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FDA Committee Votes to Withdraw Two Accelerated Approvals of Cancer Treatments
https://www.ashclinicalnews.org/online-exclusives/fda-committee-votes-withdraw-two-accelerated-approvals-cancer-treatments/

May 5th, 2021 - The U.S. Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee (ODAC) recommended withdrawing two of six accelerated approvals of cancer treatments that it reevaluated in a recent meeting, citing the failure to verify benefit in follow-up trials. The committee voted 6-2 to withdraw the accelerated approval of pembrolizumab for the treatment of patients with recurrent locally...

Pipette Tip Shortage Hinders Scientific Work Worldwide
https://www.ashclinicalnews.org/online-exclusives/pipette-tip-shortage-hinders-scientific-work-worldwide/

May 5th, 2021 - An ongoing pipette tip shortage caused by the COVID-19 pandemic, blackouts in Texas, and a manufacturing plant fire is hindering scientific work around the world, from newborn screening to drug development to basic research. While COVID-19 diagnostic tests’ reliance on pipette tips has contributed to the shortage, several other issues further up the supply chain have also played a role. Winter ...

Will the FDA Crack Down on Clinical Trial Reporting Noncompliance?
https://www.ashclinicalnews.org/online-exclusives/will-fda-crack-clinical-trial-reporting-noncompliance/

May 5th, 2021 - The U.S. Food and Drug Administration (FDA) has issued its first notice of noncompliance to Acceleron Pharma for failing to submit clinical trial results to ClinicalTrials.gov, the federal government’s database of privately and publicly funded clinical studies. If the pharmaceutical company does not submit the required data within 30 days, the agency is authorized to seek civil monetary penalti...

FDA In Brief: FDA Issues Procedural Notice on Potential Plans to Conduct Research About Use of ‘Healthy’ Symbols on Food Products
https://www.fda.gov/news-events/press-announcements/fda-brief-fda-issues-procedural-notice-potential-plans-conduct-research-about-use-healthy-symbols
US Food and Drug Administration

May 5th, 2021 - The FDA understands that consumers want healthy choices when it comes to food and nutrition. Today, we are issuing a procedural notice on preliminary consumer research we are planning on the use of symbols on food product labels. The symbol could later be used to convey the nutrient content claim ‘healthy.’

Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations | FDA
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-outlines-inspection-and-assessment-activities-during-pandemic

May 5th, 2021 - For Immediate Release: May 05, 2021 Today, the U.S. Food and Drug Administration issued a new report titled, “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the agency’s inspectional activities during the COVID-19 pandemic and its detailed plan to move toward a more consistent state of operations, including the FDA’s priorities related to this work going forward. “Like most organ...

NHS England to Introduce 3D Heart Scans for Quicker Diagnosis of CAD
https://www.medscape.com/viewarticle/950531

May 4th, 2021 - NHS England is to introduce a pioneering technology called HeartFlow for quicker diagnosis and treatment of suspected heart disease. HeartFlow transforms a regular cardiac computerised tomography (CT) scan into a three-dimensional (3D) image, enabling physicians to diagnose coronary heart disease (CAD) within 20 minutes. The technology could potentially cut the need for invasive and laborious a...

When to Refer Patients With New Memory Loss
https://www.medscape.com/viewarticle/950534

May 4th, 2021 - Asking a patient who has concerns about memory loss particular questions can guide referral decisions, according to new research. Initial questions should zero in on what the patient is forgetting, said Megan Richie, MD, a neurohospitalist at the University of California, San Francisco, who spoke to a virtual audience at the American College of Physicians (ACP) Internal Medicine Meeting. Is the...

Checkpoint Inhibitor Skin Side Effects More Common in Women
https://www.medscape.com/viewarticle/950535

May 4th, 2021 - Women had about a twofold higher risk than men of developing dermatologic adverse events while taking immune checkpoint inhibitors for metastatic melanoma in a review of 235 patients at Dana Farber Cancer Center, Boston, Massachusetts. Overall, 62. 4% of the 93 women in the review and 48 "This suggests that factors beyond sex hormones are likely contributory" to the difference in risk between m...

