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Saturday, August 8, 2020

Relief Therapeutics sees 60-70% chance of COVID-19 drug approval

Relief Therapeutics’ chairman said he was optimistic its RLF-100 (aviptadil) drug will win approval for treating COVID-19 patients in a matter of months.
The Swiss group owns the rights to the drug in the United States and Europe. Its U.S. partner NeuroRx is running multicentre clinical trials here including a Phase IIb/III trial in patients who are severely ill because of the consequences of COVID-19, the respiratory disease caused by the new coronavirus.
“The active pharmaceutical ingredient of aviptadil has been used for a lot of years in different indications. From a safety standpoint we are quite optimistic,” Raghuram Selvaraju told Swiss newspaper The Market in an interview posted late on Friday.
“From an efficacy standpoint we need more data. I would say the probability at the moment stands at 60 to 70% that we will get the drug approved,” he added.
Selvaraju said trial results could emerge within a “few more months”.
“If we get meaningful data, I would expect that the FDA (U.S. Food and Drug Administration) would act in an expedient and collaborative manner. I do not anticipate that we would need ten to 12 months for approval,” he added.
Relief Therapeutics says aviptadil, a synthetic vasoactive intestinal polypeptide, is the first COVID-19 therapeutic to block replication of the SARS-CoV-2 virus in human lung cells.
Anticipation of progress has driven shares in the Geneva-based company sharply higher this year. They closed on Friday at 0.58 Swiss francs after starting the year at 0.0010 francs.

Bristol Myers: Opdivo Plus Yervoy Beats Chemo in Mesthelioma Patients

CheckMate -743 is the first and only Phase 3 trial in which first-line immunotherapy treatment improved survival in patients with malignant pleural mesothelioma
With these positive results, Opdivo plus Yervoy has now shown clinical benefit in six different tumor types, including durable, superior overall survival vs. chemotherapy in two thoracic cancers

FDA approves Trevena’s Olinvyk opioid for intravenous use in hospitals

Trevena (NASDAQ:TRVN) +51.2% after-hours, as the Food and Drug Administration approves Olinvyk (oliceridine), an opioid agonist for the management of moderate to severe acute pain in adults, where the pain is severe enough to require an intravenous opioid.
Trevena sees a significant clinical need in the hospital setting for an effective and well-tolerated IV analgesic to help manage patients’ moderate-to-severe pain.
Shares have soared more than 4x over the past three months, and the FDA approval could shoot them past their 52-week high $3.48.

Virginia Rolls Out First U.S. Covid-19 Tracing App Using Apple And Google Tech

Virginia launched a free Covid-19 contact-tracing app Wednesday, becoming the first state to use technology Apple and Google created in May to aid in the response to the pandemic — the launch comes as public health officials have criticized the Trump administration’s objections to creating national standards for testing and contact tracing, leaving it up to the states.

Apple and Google released underlying technology that allows public health authorities to create their own contact-tracing apps.
Virginia’s free COVIDWISE app, available in Apple and Android app stores as of Wednesday, uses Bluetooth Low Energy technology to alert users who have come into contact with an individual who has tested positive for Covid-19.
At a press conference Wednesday Gov. Ralph Northam said the app “does not track or store your personal information” which was reiterated in a statement from his office.
Users have the option to choose to receive exposure notifications and someone diagnosed with Covid-19 can choose if they want to anonymously share their results.
No location data or personal information is collected, stored, tracked or transmitted to The Virginia Department of Health, according to the statement.
Canada and a number of countries in Europe and elsewhere have already rolled out apps using the technology, but a June Business Insider report found that only three U.S. states had confirmed plans to use the technology, Alabama, South Carolina and North Dakota, and 17 states said they were against building contact-tracing apps entirely.

“Knowing your exposure history allows you to self-quarantine effectively, seek timely medical attention, and reduce potential exposure risk. The more Virginians use COVIDWISE, the greater the likelihood that you will receive timely exposure notifications that lead to effective disease prevention,” State Health Commissioner M. Norman Oliver, said in the announcement.

