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Wednesday, July 7, 2021

Biden Eyes Imprint On Fed Board As Decision On Powell Approaches

 As the White House weighs the potential renomination of Jerome Powell as chair of the Federal Reserve, officials are discussing the use of openings on the board to reshape the central bank to closer align with administration priorities such as inequality and tighter banking regulations, according to people familiar with the matter.

President Joe Biden currently has one vacant Fed governor seat to fill, and could potentially replace three more top central bank officials in the coming year, depending on how much he wants to revamp the Fed’s leadership. Powell and Fed vice chairs Richard Clarida and Randal Quarles all have terms that will expire in coming months.

With several seats opening up, the White House isn’t looking at the chairmanship in isolation, but rather what mix of governors to appoint so as to reshape policy toward the administration’s agenda, according to the people, who spoke on condition of anonymity.

While no decision appears imminent, the lack of any clear candidates to replace Powell, along with his expressed interest in keeping his job, indicate that a renomination is possible. That would be in keeping with a decades-long tradition of presidents maintaining continuity in Fed leadership—one that former President Donald Trump broke.

One key influencer on Fed appointments, Treasury Secretary Janet Yellen, has told those close to her that she has a good relationship with Powell, and is pleased with how he has steered monetary policy through the pandemic-induced crisis, according to two people familiar with the matter.

Keeping Powell, 68, would remove a chance to install someone from a minority in the job for the first time in history, however, and could stoke criticism from progressive Democrats. One option to reduce potential tensions could be to present a package of appointments that addresses the need for diversity, people familiar with the matter said. All Fed board nominations are subject to Senate confirmation.

With the right mix of candidates, Biden may be able to persuade progressive allies in Congress and outside the White House to support his choices. That’s how the White House is approaching a decision that history suggests is expected this fall on whether Powell is asked to stay, or if the administration proposes a new candidate, according to people familiar with the matter.

Spokeswomen at the White House and Treasury and White House declined to comment.

“Nominations are made in a group—but usually the group is made to protect one or more of the nominees,” said former Fed Governor Laurence Meyer. In the 1990s, Meyer and Governor Alice Rivlin were part of package with Fed Chair Alan Greenspan, who was considered hawkish on policy by senators. The nomination of Powell, a Republican, to the board in 2011 was yoked with Democrat Jeremy Stein.

Yellen, who was Powell’s predecessor at the Fed’s helm, along with White House Chief of Staff Ron Klain and National Economic Council Director Brian Deese are expected to play key roles in making recommendations to Biden as his decision nears, the people said.

Cecilia Rouse, Jared Bernstein and Heather Boushey of the White House’s Council of Economic Advisers, and Bharat Ramamurti, an NEC official who previously worked for Senator Elizabeth Warren, will also be part of the process, they said.

Yellen and Powell were colleagues at the Fed board for six years before she left in early 2018 after Trump replaced her with Powell as chair. Since Yellen became Treasury chief, the pair have kept up a tradition of weekly discussions between the secretary and Fed chair.

The pandemic crisis has highlighted long-standing disparities across the U.S. economy, a major focus for Biden and his top advisers. The unemployment rate for Black workers, who have a disproportionate share of lower-wage jobs and union membership, was double that of their White counterparts during much of the past 50 years—in part because the Fed has historically tightened monetary policy just as the benefits of economic growth began to reach lower-income workers.

Powell has overseen the adoption of a new framework for monetary policy, incorporating a more inclusive assessment of the labor market and a pledge to allow inflation to overshoot a 2% target to make up for prior underperformance. He’s also pledged a gradual trajectory for the withdrawal of monetary stimulus as the U.S. economy recovers from the pandemic—moves that have been applauded by many Democrats.

“If President Biden was asking me—which he isn’t—I would advise to keep Jay Powell in place,” Alan Blinder, a former Fed vice chair appointed by President Bill Clinton, said Wednesday on Bloomberg TV. “Not so much as a reward for good behavior, although you could say that he deserves a reward, but just for the stability that it represents.”

Financial markets early this year reflected rising concerns about an inflation surge as the Fed held off from signaling any tightening. More recently, Treasury yields have slumped as some economic data undershot forecasts.