Metformin Use During Pregnancy and Maternal Outcomes
https://www.medscape.com/viewarticle/950077

May 4th, 2021 - Takeaway Use of metformin for any indication during pregnancy was associated with a reduction in gestational weight gain (GWG) and a modest reduction in the risk of pre-eclampsia, but an increased risk of gastrointestinal (GI) side effects compared with other treatments. No significant effects were observed on other maternal outcomes. Why this matters Despite the widespread use of metformin dur...

Fast Five Quiz: Squamous Cell Non-Small Cell Lung Cancer
https://reference.medscape.com/viewarticle/928233

May 4th, 2021 - Lung cancer continues to be the leading cause of cancer-related deaths worldwide. Non–small cell lung cancer (NSCLC), which accounts for 85% of all lung cancers, is divided histologically into adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. In the United States, Canada, and many European countries, squamous cell carcinoma is the second most common histologic subtype of lung c...

Ohio Surgeon Who Wrote His Own Colorful Obituary Dead at 48
https://www.medscape.com/viewarticle/950540

May 4th, 2021 - The family of Ohio surgeon Thomas Lee Flanigan, 48, who died last week, made public the obituary he wrote himself, self-eulogizing his "shocking and unexpected, yet fabulous, exit." Flanigan, who referred to himself as the "Ginger God of Surgery and Shenanigans," wrote, "Yes, I have joined the likes of Princess Diana, John Belushi, and Steve Irwin the Crocodile Hunter in leaving while still at ...

In-Hospital Glucose Management Program Gives Dramatic Savings
https://www.medscape.com/viewarticle/950563

May 4th, 2021 - Initiatives targeting hypoglycemia and insulin pen wastage could lead to dramatic cost savings in small community hospitals, new data suggest. The two projects are part of a dedicated inpatient glucose management service led by Mihail ("Misha") Zilbermint, MD, one of the few full-time endocrine hospitalists in the United States and one of even fewer who work at a small community hospital. Regar...

'Malicious Peer Review' Destroyed Doc's Career, He Says
https://www.medscape.com/viewarticle/950564

May 4th, 2021 - Cardiothoracic surgeon J. Marvin Smith III, MD, had always thrived on a busy practice schedule, often performing 20 to 30 surgeries a week. A practicing surgeon for more than 40 years, Smith says he had no plans to slow down anytime soon. But Smith says his career was derailed when leaders at Methodist Healthcare System of San Antonio initiated a sudden peer review proceeding against him. The h...

FDA Reviewers: Why We Are Against Approval of Aducanumab for Alzheimer's
https://www.medscape.com/viewarticle/950565

May 4th, 2021 - Three members of a US Food and Drug Administration (FDA) advisory committee are explaining why they do not support approval of the drug aducanumab (Biogen, Eisai) for the treatment of Alzheimer's disease (AD). G. Caleb Alexander, MD, Scott Emerson, MD, PhD, and Aaron Kesselheim, MD, JD, MPH, all serve on the FDA's Peripheral and Central Nervous System Advisory Committee and participated in the ...

Progress Stalling on Malaria Elimination
https://www.medscape.com/viewarticle/950546

May 4th, 2021 - In its final report on the E-2020 initiative, the World Health Organization (WHO) touted its progress on its goal of eliminating malaria throughout the world. But critics are charging that progress has stalled. The E-2020 initiative supported the efforts of twenty-one countries in eliminating malaria. In a remarkable achievement, especially during the COVID-19 pandemic, eight E-2020 member coun...

Hit by Higher Prices for Gear, Doctors and Dentists Want Insurers to Pay
https://www.medscape.com/viewarticle/950579

May 4th, 2021 - SACRAMENTO — Treating patients has become more expensive during the pandemic, and doctors and dentists don't want to be on the hook for all the new costs. For instance, the box of 100 gloves that cost $2. 39 in February 2020 costs $30 now, said Dr Reimbursing the cost of nonmedical supplies isn't typically the responsibility of insurers, said Mary Ellen Grant, spokesperson for the California As...

