Mon.Oct 16, 2023

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DIR Fee Changes Are Coming in 2024: Are you Prepared?

Drug Topics

Lisa Faast, CEO and Owner of DiversifyRx, discusses ways that pharmacists can prepare their business for the cash crunch that is set to happen in the first several months of next year.

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Serotonin levels are depleted in long Covid patients, study says, pointing to a potential cause for ‘brain fog’

STAT

If you’ve been following the mystery of long Covid since it emerged in 2020, you’ll recall interferons and serotonin have been clues from the start as combatants in the body’s prolonged battles against the virus. Theories about why symptoms persist long after the acute infection has cleared often point to two suspects: viral reservoirs where SARS-CoV-2 lingers and inflammation sparked by the infection that doesn’t subside.

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With COVID sales in free-fall, Pfizer slashes revenue forecast by $9B and preps for major cost cuts

Fierce Pharma

As the coronavirus outbreak has shifted to the endemic phase, drugmakers have warned of a drop in demand for COVID-19 products, with the impact coming into focus during the fall vaccination season. | Pfizer has slashed its 2023 revenue projection by $9 billion because of declining demand for COVID products. The company now expects sales to reach between $58 billion and $61 billion, down from a prior range of $67 billion to $70 billion.

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Is there a nursing shortage in the United States? Depends on who you ask

STAT

Hospitals are frustrated with a nationwide nursing shortage that’s only gotten worse since the pandemic. In 2022, the American Hospital Association quoted an estimate that half a million nurses would leave the field by the end of that year, bringing the total shortage to 1.1 million. At the same time, National Nurses United insists there isn’t a nurse shortage at all.

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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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Merck’s Keytruda wins coveted FDA nod around surgery for early lung cancer—with a surprise

Fierce Pharma

Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery. | Thanks to a new FDA approval for Merck's Keytruda, a continuous immunotherapy regimen around surgery is now available for patients with early-stage non-small cell lung cancer. The drug's label already includes an overall survival win from a key trial.

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STAT+: FDA’s warning to J&J’s Abiomed signals a crackdown on digital health tools

STAT

The Food and Drug Administration is following through on its promise to regulate more health software tools, starting with a public reprimand of Johnson & Johnson’s heart pump company, Abiomed. Abiomed, which was bought by Johnson & Johnson late last year for $16.6 billion, sells devices for heart failure patients as well as patient monitoring software.

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STAT+: White House moves closer to a ban on menthol cigarettes, amid intensifying opposition from tobacco companies

STAT

WASHINGTON — The White House is about to feel what it’s like to go up against the world’s most powerful tobacco companies. On Friday, the Food and Drug Administration requested White House clearance on a policy that would ultimately ban menthol cigarettes. The tobacco industry has already spent the last few months doing everything it can to drum up opposition, from drafting letters for members of Congress to rallying freedom-focused smokers, according to a review of advertis

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FDA Approves Nivolumab for Completely Resected Stage IIB or Stage IIC Melanoma in Adult, Pediatric Patients

Pharmacy Times

In clinical trials, nivolumab (Opdivo) demonstrated a statistically significant improvement in recurrence-free survival compared to placebo in eligible patients with stages IIB, IIC, III, and stage IV completely resected melanoma.

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Strategies for Recruiting New Employees and Reducing Turnover in Your Pharmacy

Drug Topics

Britney Beck, founder and chief people strategist at Hi-Wire HR Consulting, discusses how pharmacists can navigate the current challenges in the labor market.

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Opinion: Doctors — and patients — must seek alternatives to long-term steroids

STAT

Steroids were once the only treatment option for some chronic conditions. Today, many other treatments exist, but doctors often stick with the tried-and-true steroids. There are good reasons for this: They are low-cost and readily approved by insurance companies. But while generally safe for short-term use, long-term steroids pose significant dangers.

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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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Ocrelizumab Found to Suppress Immune Activity That Worsens Multiple Sclerosis Symptoms

Pharmacy Times

A subcutaneous injection of ocrelizumab was markedly effective at suppressing brain lesions in patients with multiple sclerosis, according to data from a phase 3 trial.

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Reduced post-acute care rates could save Medicare billions

Fierce Healthcare

A research brief out of think tank Urban Institute evaluates the prospect of reducing Medicare spending by reining in excessive post-acute care rates. | New research shows that MedPAC's previous proposal for a unified payment structure for post-acute care could save Medicare billions.

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STAT+: Teva sues Colorado over ‘unconstitutional’ program to lower cost of epinephrine injectors

STAT

In the latest tussle over the cost of medicines, Teva Pharmaceuticals has filed a lawsuit alleging that a new Colorado program aimed at making epinephrine auto-injectors more affordable violates its constitutional rights. The lawsuit was filed in response to a state law that was passed in August and requires health insurers that provide coverage for these injectors to cap out-of-pocket costs to $60 for a package of two injectors.

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NCPA launches company to assist pharmacies with litigation against PBMs over DIR fees

Fierce Healthcare

The National Community Pharmacists Association (NCPA) has launched the latest salvo in its battle with pharmacy benefit managers over controversial fees. | The National Community Pharmacists Association has launched the latest salvo in its battle with pharmacy benefit managers over controversial fees.

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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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Rite Aid files for bankruptcy, names Jeffrey Stein as new CEO

Drug Store News

Rite Aid has received a commitment for $3.45 billion in new financing; names Jeffrey Stein as CEO, succeeding Elizabeth Burr, who has served as interim CEO since January 2023.

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Studies highlight risks of excluding people with obesity from drug trials

STAT

People with obesity often go underrepresented in drug development trials, a critical gap that researchers say leaves drugmakers and doctors unsure of efficacy or risks in that patient population. “Patients and providers are not aware of how some drugs may act differently in people with obesity,” said Christina Chow, the head of research at Emerald Lake Safety, an institution that conducts independent research to make pharmaceuticals safer.

