Mon.Nov 13, 2023

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FDA Grants Priority Review to Liso-Cel in Relapsed/Refractory CLL/SLL

Drug Topics

The FDA acceptance marks the first step in addressing the unmet need for a lasting treatment option for patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

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Data Show Benefit of Intensive Blood Pressure Reduction Is Consistent in East Asian Population With Hypertension, High Cardiovascular Risk

Pharmacy Times

The SPRINT trial was the first to demonstrate the benefit of further reduction in blood pressure, but it included a limited Asian population and excluded patients with diabetes or history of stroke.

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Trending Sources

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Life expectancy for men in U.S. falls to 73 years — six years less than for women, per study

STAT

The life expectancy of men in the U.S. is nearly six years shorter than that of women, according to new research published on Monday in JAMA Internal Medicine. At least partially as a consequence of over 1 million Covid-19 deaths, life expectancy in the U.S. has declined significantly over the past few years, falling from 78.8 years in 2019 to 77 in 2020 and 76.1 in 2022 — undoing over two decades of progress.

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Prior authorization and other regulatory burdens have increased since last year, practices tell MGMA

Fierce Healthcare

Nine in 10 polled medical practices say their regulatory burden has increased over the past year with prior authorization, audits and appeals, the Medicare Quality Payment Program (QPP) and require | The latest annual poll of practices' regulatory burden outlined prior authorization, audits and appeals, Medicare QPP and other leading pain points that physicians say are weighing down theor staff and ability to deliver care.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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Study suggests Covid rebound is far more common with Paxlovid than without

STAT

A small and preliminary study published Monday seems to indicate that patients receiving the drug Paxlovid are far more likely to experience Covid rebound than those who did not take it. That conclusion runs counter to previous statements by Pfizer, which makes Paxlovid, and by researchers at the Food and Drug Administration who have argued that while it is not uncommon for people with Covid to have symptoms reemerge after they seem to have recovered, it is not clear that Paxlovid increases the

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Data Show Effect of Dietary Sodium Reduction on Blood Pressure Was Comparable to First-Line Medication

Pharmacy Times

Clinically meaningful lowering of blood pressure through reduction in dietary sodium was achieved safely and rapidly in 1 week in a middle-aged and elderly cohort.

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Pharmacy Focus: Policy Edition - Navigating the Reimbursement Maze

Pharmacy Times

Tune in to this episode of Pharmacy Focus: Policy Edition for an update on the ever-evolving landscape of pharmacy reimbursements, pharmacy benefit manager reform, and direct and indirect remuneration fees.

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The U.K. just cleared a drug to prevent breast cancer. U.S. women may not know it’s already an option

STAT

The news that the U.K. has approved a preventive drug for post-menopausal women at risk of developing breast cancer wasn’t a shock to breast medical oncologist Abenaa Brewster. But the fact that a patient in her breast cancer prevention clinic hadn’t ever heard of such a possibility before was. “I thought to myself, ‘Oh, my God, I can’t believe a woman in America is being educated about preventive therapy from European use,’ because for the last 25 years

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FDA Expands Indication of Regional Analgesic to Reduce Postsurgical Pain Without Opioids

Pharmacy Times

Bupivacaine liposome injectable suspension was shown to reduce opioid use after surgery and significantly improve pain.

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NYU radiologists tackle the challenge of making MRI machines less expensive

STAT

How many radiologists does it take to build a working MRI from scratch? New York University radiologists Leeor Alon and Tobias Block wanted to find out. The two hosted 50 researchers in New York City last month, and over the course of five days, managed to build a small, low-field MRI. Alon and Block are currently fine-tuning its imaging abilities. The overarching message of the gathering: MRIs don’t need to be as expensive as they currently are.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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SELECT Trial Data Show Benefit of Semaglutide in Patients With Obesity

Pharmacy Times

The SELECT trial expands on existing literature that have shown safety and cardiovascular benefit in individuals with diabetes to now also show benefit in obesity.