Novel Drug Offers Rapid Relief From Agitation in Serious Mental Illness
https://www.medscape.com/viewarticle/950613

May 4th, 2021 - An investigational, orally dissolving film formulation of dexmedetomidine (BXCL501, BioXcel Therapeutics) may offer rapid relief from acute agitation related to schizophrenia or bipolar disorder (BD), results of two phase 3, randomized, placebo-controlled trials show. Dr Leslie Citrome For both disorders, BXCL501 showed "superiority over placebo" by meeting the primary endpoint of reduction of ...

Docs Mobilize Help For Indian Colleagues Overwhelmed With COVID-19 Surge
https://www.medscape.com/viewarticle/950603

May 4th, 2021 - Clinicians from across the world are banding together to mobilize help for their colleagues in India, where more than 300,000 new cases of COVID-19 have been reported daily for the past 2 weeks. Some are working hotlines and disseminating critical public health information; others are crowdfunding for equipment, training young doctors, or supporting vaccine registration.  In the last 2 weeks, a...

Delays a Major Cause of Transfusion-related Deaths
https://www.medscape.com/viewarticle/950553

May 4th, 2021 - Transfusion-related circulatory overload (TACO) remains the most common cause of transfusion-related death, although deaths due to delays are increasing year-on-year, shows an analysis of reports to the UK’s transfusion safety body. "Communication is a major, major issue" when it comes to delays, which account for over one in four deaths, explained lead author Simon Carter-Graham, clinical inci...

Insomnia? Referral, Drugs Not Usually Needed
https://www.medscape.com/viewarticle/950539

May 4th, 2021 - Chronic insomnia is often underrecognized and misunderstood in primary care, sleep expert Christopher Lettieri, MD, told attendees at the American College of Physicians (ACP) Internal Medicine Meeting 2021. Too often, medications are the treatment of choice, and when used long term they can perpetuate a problematic cycle, said Lettieri, professor in pulmonary, critical care, and sleep medicine ...

India Virus Variant Identified in Two Southeast Iowa People
https://www.medscape.com/viewarticle/950600

May 4th, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. DES MOINES, Iowa (AP) — A third coronavirus variant that was first identified in hard-hit India has been uncovered in Iowa, state public health officials said Tuesday. The Iowa Department of Public Health said it has confirmed two cases of the variant, SARS-CoV-2 B.1.617. Health officials are st...

Female Physicians More Likely Than Other Women to Delay Childbearing
https://www.medscape.com/viewarticle/950436

May 4th, 2021 - (Reuters Health) - Compared to women in the general public, female physicians in Canada are less likely to have children overall, less likely to have babies when they are in their twenties, and far more likely to delay childbearing until they are in their late thirties, a new study finds. An analysis of data from 5,328 female doctors and 26,640 non-physician women revealed that the physicians w...

COVID-19 Severity Starts in Normal BMI Range, Especially in Young
https://www.medscape.com/viewarticle/950568

May 4th, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. The risk of severe outcomes with COVID-19 increases with excess weight in a linear manner beginning in normal body mass index ranges, with the effect apparently independent of obesity-related diseases such as diabetes and stronger among younger people and Black persons, new research shows. Risk ...

Exclusive: Guidance on Talking to Patients About COVID-19 Vaccines
https://www.medscape.com/viewarticle/950569

May 4th, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. Physicians remain one of the most trusted sources of nonjudgmental information for patients ― including on vaccinations ― and this could come in handy as the daily pace at which people receive COVID-19 vaccines nationwide continues to slow. "Anytime you have a new disease, new procedure, or a ne...

After Hundreds of Interviews, Here's John Whyte's View of COVID
https://www.medscape.com/viewarticle/950180

May 4th, 2021 - This transcript has been edited for clarity. Eric J. Topol, MD: This is Eric Topol for Medscape and the Medicine and the Machine podcast. It is a special privilege for me today to welcome Dr John Whyte, who is the chief medical officer at WebMD. Welcome, John. John Whyte, MD, MPH: Thanks, Eric. It's great to be with you. Topol: We're flipping the script because John has interviewed me several t...

