Search This Blog

Monday, August 9, 2021

Fed officials say tapering is near, advancing discussion on rate hike

 

Two Federal Reserve officials said on Monday that the U.S. economy is growing rapidly and that while the labor market still has room for improvement, inflation is already at a level that could satisfy one leg of a key test for the beginning of rate hikes.

Atlanta Federal Reserve Bank President Raphael Bostic said he is eyeing the fourth quarter for the start of a bond-purchase taper but is open to an even earlier start if the job market keeps up its recent torrid pace of improvement. Moreover, he and Richmond Fed President Tom Barkin both said they believe inflation has already achieved the Fed's 2% threshold, according to their separate assessments. That is one of two requirements to be met before rate hikes can be considered.

Their remarks are a sign that as Fed officials hold discussions about how and when to taper their asset purchases, they are also getting more detailed in their debate about what it will take to satisfy the Fed's inflation target under the new framework.

Bostic, who has already penciled in late 2022 for the start of rate hikes, pointed to the five-year annual average for the core personal consumption expenditures index, or core PCE inflation, which by his calculation reached 2% in May.

"There are many reasons to think that we may be at that goal target right now," Bostic told reporters. But he said the committee has yet to agree on the metrics it will use to measure that progress, something policymakers will need to discuss.

Barkin said high inflation seen this year may have satisfied one of the Fed's benchmarks for raising interest rates, though there is still room for the job market to heal before rates should rise. Under the Fed's current policy guidance, rates will rise "when inflation hits 2%, which I think you can argue it already has, and it looks like it is going to sustain there," Barkin said at the Roanoke Regional Chamber of Commerce in Virginia.

Their remarks echoed comments made by St. Louis Fed President James Bullard last month, who said that the current pace of inflation, at 3.5% annually by the Fed's preferred measure, is well above the central bank's 2% target, and adequate in his view to make up for past weak inflation as required by the central bank's new framework.

LABOR MARKET STILL BEHIND

Under a new framework unveiled last year, Fed officials agreed to leave interest rates at near zero levels until the labor market reaches maximum employment, and inflation averages 2%, on track to moderately exceed 2% for some time.

Policymakers said in December they would continue purchasing government bonds at the current pace of $120 billion a month until there is "substantial further progress" toward the central bank's goals for inflation and maximum employment.

With the elevated inflation levels reached during the pandemic, Bostic said, the Fed has effectively achieved the "substantial further progress" goal for inflation.

More progress is still needed in the labor market, but that goal could be accomplished after another month or two of strong job improvement, Bostic said. That puts the Fed on a path to begin trimming purchases between October to December, or sooner, if the gains in August are stronger than expected, he said.

Barkin did not specify a timeline for when the Fed may start to reduce its asset purchases, but said he is watching the employment to population ratio to evaluate whether the labor market has made enough progress toward the Fed's goals.

In terms of how to structure the taper, Bostic said he supports a "balanced" approach that reduces mortgage-backed securities and Treasury securities at the same rate. He also said he would be in favor of tapering asset purchases over a shorter period than what the Fed has previously done. "I am in favor of going relatively fast," Bostic said.

https://www.marketscreener.com/news/latest/Fed-officials-say-tapering-is-near-advancing-discussion-on-rate-hike--36113925/

Heart attack biotech OtiTopic joins Philip Morris on 'Beyond Nicotine' journey

 Philip Morris first starting selling tobacco products to the public all the way back in 1847, but, more than 170 years later, the company has read the tea leaves and the future is “smoke-free.”

This is pretty bad for business (although the company still rakes in around $28 billion a year)—and, as it turns out, its business is pretty bad for customers’ health. So the new idea is to help people with lung and heart conditions like ones caused by smoking.

Bitterly ironic? Maybe, but Philip Morris is putting its money where its mouth is: This summer, the cigarette maker has put $1.45 billion on the table for inhaled drug maker Vectura (though that is not going smoothly), and is now looking to branch out more with a new deal to buy OtiTopic.

The U.S. respiratory drug development company comes with a late-stage inhalable acetylsalicylic acid (ASA)—better known by the brand name Aspirin—specifically designed for acute myocardial infarction, aka heart attacks. The therapy is aimed at those at an intermediate to high risk for myocardial infarction.