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STAT+: Eli Lilly’s chief scientist on new obesity drug data, gene editing, and a potential new heart drug

STAT

PHILADELPHIA — In a sense, the annual meeting of the American Heart Association wasn’t a huge one for Eli Lilly. Its biggest news was about a very early study of a drug to lower blood levels Lp(a), a protein related to cholesterol that is mainly being watched by lipidologists and drug company analysts. But in another way, the future of Lilly, now the biggest drug company by market capitalization, hung in the balance.

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Upcoming Phase 3 Trials to Evaluate Efficacy, Safety of Milvexian in Patients with Cardiovascular Conditions

Pharmacy Times

Harrington discusses how the performance of milvexian in prior phase 2 trials focused on different patient populations creates the foundation for future research.

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STAT+: Novo Nordisk wants to be a cardiovascular company, too, with sights set on inflammation

STAT

PHILADELPHIA – Novo Nordisk, which has dominated the diabetes and obesity markets with its blockbuster drugs Ozempic and Wegovy, now also wants to be a major player in heart disease. The landmark Select trial presented over the weekend – which showed Wegovy significantly cut the risk of heart complications – is just one of many efforts by the Danish drugmaker to expand into the cardiovascular space.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Novo Nordisk says Wegovy can help heart disease patients—and not just because it produces weight loss

Fierce Pharma

Novo Nordisk has made a splash with its GLP-1 drugs that have allowed patients to achieve significant weight loss. | Novo Nordisk has made a splash with its GLP-1 drugs that have allowed patients to achieve significant weight loss. Now the Danish company appears on the verge of another breakthrough, showing that the use of its obesity treatment Wegovy can reduce the risk of heart attack.

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Opinion: Ohio has enshrined the right to an abortion. But major obstacles remain for patients and providers

STAT

Last week those of us who work in reproductive health care  celebrated a historic victory  in Ohio: Voters overwhelmingly favored Issue 1, which enshrines a right to abortion into the state constitution and makes the six-week ban many of us feared unenforceable. As an abortion provider in Cleveland, I’m relieved that my patients’ freedom to access abortion care, miscarriage care, and contraception is protected.

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Data Show Lepodisiran Was Well Tolerated, Substantially Lowered Lipoprotein (a)

Pharmacy Times

Elevated Lp(a), which was previously untreatable, may become treatable in the near future, according to the study investigator.

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STAT+: Michigan bill that would pare back pharma liability shield law moves closer to enactment

STAT

A one-of-a-kind law in Michigan that prevents the state government and residents from suing pharmaceutical companies over injuries caused by their medicines is poised to be pared back. A bill designed to allow product liability lawsuits to be filed against drug companies passed the Michigan Senate last month and then passed the House last week. The legislation , which won overwhelming majorities in both chambers but was opposed by the Michigan Chamber of Commerce and a pharmaceutical industry tr

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First OTC Rapid Antigen Test for COVID-19 Cleared By FDA

Drug Topics

The test is also the first OTC rapid antigen test cleared for any infectious disease.

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STAT+: Patients loved Carbon Health’s diabetes program. That couldn’t save it

STAT

A diabetes diagnosis was not what Jason had in mind when he set out on a cross-country road trip with his family in the fall of 2021. He had been heavy since he was a kid, but he always had felt pretty healthy — until getting home to the San Francisco Bay Area, when he started to notice his body doing strange things. “It kind of came out of nowhere,” said Jason, who asked to keep his last name private.

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Rivaroxaban Demonstrates Favorable Benefit-Risk Profile in Fragile Populations with Peripheral Arterial Disease

Pharmacy Times

Bonaca also notes that pharmacists can play a key role in educating patients and clinicians about the appropriate use and dosing of antithrombotic drugs for vascular protection.

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Opinion: Congress must reauthorize the National Advisory Committee for Seniors and Disasters

STAT

With the election of Rep. Mike Johnson as speaker of the House, the urgent and important work of passing appropriations and vital national security legislation is now advancing. But it is also the time to address additional important issues affecting the well-being of Americans, such as one highlighted during the Covid-19 pandemic as well as recent wildfires and hurricanes: the care and support for America’s most vulnerable.

