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Plus500 share price up nearly 3% as trading platform announces record year

The Plus500 share price has gained almost 3% (2.8%) today to take the financial…
The post Plus500 share price up nearly 3% as trading platform announces record year first appeared on Trading and Investment News.

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The Plus500 share price has gained almost 3% (2.8%) today to take the financial markets trading platform’s return for the year to over 7% after the company announced it is on track to announce record full-year results.

A drop in the activity of amateur traders over the last three months of 2021 saw Plus500’s share price lose almost 15% between late October and early December. However, fourth quarter results issued by the company yesterday showed the slide wasn’t significant enough to derail full-year revenue and profit figures.

plus500 ltd

A huge third quarter brought in $211 million in revenues thanks to the boom in armchair trading and especially “meme stock” trading that took off during the pandemic. By contrast the $160 million in revenues generated between October and December were slightly disappointing. However, overall, 2021 was an excellent year for the spread betting and CFDs broker.

Plus500’s market update informed investors the company had benefitted from

“an outstanding operational and financial performance throughout 2021, ahead of market expectations”.

Revenues over the calendar came in at $718 million, some way ahead of analysts’ expectations for $655 million. $702 million of that was generated from customers’ trading activities with the rest from other revenue streams such as interest earned on account balances.  The company’s official full-year results will be reported on February 15th.

Plus500 is an Israeli-owned company established in 2008 and based in Haifa. It has been listed on the London Stock Exchange since 2013 when it joined the AIM exchange before upgrading to a full listing in 2018.

The company said its number of active account holders is around 406,000 with 171,000 of those trading actively in the fourth quarter. 196,150 new customers were added last year including 33,000 in the fourth quarter. While third quarter revenues were higher than those of the fourth quarter, active customer numbers were lower at 166,310, as were new customers added – 26,169. Pre-pandemic, Plus500 was averaging about 23,000 new account holders a quarter.

The trading platform company appears to have benefitted from extending the variety of financial instruments it offers derivatives trading for. The acquisition of the regulated futures commission merchant Cunningham Commodities allowed Plus500 to establish a new position in the futures and options market.

A traditional non-leveraged stockbroking platform, Plus500 Invest, has also been launched and

“will be rolled out on more platforms and in additional target markets in the upcoming months.”

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US Allows 2 Million Baby Formula Cans In From UK, Lets Abbott Release 300,000 Specialty Cans

US Allows 2 Million Baby Formula Cans In From UK, Lets Abbott Release 300,000 Specialty Cans

Authored by Mimi Nguyen Ly via The Epoch Times…

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US Allows 2 Million Baby Formula Cans In From UK, Lets Abbott Release 300,000 Specialty Cans

Authored by Mimi Nguyen Ly via The Epoch Times (emphasis ours),

The U.S. Food and Drug Administration (FDA) announced on Tuesday it will allow about 2 million cans of baby formula from the United Kingdom into the country, and allow Abbott Laboratories to release about 300,000 cans of specialty formula, to help ease the ongoing nationwide shortage.

“We continue to do everything in our power as part of the all-of-government efforts to ensure there’s adequate infant formula available wherever and whenever parents and caregivers need it,” FDA Commissioner Robert Califf said in a statement. “Our recent steps will help further bolster supply of infant formula, including through the import of safe and nutritious products from overseas based on our increased flexibilities announced last week.

Importantly, we anticipate additional infant formula products may be safely and quickly imported into the U.S. in the near-term based on ongoing discussions with manufacturers and suppliers worldwide.”

Shelves are empty of baby formula at a store in Chelsea, Massachusetts, on May 20, 2022. (Joseph PreziosoAFP via Getty Images)

The FDA announced it is “exercising enforcement discretion” to allow the importation of the 2 million cans from UK-based company Kendal Nutricare. The cans, which are under the company’s Kendamil brand, have no safety or nutrition concerns after an evaluation, and are expected to land on U.S. store shelves starting in June, the FDA said.

