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Thursday, June 4, 2020

Gottlieb On Fed Covid Vaccine Shortlist: ‘They Chose Very Novel Platforms’

The Trump administration is prioritizing five COVID-19 vaccine programs, but ex-FDA chief Dr. Scott Gottlieb said the White House needs to spread its bets.
The Trump administration is betting that five companies have the highest chance of producing a working vaccine against COVID-19. They are: AstraZeneca plc AZN 2.05%, Johnson & Johnson JNJ 1.32%, Merck & Co, Inc. MRK 0.61%, Moderna Inc MRNA 1.17% and Pfizer Inc. PFE 0.39%.
As part of the public-private partnership, the government will prioritize clinical trial access for these five companies, Gottlieb said on CNBC’s “Squawk Box.”
The clinical trials will consist of 10,000 to 15,000 patients for each vaccine against a standard control arm of around 15,000 patients.
The White House selected three viral vector-based vaccines and two mRNA platforms, Gottlieb said. The mix does not include any “old-style technology,” which is surprising, he said.
“If you want to spread your bets, you probably want to spread your bets across different platforms,” Gottlieb said. “And they chose very novel platforms.”
Companies working on a vaccine that weren’t included in the White House’s five picks face an impediment moving forward, Gottlieb said.
Clinical trial access will be a “critical issue” into the fall season, and the five companies named by the White House will have top priority in finding patients, he said.
Companies may need to look outside of the U.S. to continue trials, but smaller ones don’t have the capacity to do so, the former agency head said.
“It’s going to be more challenging to move quickly for any of the other vaccine manufacturers.”
https://www.benzinga.com/government/20/06/16179215/ex-fda-chief-on-white-houses-coronavirus-vaccine-shortlist-they-chose-very-novel-platforms

Health Insurers Offer Premium Discounts

Anthem Inc. is joining the growing number of health insurers offering premium discounts, as the companies see savings from sharp drop-offs in surgeries and other types of care canceled because of the coronavirus pandemic.
Anthem said it would provide $2.5 billion to customers, health-care providers and others in various forms, including premium credits of 10% to 15% in July for some individual policyholders and fully insured employers. The big insurer follows others including Premera Blue Cross, Blue Cross Blue Shield of Michigan and Priority Health, as well as UnitedHealth Group Inc., that have given discounts to some customers.
“With the changes in health-care utilization as a result of Covid-19, we are returning value to our stakeholders through a number of mechanisms,” said Gail Boudreaux, the chief executive of Anthem, which is based in Indianapolis, Ind.
The industry is being pressured by some regulators. Outlays for claims have fallen in recent months as hospitals halted elective surgeries to brace for a potential coronavirus surge and many patients steered clear of other forms of care. The savings generally far exceed insurers’ costs related to Covid-19, the coronavirus illness.
“We just feel like they need to give the consumer a break,” said Mike Chaney, Mississippi’s insurance commissioner, who said he asked health insurers in his state to consider consumer rate reductions.
Auto insurers, which have also seen claims fall as stay-at-home orders kept people off the roads, have been more aggressive with discounts. The top 10 have all rolled out consumer-relief programs.
Health insurers are “not paying out much in the way of claims, and have an awful lot of premiums coming in,” said Mike Kreidler, the insurance commissioner for Washington state, who said his office had also reached out to encourage health insurers to offer financial breaks to customers. “This is one where I think insurers have a real moral responsibility.”
Insurers granting discounts said they also need to ensure they have adequate funds to handle expenses for the rest of the year. “Our costs dropped unexpectedly and substantially, and we believe we should essentially pay forward the premiums we had collected already,” said Jeff Roe, chief executive of Premera Blue Cross, based in Mountlake Terrace, Wash. But, he said, “we’re reserving some for the future.”
Analysts have said insurers’ second-quarter profits could be up sharply because of the plunge in costs. CVS Health Corp. said in early May that its Aetna unit had seen a 30% drop in the use of health-care services in April, for instance. In addition to disbursing some of the money to customers, health-care providers and others, insurers are likely to do discretionary spending in the second quarter where possible, said Matthew Borsch, an analyst with BMO Capital Markets.
“They don’t want to report windfall profits amid so much economic distress,” he said. “It just won’t look good.”
Health insurers not offering across-the-board premium discounts said they already see signs that health-care demand is ramping back up. Cigna Corp. said it was “tailoring funding arrangements to provide financial relief for clients,” including premium discounts and credits “where appropriate.” Aetna, which isn’t offering premium discounts, said that it is working with customers to “help reduce the financial burden many are facing” and that it has taken steps to support health-care providers.
By granting premium credits, health insurers are also likely reducing rebates that they could end up owing to consumers under the Affordable Care Act, said Larry Levitt, an official at the Kaiser Family Foundation. The law requires insurers to spend a certain share of premiums–80% for individual and small-business plans and 85% for large employers–on health care. If the spending ratio falls short, insurers owe rebates to customers, but rebates tied to 2020 plans won’t start flowing until the fall of 2021.
Joan Budden, chief executive of Priority Health, a Michigan insurer, said companies don’t yet know if they will owe an ACA rebate. “At the end of the year, we could be right at the ACA threshold and not required to give a rebate, but we’re giving this now,” she said. “We knew that our customers were struggling to maintain coverage.”

