Moderna under pressure after adverse patent ruling

Moderna (MRNA -9.1%) is down, albeit on average volume, in apparent response to a decision from the USPTO’s Patent Trial and Appeal Board denying the company’s motion for an inter partes review of a patent (U.S. #8,058,069) held by Arbutus Biopharma (ABUS +80.9%) due to its failure to present sufficient evidence that the patent is unpatentable.

The ‘069 patent covers lipid formulations for nucleic acid delivery.

https://seekingalpha.com/news/3594436-moderna-under-pressure-after-adverse-patent-ruling

eHealth EPS beats by $0.22, beats on revenue

eHealth (NASDAQ:EHTH): Q2 Non-GAAP EPS of $0.07 beats by $0.22; GAAP EPS of -$0.13 beats by $0.22.

Revenue of $88.77M (+35.0% Y/Y) beats by $7.83M.

https://seekingalpha.com/news/3594491-ehealth-eps-beats-0_22-beats-on-revenue

Safety of Hydroxychloroquine in Covid Outpatient Clinical Trial Participants

View ORCID ProfileSARAH, M M LOFGREN, View ORCID ProfileMelanie R Nicol, Ananta S Bangdiwala, View ORCID ProfileKatelyn A Pastick, View ORCID ProfileElizabeth C Okafor, View ORCID ProfileCaleb P Skipper, View ORCID ProfileMatthew F Pullen, View ORCID ProfileNicole W Engen, View ORCID ProfileMahsa Abassi, Darlisha A Williams, View ORCID ProfileAlanna A Nascene, View ORCID ProfileMargaret L Axelrod, Sylvian A Lother, View ORCID ProfileLauren J MacKenzie, View ORCID ProfileGlen Drobot, Nicole Marten, View ORCID ProfileMatthew P Cheng, Ryan Zarychanshi, View ORCID ProfileIlan S Schwartz, Michael Silverman, View ORCID ProfileZain Chagla, Lauren E Kelley, View ORCID ProfileEmily G McDonald, View ORCID ProfileTodd C Lee, View ORCID ProfileKatherine Huppler Hullsiek, View ORCID ProfileDavid R Boulware, View ORCID ProfileRadha Rajasingham

doi: https://doi.org/10.1101/2020.07.16.20155531

This article is a preprint and has not been certified by peer review [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.

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Abstract

Introduction: Use of hydroxychloroquine in hospitalized patients with COVID-19, especially in combination with azithromycin, has raised safety concerns. Here, we report safety data from three outpatient randomized clinical trials. Methods: We conducted three randomized, double-blind, placebo-controlled trials investigating hydroxychloroquine as pre-exposure prophylaxis, post-exposure prophylaxis and early treatment for COVID-19. We excluded individuals with contraindications to hydroxychloroquine. We collected side effects and serious adverse events. We report descriptive analyses of our findings. Results: We enrolled 2,795 participants. The median age of research participants was 40 (IQR 34-49) years, and 59% (1633/2767) reported no chronic medical conditions. Overall 2,324 (84%) participants reported side effect data, and 638 (27%) reported at least one medication side effect. Side effects were reported in 29% with daily, 36% with twice weekly, 31% with once weekly hydroxychloroquine compared to 19% with placebo. The most common side effects were upset stomach or nausea (25% with daily, 18% with twice weekly, 16% with weekly, vs. 10% for placebo), followed by diarrhea, vomiting, or abdominal pain (23% for daily, 16% twice weekly, 12% weekly, vs. 6% for placebo). Two individuals were hospitalized for atrial arrhythmias, one on placebo and one on twice weekly hydroxychloroquine. No sudden deaths occurred. Conclusion: Data from three outpatient COVID-19 trials demonstrated that gastrointestinal side effects were common but mild with the use of hydroxychloroquine, while serious side effects were rare. No deaths occurred related to hydroxychloroquine. Randomized clinical trials can safely investigate whether hydroxychloroquine is efficacious for COVID-19.

https://www.medrxiv.org/content/10.1101/2020.07.16.20155531v1

White House executive office cafeteria closed after positive coronavirus test

The White House is conducting contact tracing after a cafeteria worker tested positive for coronavirus, three Trump administration officials tell NBC News.

The cafeteria and an eatery in the Eisenhower Executive Office Building, or EEOB, were both closed this week after the case was discovered, officials said. It was unclear how long the facility will remain closed, although some staffers were told it could remain shuttered for two weeks.

“There is no reason for panic or alarm,” the White House said in an email sent to officials Wednesday night and obtained by NBC News. “The White House Medical Unit has already conducted contact tracing and based off of their interviews, they have determined that no EOP staff should self-quarantine due to exposure.”

