no known cure.
Treatment involves medications to reduce inflammation, manage symptoms and prevent organ damage.
Now, unlike traditional treatments, which can only ease the effects of the disease, new research on CAR T-cell therapy hints at a path to remission.
But the study was quite small, with just five patients. The long-term success of this approach and any long-term side effects aren’t known.
CAR T-cell therapy is a type of immunotherapy — treatments that harness the body’s immune cells to fight disease.
Five years ago, the federal Food and Drug Administration began to approve CAR T-cell therapy — which uses a type of white blood cell — for use in some blood cancers.
The first step in such a treatment is to collect blood from the patient and extract the T cells. These are then genetically modified so they will act on a specific target.
For the lupus study, researchers “taught” the CAR T cells to target the overactive immune cells that attack the body’s own tissues. Up to 100 million CAR T cells were needed for a single therapeutic dose, so the customized cells were reproduced in a lab. The patients were then infused with their own customized cells.
About three months later, after the CAR T cells had eliminated the malfunctioning immune cells, the patients’ bodies began to produce new immune cells, which behaved normally.
Each of the five patients has been able to stop taking drugs to manage their illness, and they are considered to be in remission.
But the follow-up period so faris less than two years. That and the tiny trial size mean this approach is still in the realm of investigation. More study is needed for CAR T-cell therapy to be effectively evaluated as a possible treatment for lupus.
Dr. Eve Glazier and Dr. Elizabeth Ko are internists at UCLA Health.