https://www.marketscreener.com/ANTHEM-INC-18740543/news/Health-Insurers-Offer-Premium-Discounts-30720415/

FDA OKs Merck combo antibiotic for bacterial pneumonia

Under Fast Track, Priority Review and Qualified Infectious Disease Program status, the FDA approves Merck’s (NYSE:MRK) Recarbrio (imipenem, cilastatin, relebactam) for adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.
The combo antibiotic was first approved in the U.S. in July 2019 for complicated urinary tract and complicated intra-abdominal bacterial infections.

FDA accepts Adamas application for expanded use of Gocovri

The FDA accepts for review Adamas Pharmaceuticals’ (NASDAQ:ADMS) supplemental marketing application seeking approval to use Gocovri (amantadine) to treat OFF episodes in Parkinson’s disease (PD) patients receiving levodopa-based therapy. The agency’s action date is February 1, 2021.
The dopamine promoter was first approved in the U.S. in August 2017 for the treatment of dyskinesia (uncontrolled movements) in PD patients receiving levodopa-based therapy with or without concomitant dopaminergic medications.
https://seekingalpha.com/news/3580632-fda-accepts-adamas-application-for-expanded-use-of-gocovri

Self-driving cars could only prevent a third of U.S. crashes: study

Self-driving cars, long touted by developers as a way to eliminate road deaths, could likely only prevent a third of all U.S. road crashes, according to a study released on Thursday.
The Insurance Institute for Highway Safety (IIHS), a research group financed by U.S. insurers, found the remaining crashes were caused by mistakes that self-driving systems are not equipped to handle any better than human drivers.
Partners for Automated Vehicle Education, a consortium of self-driving companies and researchers, said in a statement on Thursday the study wrongly assumed that automated cars could only prevent crashes caused by perception errors and incapacitation.
Some 72% of crashes were avoidable, based on the study’s calculations, if accidents caused by speeding and violation of traffic laws were included, the consortium said.
Traffic experts say roughly nine in 10 crashes result from human error and more than 36,000 people are estimated to have died in U.S. car crashes last year.

Self-driving vehicle developers, including traditional automakers and technology companies, have repeatedly positioned fully automated driving as a tool to drastically reduce road deaths.
But not all human mistakes can be eliminated by camera, radar and other sensor-based technology, according to the IIHS analysis of more than 5,000 representative police-reported crashes nationwide.