Democratic Senator Sherrod Brown of Ohio, who chairs the Banking Committee, said in a recent interview that Powell has rankled Republicans with his own tilt toward the issues of inequality and climate. “Don’t talk about justice, don’t talk about poverty, don’t talk about climate. Don’t talk about things that affect Americans,” Brown said in summarizing his take on GOP views.

Brown, while refraining from saying if he supports or opposes a second term as chair for Powell, said his disagreements with Powell have been mostly about Quarles, whose tenure as vice chair for supervision ends in October 2021, and about “how the Fed has been too weak on regulation and making sure banks behave in a public, reasonable way,” including on decisions like stock buybacks.

Quarles has left open the possibility of remaining a governor even if he is no longer vice chair, given that his board membership slot doesn’t expire until 2032.

Senator Elizabeth Warren, a Massachusetts Democrat, told Quarles in May that the U.S. financial system “will be safer when you are gone.”

Clarida’s term as a Fed governor expires in January 2022. He has not publicly discussed his future at the central bank.

Powell’s term as chair expires in February 2022.

Biden met with Powell for the first time since becoming president last month, when the president hosted the nation’s top financial regulators in the Oval Office.

On climate change, Powell has pushed back against any idea that the issue should be a centerpiece of monetary policy, saying it is mainly a question for government and elected representatives. But he has noted that it has implications for the financial institutions the Fed oversees, and he did bring the Fed into a club of central banks that discusses climate change.

As for the current vacancy on the Fed board, many White House officials have agreed that economists Lisa Cook and William Spriggs, both Black, are good candidates, the people said.

https://www.fa-mag.com/news/biden-eyes-imprint-on-fed-board-as-decision-on-powell-approaches-62973.html

Biohaven Stock Hits Record High As Migraine Drug Trounces Quarterly Forecasts

 Biohaven Pharmaceutical (BHVN) crushed Wall Street's expectations for second-quarter sales of migraine drug Nurtec on Tuesday, leading BHVN stock to pop.

The company pre-announced $93 million in sales of Nurtec orally dissolving tablets, or ODT. The Street forecast called for $54.7 million, Piper Sandler analyst Christopher Raymond said in a report to clients. Nurtec is a migraine treatment, and it gained approval in May to prevent migraines.

"We thought there would be second-quarter Nurtec upside, but not this much upside," he said.

On the stock market today, BHVN stock jumped 13.6% to 112.25.

BHVN Stock Surges On Strong Quarter

Nurtec belongs to a class of drugs that target the calcitonin gene-related peptide, or CGRP, tied to migraines. Amgen (AMGN), Eli Lilly (LLY), Teva Pharmaceutical (TEVA) and Lundbeck make injectable drugs. Nurtec is the only oral medicine in its class, and it trailed drugs from Amgen, Lilly and Teva to the market.

Since its launch in March 2020, Nurtec ODT has generated about $200 million in sales, Biohaven said in a news release. That accounts for more than 75,000 prescriptions. In the first half of 2021, Nurtec has generated about $137 million in sales, Piper Sandler's Raymond said.

"It is evident that fiscal year 2021 consensus (estimate) of $250 million and perhaps our own $274 million estimate will prove much too conservative," he said.

He kept his overweight rating and 110 price target on BHVN stock.

Migraine Prevention Not A Factor Yet

Wedbush analyst Laura Chico noted the recent approval for Nurtec ODT in preventing migraines likely had little impact on the pre-announced results.

"Prevention (is) not even really a factor yet," she said in a report. "As we look ahead we continue to see the acute treatment market providing the bigger impact to valuation. However, the prevention label is important to help facilitate prescribing and maintain differentiation."

She has an outperform rating on BHVN stock, and boosted her price target to 121 from 95.

Piper Sandler's Raymond noted Biohaven is also working on an intranasal migraine drug called zavegepant. He expects final-phase test results before year-end.

"We think Biohaven is emerging as a major migraine player," he said.

