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Friday Links

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Clinical trials going digital.  JAMA return-to-play guidance. Would a COVID-19 vaccine produce larger health or economic benefits?  Pros and cons of telemedicine. Are we there yet? A review of 4 value-based care programs.

Election Issue Spotlight: “Junk” Insurance Makes a Pandemic Even Worse

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By ROSEMARIE DAY and NIKO LEHMAN-WHITE One of the most important responsibilities of the American government is to protect its citizens from harmful industry practices, from lead poisoning to dangerous pharmaceuticals to financial meltdowns. Its record is far from perfect, but government regulators usually act… Read More »Election Issue Spotlight: “Junk” Insurance Makes a Pandemic Even Worse

COVID-19 is threatening the UK’s medical research prowess, say charities

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Medical research charities are urging the UK government to financially support charity-funded research to protect the UK’s position as a global leader in science. The charities, including the British Heart Foundation and Cancer Research UK (CRUK), propose the government introduces a Life Sciences-Charity Partnership Fund,… Read More »COVID-19 is threatening the UK’s medical research prowess, say charities

Guest post: Recognizing National Disability Employment Awareness Month

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Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The Catalyst welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view.

The Best Time to Get COVID-19

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During the first COVID-19 surge of the spring, the mantra was “Flatten to curve”—to buy time, using every tool available. Seven months later, it’s possible to measure what that time has bought: The death rate for COVID-19 has fallen dramatically. Hospitals in most places are… Read More »The Best Time to Get COVID-19

GSK’s Zejula (niraparib) Receives EC’s Approval as a Treatment in Advanced Ovarian Cancer

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Shots: The approval is based on PRIMA study assessing Zejula (300mg qd), later amended to incorporate an individualised starting dose of Zejula (200 mg or 300 mg, qd) based on the patient’s baseline weight and/or platelet count Results: The PRIMA study improved PFS for patients… Read More »GSK’s Zejula (niraparib) Receives EC’s Approval as a Treatment in Advanced Ovarian Cancer

AbbVie Reports Results of SKYRIZI (risankizumab) in P-III LIMMitless Study in Patients with Moderate to Severe Plaque Psoriasis

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Shots: The P-III LIMMitless study is designed to evaluate the long-term safety & efficacy assessing risankizumab (150 mg q12wks.) continuous risankizumab with a loading dose in adults with moderate to severe plaque psoriasis. The analysis includes integrated data from five P-II & III studies (ultIMMa-1,… Read More »AbbVie Reports Results of SKYRIZI (risankizumab) in P-III LIMMitless Study in Patients with Moderate to Severe Plaque Psoriasis

KHN on the Air This Week

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KHN chief Washington correspondent Julie Rovner discussed the current surge in COVID-19 cases, health policy in the election and the Affordable Care Act case before the Supreme Court with NPR’s “All Things Considered” on Sunday and WBUR’s “On Point.” Click here to hear Rovner on… Read More »KHN on the Air This Week

If They Sweep on Election Day, Dems Still Face a Challenge Meeting Health Promises

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Democrats are favored to win both chambers of Congress after years of campaign-trail promises about health care. But with a pandemic, a more conservative Supreme Court and lingering disagreements between progressives and moderates, it could be difficult for Democrats to turn those promises into law.… Read More »If They Sweep on Election Day, Dems Still Face a Challenge Meeting Health Promises

Democrats Link GOP Challengers to Trump’s COVID Record, Efforts to Undo Obamacare

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In a tweet to his 78,000 followers Sunday, U.S. Rep. Harley Rouda, a Democrat from Orange County, California, described his Republican opponent Michelle Steel’s attendance at an indoor fundraiser without a mask as “sickening.” Democratic U.S. Rep. Gil Cisneros also blasted his Republican opponent, Young… Read More »Democrats Link GOP Challengers to Trump’s COVID Record, Efforts to Undo Obamacare

Sanofi Entered into an Agreement with Merck to Conduct a P-II Study of THOR-707 in Sequenced Administration with MSD’s KEYTRUDA® (pembrolizumab) in Patients with Various Cancers