The inhaled therapy, to be known as Aspirhale, works as a dry powder inhalation of ASA delivered through a new, self-administered aerosol.

OtiTopic is hoping to finish up testing ASAP and, with the might of Philips behind it, file with the FDA for approval next year.

Early studies have shown the inhaled system “catalyzed peak plasma concentration and the desired pharmacodynamic effect, i.e., inhibition of platelet aggregation in two minutes compared with 20 minutes for coated chewable aspirin,” the company said in a statement.

“This speed is unprecedented and has significant potential implications for improving the survival of patients at risk of heart attacks,” it added.

No financial terms were included for the deal.

“This transaction aligns well with OtiTopic’s goals of unlocking what we believe to be a significant opportunity in inhaled therapeutics science,” said Kambiz Yadidi, CEO of OtiTopic. “We are entering this transaction to accelerate Aspirhale’s FDA filing, with the goal of delivering innovative therapies for people with intermediate to high risk for myocardial infarction.”

For its part, Philip Morris is pursuing a so-called "Beyond Nicotine" strategy to branch out from cigarettes into fields such as respiratory drug delivery and "selfcare wellness." It's banking on that strategy to deliver at least $1 billion in net revenues by 2025, CEO Jacek Olczak said in a statement a few weeks back.


According to the American Heart Association, cardiovascular disease, which can cause heart attacks, accounts for about 800,000 U.S. deaths every year, making it the leading cause of all deaths in the U.S. Of those, nearly 20% are due to cigarette smoking, according to the FDA.

Philip Morris has pledged to become more of a life sciences company and to one day stop selling cigarettes; it does, however, feel a little like an arsonist selling fire damage insurance.

https://www.fiercebiotech.com/biotech/philip-morris-biopharma-addiction-ramps-up-as-its-beyond-nicotine-platform-sees-its-snap-up

NRx Pharma Starts Phase 2b of Covid Vax Trial in Nation of Georgia

 NRx Pharmaceuticals (NRx) (Nasdaq: NRXP), a clinical stage, global biopharmaceutical company today announced it is initiating a phase 2b dose-confirmatory trial of the BriLife™ vaccine against COVID-19 in the Nation of Georgia. The vaccine is developed by the Israel Institute for Biological Research (IIBR). The trial is being conducted with oversight from the Senator Richard Lugar Center for Public Health Research. The purpose of the study is to confirm the vaccine's ability to generate an immune response against the COVID-19 Delta variant, prior to entering phase 3 trials in multiple nations. The phase 2b program will also incorporate a potential intradermal vaccination option where a small quantity of vaccine is placed into the skin instead of a traditional needle injection into a muscle.

The vaccine differs from other COVID-19 vaccines by presenting the entire COVID-19 spike protein to the body's immune system. The spike protein complex from variants may be added to the BriLife vaccine as new variants are discovered.

The BriLife™ vaccine also differs from other COVID-19 vaccine approaches in that it is a self-propagating, live-virus vaccine that may be updated to address new variants of COVID-19 more rapidly than some other vaccine platforms. The clinical trials in Georgia will take place at the same time as the completion of the second phase of clinical trials in Israel. NRx is recruiting volunteers, and expanding the second phase of clinical trials abroad, in order to increase the statistical sample and prepare the regulatory file necessary for further trials.

A spokesperson for Israel's Minister of Defense stated today that, "IIBR will accompany the process and will continue to provide scientific knowledge in order to complete the trials."

https://finance.yahoo.com/news/nrx-pharmaceuticals-announces-initiation-phase-171300225.html

Upcoming Regulation of Juul E-Cigarettes

 For years, FDA has allowed the vast majority of e-cigarettes to stay on the market even though none of them have the premarket tobacco product application (PMTA) orders they need to be sold legally. But all that is changing. Following a court ruling, FDA must issue PMTA orders by September 9, pro or con, for every e-cigarette brand or variant that has applied to stay on the market and take any not receiving permissive orders off the market.

So, the big questions are whether FDA will issue PMTA orders to allow the continued marketing of any e-cigarettes, and if so, what restrictions and requirements FDA might put on the permitted e-cigarettes, their flavors, and their marketing.

Juul in the Spotlight

One of the first PMTA orders FDA issues will likely be for Juul's e-cigarettes. Juul has applied to market e-cigarettes in just two flavors, tobacco and menthol, and with two different nicotine strengths. Juul says its application includes data-driven ways the company will address possible underage use of its e-cigarettes -- but what those are has not been made public.