The news sent BHVN stock to a record high. Shares are near a profit-taking zone after breaking out of a double bottom base with a buy point at 93.64 last month, according to MarketSmith.com.

https://www.investors.com/news/technology/bhvn-stock-hits-record-high-as-migraine-drug-nurtec-trounces-second-quarter-forecasts/

Digital Pharmacies Filling Orders Online Go After CVS, Walgreens

 Filling a prescription can be time-consuming and frustrating. There’s the trip to the pharmacy, then the wait in line. Best case, you walk away with your medication. Worst case, you learn the drug is too expensive, and you leave empty-handed. Tech companies say they can do better than the brick-and-mortar chains most Americans visit for their pills, saving customers time, money, and headaches with their apps. 

At least a dozen startups are trying to disrupt a $465 billion U.S. industry, in which sales are largely concentrated among 15 big pharmacies, led by CVS Health Corp. and Walgreens Boots Alliance Inc., according to researcher Drug Channels Institute. Amazon.com Inc. gave the emerging sector a vote of confidence with its 2018 acquisition of PillPack, which delivers prescription drugs in packets sorted by when they’re meant to be taken. The $753 million deal was a springboard that helped Amazon build a broader digital pharmacy business. Three closely watched startups, AltoCapsule, and Medly, have together raised more than $650 million since January 2020. 

Digital pharmacies have apps that let consumers input and track prescriptions, ask questions, find help paying, and arrange for delivery. The cost of medicines is a critical issue in the U.S., where one prescription can run thousands of dollars a year. People might not have a clue how much the medication their doctor has ordered costs until they walk up to the pharmacy counter. Some of the apps help customers find discounts or programs from pharmaceutical companies that subsidize the cost of the drug. “There are huge service gaps that technology can address,” says Larry Cheng, a managing partner at Volition Capital, which is backing New York-

Each digital player takes a slightly different approach. Capsule Corp., based in New York, wants to fully replace the traditional drugstore, while San Francisco-based Alto Pharmacy LLC and Medly focus on helping patients manage the complexities of specialty medications, typically the most expensive and complicated therapies for people with chronic illnesses such as rheumatoid arthritis or diabetes. The drugs often require approval from an insurance company, and some need to be refrigerated or administered by injection. Medly is exploring the sale of anonymous customer data to drug manufacturers, which would show whether medications are helping patients, how regularly people take them, side effects, and insurance-related information.

Digital pharmacies have captured less than 1% of market share by revenue or prescriptions filled, according to Drug Channels. Alto, Capsule, and Medly aren’t yet profitable, say their founders, who couldn’t provide firm estimates for achieving that milestone. To be successful, the startups will have to provide more than just convenience, and it’s not clear what problems they’re solving, says Jan Berger, chief executive officer of consulting firm Health Intelligence Partners. “Do you want to be the digital pharmacy today competing with the new Amazon Pharmacy and Walmart offers?” asks Berger. Amazon sells six-month supplies of generic medications for as low as $6. Walmart Inc. offers free and discounted prescriptions for members of its paid Walmart+ subscription. 

CVS and Walgreens also take online orders, emphasizing same-day delivery—posing a threat to the digital pharmacies taking them on. Both companies say there will always be demand for in-store pharmacists, who can offer medical advice. “New entrants to the highly competitive pharmacy market come as no surprise to us. But CVS Health is a lot more than pharmacy—and pharmacy is a lot more than just delivering medications,” says Matt Blanchette, a CVS spokesman, in an email. Walgreens, in a statement from a spokeswoman, says it gives customers physical and digital options, highlighting same-day delivery, express pick-up in store, curbside pickup, telehealth, and 24/7 chat services.

relates to Digital Pharmacies Filling Orders Online Go After CVS, Walgreens

Americans have been able to receive their prescriptions in the mail for decades. It was once seen by consumers as a revolutionary service, but interest has waned: The number of prescriptions filled via mail has tumbled 22% over the past decade and now accounts for 9% of the total, according to data from Drug Channels. That compares with a 33% increase at retail community pharmacies over the same period. The data show a small spike in mail orders in the first half of 2020 when stay-at-home restrictions were imposed, but the increase dissipated once restrictions were lifted.