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Shots: Sanofi will sponsor the clinical trials while MSD will provide KEYTRUDA. Additionally, Sanofi is separately evaluating the activity of THOR-707 in combination with other anti-PD-1 antibodies, including Libtayo (cemiplimab-rwlc) and with anti-EGFR and anti-CD38 antibodies for various types of cancer tumors In preclinical studies,… Read More »Sanofi Entered into an Agreement with Merck to Conduct a P-II Study of THOR-707 in Sequenced Administration with MSD’s KEYTRUDA® (pembrolizumab) in Patients with Various Cancers

Free online training for psychosocial risk assessment

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30/10/2020 Free online training for psychosocial risk assessment Psychosocial risk assessment (PRA) is a legal requirement and a complicated process faced by companies that want to offer their employees optimal working conditions. A free online training offered through PsyHealth worXs! has been specifically…

Roche’s Tecentriq in Combination with Avastin Receives China NMPA’s Approval for the Treatment of Unresectable Hepatocellular Carcinoma

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Shots: The approval was based on the P-III IMbrave150 study (n=501) assessing the combination of Tecentriq (1200 mg, IV) and Avastin (15 mg/kg, IV) or sorafenib (400 mg, bid) in unresectable HCC patients who had not received prior systemic therapy which included analyses of a… Read More »Roche’s Tecentriq in Combination with Avastin Receives China NMPA’s Approval for the Treatment of Unresectable Hepatocellular Carcinoma

Medicare, Medicaid will cover costs of future COVID-19 vaccine under new policy

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Medicare, Medicaid will cover costs of future COVID-19 vaccine under new policy Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 In an official announcement on Wednesday, CMS said Medicare beneficiaries will receive any FDA-approved coronavirus vaccine for free. The new policy calls for providers… Read More »Medicare, Medicaid will cover costs of future COVID-19 vaccine under new policy

Opinion: I’m the FDA point person on COVID-19 vaccines. We’ll make sure they’re safe and effective.

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Opinion: I’m the FDA point person on COVID-19 vaccines. We’ll make sure they’re safe and effective. Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, says to encourage trust in any COVID-19… Read More »Opinion: I’m the FDA point person on COVID-19 vaccines. We’ll make sure they’re safe and effective.

Stop & Shop offers free virtual education series for National Diabetes Awareness Month

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Stop & Shop offers free virtual education series for National Diabetes Awareness Month Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 Stop & Shop will host a month-long webinar series highlighting National Diabetes Awareness Month this November. The series is designed to educate participants,… Read More »Stop & Shop offers free virtual education series for National Diabetes Awareness Month

CVS pharmacies in Philadelphia closed early Wednesday after 20 stores damaged during looting

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CVS pharmacies in Philadelphia closed early Wednesday after 20 stores damaged during looting Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 Civil unrest in Philadelphia, marked by protests and looting, prompted CVS Pharmacies to lock up local stores early on Tuesday and Wednesday. With… Read More »CVS pharmacies in Philadelphia closed early Wednesday after 20 stores damaged during looting

Kroger Health launches COVID-19 rapid antibody testing at pharmacy locations

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Kroger Health launches COVID-19 rapid antibody testing at pharmacy locations Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 Kroger Health announced Wednesday the launch of rapid antibody COVID-19 testing at its California (Ralphs) and Michigan pharmacies. According to the company, the rapid antibody testing… Read More »Kroger Health launches COVID-19 rapid antibody testing at pharmacy locations

Somatic mutations in UBA1 and severe adult-onset autoinflammatory disease

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Somatic mutations in UBA1 and severe adult-onset autoinflammatory disease Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 A study partially funded by NIH examined differences in ubiquitin-related genes, which play a role in autoinflammatory disease and may characterize previously unknown conditions. The research involved… Read More »Somatic mutations in UBA1 and severe adult-onset autoinflammatory disease

Ticagrelor vs. clopidogrel and adverse events in patients with acute coronary syndrome undergoing PCI

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Ticagrelor vs. clopidogrel and adverse events in patients with acute coronary syndrome undergoing PCI Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 Ticagrelor is the recommended P2Y12 platelet inhibitor for patients with acute coronary syndrome (ACS), but because this indication is largely based on… Read More »Ticagrelor vs. clopidogrel and adverse events in patients with acute coronary syndrome undergoing PCI

