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The U.S. recorded more than 83,000 new coronavirus cases for the second day in a row on Saturday amid a surge as the weather turns colder.  Some 83,718 new cases were reported on Saturday, according to a count from Johns Hopkins…

Abortion rights supporters and opponents have said the issue is on the ballot this November with the battle between President Trump, who considers himself “pro-life,” and Joe Biden, who says he is “pro-choice.”But abortion is literally on the ballot…

With coronavirus infections reaching their highest peak of the pandemic just as the election headed into the home stretch, President Donald Trump and former Vice President Joe Biden took starkly different approaches to the public health crisis in appealing for votes in battleground states.

While COVID-19 infections spike uncontrollably across the country, California has turned the corner.After a brutal summer as one of the worst coronavirus hot spots, the most populous state in the country is once again being touted as a success story…

Texas regulators approved the sale of three hospitals via a Certificate of Public Advantage law, despite scrutiny from federal overseers. Modern Healthcare Hospital Operations Reporter Alex Kacik spoke with Finance Reporter Tara Bannow to discuss how the framework of the COPA could spur more hospital… Read More »Beyond the Byline: Texas COPA law may pave the way for more hospital M&A

Anthony Fauci, the nation’s top infectious disease expert, said on Friday that the U.S. may want to mandate face coverings amid the latest surge of coronavirus cases. In a CNN interview on Friday, Fauci was asked if he thought Democratic…

President Trump and Democratic nominee Joe Biden are offering opposing visions of responding to the coronavirus crisis as a new wave of cases mounts just ahead of Election Day. Biden warned of a “dark winter” at Thursday night’s debate as new…

The pandemic may have marked the beginning of the end of state physician licensure, if telehealth proponents get their way.

While the pandemic may have led to layoffs of scribes in the U.S., companies offering remote scribing have seen growth.

Healthcare leaders can look to their own career trajectories and see how others helped them reach the pinnacle of their careers, and how they can help others forge similar paths.

Telehealth became an instant necessity amid the COVID-19 pandemic. With its newfound prominence, it is catapulting American healthcare forward in ways that make care more accessible, adaptable and affordable. 

A new streaming service is gearing up to offer consumers healthcare and wellness videos. Planned series will cover living well, cancer, the brain, aging, behavioral health, chronic illness, and disability.

Industry leaders share their thoughts on how healthcare can begin improving diversity and inclusion efforts to increase minority representation in leadership roles.

About 24 people per minute are victims of violence by an intimate partner, and the increased economic stress and isolation brought on by the pandemic threatens to exacerbate an already challenging problem.

All manner of programs for “breaking bias” haven’t been working. If you do what you’ve always done, you’ll get what you’ve always got.

The results of Modern Healthcare’s annual survey rank the nation’s 17 largest patient-satisfaction measurement firms by total number of clients in 2019.

Scrubs marketer Figs managed to pull off an outrage two-fer with a recent video: offending both osteopaths and women clinicians. 

The presidential race will likely be top of mind for voters this fall, but the November election will also decide legislative agendas for healthcare reform in Congress and in the states.

The U.S. set a new record for new coronavirus cases in a single day Friday as the country undergoes an alarming new surge in infections. According to the COVID Tracking Project’s tally, there were over 83,000 new confirmed COVID-19 cases across…

FDA approves first treatment for COVID-19 Thu, 10/22/2020 – 20:00 cbaker_admin Fri, 10/23/2020 – 19:00 FDA approved on Thursday remdesivir (Veklury—Gilead Sciences) for the treatment of hospitalized COVID-19 patients aged 12 years and older and weighing at least 40 kilograms (about 88 lbs). This is… Read More »FDA approves first treatment for COVID-19

FDA advisory committee debates safety and efficacy standards for a coronavirus vaccine Thu, 10/22/2020 – 20:00 cbaker_admin Fri, 10/23/2020 – 19:00 FDA’s Vaccines and Related Biological Products Advisory Committee spent Thursday scrutinizing the agency’s planned standards for fast approval of a coronavirus vaccine for widespread… Read More »FDA advisory committee debates safety and efficacy standards for a coronavirus vaccine

Landmark TB trial identifies shorter-course treatment regimen Thu, 10/22/2020 – 20:00 cbaker_admin Fri, 10/23/2020 – 19:00 A Phase III, open-label trial, known as Study 31/A5349, led by CDC’s Tuberculosis Trials Consortium, suggests that a 4-month daily treatment regimen containing high-dose, or “optimized,” rifapentine with moxifloxacin… Read More »Landmark TB trial identifies shorter-course treatment regimen