Kendal Nutricare currently has over 40,000 cans in stock for immediate dispatch, the agency said, adding that the U.S. Department of Health and Human Services is discussing options to get those cans into the country as soon as possible.

The FDA also announced it is letting Abbott release some 300,000 cans of its EleCare amino acid-based formula for babies and infants who urgently need it to survive, on a case-by-case basis.

The cans of specialty formula were previously produced at Abbott’s facility in Sturgis, Michigan, where other baby formula products that were recalled by Abbott on Feb. 17 were produced.

These products will undergo enhanced microbiological testing before release. Although some EleCare product was included in Abbott Nutrition’s infant formula recall, these EleCare products that will be released were in different lots, have never been released and have been maintained in storage under control by Abbott Nutrition,” the FDA noted.

“Given the critical need of this product for some individuals, the FDA encourages parents and caregivers to consult with their health care providers to weigh the potential risk of bacterial infection with this product,” it added. “Parents and caregivers seeking access to these products should contact Abbott directly to request that a product be made available to them by calling 1-800-881-0876.”

The ongoing baby formula shortage in the United States was recently exacerbated after Abbott Laboratories, the biggest U.S. supplier of powder baby formula, in February recalled some products, including those under the brand Similac, and temporarily shuttered its manufacturing facility in Sturgis, Michigan, which was producing up to one-quarter of the country’s baby formula.

The recall came after reports of bacterial infections among four infants, two of whom died. The FDA, which launched an investigation into the matter following consumer complaints, cannot conclude whether the cases of infants that fell sick were directly related to the Abbott facility until its investigation is concluded, Califf previously said.

Production at the Sturgis facility is set to restart on June 4, Abbott said in a statement. The company said it would prioritize making EleCare and supplying it on or about June 20. It also the formula would be provided to children in need for free.

Prior to the Abbott recall, the baby formula shortage among multiple manufacturers was brought on by supply chain pressures linked to COVID-19 pandemic lockdowns.

Also on Tuesday, the Federal Trade Commission launched an inquiry into the ongoing shortage of baby formula in the country, calling for public input on the matter.

The Biden administration has sought to relieve the shortage by importing emergency supplies from Europe via Defense Department-contracted commercial aircraft under “Operation Fly Formula.” The first lots of formula arrived in Indianapolis, Indiana, from Germany on Sunday.

President Joe Biden has also invoked the Cold War-era Defense Production Act to help manufacturers obtain ingredients to produce more formula.

Tyler Durden Thu, 05/26/2022 - 07:20

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Why are clinical trials struggling with diversity?

In the diverse world we live in, the products we produce, the services we create and the places
The post Why are clinical trials struggling with diversity?…

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In the diverse world we live in, the products we produce, the services we create and the places we work should be as equally representative. In recent years this has seen diversity, equity, and inclusion (DEI) become a big focus for industries to get right.

Within pharma and healthcare, where greater representation has been proven to lead to better health outcomes for all patients and the pharmaceutical companies developing medicines, change is also happening.

Fair and timely access to efficacious medicine is one of the vital tenets of the healthcare industry and is a critical building block of the sector’s environmental, social and governance (ESG) objectives. But historically there are groups that are typically neglected due to the current systems in place. Racial disparities are still commonplace in many clinical trials with white-ethnic groups often overrepresented amongst trial participants.

Factors such as ethnicity, gender, sexual orientation and age can contribute to interindividual differences in treatment responses and risks of adverse events. Inadequate clinical trial representations of all populations can therefore leave underrepresented groups vulnerable due to the lack of subgroup-specific data.

While many pharma companies are actively working on initiatives to improve diversity in clinical trials, we still have a long way to go. The good news is that technology is being harnessed to promote a DEI-conscious agenda within the clinical trial space, making diversity more attainable than it ever has been.