If any of the digital pharmacies—big or small—can get it right, it would be a transformative moment for the industry. If nothing else, the competition could benefit patients. “Pharmacy hasn’t had any meaningful innovation for the last 50 to 100 years,” says Eric Kinariwala, founder and chief executive officer of Capsule.

https://www.bloomberg.com/news/articles/2021-07-07/online-pharmacies-go-after-cvs-walgreens-wba

Tuesday, July 6, 2021

Japan is reportedly considering barring all spectators from Olympic events

 Japan’s government is floating proposals that would ban fans from all events at this month’s Olympics, the Mainichi newspaper reported on Wednesday, as officials scramble to address public concerns about the spread of the coronavirus.

Medical experts have said for weeks that no spectators at the global sporting extravaganza that starts on July 23 would be the least risky option.

Organizers have already banned overseas spectators and set a cap on domestic spectators at 50% of capacity, up to 10,000 people, to contain a lingering outbreak of infections.

The Mainichi, citing sources within government, said such discussions were partly the result of political considerations after Prime Minister Yoshihide Suga’s ruling party failed to win a majority in an election for the Tokyo’s assembly on Sunday. The vote, ahead of a general election later this year, was seen as reflecting some voter dissatisfaction over the government’s virus response.

The report further highlights the steep logistical challenges surrounding the Games, which have been dogged by a year of near daily debate about its possible impact on the spread of Covid-19 in Japan.

In response to the Mainichi story, the Tokyo 2020 organizing committee said restrictions on the number of spectators, including non-spectator competitions, will be based on the content of the state of emergency or other relevant measures in force at any time after July 12.

On Thursday, the government is likely to extend a state of quasi-emergency in Tokyo and three nearby prefectures beyond an original end-date of July 11, government sources have said.

Kyodo News reported the extension would likely last a month, meaning the curbs will be in place throughout the Olympics, which close on Aug. 8.

Talks

The issue of spectators at other Olympic events is due to be decided at five-way talks on Thursday including the Tokyo governor and IOC President Thomas Bach, who arrives in Japan that day.

Asked about the issue of spectators at a press conference on Tuesday, top government spokesman Katsunobu Kato said Suga has said holding the Games without spectators was a possibility.

Shigeru Omi, the government’s top health adviser, told a parliamentary health committee on Wednesday it was important to reduce the number of Olympic officials and others attending events as much as possible.

Early July to September, which covers the period of the Olympic Games, represents “one of the most important periods” in combating the virus in Japan, he said.

“We have been saying that it’s preferable that the events be held without spectators,” said Omi. “We are asking many people to take steps to prevent further spread of the infection. Images of spectators would be sending out a contradictory message to a lot of people ... In formulating our coronavirus response, people’s feelings are a very important factor.”

In a another blow to the spectacle of the Games, Tokyo organizers announced on Tuesday they would ask the public not to gather on the streets for the Olympic marathon, one of the most popular and iconic events of the Games.

Tokyo’s metropolitan government has also decided to move most of the torch relay, set to reach the capital on Friday, off public roads.

Japan has not experienced the kind of explosive Covid-19 outbreaks seen elsewhere but has seen more than 800,000 cases and 14,800 deaths. A slow rollout has meant only a quarter of its population has had at least one Covid-19 vaccination shot.

Disclosure: CNBC parent NBCUniversal owns NBC Sports and NBC Olympics. NBC Olympics is the U.S. broadcast rights holder to all Summer and Winter Games through 2032

https://www.cnbc.com/2021/07/07/tokyo-olympics-japan-fans-at-events.html

Singapore not counting Sinovac shots in COVID-19 vaccination tally

 Singapore has excluded those who received Sinovac Biotech's shots from its national COVID-19 vaccination count, according to the city-state's health ministry.

"The national vaccination numbers reflect only those vaccinated under the national vaccination programme," the ministry said in an emailed statement on Wednesday.

Currently, this only includes those vaccinated with the Moderna Inc and Pfizer-BioNTech/Cominarty vaccines, it said.

Sinovac's CoronaVac shot is not part of Singapore's national vaccination programme and the city-state has said it is still awaiting critical data from the company.

It has, however, allowed the usage of the vaccine by private healthcare institutions under a special access route, following an emergency use approval by the World Health Organization (WHO). Selected private clinics can draw on the country's current stock of 200,000 CoronaVac doses.

About 3.7 million people have received at least one dose of the Pfizer or Moderna's vaccines, covering about 65% of the population, and nearly 2.2 million have completed the regimen.