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Simplified Model Successfully Predicts Risk of Asthma Exacerbations

Pharmacy Times

Investigators created a model to predict asthma exacerbations that can be integrated in WhatsApp chatbot and relies on self-reported data.

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AI/ML-enabled Medical Devices Have Everyone’s Attention, Including FDA’s

The FDA Law Blog

By Gail H. Javitt & Steven J. Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. The first article—“Is the Eye the Window to Alzheimer’s?

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New California law requires gradual minimum wage increase to $25 per hour for healthcare workers

Fierce Healthcare

California Gov. Gavin Newsom signed into law Friday a bill that raises the minimum wage for healthcare workers to $25 per hour across the state over the next several years. | The law is estimated to bring more than $10,000 per year in wage increases for about 450,000 of the Golden State’s low-wage healthcare workers. It requires provider organizations to incrementally raise minimum wages at different rates depending on their size and type.

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AI Is Revolutionizing Oncology With a Quantum Leap in Cancer Treatment

Pharmacy Times

AI systems can detect minute anomalies often missed by the human eye, reducing false negatives.

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STAT+: Cell and gene therapy CEOs share survival strategies amid biotech slump

STAT

CARLSBAD, Calif. — Biotech CEOs leading cell and gene therapy companies spoke frankly at a conference here last week about the tough choices they’re making to preserve limited cash amid the industry’s ongoing slowdown. The company leaders said that they’ve felt added pressure to use smaller teams to work quickly on fewer projects, and at times to partner with outside firms that have specific manufacturing and research expertise.

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More leadership changes at CVS as chief financial officer goes on leave

Fierce Healthcare

There's another shake-up at the top for CVS Health, the retail health giant announced Monday. | There's another shake-up at the top for CVS Health, the retail health giant announced Monday.

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10 Tips to Survive a Toxic Work Environment

Pharmacy Times

Maintaining a strict work-life balance, setting boundaries, and trusting instincts can help technicians manage a challenging workplace.

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CVS Health CFO taking leave of absence

Drug Store News

Thomas Cowhey, senior vice president of corporate finance, has been appointed interim CFO, while CEO of Oak Street Health Mike Pykosz has been named interim president of Health Services.

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Pharmacy Facts: Is Chocolate Syrup Medicinal?

Pharmacy Times

With Halloween just around the corner, now is the perfect time to discuss how medicine was, and still can be, sweet.

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Bristol Myers Squibb's Opdivo reign expands with new earlier-stage melanoma nod

Fierce Pharma

Bristol Myers Squibb’s star Opdivo now can lay claim to an earlier melanoma stage with a new approval that “reinforces the company’s legacy” in treating the cancer type, it said. | Bristol Myers Squibb's Opdivo can now treat completely resected stage 2B or 2C melanoma, adding to its existing approvals in stages 3 and 4 tumors and setting up an expanded market battle with Merck & Co.'s star Keytruda.

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12 ways to reduce swelling

The Checkup by Singlecare

Have you ever had an accident where you hit your ankle on a sharp corner and it starts to swell? Or maybe you’re looking at your phone while lying down, and you drop it smack onto your forehead? Swelling, also known as edema, is your body’s response to injury, illness, or some other outside stimuli. Depending on its severity, it can last days to weeks and can cause pain and discomfort.

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STAT+: Pharmalittle: Rite Aid files for bankruptcy; Alzheimer’s brain scans get broader Medicare coverage

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was sufficiently relaxing and invigorating, because that oh-so-familiar routine of online calls and deadlines has returned. After all, the world — such as it is — continues to spin. And to nudge it in a much-needed better direction, we are quaffing cups of stimulation.

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What conditions qualify for disability benefits?

The Checkup by Singlecare

If you or a loved one have recently been injured or diagnosed with an illness that impedes your daily life, you might wonder: What medical conditions automatically qualify you for disability? What criteria do you need to meet to get federal disability benefits? Where do you go to start the process? You can begin with the Social Security Administration (SSA).

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Candor on gene therapy, Abiomed is warned, & BTK success in MS

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning! Today, cell and gene therapy executives describe how they’re handling their sector’s contraction, we talk about how regulators are cracking down on clinical decision support software, and we look at some impressive BTK data in multiple sclerosis from Roche.

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Rite Aid Initiates Voluntary Chapter 11 Process to Aid Company Financial Restructuring

Pharmacy Times

Rite Aid filed for bankruptcy protection and said it plans to close several hundred retail stores.

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Podcast: The British start-up taking psychedelic therapy mainstream

Outsourcing Pharma

In our first podcast interview of 2023, BioPharma Reporter spoke with Dr Sarah Bateup, therapy lead at Clerkenwell Health, about the potential of psychedelic medicine and her work within the psychedelic therapy training space.

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Lonza to enhance commercial antibody-drug conjugate supply capacity

European Pharmaceutical Review

Lonza is planning to build a commercial-scale aseptic current good manufacturing practice (cGMP) filling line at its site in Stein, Switzerland. The new filling line will facilitate the aseptic filling of highly-potent antibody drug conjugates (ADCs) and lyophilisation under containment. The added capabilities will increase Lonza’s capacity to support clinical and commercial supply of bioconjugates.

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GoodRx COO: Improve Brand Performance through Partnerships, Personalization, and Progressing the Patient Journey

Fierce Pharma

Dorothy Gemmell, Chief Commercial Officer at GoodRx, discusses two powerful and practical opportunities in pharma marketing today: personalization and partnerships. | Dorothy Gemmell, Chief Commercial Officer at GoodRx, discusses two powerful and practical opportunities in pharma marketing today: personalization and partnerships.

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