To understand why improving diversity, mitigating bias, and reinforcing inclusion in clinical trials is such a big task, it’s important to understand the challenges currently at play.

Unpacking the status quo

Traditional Randomised Control Trials (RCTs) continue to form the backbone of clinical efficacy and safety data submitted to health authorities for regulatory review. A risk-benefit approach underpins the decision-making process to evaluate human drugs, drug/device combinations and advanced therapy medicinal products for licensing of human medicines.

It is well-established that safety and efficacy data is highly influenced by internal (intrinsic: ethnicity, sex, age, genetic background) and external (extrinsic: climate, education, access to healthcare) factors. The challenge for regulators and pharma companies is that safety and efficacy data from an RCT may not always translate to the real world ‘effectiveness’ of a medicine (how efficacious the drug is in patients once marketed) which is governed by these complex intrinsic and extrinsic factors.

To mitigate against potentially lower drug efficacy or a different drug safety profile in a wider population vs those findings evidenced in RCTs it is important for companies to include ‘patient-orientated’ outcomes (relief of symptoms) alongside traditional endpoints (blood pressure, glucose concentrations). The diversity of clinical trial patients in the context of disease prevalence is key to capturing ‘patient-orientated’ outcomes in populations. For example, with skin conditions, textbooks, studies, and trial photos often present lighter-skinned individuals’ symptoms, which are bound to differ in darker skinned individuals.

The pandemic brought imbalances into sharp focus

The race to produce a vaccine which could protect the world against COVID-19 brought the topic of diversity in clinical trials, or lack of it, into sharp focus.

Vaccines approved for public use require comprehensive RCTs to establish their safety and efficacy. The demographics of vaccine trial participants should reflect the vulnerable groups to whom infection with the disease presents the greatest risk of harm and mortality. However, this did not happen to the extent it could have during trials for the COVID-19 vaccine.

Research has shown a disproportionately higher rate of COVID-19 infection and mortality among the elderly and minority ethnic groups who are more likely to be negatively impacted by social and economic deprivation linked to pre-existing health conditions. In the UK, during the first wave of the COVID-19 pandemic, ethnic minority groups (except for women in “Chinese” or “White Other” categories) had higher rates of death post-exposure compared with the “White British” population.

These issues are not confined to the UK; in the US, some minority groups including Black, Latino, Pacific Islander and Indigenous peoples have been shown to have twice the COVID mortality rate of Caucasian people.

Despite policies, guidelines, and regulations to promote the diversification of clinical trial groups by the European Medicines Agency (EMA) and FDA, the inclusion of key demographic populations within clinical research continues to be less than proportionate to their representation in society.

Why are certain ethnic groups underrepresented?

Redressing the imbalance in trial participation is not a simple task. Throughout the pandemic, the issue of vaccine hesitancy was compounded by ethnic disparities. This is underpinned by historical mistrust in healthcare organisations, governments, and clinical research, which is still prevalent in some communities.

Factors influencing trust vary between ethnic groups. Reported experiences of discrimination, perceived structural inequalities impacting the access to and quality of healthcare, and concerns of trial under-representation are likely to influence trust issues, of which the latter is within the remit of companies to acknowledge and address with appropriate measures to effect change. Without diverse participation in clinical research there is a lack of breadth in safety and efficacy data. Certain groups of individuals may then not trust that the medicines have been produced with them in mind and may be highly sceptical of the resulting evidence base and prescribing label of medicines.

In the second half of this article, we’ll look at how technology is being used to make clinical trials more diverse and consider some of the lessons learned during the COVID-19 pandemic.