Singapore has set a target for two-thirds of its people to complete the two-dose regimen by around Aug. 9.

Both have shown efficacy rates of well over 90% against symptomatic disease in clinical trials, compared with trials for Sinovac that shown results from as low as 51% to about 84%. Sinovac did not respond to a request for comment on its efficacy rates earlier this week.

Kenneth Mak, Singapore's director of medical services, said last month evidence from other countries showed people who had taken the Sinovac vaccine were still getting infected. "There is a significant risk of vaccine breakthrough," he said.

Just over 17,000 people in Singapore have received one dose of CoronaVac as of July 3. These records will be captured in a national immunisation registry.

Recipients of the Sinovac vaccine are also not exempt from COVID-19 tests required before attending certain events or entering some venues. Those who have completed the full vaccination regimen with Moderna or Pfizer are exempt from such pre-event testing.

"COVID-19 vaccines that are not part of our national vaccination programme may not have documented sufficient data on their protection against COVID-19 infection, especially against the Delta variant that is currently circulating," the health ministry said last week. 

https://news.trust.org/item/20210707024104-1tbek

Source of remarkable memory of 'superagers'

 As we age, our brains typically undergo a slow process of atrophy, causing less robust communication between various brain regions, which leads to declining memory and other cognitive functions. But a rare group of older individuals called "superagers" have been shown to learn and recall novel information as well as a 25-year-old. Investigators from Massachusetts General Hospital (MGH) have now identified the brain activity that underlies superagers' superior memory. "This is the first time we have images of the function of superagers' brains as they actively learn and remember new information," says Alexandra Touroutoglou, Ph.D., director of Imaging Operations at MGH's Frontotemporal Disorders Unit and senior author of the paper published in Cerebral Cortex.

In 2016, Touroutoglou and her fellow researchers identified a group of adults older than 65 with remarkable performance on memory tests. The superagers are participants in an ongoing longitudinal study of aging at MGH led by Bradford Dickerson, MD, director of the Frontotemporal Disorders Unit at MGH, and Lisa Feldman Barrett, Ph.D., a research scientist in Psychiatry at MGH. "Using MRI, we found that the structure of superagers' brains and the connectivity of their neural networks more closely resemble the brains of young adults; superagers had avoided the brain atrophy typically seen in older adults," says Touroutoglou.

In the new study, the investigators gave 40 adults with a mean age of 67 a very challenging memory test while their brains were imaged using functional magnetic resonance imaging (fMRI), which, unlike typical MRI, shows the activity of different brain areas during tasks. Forty-one young adults (mean age of 25) also took the same memory test while their brains were imaged. The participants first viewed 80 pictures of faces or scenes that were each paired with an adjective, such as a cityscape paired with the word "industrial" or a male face paired with the word "average." Their first task was to determine whether the word matched the image, a process called encoding. After 10 minutes, participants were presented with the 80 image-word pairs they had just learned, an additional 40 pairs of new words and images, and 40 rearranged pairs consisting of words and images they had previously seen. Their second task was to recall whether they had previously seen each specific word-picture pair, or whether they were looking at a new or rearranged pair.

While the participants were in the scanner, the researchers paid close attention to the , which is the area of the brain that processes what you see and is particularly sensitive to aging. "In the visual cortex, there are populations of neurons that are selectively involved in processing different categories of images, such as faces, houses or scenes," says lead author Yuta Katsumi, Ph.D., a postdoctoral fellow in Psychiatry at MGH. "This selective function of each group of neurons makes them more efficient at processing what you see and creating a distinct memory of those images, which can then easily be retrieved."

During aging, this selectivity, called neural differentiation, diminishes and the group of neurons that once responded primarily to faces now activates for other images. The brain now has difficulty creating unique neural activation patterns for different types of images, which means it is making less distinctive mental representations of what the person is seeing. That's one reason older individuals have trouble remembering when they may have seen a television show, read an article, or eaten a specific meal.

But in the fMRI study, the superagers' memory performance was indistinguishable from the 25-year-olds', and their brains' visual cortex maintained youthful activity patterns. "The superagers had maintained the same high level of neural differentiation, or selectivity, as a young adult," says Katsumi. "Their brains enabled them to create distinct representations of the different categories of visual information so that they could accurately remember the image-word pairs."

