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Thursday, June 11, 2020

Woman in her twenties has double lung transplant due to coronavirus

A Chicago woman received a double lung transplant after a bout with coronavirus wreaked damage on the organs, the hospital announced Thursday.
The patient, a Hispanic woman in her 20s, was on a ventilator and heart-lung machine for six weeks before her life-saving operation Friday, according to Northwestern Memorial Hospital.
The woman had been otherwise in pretty healthy shape, but her health rapidly deteriorated when she was hospitalized in late April with the virus, doctors said.
“For many days, she was the sickest person in the COVID ICU – and possibly the entire hospital,” said Dr. Beth Malsin, a pulmonary and critical care specialist at Northwestern Memorial Hospital in a statement.
“There were so many times, day and night, our team had to react quickly to help her oxygenation and support her other organs to make sure they were healthy enough to support a transplant if and when the opportunity came.”
Dr. Ankit Bharat, who performed the operation, said they waited six weeks for her to recover from the virus before considering a transplant.
She was moved to the top of the transplant list because she was in bad shape, with signs that her heart, kidneys and liver were beginning to fail, he said.
Bharat said the 10-hour procedure was still challenging since the virus left her lungs with holes and nearly fused to the chest wall.
“We want other transplant centers to know that while the transplant procedure in these patients is quite technically challenging, it can be done safely, and it offers the terminally ill COVID-19 patients another option for survival,” Bharat said in a statement.
The operation was successful but doctors say they will still keep her ventilator and heart-lung machine as her body heals.
“We are anticipating that she will have a full recovery,” said Dr. Rade Tomic, medical director of the hospital’s lung transplant program.
The hospital said it believes it’s one of the first to perform a double-lung transplant on a patient recovering from the virus. There have only been a few other survivors, in China and Europe, who have received the transplants.
Doctors said they now want to better understand why she became so severely ill compared to other cases of the virus.
“How did a healthy woman in her 20s get to this point? There’s still so much we have yet to learn about COVID-19. Why are some cases worse than others?” said Dr. Rade Tomic, a pulmonologist and medical director of the Lung Transplant Program.
https://nypost.com/2020/06/11/patient-has-double-lung-transplant-due-to-coronavirus/

Use of Ivermectin Linked to Lower Mortality in Hospitalized Covid Patients

Juliana Cepelowicz Rajter, Michael Sherman, Naaz Fatteh, Fabio Vogel, Jamie Sacks, Jean-Jacques Rajter

Abstract

Abstract Importance: No therapy to date has been shown to improve survival for patients infected with SARS-CoV-2. Ivermectin has been shown to inhibit the replication of SARS-CoV-2 in vitro but clinical response has not been previously evaluated. Objective: To determine whether Ivermectin is associated with lower mortality rate in patients hospitalized with COVID-19. Design and Setting: Retrospective cohort study of consecutive patients hospitalized at four Broward Health hospitals in South Florida with confirmed SARS-CoV-2. Enrollment dates were March 15, 2020 through May 11, 2020. Follow up data for all outcomes was May 19, 2020. Participants: 280 patients with confirmed SARS-CoV-2 infection (mean age 59.6 years [standard deviation 17.9], 45.4% female), of whom 173 were treated with ivermectin and 107 were usual care were reviewed. 27 identified patients were not reviewed due to multiple admissions, lack of confirmed COVID results during hospitalization, age less than 18, pregnancy, or incarceration. Exposure: Patients were categorized into two treatment groups based on whether they received at least one dose of ivermectin at any time during the hospitalization. Treatment decisions were at the discretion of the treating physicians. Severe pulmonary involvement at study entry was characterized as need for either FiO2 ≥50%, or noninvasive or invasive mechanical ventilation. Main Outcomes and Measures: The primary outcome was all-cause in-hospital mortality. Secondary outcomes included subgroup mortality in patients with severe pulmonary involvement and extubation rates for patients requiring invasive ventilation. Results: Univariate analysis showed lower mortality in the ivermectin group (25.2% versus 15.0%, OR 0.52, 95% CI 0.29-0.96, P=.03). Mortality was also lower among 75 patients with severe pulmonary disease treated with ivermectin (38.8% vs 80.7%, OR 0.15, CI 0.05-0.47, P=.001), but there was no significant difference in successful extubation rates (36.1% vs 15.4%, OR 3.11 (0.88-11.00), p=.07). After adjustment for between-group differences and mortality risks, the mortality difference remained significant for the entire cohort (OR 0.27, CI 0.09-0.85, p=.03; HR 0.37, CI 0.19-0.71, p=.03). Conclusions and Relevance: Ivermectin was associated with lower mortality during treatment of COVID-19, especially in patients who required higher inspired oxygen or ventilatory support. These findings should be further evaluated with randomized controlled trials.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

n/a

Funding Statement

No funding.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes

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https://www.medrxiv.org/content/10.1101/2020.06.06.20124461v2

IRS Eyes New Way to Pay for Routine Care

The Internal Revenue Service hopes to give workers a new way to pay for health care: letting them use ordinary health reimbursement arrangements (HRAs) to pay for direct primary care program memberships.
The IRS proposal could help a worker lock in everyday health care costs for a year, while owning low-deductible major medical insurance, or major medical insurance with a very high deductible.
The proposal could also help primary care doctors reduce the amount of time and money they spend on billing insurers and patients for specific services. The doctors could simply ask the patients to pay the direct primary care program membership fee on an annual, quarterly or monthly basis.
Those doctors could focus solely on providing care through direct primary care arrangements, and stop working directly with health insurers, or they could work with insurers only when delivering unusual or advanced forms of care outside of the direct primary care arrangements.
The IRS has described the proposal in a notice of proposed rulemaking published today in the Federal Register.