CDC now “strongly recommends” masks on public transport and at hubs Thu, 10/22/2020 – 20:00 cbaker_admin Fri, 10/23/2020 – 19:00 New CDC guidance says the agency “strongly recommends appropriate masks be worn by all passengers and by all personnel” operating public transport across the country.… Read More »CDC now “strongly recommends” masks on public transport and at hubs

COVID-19 surge prompts warnings that anticipated ‘third wave’ is now here Thu, 10/22/2020 – 20:00 cbaker_admin Fri, 10/23/2020 – 19:00 The increase in COVID-19 infections and hospitalizations is sparking concerns that a fall and winter wave of the pandemic may be on the horizon. “We’ve… Read More »COVID-19 surge prompts warnings that anticipated ‘third wave’ is now here

As COVID-19 intensifies, shortages of staple drugs may grow worse Thu, 10/22/2020 – 20:00 cbaker_admin Fri, 10/23/2020 – 19:00 A new report by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota warns that the pandemic could intensify existing medicine… Read More »As COVID-19 intensifies, shortages of staple drugs may grow worse

Walmart and Sam’s Club support Prescription Drug Take Back Day events nationwide Thu, 10/22/2020 – 20:00 cbaker_admin Fri, 10/23/2020 – 19:00 As part of DEA’s biannual National Prescription Drug Take Back Day, Walmart and Sam’s Club will host in-person medication disposal events at select store… Read More »Walmart and Sam’s Club support Prescription Drug Take Back Day events nationwide

CVS Health adds resources to prevent opioid abuse amid the pandemic Thu, 10/22/2020 – 20:00 cbaker_admin Fri, 10/23/2020 – 19:00 CVS Health is introducing new initiatives to help prevent the misuse of opioid analgesics, including free digital resources that encourage educators to discuss the facts… Read More »CVS Health adds resources to prevent opioid abuse amid the pandemic

Georgia pharmacists report high-dose influenza vaccine in limited supply Thu, 10/22/2020 – 20:00 cbaker_admin Fri, 10/23/2020 – 19:00 Some Georgia pharmacists say they are struggling to find enough influenza vaccines for older patients this year. Nikki Bryant, owner of Adams Family Pharmacy in south Georgia,… Read More »Georgia pharmacists report high-dose influenza vaccine in limited supply

Pharmacy instrumental during pandemic, recognized during Pharmacy Week Thu, 10/22/2020 – 20:00 cbaker_admin Fri, 10/23/2020 – 19:00 The third full week in October is Pharmacy Week, which acknowledges pharmacy contributions to patient care in hospitals, outpatient clinics, and other health care settings. The distribution of… Read More »Pharmacy instrumental during pandemic, recognized during Pharmacy Week

Walmart files pre-emptive lawsuit against federal government in opioid case Thu, 10/22/2020 – 20:00 cbaker_admin Fri, 10/23/2020 – 19:00 Walmart lodged a lawsuit against the federal government on Thursday, acting before the Justice Department could bring civil litigation against the company related to questionable opioid… Read More »Walmart files pre-emptive lawsuit against federal government in opioid case

Community health centers sue HHS to install method to handle 340B violations after drugmaker feud Thu, 10/22/2020 – 20:00 cbaker_admin Fri, 10/23/2020 – 19:00 The National Association of Community Health Centers (NACHC) is suing HHS over the 340B drug discount program, contending that some drug… Read More »Community health centers sue HHS to install method to handle 340B violations after drugmaker feud

The U.S. regulator granted a full approval after allowing emergency use earlier this year. New results from a WHO study, however, raise questions about the drug’s ultimate effectiveness.

A handful of states are unable to post accurate data on COVID-19 dashboards because of a flaw in the federal reporting system.

The 2% payment cut was suspended under the CARES Act, but providers say the ongoing financial pain they are feeling due to the COVID-19 pandemic means it should continue to be on hold well into next year.

Welcome to Friday’s Overnight Health Care.Joe Biden detailed his plan to combat the COVID-19 pandemic as the U.S. approached its July peak in cases. A new study suggests masks can save 130,000 lives, and Anthony Fauci said Trump listens to Scott…

Coronavirus (COVID-19) Update: Daily Roundup

“Wearables have the potential to change the world.” While João Bocas’ statement is bold, you might find yourself wholeheartedly agreeing with him after just a brief conversation. His passion for wearable devices and their potential benefits for healthcare was evident in a recent call with HealthTech.… Read More »Q&A: João Bocas Shares the Latest on Wearables in Healthcare

Some healthcare organizations that received federal relief funding are incurring hundreds of thousands of dollars in additional expenses as they navigate mergers and acquisitions.