Part of the White House complex, the Eisenhower Executive Office Building sits just across West Executive Ave. from the West Wing. It houses the offices of much of the senior White House staff, including officials from the coronavirus task force, the vice president’s office, the National Security Council and several economic policy shops.

Unlike the White House Mess, which is located inside the West Wing and run by the U.S. Navy, the cafeteria and an Ike’s Eatery in the neighboring EEOB are run by a government contractor. The White House referred questions about the situation to the General Services Administration, which maintains the building.

“All proper protocols were in place by the vendor including masks, gloves, plastic shielding at check out, and no dine-in service,” a GSA spokesperson said. “The White House Medical Unit has done contact tracing and determined that the risk of retransmission is low.”

https://www.nbcnews.com/politics/white-house/white-house-executive-office-cafeteria-closed-after-positive-coronavirus-test-n1234662

Parents are paying up to $100 an hour for ‘teaching pods’ during the pandemic

With major school districts across the country offering limited in-person instruction this fall, parents who can afford it are scrambling to find ways to avoid another semester of balancing Zoom lessons with conference calls.

An entire industry is mobilizing to help them.

From nanny agencies, to tutoring companies to teacher placement services, a variety of businesses are hiring extra staff and launching new websites and program offerings to meet the demand from parents.

In some cases, families are seeking a teacher who can provide in-person instruction to supplement what their children are learning virtually from their schools. In other cases, parents are hoping that these businesses will help them replace school entirely.

The desire for these services is easy to understand. For many students and parents, the remote learning that schools cobbled together quickly in the spring was inadequate and hard to manage. In addition, by learning on Zoom and other platforms, students are missing out the interactions with friends and teachers that can be key to their socialization and development. And finally, for many parents, having their children in the house when they would normally be at school has made it nearly impossible to focus on work.

https://www.marketwatch.com/story/affluent-parents-are-setting-up-their-own-schools-as-remote-learning-continues-its-the-failure-of-our-institutions-to-adequately-provide-for-our-students-11595450980

Low Covid incidence in DMARD treated chronic rheumatic inflammatory diseases

July 23, 2020

1. http://orcid.org/0000-0001-8180-6660Maurizio Benucci1,
2. Arianna Damiani2,
3. Gianfranco Giannasi3,
4. Francesca Li Gobbi1,
5. Luca Quartuccio4,
6. Valentina Grossi5,
7. http://orcid.org/0000-0002-6200-4467Maria Infantino5,
8. Mariangela Manfredi5

Author affiliations

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http://dx.doi.org/10.1136/annrheumdis-2020-218214