Resources

  • A copy of the proposed HRA regulations is available here.
  • An article about efforts to help people use health savings accounts to pay for direct primary care arrangements is available here.
Comments on the proposal are due Aug. 10.
The proposal contact people are Richard Gano IV , an income tax and accounting specialist at the IRS Office of Associate Chief Counsel, and  William Fischer, an employee benefits specialist at the IRS Office of Associate Chief Counsel.
https://www.thinkadvisor.com/2020/06/10/irs-hopes-to-create-new-way-to-pay-for-routine-care/?cmp=share_twitter

Avidity Biosciences Boosts IPO Size, Expected Price Range

Avidity Biosciences Inc., a preclinical-stage biopharmaceutical company backed by Eli Lilly & Co., Thursday raised the size and expected price range of its planned initial public offering.
The La Jolla, Calif., company said it now plans to offer 12 million shares at $17 to $18 apiece in the IPO, up from previous plans to sell 10 million shares at $14 to $16 each.
At the $17.50 midpoint of the new price range, Avidity said it expects net proceeds of about $192.4 million, or roughly $221.6 million if the underwriters exercise an option to buy an additional 1.8 million shares.
Avidity said it will have about 34.8 million shares outstanding after the IPO, assuming exercise of the overallotment option, for a valuation of about $608.1 million at the $17.50-a-share midpoint.

https://www.marketscreener.com/ELI-LILLY-AND-COMPANY-13401/news/Eli-Lilly-and-Avidity-Biosciences-Boosts-IPO-Size-Expected-Price-Range-30756291/

Reata to Get $350 Million Investment From Blackstone Life Sciences

Reata Pharmaceuticals Inc. on Thursday said it will receive $350 million under a royalty and equity investment deal with private-equity firm Blackstone Group Inc.
The Plano, Texas, clinical-stage biopharmaceutical company said funds managed by Blackstone Life Sciences will lead the investment to fund the development and potential commercialization of bardoxolone, which the company is studying in rare and serious forms of chronic kidney disease.
Reata said the investment, which extends its cash runway through the end of 2023, includes $300 million in return for royalty payments on sales of bardoxolone.
Blackstone also will invest $50 million to buy 340,793 Reata shares at $146.72 apiece, a 12% premium to Wednesday’s closing price of $130.92.
Reata said it will receive the $350 million investment at closing, which is expected to occur by June 24.

https://www.marketscreener.com/REATA-PHARMACEUTICALS-IN-28377265/news/Reata-Pharmaceuticals-to-Get-350-Million-Investment-From-Blackstone-Life-Sciences-30756706/

Takeda to sell some Asia-focused drugs to Celltrion for $278M

Takeda Pharmaceutical Co Ltd has agreed to sell a portfolio of over-the-counter and prescription drugs marketed in the Asia Pacific region to South Korea’s Celltrion Inc for $278 million, it said on Thursday
Takeda, Japan’s biggest drugmaker, will get $266 million upfront in cash and up to an additional $12 million in potential milestone payments, the company said.
The portfolio to be sold to Celltrion includes OTC and pharmaceutical products marketed mainly in Australia, Hong Kong, South Korea, and elsewhere in Asia, it said.
Takeda will continue to manufacture the products and supply them to Celltrion.
The Japanese company pledged to dispose of $10 billion in non-core assets following its $59 billion purchase of Shire Plc completed last year, which left it saddled with debt.
Prior to Thursday’s announcement it had divested $7.7 billion in non-core assets so far, with the latest deal being the sale of OTC and prescription products to Denmark-based Orifarm Group for about $670 million.
Nikkei Business reported last month that Takeda is looking to sell its Japanese OTC business for around 400 billion yen ($3.72 billion).
After Takeda reported full-year earnings on May 13, Chief Executive Christophe Weber said “we are not an OTC company.”

https://www.marketscreener.com/CELLTRION-INC-40742914/news/Japan-s-Takeda-to-sell-some-Asia-focused-drugs-to-Celltrion-for-278-million-30756542/

U.S. cannot shut down economy again, Treasury’s Mnuchin says

The United States cannot let the coronavirus shut down its economy again, U.S. Treasury Secretary Steven Mnuchin said on Thursday, adding that more than $1 trillion in rescue funds will flow into the economy over the next month.
Mnuchin, speaking on CNBC television, said he was prepared to go back to Congress for more money to support the economy, but additional funds would be targeted to sectors with the most need, including hotels, restaurants, travel and entertainment firms.
The Treasury chief, who has been the Trump administration’s point man for negotiating rescue programs, said that he was confident that COVID-19 infection spikes in certain areas could be dealt with due to improvements in testing, contact tracing and ample hospital capacity.
“We can’t shut down the economy again. I think we’ve learned that if you shut down the economy, you’re going to create more damage and not just economic damage,” he said, adding that this includes other problems.
Mnuchin said of the $3 trillion in coronavirus rescue spending approved by Congress this year, only about $1.6 trillion has filtered through the economy so far.
“Over the next month, you’re going to see over another $1 trillion pumped into the economy, that’s going to have a big impact,” Mnuchin said. The Federal Reserve’s Main Street Lending program for mid-size businesses is just getting started and “we’re prepared to go back to Congress for more money to support the American worker,” he added.
Asked if he was considering more aid to states, Mnuchin said that would be subject to negotiations with Congress.
Mnuchin added that due to an extension of forgivable Paycheck Protection Program loans to 24 weeks, he expects many restaurants that had previously been reluctant to seek loans will come forward to take up a significant portion of the program’s remaining funds.

https://www.marketscreener.com/news/U-S-cannot-shut-down-economy-again-Treasury-s-Mnuchin-says–30757775/?countview=0