AstraZeneca announced on Friday that the Food and Drug Administration (FDA) has allowed the company to restart its phase 3 COVID-19 vaccine trial in the U.S. The company has said the FDA has reviewed all data and concluded that it is safe…

Individual coverage health reimbursement arrangements could lead to higher individual market premiums, loss of employer-sponsored insurance and increased consumer burden, a report found.

While healthcare providers are more interested in addressing social determinants of health, many still don’t screen all of their patients to identify their potential needs.

Democratic nominee Joe Biden on Friday called for a sevenfold increase in the country’s testing, as he laid out further plans for fighting the pandemic in a speech taking aim at President Trump. Biden is making the worsening pandemic a central…

A group of Ohio landlords and the National Association of Home Builders (NAHB), a national trade group for the housing industry, filed a lawsuit Friday to overturn the Centers for Disease Control and Prevention (CDC) eviction ban.In a lawsuit filed…

Financial problems at the hospital were worsened by the pandemic, which forced many patients to delay or cancel elective procedures.

The U.S. is approaching a record for the number of new daily coronavirus cases in the latest ominous sign about the disease’s grip on the nation, as states from Connecticut to Idaho reel under the surge.

Prescription Drug User Fee Act (PDUFA) that provides FDA with the necessary resources to maintain a predictable and efficient review process for human drug and biologic products.

Gov. Phil Murphy signed two bills into law aimed at addressing staffing shortages and residents’ isolation at New Jersey’s long-term care facilities, two areas of vulnerability exposed during the coronavirus pandemic.

Though much of healthcare has made progress with value-based payment models, most federally qualified health centers remain tethered to an outdated payment structure. Without change, many centers will not stay afloat for long.

Efficient Laboratories, Inc. is voluntarily recalling one lot each of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAXliquid. Specifically, we are recalling the following lots: Rompe Pecho EX lot 19F332, exp June 2022, Rompe Pecho CF lot 19H359, exp August 2022 and Rompe… Read More »Efficient Laboratories, Inc. Issues Voluntary Nationwide Recall of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX due to Microbial Contamination

President Trump has not been to a White House coronavirus task force meeting in several months, Anthony Fauci said Friday.During an interview on Meet the Press Daily, Fauci, the nation’s top infectious disease doctor said he hasn’t directly…

The FDA had granted remdesivir emergency authorisation in May after a trial by the National Institutes of Health found that it modestly reduced the recovery time in people hospitalised with Covid-19. US President Donald Trump, too, received the antiviral drug after he began showing symptoms… Read More »India to seek latest data on efficacy of Gilead’s Remdesivir

The Pharmaceutical Product Stewardship Work Group (PPSWG) is a non-profit membership association for producers of pharmaceutical products. PPSWG was founded in 2014 to organize and facilitate cooperative efforts among pharmaceutical producers to address the disposal of unwanted, unused, or expired medicines from households. PPSWG’s vision… Read More »Safe drug disposal: National Prescription Drug Take Back Days and other year-round opportunities

Universal mask-wearing could prevent nearly 130,000 deaths from COVID-19 through the end of February, according to new research released Friday.The analysis, published in the journal Nature Medicine, found that even if only 85 percent of the…

Telehealth and digital health companies dominated much of the investment activity, according to a report from S&P Global Market Intelligence.

The vaccine ‘Covaxin’ is being indigenously developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

Pollsters have been busy this year tracking public sentiment around the top issues of concern for voters. Recent public polling shows that voters priorities have shifted dramatically over the course of the year. With the election less than two weeks away, what is truly on… Read More »Three things you should know about recent health care polling

Information of particular interest to sponsors/applicants of medical countermeasures to treat, prevent, diagnose, and detect chemical, biological, radiological, and nuclear threats and emerging infectious diseases

Former Indivior CEO gets 6 months in jail for role in Suboxone marketing scheme kblankenship Fri, 10/23/2020 – 11:13

Most of these $1 billion-plus projects were planned before the pandemic and will help provide much-needed beds and healthcare services.

This material is intended to be a helpful resource that consolidates information relevant for drug manufacturers making products for the U.S. market. It is not a comprehensive list of all applicable statutory and regulatory requirements.

INMAZEB is a drug used to treat pediatric and adult patients who have an infection caused by Zaire ebolavirus.

A report released this week from the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota said that COVID-19-related drug shortages in the United States have reached “unacceptable” levels.“Ensuring a Resilient US…

Subscription services revenue rose 17% to $36.9 million for NextGen’s fiscal 2021 second quarter, which ended Sept. 30.