One-third of all crashes were the exclusive result of sensing and perception errors, or driver incapacitation, the study found.
Most crashes were due to more complex errors, such as making wrong assumptions about other road users’ actions, driving too fast or too slow for road conditions, or making incorrect evasive maneuvers. Many crashes resulted from multiple mistakes.
“Our goal was to show that if you don’t deal with those issues, self-driving cars won’t deliver massive safety benefits,” said Jessica Cicchino, IIHS vice president for research and a coauthor of the study.
https://www.reuters.com/article/us-autos-self-driving/self-driving-cars-could-only-prevent-a-third-of-u-s-crashes-study-idUSKBN23B294

Protesters should ‘highly consider’ coronavirus tests, U.S. health official says

A top U.S. health official cautioned on Thursday that protests sweeping across the country could increase the spread of the novel coronavirus, particularly in cities that have struggled to control the outbreak, and that participants should “highly consider” getting tested.
Huge crowds have taken to the streets of dozens of cities since the death of George Floyd in Minneapolis police custody set off unrest that has roiled America in the midst of the coronavirus pandemic.
Protests have occurred in Minneapolis and Washington, D.C., where there has been significant transmission of the virus, Robert Redfield, director for the Centers for Disease Control and Prevention (CDC), testified before a Congressional committee.
“Those individuals that have partaken in these peaceful protests or have been out protesting, and particularly if they’re in metropolitan areas that really haven’t controlled the outbreak…we really want those individuals to highly consider being evaluated and get tested,” Redfield told a U.S. House of Representatives subcommittee.

“I do think there is a potential unfortunately for this to be a seeding event,” he said, referring to spreading the virus.
Other public health experts and government officials have also warned the large street protests could cause a spike in new coronavirus cases.
Concerns that a second wave of the virus could also spill over into flu season in the fall have heightened fears of the potential pressure on the nation’s healthcare system.
The CDC is seeking emergency use authorization for a test to detect and differentiate flu from COVID-19, Redfield said in prepared testimony for the House subcommittee on Labor, Health and Human Services, Education, and Related Agencies.

Redfield said in the prepared testimony the CDC is working with drugmakers to maximize the availability of influenza vaccines, and with healthcare providers “to develop contingency plans so that people can be vaccinated in a safe environment.”
Major flu vaccine makers include British-based GlaxoSmithKline, France’s Sanofi and Australia’s CSL.
U.S. pharmacy chains have been preparing a big push for flu vaccinations in October, hoping to prevent tens of thousands of serious cases that could flood hospitals along with new COVID-19 cases.
Redfield also said the World Health Organization (WHO) continues to be a “close colleague” in public health efforts.
President Donald Trump said on Friday the United States will end its relationship with the WHO over the body’s handling of the coronavirus pandemic.
During Redfield’s appearance, Democrats criticized the Trump administration’s response to the outbreak, which has led to more than 107,000 U.S. deaths.
“I have such admiration for the work that you and the CDC do, but if you and the CDC are driving this bus, you’re taking us in a dangerous direction,” said Rosa DeLauro, a Democratic congresswoman from Connecticut.
Asked about the delay in widely available coronavirus testing long into the U.S. outbreak, Redfield pointed to corporate America.
“It took unfortunately weeks and weeks and weeks before the private sector stepped up and developed what we now have,” he told the panel, noting that more than 17 million coronavirus tests have now been done in the United States.
https://www.reuters.com/article/us-health-coronavirus-congress-cdc/protesters-should-highly-consider-coronavirus-tests-u-s-health-official-says-idUSKBN23B2HE

Inovio to begin Phase 1/2 trial of COVID-19 DNA vaccine in South Korea

Inovio Pharmaceuticals (NASDAQ:INO), the International Vaccine Institute, and Seoul National University Hospital announce a partnership to start a Phase 1/2 clinical trial of Inovio’s COVID-19 vaccine INO-4800 in South Korea.
The 2nd-stage trial of INO-4800 will assess the safety, tolerability, and immunogenicity of the candidate vaccine in 40 healthy adults aged 19-50 years, and will further expand to enroll an additional 120 people aged 19-64 years.
The trial is expected to start later in June.
https://seekingalpha.com/news/3580328-inovio-to-begin-phase-1-2-trial-of-covidminus-19-dna-vaccine-in-south-korea