Some public health officials have said that while technology can help with the contact-tracing process, it is still essential to hire thousands of contract tracers, humans who are trained to track down and notify people who have been potentially exposed. Public health experts at Johns Hopkins University predicted a need for at least 100,000 contact tracers in the U.S. at a time when unemployment numbers are high. In some states like New York, contact tracers can make about $57,000 per year and earn benefits, according to CNBC.

Big number: 4,748,806. That is how many confirmed Covid-19 cases there were in the U.S. as of Tuesday, according to the U.S. Centers for Disease Control and Prevention.

2-Step Testing Could Slow Covid-19 Transmission Dramatically

In the United States, testing for Covid-19 has become a persistent problem. For some without insurance, it is too costly. For others living in remote or underserved areas, too inaccessible. For us all, far too slow.
While some tests take only a few minutes to complete, most tests take much longer to deliver results. If the person awaiting results isn’t cautious, the time needed to process samples in a lab—anywhere from a few days to a few weeks—becomes time enough for the virus to spread far and wide.
The two-step method is not only a better way to test, but could potentially reduce transmission by 50 percent or more—and do so quickly.
Key advances in our ability to detect SARS-CoV-2, the virus that causes Covid-19, make this new method possible. Tests were created early on that could measure the presence of viral RNA in any given sample using the polymerase chain reaction (PCR), which copies the sample a million times over to make traces of the virus easy to identify.

Of all the different kinds of tests available for Covid-19, PCR tests have proven to be the most accurate. They’re also the most expensive and time-consuming. Since processing a PCR test requires special machinery that can only be found in labs and research centers, the wait for results tends to drag out, especially in places where case counts are surging and capacity strained.
Another critical development was the creation of tests that detect SARS-CoV-2 by looking for viral proteins, or antigens, instead. Aptly called antigen tests, compared to the PCR tests these have the advantage of speed and convenience, in addition to being quick and easy to manufacture. A rapid antigen test authorized for use in India, the Pathocatch COVID-19 Antigen Rapid testing kit, reduces the wait time for results to as little as 30 minutes.
Like a pregnancy test, the rapid antigen test can potentially be used in the convenience and privacy of the home. But there is one major caveat to using antigen tests over PCR tests: they’re not nearly as accurate. Set loose in a sea of infections, the Pathocatch test, for instance, would only detect half.
The two-step testing method combines antigen tests together with PCR tests such that the strengths of both are exploited. The first step? Conduct widespread antigen tests using existing testing facilities. Those who test positive are assumed to be infected and instructed to self-isolate at home, where they can be monitored by local health authorities. Within 24 hours a contact tracing team interviews them about recent contacts who may have been infected, all of whom are brought in for testing as well.
Those who test negative proceed to the second step—the PCR test with a slower turnaround, but more accurate result. Until the PCR test results confirm or disprove their negative status, those who test negative the first time around must quarantine. Either way, the virus is stopped in its tracks.
In India, this two-step takedown is already underway. In Egypt, it was successfully used to screen 68 million Egyptians for hepatitis C, though with antibody tests instead of antigen tests as a first step. It could be implemented just as easily here, where the U.S. Food and Drug Administration has already approved a rapid antigen test with a higher detection rate than the Pathocatch.
Testing is nothing short of essential to our ability to monitor and mitigate Covid-19, and in the United States this component has so far been lacking. Studies conducted across Spain and the United States have shown that for every case of Covid-19 confirmed using PCR tests, as many as five to 10 more go undetected. Confirmed cases in the United States currently exceed 4.5 million, which means tens of millions of infections may be eluding our grasp.
Even if the two-step testing method enables detection of just 50 percent of infected people, removing those 50 percent from circulation would slow the spread of Covid-19 dramatically. In other words, it is just the sort of sweeping intervention we need to make up for months of inefficiency and inaction. Why not start now?