COVID and False Beliefs: How Social Media Exploits Cognitive Bias
https://www.medscape.com/viewarticle/950367

May 4th, 2021 - Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. This transcript has been edited for clarity. Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I'm Dr F. Perry Wilson of the Yale School of Medicine. Medical misinformation is nothing new, but I think we can all agree that the coronavirus pandemic has added fuel to the misinforma...

Big Three Drug Distributors Blame Doctors, Regulators in Trial Over Opioid Epidemic
https://www.medscape.com/viewarticle/950438

May 4th, 2021 - (Reuters) - The three largest U.S. drug distributors, facing their first trial over claims that they fueled the opioid crisis, said responsibility for ballooning painkiller sales lies with doctors, drugmakers and regulators. AmerisourceBergen Corp, McKesson Corp and Cardinal Health Inc are defending themselves against a lawsuit brought by the city of Huntington and Cabell County in West Virginia.

Corticosteroid Bursts May Increase GI Bleeding, Sepsis Risk in Children
https://www.medscape.com/viewarticle/950567

May 4th, 2021 - Oral corticosteroid bursts are associated with an increased risk of gastrointestinal bleeding, sepsis, and pneumonia during the month after treatment initiation, according to a nationwide cohort study of children in Taiwan. The adverse events are rare, and the risk attenuates in subsequent months, the analysis shows. Still, the study "provides evidence that corticosteroid bursts are not innocuo...

Marijuana Vaping More Common Among Hispanic Teens
https://www.medscape.com/viewarticle/950571

May 4th, 2021 - Hispanic adolescents were more likely to use e-cigarettes to vape marijuana than were their Black and White counterparts in 2020, according to a recent study conducted by the Centers for Disease Control and Prevention and published in JAMA Pediatrics. Researchers found that 25. 6% of Hispanic students reported vaping marijuana, compared to 19 "We are probably missing access to some of the kids ...

New Federal Program Reimburses Vaccine Administration Fees for Underinsured Patients
https://www.medscape.com/viewarticle/950544

May 4th, 2021 - A new federal program will cover physicians' costs of administering COVID-19 vaccines to patients enrolled in health plans that either do not cover vaccination fees or cover them with patient cost-sharing. Physicians will be compensated for vaccine administration at national Medicare rates, which were raised in March. The new COVID-19 Coverage Assistance Fund (CAF), which the Department of Heal...

'Last Resort': Desperate for Oxygen, Indian Hospitals Go to Court
https://www.medscape.com/viewarticle/950439

May 4th, 2021 - NEW DELHI (Reuters) - A court in India's capital New Delhi has become the last hope for many hospitals struggling to get oxygen for COVID-19 patients as supplies run dangerously short while government officials bicker over who is responsible. A two-judge bench of the Delhi High Court has been holding almost daily video conferences to hear petitions from hospitals invoking India's constitutional...

Formal Geriatric Assessment Should Be Routine
https://www.medscape.com/viewarticle/950609

May 4th, 2021 - As the number of elderly patients with cancer continues to rise — and geriatricians remain in short supply — primary care providers and community oncologists need to incorporate formal geriatric assessment into routine practice, a geriatric oncologist said during a presentation at the American College of Physicians annual Internal Medicine meeting. A 2020 ASCO survey, which the speaker, Grant R...

Montana Tribe Gifts Vaccines to Neighbors Across the Border
https://www.medscape.com/viewarticle/950591

May 4th, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. BABB, Montana (AP) — On a cloudy spring day, hundreds lined up in their cars on the Canadian side of the border crossing that separates Alberta and Montana. They had driven for hours and camped out in their vehicles in hopes of receiving the season's hottest commodity — a COVID-19 vaccine — from...

