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NIH scientists say they could have discovered a promising new oral antiviral drug

Alex Raths | Getty Images

Scientists may have found promising new treatment for Covid-19 after an experimental oral antiviral drug demonstrated the ability to prevent the coronavirus from replicating, the National Institutes of Health said Thursday, citing a new study.

The drug called TEMPOL can reduce Covid-19 infections by interfering with an enzyme that the virus needs to make copies of itself once it’s in human cells, which could potentially limit the severity of the disease, des researchers said NIH. The drug was tested in a live virus cell culture experiment.

“We urgently need additional effective, accessible treatments for COVID-19,” wrote Dr. Diana W. Bianchi, director of the National Institute of Child Health and Human Development at the NIH, in a statement. “An oral drug that prevents SARS-CoV-2 from replicating would be an important tool in reducing the severity of the disease.”

The results were published in the journal Science.

While vaccines have been incredibly useful in containing Covid-19 cases in the United States and other parts of the world, scientists say treatments are still badly needed for those who contract the virus.

According to the Johns Hopkins University, the US reported an average of around 16,300 infections per day on Wednesday. Gilead Sciences’ remdesivir is the only drug that has received full US approval from the Food and Drug Administration for the treatment of Covid and that must be administered intravenously in a hospital.

Pfizer, who worked with German drug maker BioNTech to develop the first approved Covid-19 vaccine in the United States, is also developing an oral drug against Covid that can be taken at home at the first signs of illness. The researchers hope the drug will prevent the disease from getting worse and prevent hospital stays. It started with an early trial in March.

The NIH researchers said they intend to conduct additional preliminary studies and look for ways to evaluate the drug in a clinical study on Covid.

The results of the study are “hopeful,” said Dr. Tracey Rouault, another NIH officer who led the study.

“However, clinical trials are needed to determine whether the drug will be effective in patients, especially early on in the disease process when the virus begins to replicate.”

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Health

Moderna says vaccine generates promising immune response in opposition to variants

A doctor draws a syringe of Moderna’s vaccine.

Oliver Berg | Image Alliance | Getty Images

A booster of Moderna’s Covid-19 vaccine triggered a promising immune response against variants B.1.351 and P.1, which were first identified in South Africa and Brazil, respectively, the company announced on Wednesday, citing early data from an ongoing clinical study.

In the study, Moderna is testing a 50 microgram dose of its vaccine in previously vaccinated people. The booster dose was found to increase neutralizing antibody responses against the original virus, as well as against B.1.351 and P.1, two variants that have since spread to other countries, including the United States

The company also said that a booster shot of its other vaccine, which it calls mRNA-1273.351, produced an even better immune response over its current vaccine against the B.1.351 variant from South Africa. The new vaccine is a variant-specific booster shot that targets B.1.351.

The preliminary results, which Moderna says will be published online, have not yet been peer-reviewed.

“As we seek to defeat the ongoing pandemic, we continue to seek to be proactive as the virus evolves,” said Stephane Bancel, CEO of Moderna, in a press release. “We are encouraged by this new data, which increases our confidence that our booster strategy should protect against these newly discovered variants.”

According to Moderna, the side effects were similar to those seen after the second dose of the vaccine in the previously reported studies. Side effects included injection site pain, fatigue and headache, and muscle and joint pain.

The new data comes as drug makers and scientists now say people will likely need a booster shot of Covid-19 vaccines and possibly additional shots each year, just like they did with seasonal flu.

Moderna’s vaccine requires two doses four weeks apart. As with Pfizer and Johnson & Johnson, the shot against Covid is very effective, although company executives and officials now say they expect this strong protection to wear off over time. Pfizer’s vaccine is also a two-dose therapy, while the J&J immunization is just one burst.

The Chief Medical Officer of the White House, Dr. Anthony Fauci, previously said that Americans may need booster vaccinations to better protect themselves from variants.

Earlier Wednesday, US health officials said highly contagious variants are still a “wild card” in their nationwide campaign to vaccinate most American adults by July 4th.

A report by the Centers for Disease Control and Prevention published on Wednesday predicted that Covid-19 cases will increase until May due to the highly contagious variant B.1.1.7 first identified in the UK, before declining sharply by July, because vaccinations reduce infections. Still, variants threaten to reverse the nation’s progress, officials said,

“We are seeing that our current vaccines protect against the pollutants circulating in the country. Put simply, the sooner more people are vaccinated, the sooner we will all get back to normal,” said CDC Director Dr. Rochelle Walensky during a Covid press conference at the White House.