About the authors

Tanya Chambers is an ex-MHRA (Medicine and Healthcare Regulatory Agency) Senior Assessor with over 15 years’ experience principally evaluating preclinical data packages (small molecules and biologics) accompanying clinical trial applications, EU & UK marketing authorization applications (MRP/DCP/Centralised submissions) and variations across all therapeutic areas. Most recently, Tanya led the preclinical rolling review for COVID anti-viral applications resulting in national roll-out, and was product lead for the review of a vast array of development programmes via UK innovative licensing pathways: iLAP and EAMs. In addition, Tanya has working knowledge of the collaborative review of promising oncology treatments alongside Australia (TGA), Canada (Health Canada), UK (MHRA), Singapore (HSA), Switzerland (Swissmedic) and Brazil (ANVISA): ‘Project ORBIS’.

Liam Johnstone has six years of toxicology experience working across regulators in the UK, developing expertise in medicine, consumer product and agrochemical safety whilst working at the MHRA, OPSS and HSE, respectively. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and generic medicines. He has provided scientific advice to companies both nationally and as part of the Scientific Advice Working Party (SAWP) on the suitability of non-clinical data packages and study plans, as well as generating guidance for the European Medicines Agency (EMA)

 

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After mass shootings like Uvalde, national gun control fails – but states often loosen gun laws

After mass shootings, politicians in Washington have failed to pass new gun control legislation, despite public pressure. But laws are being passed at…

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A girl cries outside the Willie de Leon Civic Center in Uvalde, Texas, on May 24, 2022. Allison Dinner/AFP via Getty Images

Calls for new gun legislation that previously failed to pass Congress are being raised again after the May 24, 2022, mass shooting at an elementary school in the small town of Uvalde, Texas.

An 18-year-old shooter killed at least 19 fourth grade students and two teachers at Robb Elementary School, marking the deadliest school shooting in the U.S. in a decade.

The U.S. has been here before – after shootings in Tucson, Aurora, Newtown, Charleston, Roseburg, San Bernardino, Orlando, Las Vegas, Parkland, El Paso, Boulder, and 12 days earlier at a grocery store in Buffalo, N.Y.

Gun production and sales in the U.S. remain high, following a purchasing surge during the COVID-19 pandemic. In 2021, the firearms industry sold about six guns for every 100 Americans.

Senator Chris Murphy of Connecticut was among the Democratic politicians who pleaded for action on gun control as horrifying details of the Uvalde school shooting unfolded.

“What are we doing?” Murphy asked other lawmakers, speaking from the Senate floor on the day of the shooting. “Why are you here if not to solve a problem as existential as this?”

Congress has declined to pass significant new gun legislation after dozens of shootings, including those that occurred during periods like this one, with Democrats controlling the House of Representatives, Senate and presidency.

This response may seem puzzling given that national opinion polls reveal extensive support for several gun control policies, including expanding background checks and banning assault weapons.

In October 2021, 52% of people polled by Gallup said that they thought firearm sales laws should be made more strict.

But polls do not determine policy.

I am a professor of strategy at UCLA and have researched gun policy. With my co-authors at Harvard University, I’ve studied how gun laws change following mass shootings.

Our research on this topic finds there is legislative activity following these tragedies, but it’s at the state level.

A Democratic senator and Sandy Hook parents and teachers at a press conference in the US Capitol in 2013.
U.S. Senator Richard Blumenthal (D-Conn.) speaks to the media as teachers, parents and residents from Newtown, Conn. – where the Sandy Hook school massacre happened – listen after a Capitol Hill hearing on Feb. 27, 2013, on the Assault Weapons Ban of 2013. Alex Wong/Getty Images

Restrictions loosened

Stricter gun laws at the national level are more popular among Democrats than Republicans, and major new legislation would likely need votes from at least 10 Republican senators. Many of these senators represent constituencies opposed to gun control.

Despite national polls showing majority support for an assault weapons ban, not one of the 30 states with a Republican-controlled legislature has such a policy.

U.S. Texas Senator Ted Cruz said on May 24 that more gun control laws could not have prevented the Uvalde attack, explaining “that doesn’t work, it’s not effective, it doesn’t prevent crime.”