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Half a year later, Teva's 'pivot to growth' strategy appears to be bearing fruit

Fierce Pharma

Six months on, Teva’s new “pivot to growth” strategy appears to be paying off. | In 2023’s third quarter, the Israeli-American generics giant reported global sales of $3.9 billion, up 7% from the same period in 2022. The company credited that growth to the strong momentum behind its branded meds Austedo and Ajovy, plus a “stable and sustainable generics business” in the U.S. that’s also seen “continued growth” in Europe and other international markets.

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12 types of diabetes rash and skin problems

The Checkup by Singlecare

Diabetes has become a common condition in the United States. In fact, the Centers for Disease Control and Prevention (CDC) estimate about 1 in 10 Americans have the chronic condition. The good news is that diabetes, characterized by having too much sugar in your blood, can be managed with diet, exercise, and medication in conjunction with guidance from a healthcare provider.

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BravoCon brings reality stars and beauty to the forefront

Drug Store News

BravoCon 2023 made waves in Las Vegas, and DSN spoke to an NBCUniversal executive to learn all about the beauty activations at the largest event celebrating reality television.

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How long does it take ibuprofen to work?

The Checkup by Singlecare

Ibuprofen is a nonsteroidal anti-inflammatory drug ( NSAID ) that is available over the counter (OTC) and by prescription in higher doses. Commonly referred to by brand names Advil and Motrin , ibuprofen works by reducing hormone-like substances called prostaglandins that cause pain and inflammation in the body. After administration, you should start feeling relief from symptoms as quickly as 20-30 minutes—depending on the form of medication you take and what you’re treating.

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These are the need-to-know biotech stories from this weekend

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Lots of news on the cardiovascular front this morning: We discuss Novo Nordisk’s plans in heart disease, and Verve’s gene editing therapy for familial hypercholesterolemia. We also learn about a new initiative to try and prevent gonorrhea spread with a meningitis vaccine.

Vaccines 101
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Implement Strategies Now to Prevent Patient Death From Accidental Daily Methotrexate Dosing

Pharmacy Times

Specifying a day of the week to take the medication could help avoid inadvertent daily dosing

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Is there a bigger move being planned at Cigna?

STAT

You’re reading the web version of Health Care Inc.,  STAT’s weekly newsletter  following the flow of money in medicine.  Sign up  to get it in your inbox every Monday.  The crushing weight of ambulance bills Over the summer, Precious Mae Clark (in the photo above) emailed me with a desperate plea: She was staring down the barrel of a $7,370 (I repeat, $7,370!

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Walgreens Boots Alliance sells shares of Cencora for $674M of initial proceeds

Drug Store News

Walgreens Boots Alliance said there will be no changes to its ongoing collaboration and long-term strategic partnership with Cencora.

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STAT+: Pharmalittle: Wegovy cuts heart attack risk in milestone trial; AstraZeneca prioritizes U.S. for RSV drug amid surge

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of online calls, meetings, and deadlines has predictably returned. But what can you do? The world, such as it is, continues to spin. To nudge it in a better direction, we are firing up the coffee kettle to brew another cup of stimulation.

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Could GSK myelofibrosis treatment gain EU-first approval?

European Pharmaceutical Review

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for GSK’s momelotinib, recommending marketing approval. The Committee deemed it beneficial as a treatment for disease-related splenomegaly (enlarged spleen) or symptoms in adults with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus kinase (JAK) inhibitor n

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STAT+: Former MIT biologist, who lost positions after engaging in a prohibited sexual relationship, accepts new science position in Prague

STAT

Former MIT and Whitehead Institute star biologist David Sabatini, who lost his positions after he was accused of violating sexual harassment policies in 2021, is resuming his science career, taking a post at a Czech research institute in Prague. Sabatini, of Cambridge, confirmed in a phone call from Prague that he has accepted a position as a “senior group leader” at the Institute of Organic Chemistry and Biochemistry, known as IOCB Prague.

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NACDS’ health, wellness initiatives take center stage at 2023 Milken Institute Future of Health Summit

Drug Store News

NACDS’ initiatives regarding health and wellness were on display at the 2023 Milken Institute Future of Health Summit.

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