Many blame Juul's aggressive marketing of multi-flavored versions of its especially addictive e-cigarettes for the sharp rise in youth e-cigarette use. North Carolina recently settled its lawsuit against Juul for $40 million, and a number of other lawsuits against Juul are pending. Before that, following bad publicity and pressure from FDA, Juul stopped all television, print, and digital advertising of its e-cigarettes, and then stopped selling flavors other than tobacco or menthol. Largely because of the rise in youth use, in January 2020 FDA initiated an enforcement action to remove any Juul-type cartridge-based e-cigarettes from the U.S. market if they had any flavors other than tobacco or menthol.

Similarly, FDA's ruling on Juul will establish a framework for FDA's PMTA decisions for all other e-cigarettes.

What Factors Play Into the PMTA?

FDA can allow an e-cigarette's marketing only if it finds that doing so is "appropriate for the protection of the public health" -- i.e., will reduce overall tobacco-related harms. If e-cigarette use is less harmful than smoking, the only sure way e-cigarettes can reduce health harms and risks is if smokers who would not have otherwise quit smoking switch entirely to using e-cigarettes. Or if youths who would otherwise have become addicted smokers become regular e-cigarette users instead.

Any other regular use of e-cigarettes will increase health harms. Most clearly, any use by youth or adults who would not otherwise use any tobacco product will increase overall harms (especially if it later evolves into smoking). And any e-cigarette use by smokers that stops or delays their smoking cessation or quitting all tobacco-nicotine use will also increase overall health harms.

So, to let any e-cigarettes stay on the market, FDA has to determine that the harm reductions from their future use as a complete substitute for traditional cigarette smoking by those who would otherwise smoke will be larger than the new health harms potentially caused by e-cigarettes.

So far, e-cigarette use among youth who would not otherwise smoke appears to be much more common than otherwise smokers using only e-cigarettes. It remains unclear whether smoker e-cigarette use will end up accelerating and increasing smoking cessation or reducing or delaying it. Accordingly, it might seem quite difficult for FDA to find that it is "appropriate for the protection of the public health" to allow any e-cigarettes to stay on the market.

However, in any PMTA orders to allow e-cigarette marketing, FDA has the power to include any restrictions and requirements on their labeling, packaging, marketing, and sale that would increase their harm-reducing potential or reduce any collateral risks or harms. For example, in the PMTA order allowing Philip Morris' "heat-not-burn" IQOS cigarette on the market, FDA stated that it may not be advertised or sold via any electronic media without strict age and ID verification to prevent youth exposure or purchases. FDA will likely place that same requirement on any e-cigarettes it allows to be marketed -- but FDA could include much more to protect public health.

For example, FDA could prohibit any e-cigarettes with any added flavors other than tobacco and menthol (the only flavors now allowed for cigarettes). Or could allow only tobacco and unflavored versions, and use other measures, instead of flavors, to prompt smokers to switch. FDA could further prevent youth use by allowing e-cigarette sales only in stores that do not allow youth, such as adult-only vape shops or tobacconists. FDA could also allow e-cigarette advertising only via direct communications to pre-verified adult smokers, and prohibit the sale of cheaper, disposable e-cigarettes, which tend to be used more by youth than by smokers trying to switch.

To try to ensure that e-cigarettes are used only in harm-reducing ways, FDA could require that e-cigarette labeling, package inserts, and ads explain how to use them to reduce health harms and how all other uses increase health harms and risks.

Putting such restrictions and requirements in any e-cigarette PMTA orders FDA issues would directly prevent and reduce future harm-increasing uses, especially among youth. But the e-cigarettes would still be readily available to adult smokers as a presumably less-harmful alternative. And FDA could put parallel restrictions on cigarettes and other smoked tobacco products to reduce smoking even more.

In the few PMTA orders FDA has already issued to allow the marketing of other types of tobacco products, FDA failed to include numerous measures that would have better protected the public health. However, the public health risks from the marketing and sale of e-cigarettes are clearly much larger, which could prompt FDA to act more responsibly this time. Also, FDA's failure to comply with applicable laws to protect the public health more effectively in its prior PMTA orders is now a matter of public record, making FDA vulnerable to corrective lawsuits. That should make continued FDA PMTA failures less likely. It is also possible that some e-cigarette manufacturers have proposed certain product and marketing restrictions and requirements in their applications in order to increase their chances that FDA will find it appropriate for the protection of the public health to issue orders allowing their marketing.