Sunstar Americas Inc. issues recall of chlorhexidine gluconate oral rinse USP, 0.12% due to microbial contamination

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Sunstar Americas Inc. issues recall of chlorhexidine gluconate oral rinse USP, 0.12% due to microbial contamination Wed, 10/28/2020 – 20:00 cbaker_admin Fri, 10/30/2020 – 00:30 Sunstar Americas, Inc. (SAI) announced a voluntary, nationwide recall of certain chlorhexidine gluconate oral rinse (Paroex), USP, 0.12% products because… Read More »Sunstar Americas Inc. issues recall of chlorhexidine gluconate oral rinse USP, 0.12% due to microbial contamination

Virtual campaign partnership meeting: Healthy Workplaces Lighten the Load 2020-2022

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29/09/2020 Virtual campaign partnership meeting: Healthy Workplaces Lighten the Load 2020-2022 Ahead of the launch of the 2020-2022 campaign — Healthy Workplaces Lighten the Load — representatives of European and international enterprises and organisations joined EU-OSHA for a virtual campaign partnership meeting. They learned about… Read More »Virtual campaign partnership meeting: Healthy Workplaces Lighten the Load 2020-2022

Strengthening European food research

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The food industry will face significant challenges in the future. However, an EU-funded project has created an international research network capable of confronting environmental threats as well as consumer demand for traceable, ethical ingredients.

Pelosi, Trump administration trade blame over virus aid

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House Speaker Nancy Pelosi says remaining obstacles to an agreement include more than half a dozen big-ticket items, including a testing plan, aid to state and local governments, funding for schools, jobless benefits and a GOP-sought shield against coronavirus-related lawsuits.

[Updated] CMS Finalizes 1.9% Home Health Rate Increase for 2021, Keeps PDGM’s Behavioral Adjustment

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The U.S. Centers for Medicare & Medicaid Services (CMS) issued its final 2021 home health payment rule Thursday. In doing so, it changed very little from what it first proposed in June. The final rule adds an estimated $390 million home health payment boost for… Read More »[Updated] CMS Finalizes 1.9% Home Health Rate Increase for 2021, Keeps PDGM’s Behavioral Adjustment

Encompass Health Gaining Ground with ACOs, But Still Facing Assisted Living ‘Lockdowns’

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Hundreds of thousands of dollars’ worth of monthly personal protective equipment (PPE) costs. Nationwide lockdowns of assisted living communities. Continued restrictions on elective surgeries in most markets. These remain just a few of the major pain points that Encompass Health Corp. (NYSE: EHC) and its… Read More »Encompass Health Gaining Ground with ACOs, But Still Facing Assisted Living ‘Lockdowns’

Ascension expands pharmacy services

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Ascension Rx—the newly launched brand for its national pharmacy—offers specialty medication packaging and delivery, infusion therapy and medication management, including financial aid coordination.

Overnight Health Care: Winter COVID-19 wave poses threat to nation’s hospitals | Two people who attended Trump’s North Carolina rally test positive | Documents show ‘political’ nature of Trump coronavirus ad campaign, lawmakers say

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Welcome to Thursday’s Overnight Health Care.The spike in COVID-19 cases is putting a massive strain on the nation’s hospitals as the country reached a record number of new infections this week. Meanwhile, House Democrats released documents showing…

CMS makes telehealth permanent for home health

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Providers will be able to use telehealth if it’s outlined in a patient’s care plan and tied to a specific goal to improve treatment. CMS bumped pay for home health by 1.9%, or about $390 million.

US sets weekly record with over 500,000 new COVID-19 cases

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The U.S. on Thursday set a new weekly record for COVID-19 infections with more than 500,000, according to data from the COVID Tracking project, as a wave of cases builds ahead of winter.Twenty-five states have set a new record for cases in…

Comcast NBCUniversal, Independence Health Group Offshoot Quil Launches Aging In Place Platform

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The brainchild of Comcast NBCUniversal and Independence Health Group — Quil — has set its sights on solidifying its place in the home. The company recently unveiled plans to launch Quil Assure, a sensor-based technology platform that aims to keep seniors and their informal caregivers… Read More »Comcast NBCUniversal, Independence Health Group Offshoot Quil Launches Aging In Place Platform

To avoid crisis, pharma must address costs

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Scrutiny of drug prices will continue whether Trump or Biden wins. But pharma can take steps to address critics and cut costs before they reach a crisis point, according to a panel of industry experts.