With RA in Remission, Tapering of Conventional DMARDs May Lead to Disease Flares for Some Patients
https://www.medscape.com/viewarticle/950455

May 4th, 2021 - NEW YORK (Reuters Health) - In patients with rheumatoid arthritis (RA) in remission taking conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), cutting the drug dose in half could lead to more disease flares, according to a randomized controlled trial. Sustained remission is now achievable for RA patients receiving csDMARDs, but how to best manage patients in clinical remiss...

Peloton, Feds Agree to Treadmill Recall
https://www.medscape.com/viewarticle/950587

May 4th, 2021 - Exercise giant Peloton has agreed to recall its popular and pricey treadmill after at least one child was killed after becoming caught underneath the machine's belt. Peloton has also agreed to recall its limited-edition Tread, after 18 reports of the touchscreen loosening and six reports of the screen detaching and falling off. No injuries have been reported for the Tread Among the 72 reports o...

Nutritional Support May Be Lifesaving in Heart Failure
https://www.medscape.com/viewarticle/950599

May 4th, 2021 - Personalized nutritional support for adults hospitalized with chronic heart failure and deemed to be at high nutritional risk reduced the risk of dying or suffering adverse cardiovascular events compared with standard hospital food, new research indicates. The Swiss EFFORT trial focused on patients with chronic heart failure and high risk of malnutrition defined by low body mass index (BMI), we...

COVID Shot in the Arm Not Enough to Keep Pharmacies in Business
https://www.medscape.com/viewarticle/950584

May 4th, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. Joe Moose, co-owner of Moose Pharmacies in the Charlotte, North Carolina, area, is trying to adapt to the changes dealt by COVID. The chain expanded curbside services, hired additional drivers and tripled home deliveries Most pharmacies, he said, saw a decline in prescriptions last year as custo...

N Carolina GOP Advances Bill to Ban Down Syndrome Abortions
https://www.medscape.com/viewarticle/950573

May 4th, 2021 - RALEIGH, NC (AP) — North Carolina lawmakers on Tuesday advanced a bill to make it illegal for physicians to perform abortions because of the fetus' race or a prenatal diagnosis of Down syndrome. A physician would be subject to monetary damages if he or she performed an abortion despite being aware that the pregnant woman's decision to get the procedure was influenced by either of those two conc...

Pharma Company to Pay $12.6M to Settle Kickback Allegations
https://www.medscape.com/viewarticle/950585

May 4th, 2021 - DOVER, Del. (AP) — A Delaware pharmaceutical company has agreed to pay $12.6 million to resolve allegations that it violated the federal False Claims Act by paying kickbacks. Department of Justice officials said in a news release Tuesday that the settlement resolves allegations that Incyte Corp. improperly used an independent foundation to cover the copays of certain people taking the company's...

Biden Wants 70% of the US Vaccinated by July 4
https://www.medscape.com/viewarticle/950597

May 4th, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. President Joe Biden has announced new strategies for the national COVID-19 vaccination program as demand for vaccinations drops. He also set a new goal for getting shots into people's arms. "Our goal by July Fourth is to have 70% of adult Americans with at least one shot and 160 million American...

Tofacitinib: Small Study Shows Big Cutaneous Sarcoidosis Response
https://www.medscape.com/viewarticle/950598

May 4th, 2021 - Researchers are reporting impressive results in a small, open-label trial of the JAK inhibitor tofacitinib in cutaneous sarcoidosis: 6 of 10 patients improved so much that they reached a disease activity level of zero, and all patients improved by an average of 83% via a scoring system. "Not only did patients get better, but they were in many cases able to come off their baseline immunosuppress...

Therapeutic Drug Monitoring Has Little Value During Infliximab Induction
https://www.medscape.com/viewarticle/950456

May 4th, 2021 - NEW YORK (Reuters Health) - Results of a randomized controlled trial do not support routine use of proactive therapeutic drug monitoring (TDM) during infliximab induction for improving disease remission rates in patients with rheumatoid arthritis (RA) and other chronic immune-mediated inflammatory diseases. Proactive TDM tailors biologic therapy to individual patients by measuring serum drug le...