Moderna is evaluating three approaches to increasing immunity. The first approach would use variant-specific booster vaccinations such as mRNA-1273.351, but at a lower dose than the original vaccine. The second would combine the original vaccine with a variant-specific vaccine into a single shot at 50 micrograms or less, Moderna said. The third would test a third shot of the original vaccine at a lower dose.

Bancel told CNBC last month that the company is hoping to have a booster shot for its two-dose vaccine in the fall.

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Health

Analysts level to promising pipeline regardless of Covid vaccine jitters

A healthcare worker prepares to inject a vaccine against AstraZeneca coronavirus disease (COVID-19).

Eloisa Lopez

The AstraZeneca Covid-19 vaccine controversy has sparked some investor concerns about its stock, according to Jefferies – but it’s not all bad news for the UK pharmaceutical company.

Australia, the Philippines and the African Union have either contained or abandoned proposed Oxford-AstraZeneca University coronavirus purchases due to possible links to blood clots.

This came after UK health and vaccine regulators issued a change to guidelines on Wednesday on who should get the shot, suggesting that those under 30 should be given an alternative vaccine. Both UK and European Medicines Regulators (MHRA and EMA, respectively) have stressed that the benefits of the sting still outweigh the risks, but EU leaders have yet to agree on a common policy on the shots.

In a research report earlier this week, Jefferies Research Analyst Peter Welford said he received a pushback from customers because he recently decided to buy AstraZeneca’s shares to buy based on the “noise” about the vaccine .

This is despite the fact that the company has promised that the vaccine will be non-profit making for the “duration of the pandemic” and that it will be offered to low- and middle-income countries on a permanent basis.

The overall risk of blood clots has been estimated at around one in 250,000 and British policymakers and health experts have rushed to defend the vaccine in recent days.

Welford noted that, despite the company’s “notable successes” in gaining regulatory approval and accelerating the manufacture of its profitable vaccine, safety concerns expressed in Europe “are of paramount concern to many generalists.”

“We see FDA emergency use approval and UK / EU dose distribution agreements as key to moving the debate beyond the COVID-19 vaccine, despite concerns that it will be a distraction for management,” he explained.

The vaccine has been approved for use in the UK, Europe and other countries, and hundreds of millions of doses have been ordered from countries around the world. However, no emergency permit has yet been issued in the United States

Jefferies thought outside the box and upgraded AstraZeneca to buy in mid-March. He noted its “compelling growth profile within the EU pharmaceuticals industry” and its relative discount based on the expected strategic benefits of the $ 37 billion acquisition of Alexion Pharmaceuticals in the third quarter.

Welford defended the move by highlighting that 15 times the company’s estimated price-earnings ratio by 2022 – a mechanism for determining whether a company’s stock is fairly valued – is similar to its peers despite its “leading growth profile” .

Promising pipeline

AstraZeneca was trading on the London Stock Exchange on Friday at £ 7,337 a share and Jefferies has set a price target of £ 8,850. In Wednesday’s research note, Welford again pointed to several catalysts in the pipeline that could drive stocks higher in the coming months.

The phase 3 study data for the breast cancer treatment enhertu is expected to be available in the second half of 2021, along with possible approvals for the anifrolumab drug for the treatment of lupus. Jefferies is also anticipating approvals for the asthma drug tezepelumab in the first half of 2022 after “impressive” phase three data and a long delayed approval for the anemia candidate Roxadustat in the second half of 2021. Updated first and second phase data from Lung cancer datopotamab is also expected soon.

In a recent announcement, Damien Conover, Director of Healthcare Equity Research at Morningstar, said of AstraZeneca, “The strong overall innovation that has come from the vaccine and pipeline strengthens our beliefs in the company’s vast moat.”

He added that AstraZeneca had “made progress in addressing areas of unmet medical need” and forecast that data from the company’s Phase 3 trial of Farxiga treatment for conserved heart failure would likely lead to approval of the drug.

Conover rated anifrolumab as a “higher regulatory risk”, while roxadustat was rated as a “medium risk” and tezepelumab as a “lower risk”.