Friday, August 7, 2020

Pfizer CEO: We’ll Know By October Whether Covid-19 Vaccine Works

Pfizer chief executive Albert Bourla said Thursday clinical trials should reveal by October whether the company’s vaccine against the Coronavirus strain Covid-19 is safe and effective.
The top executive at one of the world’s largest drug makers said the 30,000 patients in a final-stage “phase 3” clinical trial for its Covid-19 vaccine should be enrolled by the end of August. Enrollment in phase 3 clinical trials for Pfizer’s vaccine and another in development from Moderna began in July. Half, or about 15,000, in each company’s trials are getting the vaccine while the other 15,000 are receiving placebo.
“October is coming,” Bourla said Thursday afternoon in an interview with the Washington Post Live. “In October, the truth will be revealed.”

The update from Pfizer comes less than a month after the U.S. Department of Health and Human Services and the Department of Defense announced a $1.95 billion agreement with Pfizer and its German biotech partner to deliver 100 million doses of a Covid-19 vaccine by December. The agreement announced July 22 also allows the U.S. government to acquire an additional 500 million doses.
On Thursday, Bourla said Pfizer, which is working with the Germany biotech company BioNTech to develop Covid-19 investigational vaccines, expects to submit a vaccine to the U.S Food and Drug Administration in October for possible approval. That will then trigger what is expected to be an expedited approval process that could even win Pfizer’s vaccine an emergency use authorization based on comments FDA commissioner Dr.
In an interview last week with JAMA, Hahn said the FDA would “consider an emergency use authorization if we felt that the risks associated with the vaccine were much lower than the risks of not having a vaccine and the potential benefit of having a vaccine.”
Both the Moderna and Pfizer-BioNTech products are using a new technology that those involved say speeds the development and manufacturing of the vaccines. Both use a synthetic version of genetic material known as messenger RNA, or mRNA, that teaches the patient’s immune system to recognize – and then attack – the coronavirus Covid-19.
In the Pfizer vaccine, Bourla said it will require two doses 21 days apart. Over time, the technology allows for a patient to get a boost of the vaccine if needed to protect against the virus.
“We will follow the patients for two years,” Bourla said in the Washington Post Live interview.  “If the virus changes this technology allows us to change the vaccine in weeks rather than months.”

Trump to take executive action after coronavirus talks collapse

Top administration officials said Friday they will recommend President Trump move forward with executive orders to address the economic fallout from the coronavirus as negotiations on Capitol Hill collapsed.
“In the meantime, we’re going to take executive orders, to try to alleviate some of the pain that people are experiencing,” White House chief of staff Mark Meadows told reporters.
Treasury Secretary Steven Mnuchin said that he and Meadows “will recommend to the president based upon our lack of activity today to move forward with some executive orders.”
“Again we agree with the Speaker, this is not the first choice,” he added.
Mnuchin said administration officials will be recommending executive orders to deal with unemployment after the $600 per week federal benefit expired last week. They will also recommend that Trump sign orders relating to rental foreclosures and student loans.
“It’s going to take a little bit of time for us to finalize these and process them but we’ll do them as quickly as we can because the president wants action,” Mnuchin said.
The executive orders could be signed as soon as the weekend, the GOP negotiators said.
They did not specifically mention trying to use an executive order to enact a payroll tax cut, something Trump has floated in recent days. White House economic advisor Larry Kudlow said earlier Friday that an executive order suspending the payroll tax was nearly completed and that he thinks Trump will sign it.
Mnuchin and Meadows met for less than two hours on Friday with House Speaker Nancy Pelosi (D-Calif.) and Senate Minority Leader Charles Schumer (D-N.Y.) as part of a Hail Mary effort to revive the negotiations on a fifth coronavirus bill, which already appeared to be on life support nearly two weeks of no progress.
But they made no progress during the meeting, with both sides trading blame for who was at fault for the holdup.
There are no plans to meet again over the weekend, according to Mnuchin and Meadows.
The stalemate guarantees that the negotiators will blow past a self-imposed Friday deadline for getting an agreement in principle, with chances of a quick deal on another coronavirus relief package appearing all-but dead.
“Unfortunately, we did not make any progress today and we discussed the same issues,” Mnuchin said.
Schumer and Pelosi said they doubled down on their offer to reduce their $3.4 trillion price tag in exchange for Republicans agreeing to raise their figure by $1 trillion, but were rebuffed.