Pfizer Bets on COVID-19 Vaccine Demand for Years, Sees Sales of $26 Bln in 2021
https://www.medscape.com/viewarticle/950462

May 4th, 2021 - (Reuters) - Pfizer Inc on Tuesday raised its forecast for 2021 COVID-19 vaccine sales by more than 70% to $26 billion and said demand from governments around the world trying to halt the pandemic could contribute to its growth for years to come. The company said it expects by the end of this month to file for full approval of the vaccine for people over the age of 16 in the United States, where...

EU Regulator Begins Real-time Review of First Chinese COVID-19 Vaccine
https://www.medscape.com/viewarticle/950441

May 4th, 2021 - (Reuters) - Europe's medicines regulator said on Tuesday it has started a real-time review of Sinovac's COVID-19 vaccine, based on preliminary results from animal and human trials that suggested the vaccine produces an immune response against the coronavirus. Data on the vaccine, COVID-19 Vaccine (Vero Cell) Inactivated, will be assessed as they are made available to help speed up potential app...

UK COVID-19 Update: 'Significant' Pandemic Burden on Female Staff, Porton Down Investment
https://www.medscape.com/viewarticle/950537

May 4th, 2021 - These are the UK coronavirus stories you need to know about today. 'Significant' Pandemic Burden on Female Staff There was a significant worsening in the physical and mental wellbeing of female health and care workers in England during the pandemic, according to 900 responses to an NHS Confederation poll of male and female staff carried out in February and March. More than 80% of female respond...

RUC Alternative Might Address Lagging Primary-Care Pay: Report
https://www.medscape.com/viewarticle/950532

May 4th, 2021 - Tucked within a new National Academies report on the future of primary care is a challenge to an influential panel whose approach to valuing US physician pay has been criticized for being skewed toward specialists. The Centers for Medicare & Medicaid Services (CMS) should independently value physicians' services, given the limits of the existing Relative Value Scale Update Committee (RUC) of th...

Who Can Call Themselves 'Doctor'? The Debate Heats Up
https://www.medscape.com/viewarticle/950556

May 4th, 2021 - Physicians and non-physicians clearly differ in whether or not a PhD or EdD should be able to call themselves 'doctor,' a new Medscape poll Who Should Get to Be Called 'Doctor'? shows. The topic has clearly struck a nerve, since a record number of respondents — over 12,000 — voted in the poll. Most physicians think it's appropriate for people with other doctorate degrees such as a PhD or EdD to...

For Diagnosing Skin Lesions, AI Risks Failing in Skin of Color
https://www.medscape.com/viewarticle/950572

May 4th, 2021 - In the analysis of images for detecting potential pathology, artificial intelligence (AI) is showing enormous promise across multiple fields of medicine. But the technology in dermatology is bound to fail in skin of color if training does not specifically address these skin types, according to Adewole S. Adamson, MD, who outlined this issue at the American Academy of Dermatology Virtual Meeting...

Neonatal Nurses, Doctor Help Woman Who Delivered Baby on Plane
https://www.medscape.com/viewarticle/950575

May 4th, 2021 - Three neonatal intensive care nurses and a family physician were in the right place ― on an airliner traveling to Hawaii ― at the right time ― when a woman unexpectedly delivered a baby prematurely on the flight. The medical professionals sprang into action to keep baby Raymond, who came into the world at 29 weeks, healthy until the flight got to Honolulu, according to a news release from Hawai...

Hospira Issues A Voluntary Nationwide Recall for One Lot of Sterile Water for Injection, USP, Due to the Potential Presence of Visible Particulate | FDA
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-issues-voluntary-nationwide-recall-one-lot-sterile-water-injection-usp-due-potential

Summary Company Announcement Date: May 04, 2021 FDA Publish Date: May 04, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to visible particulate Company Name: Hospira, Inc. Brand Name: Brand Name(s) Hospira, Inc. Product Description: Product Description Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial Company Announcement Hospira, Inc., a P...