“In the longer term, we are encouraged by the robustness of the early-stage pipeline and the opportunities to develop combinations with Farxiga appear well-positioned to address several major cardiometabolic indications where unmet medical needs remain high,” said Conover. He added that Morningstar also remains bullish on AstraZeneca’s cancer drugs pipeline.

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Health

Research exhibits promising immune response towards variants

Scientists at the Mirimus Laboratory prepare to test COVID-19 samples from recovered patients on April 8, 2020 in Brooklyn, New York.

Mischa Friedman | Getty Images

One type of T cell responsible for destroying cells infected with viruses was able to detect three variants of Covid-19 in a small US study, a promising sign that vaccines should continue to protect against new, emerging strains researchers at the National Institute of Allergy and Infectious Diseases said Tuesday.

Researchers led by NIAID researcher Andrew Redd investigated whether T cells were found in blood samples from patients recovering from the original strain of virus that recognized B.1.1.7, the variant B.1.351 originally detected in the UK was originally found in South Africa and P.1, first seen in Brazil. The NIAID is part of the National Institutes of Health, which published the study.

Each of the three variants the scientists examined contained mutations in what is known as the spike protein, which the virus uses to enter human cells. Mutations in this spike protein region could make it less noticeable to T cells and neutralizing antibodies, another important part of the immune response, after infection or vaccination, the researchers said.

In the study, which used blood samples from 30 recovered Covid-19 patients, T-cell responses “remained largely intact and were able to detect virtually all mutations in the variants studied,” they said, adding that even larger studies are required.

“The researchers note that their results suggest that the T-cell response in convalescents, and most likely in vaccines, is largely unaffected by the mutations found in these three variants and should provide protection against emerging variants,” the US wrote Authority a press release.

The results of the study could give hope to public health officials as they attempt to vaccinate the US and other parts of the world. New variants have been a problem for health officials as studies have shown that variants can reduce the effectiveness of current vaccines. The Chief Medical Officer of the White House, Dr. Anthony Fauci, urged Americans to get vaccinated as soon as possible before potentially more dangerous variants emerge.

On Monday, the head of the Centers for Disease Control and Prevention, Dr. Rochelle Walensky, the reporter. She said she was concerned the nation was facing “impending doom” as variants spread and daily Covid-19 cases rise again, threatening to send more people to the hospital.

Scientists say strong responses from both antibodies and T cells are likely required for an effective immune response against the virus. Further studies to examine immune responses are still needed, the researchers stressed, including whether a booster shot would be effective against emerging variants.

“New variants continue to be identified around the world and it will be important to continuously monitor them for possible accumulation of T cell escape mutations,” the researchers wrote.

The researchers also noted that the study had limitations, including the relatively small size of the population studied and that all participants were from North America.

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Business

Cramer says GameStop stays overvalued, regardless of promising This fall report

CNBC’s Jim Cramer said Wednesday that GameStop’s turnaround story is promising, despite believing the company remains overvalued following its latest quarterly report.

“I am a lot more devout than yesterday, but I also think that if you buy the stock up here you will take control of your life,” said the host of “Mad Money”. “Let it drop to the middle double-digit numbers and I’ll get back to you.”

The competitive video game retailer’s shares fell 34% on Wednesday, a day after the company released quarterly results that missed analysts’ income statement estimates.

The company reported earnings per share of $ 1.34 and revenue of $ 2.1 billion for the quarter, a decrease of 3% year over year. According to FactSet, analysts were expecting $ 1.35 and $ 2.2 billion. Revenue declined 21% for the full fiscal year ended Jan. 30 as the company suffered losses due to Covid-19 disruptions.

Cramer said results were “about as good as could reasonably have been expected,” though he said the stock could have rallied on the report if it had traded at $ 30 or less apiece, one Fraction of their three-digit share price.

Cramer also criticized management for lacking guidance or details on GameStop’s transformation plan. The company has reduced the number of its branches and is expected to work on a plan to improve its digital operations and be competitive in the internet age.

“As long as it is in three digits, it acts as if the turnaround has already taken place,” he said. “If you buy this stock here, you are betting that Ryan Cohen’s plan will be hugely successful. This seems like a stretch since we don’t even know what the plan is.”