We read the interesting epidemiological study on 600 patients with rheumatic diseases hospitalised for COVID-19 infection (COVID-19 Global Rheumatology Alliance Registry) published by Gianfrancesco et al.1 Data analysis showed a slightly increased risk of hospitalisation for prednisone doses of ≥10 mg, while biological disease-modifying anti-rheumatic drug (b-DMARD)/targeted synthetic disease-modifying anti-rheumatic drug (ts-DMARD) monotherapy just prior to COVID-19 diagnosis appeared protective, in particular, the tumour necrosis factor targeting agents, as result of a subsequent subanalysis. The epidemiological impact of COVID-19 in patients with rheumatic diseases being treated with b-DMARD has been the subject of several reports by Italian groups. In the first report, only 4 cases were confirmed through rhinopharyngeal swabs out of 320 observed cases.2 In another study assessed in the emergency period in Lombardy through visit or phone contact, only 3 cases through rhinopharyngeal swabs out of 520 cases were confirmed.3 Another study of 859 patients in another rheumatology centre in Tuscany, which applied a phone contact methodology, identified only 2 patients suffering from COVID-19 pneumonia.4 As part of the Tuscany population serological screening, the Incidence COVID-19-Rheumatic Disease–Biologics study has been planned. The anti-Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) IgM and IgG were quantitatively measured in consecutive rheumatic patients followed up at our centre in the period from 25 March to 25 May 2020. In one previous study coming from our centre and performed by iFlash1800 CLIA Analyzer for anti‐SARS-CoV‐2 antibodies IgM and IgG in patients who were positive for gold/nasopharyngeal swab reverse transcription PCR, a high sensitivity as well as a very good specificity performance was achieved, with a cut-off value of 10.0 absorbance unit (AU)/mL for both IgM and IgG antibodies.5 Comparison between the study population and the general reference population was performed by Fisher exact test. A p value of <0.05 was considered significant. The OR was then calculated with 95% CI. The incidence of COVID-19 in the reference general population was checked in the Regional Health Agency website, considering all the positive cases among the inhabitants of the Unità Sanitaria Locale (USL) Toscana Centro. The study was approved by the local ethics committee of the ASL-Toscana Centro, within the COVID-TC Project. A total of 295 patients were studied (138 with rheumatoid arthritis (46.8%), 76 with psoriatic arthritis (25.8%), 55 with ankylosing spondylitis (18.6%) and 26 with other rheumatic diseases (8.8%) (8 with systemic lupus erythematosus, 12 with giant cell arthritis and 6 with polymyositis). Six out of 295 patients (2.03%) were positive for IgM or IgG anti SARS-CoV-2. Among them, in only 4 patients (66.7%), the presence of SARS-CoV-2 was confirmed by nasal pharyngeal swab. The four patients were women and all were hospitalised for SARS-CoV-2 pneumonia. Online supplementary table S1 summarises the clinical characteristics of the four patients and their outcome. Finally, the incidence of COVID-19 in our study was calculated, taking into account the number of patients with a positive nasal pharyngeal swab among the 295 initially tested for SARS-CoV2 serology. The incidence of COVID-19 in patients taking b-DMARDs resulted 4/295 (1.4% (95% CI 0.4% to 3.4%)), while the incidence in the ‘USL Toscana Centro’ population was 7393/1 620 952 (0.5% (95% CI 0.4% to 0.5%)), with a p value of 0.047 and an estimated OR of 3.01 (95% CI 1.13 to 8.09). The results of this study showed a tendency for an increase risk of COVID-19 infection in patients receiving b-DMARD. The data also confirm a prevalence study where, although not significant, patients on biological therapies showed a higher value of COVID-19 infection than the general population.6 Quantitative serological tests can capture a greater number of positive patients, including those who were asymptomatic, and the integration of serology with nasopharyngeal swab test may provide the best picture of COVID-19 infection among rheumatic patients. In our case history, a patient with RA receiving baricitinib and a patient with ankylosing spondylitis receiving secukinumab, despite the positivity of IgM 41.1 AU/mL in the first case and IgM 61.9 AU/mL and IgG 25.9AU/mL in the second case, showed a negative nasopharyngeal swab, and they did not develop symptoms compatible with the COVID-19 infection. Our four confirmed patients were then included in the COVID-19 Italian Society of Rheumatology Registry sponsored registry and the European EULAR-COVID-19 Database. We recognise the great value of the study on patients hospitalised for COVID-19 infection,1 but we believe that a general screening with serological tests integrated by swab-based COVID-19 testing may bring new data in asymptomatic patients with rheumatic diseases.

https://ard.bmj.com/content/early/2020/07/05/annrheumdis-2020-218214

Texas hospital to turn away COVID-19 patients with poor survival chances

A Texas hospital has formed an ethics committee to screen all COVID-19 patients for survival potential and send home those with low survival chances, according to Border Report.

Rio Grande City, Texas-based Starr County Memorial Hospital, implemented an ethics committee and a triage committee to review incoming COVID-19 patients, Starr County Health Authority Jose Vazquez, MD, said during a July 21 videoconference call. The committees will determine what type of treatment patients will likely require and whether they are likely to survive. Those deemed too fragile, sick or elderly will be advised to go home. Patients with low recovery chances will be better cared for at home with loved ones rather than dying at a hospital thousands of miles away, Dr. Vazquez said.

“There is nowhere to put these patients. The whole state of Texas and neighboring states have no ICU beds to spare for us,” Dr. Vazquez said. The county of 61,000 residents has recorded 1,573 COVID-19 cases and 16 related deaths with 27 fatality cases pending, according to Border Report. As of July 22, 11,461 of 55,263 hospital beds are available statewide, with 1,088 ICU beds open. Currently, Texas has more COVID-19 patients hospitalized than any other state, with 10,848 COVID-19 patients as of July 22.

Physicians at Starr County Memorial Hospital, the only hospital in the county, have to make these end-of-life decisions because residents aren’t following social distancing guidelines, Starr County Judge Eloy Vera said, adding, “Our backs are to the wall.”

“The number of cases we see in the ER are growing every day; 50 percent of cases in the ER are COVID. The situation is desperate,” Dr. Vazquez said. “We cannot continue functioning at Starr County Memorial Hospital the way things are going.”

The county of 61,000 residents has recorded 1,573 COVID-19 cases and 16 related deaths with 27 fatality cases pending, according to Border Report.

https://www.beckershospitalreview.com/patient-flow/our-backs-are-to-the-wall-texas-hospital-to-turn-away-covid-19-patients-with-poor-survival-chances.html