Amedisys Makes Progress on SNF-at-Home Model, Anticipates Positive 2021 Operating Environment

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When there are challenges in any industry, the organizations that hurdle them quickly and efficiently end up gaining an advantage. Amedisys Inc. (Nasdaq:AMED) feels like it has done that. After a census bounce-back from COVID-19, a successful transition to the Patient-Driven Groupings Model (PDGM) and… Read More »Amedisys Makes Progress on SNF-at-Home Model, Anticipates Positive 2021 Operating Environment

Founders’ Story: Activ Surgical

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Activ Surgical is building hardware-agnostic surgical software that allows surgical systems to collaborate with surgeons. Founder and Chief Science and Medical Officer Dr. Peter Kim and CEO Todd Usen discussed the company’s goals in an emailed response to questions.

KHN’s ‘What the Health?’: As Cases Spike, White House Declares Pandemic Over

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Can’t see the audio player? Click here to listen on SoundCloud. White House chief of staff Mark Meadows said this week that “we’re not going to control the pandemic,” effectively conceding that the administration has pivoted from prevention to treatment. But COVID-19 cases are rising rapidly… Read More »KHN’s ‘What the Health?’: As Cases Spike, White House Declares Pandemic Over

Here are the benefits of data consolidation

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Data consolidation and a modern approach to data management across health care organizations are critical for driving operational efficiency, protecting critical patient data and, most importantly, delivering optimal health outcomes.

FBI warns ransomware assault threatens healthcare system

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Federal agencies warned that cybercriminals are unleashing a wave of data-scrambling extortion attempts against the U.S. healthcare system designed to lock up hospital information systems, which could hurt patient care just as nationwide cases of COVID-19 are spiking.

Integration of Movilitas.Cloud and NiceLabel simplifies serialised label printing for highly regulated industries

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Movilitas has announced the integration of its Movilitas.Cloud with NiceLabel’s cloud-based label printing solution to simplify serialised label printing for highly regulated industries. With 50 percent of all label printers globally shipped with NiceLabel technology and over 16 million labels printed on cloud-connected printers monthly,… Read More »Integration of Movilitas.Cloud and NiceLabel simplifies serialised label printing for highly regulated industries

CMS finalizes insurer transparency rule

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The rule forces employer health plans and insurance companies to post in-network and out-of-network rates they negotiate with providers. It also requires insurers to develop online price transparency tools to give patients cost-sharing information.

Boehringer Ingelheim Initiates P-II Study of BI 764198 for Patients with Severe Respiratory Illness from COVID-19

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Shots: The P-II trial will assess BI 764198 (qd for ~4wks.) in patients hospitalized for COVID-19 with expected enrollment initiation in Oct’2020. The 1EPs will be the percentage of patients who are alive and free of mechanical ventilation at day 29 of treatment while other… Read More »Boehringer Ingelheim Initiates P-II Study of BI 764198 for Patients with Severe Respiratory Illness from COVID-19

Fauci expresses support for national mask mandate

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The nation’s top infectious disease expert, Dr. Anthony Fauci, expressed support for a national mask mandate in an interview late Wednesday with CNBC.Fauci explained that the U.S. rate of new coronavirus infections is trending in the wrong…

BMS joins forces with insitro to develop neurodegenerative treatments

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insitro has landed another big biopharma partnership, signing a five-year collaboration with Bristol Myers Sqibb to develop therapies for amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD).  Neurodegenerative disorders such as ALS and FTD are considered a challenging therapeutic area, with no disease modifying treatments… Read More »BMS joins forces with insitro to develop neurodegenerative treatments

Guidances (Drugs)

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Newly added and withdrawn guidances can be found at Guidances (Drugs). FDA guidance documents discuss the production, labeling, manufacturing of regulated products and denote FDA’s current thinking and policy interpretation.