The absence of strict control policies in Republican-controlled states shows that senators crossing party lines to support gun control would be out of step with the views of voters whose support they need to win elections.

But a lack of action from Congress doesn’t mean gun laws are stagnant after mass shootings.

To examine how policy changes, we assembled data on shootings and gun legislation in the 50 states between 1990 and 2014. Overall, we identified more than 20,000 firearm bills and nearly 3,200 enacted laws. Some of these loosened gun restrictions, others tightened them, and still others did neither or both – that is, tightened in some dimensions but loosened in others.

We then compared gun laws before and after mass shootings in states where mass shootings occurred, relative to all other states.

Contrary to the view that nothing changes, state legislatures consider 15% more firearm bills the year after a mass shooting. Deadlier shootings – which receive more media attention – have larger effects.

In fact, mass shootings have a greater influence on lawmakers than other homicides, even though they account for less than 1% of gun deaths in the United States.

As impressive as this 15% increase in gun bills may sound, gun legislation can reduce gun violence only if it becomes law. And when it comes to enacting these bills into law, our research found that mass shootings do not regularly cause lawmakers to tighten gun restrictions.

In fact, we found the opposite. Republican state legislatures pass significantly more gun laws that loosen restrictions on firearms after mass shootings.

In 2021, Texas Governor Greg Abbott signed a new law that eliminated a requirement for Texans to obtain a license or receive training to carry handguns. This came two years after a 2019 mass shooting at a Walmart in El Paso.

That’s not to say Democrats never tighten gun laws – there are prominent examples of Democratic-controlled states passing new legislation following mass shootings.

California, for example, enacted several new gun laws following a 2015 mass shooting in San Bernardino. Our research shows, however, that Democrats don’t tighten gun laws more than usual following mass shootings.

After the Buffalo shooting in early May 2022, New York Governor Kathy Hochul said that she would work to increase the age for legal gun purchasing from 18 to 21 “at a minimum.”

'Change gun laws or change Congress' reads a sign at a 2018 rally in New York City.
In August 2018, Moms Demand Action hosted a rally at New York City’s Foley Square to call upon Congress to pass gun safety laws. Erik McGregor/LightRocket via Getty Images

Ideology governs response

The contrasting response from Democrats and Republicans is indicative of different philosophies regarding the causes of gun violence and the best ways to reduce deaths.

While Democrats tend to view social factors as contributing to violence, Republicans are more likely to blame the individual shooters.

Cruz, for example, has said that stopping individuals with criminal records from committing violence could help prevent mass shootings.

Politicians favoring looser restrictions on guns following mass shootings frequently argue that more people carrying guns would allow law-abiding citizens to stop perpetrators.

In fact, gun sales often surge after mass shootings, in part because people fear being victimized.

Democrats, in contrast, typically focus more on trying to solve policy and societal problems that contribute to gun violence.

For both sides, mass shootings are an opportunity to propose bills consistent with their ideology.

Since we wrote our study of gun legislation following mass shootings, which covered the period through 2014, several additional tragedies have energized the gun control movement that emerged following the December 2012 shooting at Sandy Hook Elementary School in Connecticut. These include the May 2022 shooting at the Tops grocery store in Buffalo, as well as the Uvalde school massacre.

While President Joe Biden issued executive orders in 2021 with the goal of reducing gun violence, action in Congress remains elusive. States, meanwhile, have been more active on the issue.

Student activism following the 2018 shooting at Marjory Stoneman Douglas High School in Parkland, Florida, did not result in congressional action but led several states to pass new gun control laws.

With more funding and better organization, this new movement is better positioned than prior gun control movements to advocate for stricter gun policies following mass shootings. Public outcry and devastation over the Uvalde shootings will likely provide fuel to this advocacy work.

But with states historically more active than Congress on the issue of guns, both advocates and opponents of new restrictions should look beyond Washington for action on gun policy.

This is an updated version of an article originally published on March 21, 2021.

Christopher Poliquin does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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