An important question that researchers still must answer is whether "superagers' brains were always more efficient than their peers, or whether, over time, they developed mechanisms to compensate for the decline of the aging brain," says Touroutoglou.

Previous studies have shown that training can increase the selectivity of brain regions, which may be a potential intervention to delay or prevent the decline in neural differentiation in normal aging adults and make their brains more like those of superagers. Currently the researchers are conducting a clinical trial to evaluate whether noninvasive electromagnetic stimulation, which delivers an electrical current to targeted areas of the brain, can improve memory in older adults. The researchers also plan to study different  regions to further understand how superagers learn and remember, and they will examine lifestyle and other factors that might contribute to superagers' amazing .


Explore further

'Superagers' over 80 have the memory and brain connectivity of twenty-somethings

More information: Yuta Katsumi et al, Greater Neural Differentiation in the Ventral Visual Cortex Is Associated with Youthful Memory in Superaging, Cerebral Cortex (2021). DOI: 10.1093/cercor/bhab157
https://medicalxpress.com/news/2021-07-reveals-source-remarkable-memory-superagers.html

Seeking COVID protection boost for people with weakened immunity

 How effective are COVID vaccines if your immune system is compromised by HIV, cancer or a recent organ transplant?

Faced with very little data—and fears that some of these patients could be particularly vulnerable to the virus—scientists are seeking to figure out how to best protect them.

In one of the largest research projects into the issue so far, dozens of French hospitals have launched a two-year study of some 10,000 people to help shine light onto how people with these conditions respond to immunisation for the coronavirus.

"The goal is to find out how we can best protect those patients," the study's head Odile Launay told AFP.

Authorities like the United States Centers for Disease Control and Prevention say people with compromised immune systems can receive the vaccine, but stress that there is still little data on safety.

"If you have a condition or are taking medications that weaken your , you may NOT be fully protected even if you are fully vaccinated," the CDC adds, urging people to continue to take precautions and to consult their doctor.

Multiple doses

People's immune systems can be suppressed by disease—or by treatments taken to deal with other conditions—and this may mean their body has trouble producing the antibodies vaccines are meant to trigger.

Conditions where this might be the case include diabetes, obesity, cancer, organ and , chronic severe kidney failure, HIV or multiple sclerosis.

In the case of a transplant, a patient's  is suppressed on purpose to prevent his or her body from attacking the new organ.

Another French study published in the New England Journal of Medicine looked at 100  and found their immune response to vaccines was insufficient after two doses.

Scientists recommended three doses for those patients, which is now the rule in France.

The new study, which involves 30 hospitals and has been signing up participants since March, is aiming for 8,650 participants with compromised immune systems and a control group of 1,850 un-compromised people.

Participants will have their blood drawn to measure the presence of antibodies at the time of vaccination and then again after one month, six months, one year and then two years after the last dose.

"The data will allow us to adapt our vaccine recommendations to specific patient populations," Launay said.

Other measures

Health authorities could for example decide to shorten the waiting period between the first dose and the two or three booster shots that would likely follow for immune compromised patients.

And in cases where vaccines failed to produce any results, doctors would opt for other strategies like vaccinating the patient's family and caregivers and maintaining social distancing.

If a  failure results in infection with COVID-19, researchers will also sequence the virus.

This could pick up whether the illness is caused by an existing variant—or even pick up any new mutations.

While the COVID-19 virus typically infects individuals for around 10 days before being neutralised by the body, some studies have shown that certain patients, particularly those with compromised immune systems, may carry it for several weeks or longer.

This increases the window of opportunity for the virus to mutate, potentially resulting in new variants.

A similar study was launched in the UK in March, which will monitor 5,000 immunocompromised ' responses to COVID-19 vaccinations.

"We urgently need to understand if patient populations with chronic conditions such as cancer, inflammatory arthritis and kidney and liver disease are likely to be well-protected by current COVID-19 vaccines," lead researcher Iain McInnes of the University of Glasgow said at the time.


Explore further

For transplant patients, COVID-19 vaccination presents a different uncertainty
https://medicalxpress.com/news/2021-07-scientists-covid-boost-people-weakened.html