GameStop’s report was the first since Reddit traders short-squeezed the stock in January. GameStop shares rose nearly 2,000% in a week.

The stock closed at $ 120.30 on Wednesday, a 75% decline from its high during the high-profile Reddit rally.

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Business

Whistle-Blower Says Credit score Suisse Helped Purchasers Skip Taxes After Promising to Cease

The Swiss bank also hired Mr. Wray, then a partner at King & Spalding in Washington, who served as head of the Department of Justice’s crime department and oversaw the Enron task force. (Mr. Wray became director of the FBI three years after negotiating the final plea for Credit Suisse.)

“It is a mystery to me why, under the agreement, the US government did not require the bank to spit out some names of US customers with secret Swiss bank accounts,” said Carl Levin, then a senator in Michigan who was leading an investigation into Offshore Tax Avoidance said after the 2014 opposition agreement.

In the interview, Mr Neiman, the whistleblower’s attorney, said that in July 2014, after the plea deal was signed and Credit Suisse awaited his final conviction, he told officials from the Justice Department’s tax department and federal prosecutors who was on worked on the case that his client had information that the bank was still camouflaging money held by some US account holders. He gave them a name in particular – Dan Horsky, the retired economics professor who lived in Rochester, NY

The tip was checked out. The following year, federal agents arrested Mr. Horsky, who had amassed a fortune of $ 200 million and hidden with the help of Credit Suisse bankers using offshore shell companies, court documents show. The deal lasted several months after the bank signed its pleading agreement.

It is unclear why the Justice Department failed to notify the court and change the terms of its settlement with Credit Suisse based on information from the whistleblower – either prior to Credit Suisse’s final conviction or after Mr Horsky’s case became public. At the time of the conviction, lawyers on both sides told the court that they had no information that could affect the agreement.

Officials with authority to make the decision to review the Credit Suisse case for possible violations in 2014 and 2015 – including James Cole, who was then assistant attorney general, and Dana Boente, the US attorney at Eastern District of Virginia – did not respond to requests for comment.

In 2015, Mr Horsky pleaded guilty to defrauding the US government and said he would work with prosecutors. In 2017 he was sentenced to seven months in prison. Some details of his conviction have been sealed, and a federal judge denied a request from Bloomberg News to lift the seal. The judge said he denied the application after consulting with the Justice Department and Mr Horsky’s lawyers.

Mr Neiman’s client could be amply rewarded if the prosecution imposed further fines on Credit Suisse. According to an IRS rule, whistleblowers can receive up to 30 percent of the amount of additional money the government receives. And, said Mr. Neiman, the whistleblower has more American account holder names than Mr. Horsky’s, although he wouldn’t say how many.

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Entertainment

Watch a Queasy Encounter in ‘Promising Younger Girl’

In Anatomy of a Scene, we ask the directors to reveal the secrets that go into creating key scenes in their films. Watch new episodes in the series on Fridays. You can also watch our collection of 150+ videos on YouTube and subscribe to our YouTube channel.

“I’m a nice guy,” says Neil, the character played by Christopher Mintz-Plasse in this scene from Promising Young Woman, which received four Golden Globe nominations this week and is available upon request. He pronounces the line (more than once) after picking up Cassandra (Carey Mulligan). He thought she was too drunk to refuse, and she turns out to be anything but. The film is a kind of revenge story with Cassandra at the center, but in some ways it defies simple categorization of genres.

With this sequence, the film’s writer and director, Emerald Fennell, said she was aiming for a subversion of the scene normally found in romantic comedies, and even cast Mintz-Plasse, who may be best viewed by the comedy “Superbad” knows.

“The nerdy nice guy who is not very confident with women and may have trouble writing his first novel,” she said, “may use alcohol as a cover for more shameful activities.”

The situation plays out in the fact that two narratives are perceived very differently by the characters involved, and Fennell directed her cast in such a way that these contrasts are enhanced.

“If you look at Chris’ performance, what I said to him, like I said to everyone in this movie, was really, this is your movie, you are the romantic hero, you are the nice guy, and that is your fall-in-love moment. “

For Cassandra, a woman who regularly advocates this behavior, Fennell admired how well Mulligan embodied the two elements of character.

“She’s just so brilliant at drawing that line between being completely real and knowing.”

Read the “Promising Young Woman” review.