Is It Really About Public Health?

What FDA actually ends up doing could, unfortunately, depend largely on a range of political and bureaucratic factors, rather than on what's best for the public health. Since the 2009 Tobacco Control Act gave FDA extensive powers to regulate tobacco products, FDA has never received the White House support it needs to take strong, effective action to sharply reduce the many deaths and harms caused by smoking. With luck, the Biden administration will support FDA more than the Trump or Obama administrations did. One key indicator of whether that is happening is if the PMTA orders FDA issues for Juul and other e-cigarettes are clearly designed to effectively protect and promote public health, and are also supplemented with strong new FDA rules to directly prevent and reduce smoking.

Eric N. Lindblom, JD, a former official at FDA's Center for Tobacco Products, is now an independent legal and policy consultant on tobacco control and other public health matters, and a senior scholar at Georgetown Law's O'Neill Institute for National & Global Health Law.

https://www.medpagetoday.com/opinion/second-opinions/93938

Canada Opens US Border For 1st Time Since March 2020, But Only For Vaccinated

 Almost one-and-a-half years since it first closed in March 2020, the Canadian government announced Monday that it's finally opening the US-Canadian border, but only for those fully vaccinated against coronavirus. "When the clock struck midnight on Monday, Canada reopened its borders to U.S. citizens after more than a year of only allowing essential travel," Detroit Free Press observed.

The government is citing it as a big step toward 'normalcy' on the border. "Canadians' safety and security always come first. With rising vaccination rates and fewer cases in Canada, we can begin to safely ease border measures," Canada's minister of health Patty Hajdu said in a statement.

"A gradual approach to reopening will allow our health authorities to monitor the COVID-19 situation here and abroad. Canadians have worked hard and sacrificed for each other, and because of that work, we can take these next steps safely," she added.

It's expected that there will be long wait times to cross the border, however. A statement and bit of a 'warning' by the Canada Border Services Agency said "The CBSA will not compromise the health and safety of Canadians for the sake of border wait times."

The Canadian government has set up the ArriveCAN app to track travelers' vaccination status. Vaccine confirmation must be submitted via the app within 72 hours before arrival. It's also being advised that travelers carry their physical vaccine documentation, ready to show border officials when asked. 

All must also submit to a COVID-19 test. Only those showing symptoms or a positive test will have to quarantine. "Fully vaccinated travellers who meet the requirements will be exempt from quarantine; however, all travellers must still provide a quarantine plan and be prepared to quarantine, in case it is determined at the border that they do not meet the necessary requirements," a new government directive indicated.

USA Today notes that US carriers have added flights to Canada amid the easing of border restrictions and the steady rise in demand. The following nine Canadian airports have been authorized to receive international flights effective Monday:

  • Montréal-Trudeau International Airport
  • Toronto Pearson International Airport
  • Calgary International Airport
  • Vancouver International Airport
  • Halifax Stanfield International Airport
  • Québec City Jean Lesage International Airport
  • Ottawa Macdonald–Cartier International Airport
  • Winnipeg James Armstrong Richardson International Airport
  • Edmonton International Airport

The government is also warning against efforts to present fraudulent documents, as was recently the case with an American couple, fined $25,000 each for attempting to falsify their vaccination status, apparently a rising trend globally.

Despite the Canadians now opening the border to inbound Americans, the US government has yet to open it up the other way, still refusing Canadian tourist travel into the states via land borders.

https://www.zerohedge.com/covid-19/canada-opens-us-border-1st-time-march-2020-only-vaccinated-americans

Cortexyme Business Update, Q2 Results

GAIN Trial top-line data for disease modification in Alzheimer’s expected by mid-November 2021

Phase 2 REPAIR sub-study results evaluating periodontal disease expected by mid-November 2021

Current cash position sufficient to fund operations through 2023

https://finance.yahoo.com/news/cortexyme-provides-business-reports-second-120000774.html

1Life Healthcare cut to Neutral from Outperform by Baird

 Target to $31 from $43

https://finviz.com/quote.ashx?t=ONEM