App-Based Companies Pushing Prop. 22 Say Drivers Will Get Health Benefits. Will They?

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App-based driving services such as Uber, Lyft, DoorDash and Instacart are bankrolling California’s Proposition 22, which would keep their drivers classified as independent contractors, not employees. Leading into the Nov. 3 election, the ballot measure — which has become the most expensive in state history… Read More »App-Based Companies Pushing Prop. 22 Say Drivers Will Get Health Benefits. Will They?

Dr Reddy’s partners with Department of Biotechnology for Sputnik V vaccine clinical trials in India

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Chairman of Dr Reddys Laboratories, Satish Reddy said, “We are pleased with the collaboration with BIRAC as an advisory partner for clinical trials of the Sputnik V vaccine in India. We look forward to working with them to accelerate our efforts in bringing the vaccine… Read More »Dr Reddy’s partners with Department of Biotechnology for Sputnik V vaccine clinical trials in India

Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-II BLAZE-1 Study in New England Journal of Medicine

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Shots: The P-II BLAZE-1 study assesses bamlanivimab (700, 2800 & 7000 mg) vs PBO in the outpatient setting in patients with mild or moderate symptoms of COVID-19 as well as a positive SARS-CoV-2 test based on a sample collected no more than 3 days prior… Read More »Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-II BLAZE-1 Study in New England Journal of Medicine

Regeneron Reports Results of REGN-COV2 in P-ll/lll Study in Patients with COVID-19 in Outpatient Setting

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Shots: The P-ll/lll trial involves assessing of REGN-COV2 (8gm/2.4gm) + SOC vs PBO + SOC in 524 patients with mild-to-moderate COVID-19 in an outpatient setting The study met its 1EPs & 2EPs demonstrating a reduction in viral load and patient medical visits. Moreover, Regeneron is… Read More »Regeneron Reports Results of REGN-COV2 in P-ll/lll Study in Patients with COVID-19 in Outpatient Setting

Gateway Health and Giant Eagle Pharmacy pilot an innovative approach to addressing the opioid epidemic in Allegheny County

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Gateway Health and Giant Eagle Pharmacy pilot an innovative approach to addressing the opioid epidemic in Allegheny County Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 Pittsburgh-based Gateway Health Plan has partnered with Giant Eagle Pharmacy to introduce Medicaid members to Project Lifeline, a… Read More »Gateway Health and Giant Eagle Pharmacy pilot an innovative approach to addressing the opioid epidemic in Allegheny County

Despite the Trump administration’s new policy, many pharmacies still won’t vaccinate children against influenza

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Despite the Trump administration’s new policy, many pharmacies still won’t vaccinate children against influenza Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 Although the Trump administration has empowered U.S. pharmacists to administer influenza vaccine to children in hopes of reducing the effect of concurrent… Read More »Despite the Trump administration’s new policy, many pharmacies still won’t vaccinate children against influenza

Association of therapies with reduced pain and improved quality of life in patients with fibromyalgia

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Association of therapies with reduced pain and improved quality of life in patients with fibromyalgia Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 Researchers in Brazil and Australia scrutinized therapies for alleviating pain and enhancing quality of life (QOL) in people with fibromyalgia, most… Read More »Association of therapies with reduced pain and improved quality of life in patients with fibromyalgia

Preventing the spread of SARS-CoV-2 with masks and other ‘low-tech’ interventions

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Preventing the spread of SARS-CoV-2 with masks and other ‘low-tech’ interventions Tue, 10/27/2020 – 20:00 cbaker_admin Thu, 10/29/2020 – 00:00 Use of face masks is essential for combating coronavirus infection, which is primarily transmitted through respiratory droplets, explains National Institute of Allergy and Infectious Diseases… Read More »Preventing the spread of SARS-CoV-2 with masks and other ‘low-tech’ interventions

Medicare to cover all FDA-approved Covid-19 vaccines

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CMS’ interim rule states that Medicare will cover Covid-19 vaccines approved by the FDA, including those receiving emergency use authorization, in a reversal from its usual policy. The vaccine will be made available at no cost to Medicare beneficiaries.