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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 ...