Deaths rattle South Korea’s seasonal flu vaccination, but authority presses ahead with free scheme aliu Fri, 10/23/2020 – 10:20

Merck, Pfizer pneumonia vaccines running low in EU as researchers fight COVID-19: report kblankenship Fri, 10/23/2020 – 10:10

The prescription of potentially inappropriate medications to older adults is linked to increased hospitalizations, and it costs patients, on average, more than $450 per year, according to a new study.

Since the Drug Supply Chain Security Act (DSCSA) was enacted in 2013, FDA has issued the following guidance and policy documents

Gilead scored a full FDA approval for COVID-19 drug Veklury, but experts aren’t convinced esagonowsky Fri, 10/23/2020 – 09:28

The United States on Thursday reported at least 75,049 new coronavirus cases, the second-highest daily total across the country since the onset of the pandemic, according a database from The New York Times.There has been an average of 62,166…

The organiser of Chemspec Europe, Mack-Brooks Exhibitions, has announced a new digital event for the international fine and speciality chemicals industry in order to help pave the way for the recovery from the COVID-19 pandemic. Chemspec Digital 2020 provides a dedicated virtual marketplace for bespoke… Read More »Chemspec Digital 2020: pave the way for the recovery of the fine and speciality chemicals industry

Early analysis of the unprecedented shift from traditional face-to-face healthcare towards virtual digital care during the pandemic show that patients have embraced this new care paradigm and expect it to endure beyond 2020.   Patient surveys carried out globally by therapeutics company, Medisafe, during March… Read More »Digital companions: helping improve patient treatment journeys

Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy Guidance for Industry

The UK National Institute of Health and Care Excellence (NICE) has published final draft guidance recommending Keytruda (pembrolizumab) for the treatment of untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC). The drug is produced by Merck Sharp & Dohme. The treatment will be available as… Read More »NICE recommends Keytruda (pembrolizumab) for treatment of HNSCC

The US Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for use in adult and paediatric patients 12 years of age and older for the treatment of COVID-19 requiring hospitalisation. The marketing authorisation has been granted to Gilead Sciences. The company… Read More »FDA approves remdesivir for treatment of COVID-19

Read the Prime Minister’s update following the National Cabinet meeting on 23 October 2020.

23/10/2020 14th Greening Network Meeting – Exchange of experiences on environmental matters kreativkolors – www.freepik.es As part of its continuous effort and commitment to raising awareness about the environment, on 15 th October the Agency has hosted online – for the first time ever –… Read More »14th Greening Network Meeting – Exchange of experiences on environmental matters

Hospitalised COVID-19 patients who were taking a daily low-dose aspirin to protect against cardiovascular disease had a significantly lower risk of complications and death compared to those who were not taking aspirin, according to a new study. The research was led by scientists at the… Read More »Aspirin could protect patients from severe COVID-19 complications

FiercePharmaAsia—Dr. Reddy’s under cyberattack; Insilico-Taisho AI collab; Fosun’s Gland IPO aliu Fri, 10/23/2020 – 04:47

Agreement will see partners develop SARS-CoV-2 neutralising monoclonal antibodies

Collaboration will involve applying machine learning for research into rare blood diseases

Keytruda backed for monotherapy treatment but combination therapy rejected

Antiviral becomes first COVID-19 treatment approved in the US

Albuterol is a bronchodilator which helps open up the airways in the lungs to make it easier to breathe. The medicine is used to treat and to prevent bronchospasm.

The Framework for National Reopening builds on the 3-Step Framework for a COVIDSafe Australia, to nationally reopen to a state of ‘COVID Normal’, wherever it is safe to do so, by December 2020.

Trump boasted about dismantling the Affordable Care Act’s individual mandate, while Biden maintained his support for private insurance with a public option.

The approval of Veklury (remdesivir) was supported by the agency’s analysis of data from three randomized, controlled clinical trials that included patients hospitalised with mild-to-severe COVID-19, the FDA said.

Democratic presidential nominee defended his health plan against attacks from President Trump, pushing back against claims that he supports socialized medicine. During the presidential debate Thursday, Trump said Biden’s public option will…

Senate Majority Leader Mitch McConnell (R-Ky.) said Thursday there were “no concerns” about his health, after bandages and what appeared to be bruises on his hands drew widespread attention this week.McConnell, 78, batted down questions from…

President Trump and Democratic nominee Joe Biden had an extended clash over the response to the coronavirus in Thursday’s debate, with Biden pointing to the mounting death toll and Trump saying the country cannot remain closed down.Biden pointed to…