Fri.Aug 18, 2023

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Case Study: Positive HIV-1 Status Should Not Preclude Heart Transplant

Pharmacy Times

Previous studies have shown promising results with liver or kidney transplants in patients with HIV, but there was a lack of literature regarding heart transplants specifically.

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Podcast: Is The Pharmacy World Prepared For DSCSA?

Drug Topics

Todd Eury of the Pharmacy Podcast Network is joined by Josh Bolin of the NABP to talk about DSCSA, what benefits it will provide, and how to make sure your pharmacy is ready when it goes into effect this November.

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Use of First-Line Treatment for Insomnia Low Among Adults With Mental Health Conditions

Pharmacy Times

Although the rate of people with probable insomnia who discussed their sleep habits with a physician was relatively high, the number of people who went on to seek actual treatment was low.

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MorningRX: August 18, 2023

Drug Topics

NIH establishes research centers for maternal health, FDA grants priority review for IgA nephropathy treatment, and the CDC begins tracking a new COVID-19 variant.

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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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Data Show Durable Efficacy With Repotrectinib for Locally Advanced or Metastatic ROS1-Positive NSCLC

Pharmacy Times

Based on results from a trial of repotrectinib in patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer, the FDA accepted the New Drug Application and set a Prescription Drug User Fee Act goal date of November 27, 2023.

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STAT+: An innovative eye stem cell transplant could help restore vision in people with chemical injuries

STAT

The first time Phillip Durst saw the big A on the chart, he could hardly believe it. It was the first in a series of letters to check his vision in his left eye. “They keep flipping the chart and it keeps getting smaller and smaller, and I keep identifying the letters — that was huge,” said Durst. “It’s like a miracle.

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Biogen kicks off 1,000 layoffs as part of CEO Viehbacher’s ‘complete redesign’

Fierce Pharma

It was only last spring that Biogen started a | It was only last spring that Biogen started layoffs that eventually shrank the company’s headcount by nearly 900 people last year. Now, a fresh round of job cuts targeting 1,000 positions has kicked off at the struggling drugmaker. At the same time, Biogen is spending $7.3 billion to buy rare disease specialist Reata Pharmaceuticals.

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How Pharmacists Can Help Protect Patients’ Skin From Sunburn, Skin Cancer

Pharmacy Times

Pharmacists can offer valuable information about sunburn, sunscreen, and skin cancer screening and provide OTC recommendations on sunburn treatment and prevention.

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Viome Life Sciences banks $86.5M round, partners with CVS to sell at-home diagnostic tests

Fierce Healthcare

At-home diagnostics startup Viome Life Sciences snagged $86.5 million in an oversubscribed series C funding round and will roll out its gut microbiome testing kit into 200 CVS stores. | At-home diagnostics startup Viome Life Sciences snagged $86.5 million in an oversubscribed series C funding round and will roll out its gut microbiome testing kit into 200 CVS stores.

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New Method Enables Assessment of Immunological Reaction to mRNA SARS-CoV-2 Vaccine

Pharmacy Times

The approach allows investigators to assess post-vaccine response in immunocompromised patients who have received antibody prophylaxis.

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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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Why so few get screened for lung cancer, the deadliest cancer in the U.S.

STAT

It was Thanksgiving 2021, and Michael Young was at Target buying a turkey baster. “I’m in the parking lot, and my chest starts to feel like somebody’s sitting on me,” Young recounted. But he didn’t think too much of it and waited until February to tell the doctor about these on-and-off chest pains. “8:30 a.m.

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List prices for Ozempic, Wegovy far higher in the US than in peer nations: KFF

Fierce Healthcare

It's not a secret that Americans pay far more than people living in other countries for drugs, and those data hold for trendy weight loss and diabetes treatments as demand for these therapies grows | It's not a secret that Americans pay far more than people living in other countries for drugs, and those data hold for trendy weight loss and diabetes treatments like Ozempic and Wegovy.

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Opinion: Medicine robs physicians of their fertility. Here’s how to fix it

STAT

“T he Retrievals,” a disturbing podcast from Serial and the New York Times released this summer, painstakingly tells the stories of women who sought fertility treatments at the Yale Fertility Center in 2020. Over the course of five months, women underwent egg retrievals without any pain medication. Although this procedure is typically done under heavy sedation, a nurse at the clinic had replaced fentanyl with saline.

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Moderna's updated COVID shot stands strong against new variants in first look at trial data, company says

Fierce Pharma

Vexed by plummeting demand for their shots, COVID-19 vaccine producers are anxiously awaiting the fall inoculation season to get a glimpse of the post-pandemic market landscape, which includes a sh | Vexed by plummeting demand for their shots, COVID-19 vaccine producers are anxiously awaiting the fall inoculation season to get a glimpse of the post-pandemic market landscape.

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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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ProMED sees offers of support, but its future remains unclear

STAT

With its future in doubt, ProMED, the financially strapped infectious diseases surveillance network, has seen waves of support pour in in recent weeks, with universities and other funders seeking to rescue it, according to the president of the committee that oversees it. Both the International Society for Infectious Diseases, which has hosted ProMED since 1999, and its moderators, many of whom went on strike earlier this month to protest plans to put the service behind a paywall, have been in di

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Regeneron wins FDA approval for rare immune disease med Veopoz, expects high-dose Eylea decision in the coming weeks

Fierce Pharma

Along with resolving site inspection issues that cost Regeneron a high-dose Eylea launch in June, the company has scored an FDA nod for Veopoz as the first treatment for the ultra-rare inherited im | Alongside a Friday approval for its ultra-rare disease medicine Veopoz, Regeneron now expects a high-dose Eyelea nod in the next few weeks after resolving inspection issues at third-party filler Catalent.

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Having celiac disease and a thyroid condition sent her on a quest to become an empathetic doctor

STAT

A third-year med school student, Brianna Celix doesn’t get a lot of free time. Even with the one afternoon off she gets each week at the Medical College of Wisconsin in Milwaukee, Celix is being challenged to take care of herself. Her cat, Frankie, dense as a log, offers plenty of cuddles. But managing two autoimmune conditions requires more than animal affection.

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Novartis floats share distribution scheme as it plots Sandoz spinoff for Oct. 4

Fierce Pharma

Novartis’ Sandoz spinoff is right around the corner, and, to celebrate the occasion, the Swiss pharma is plotting a special stock distribution scheme. | Novartis’ Sandoz spinoff is right around the corner, and to celebrate the occasion, the Swiss pharma is plotting a special stock distribution scheme.

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STAT+: Pharmalittle: Weight loss drugs cost much more in the U.S.; PBMs win a key victory over an Oklahoma law

STAT

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is rather modest. We plan to catch up on our reading, promenade with the official mascots, and have a listening party with Mrs. Pharmalot. The rotation will likely include this , this , this , and this.

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On blockbuster mission, Merck says Welireg hit endpoint in renal cell carcinoma trial

Fierce Pharma

Two years after Welireg's original approval in the rare von Hippel-Lindau (VHL) disease, Merck is looking to expand its drug's reach and turn it into a blockbuster. | The drug, which was originally approved in rare von Hippel-Lindau (VHL) disease, showed improvements in progression-free survival in a phase 3 trial comparing the med with Novartis' Afinitor.

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What You Need to Know About the Drug Supply Chain Security Act Before November’s Deadline

Drug Topics

A Q&A with Matt Sample, senior vice president of manufacturer and replenishment operations at AmerisourceBergen.

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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.   That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. Please note that our regular feature — in which we spotlight someone — will return later this month.

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Understand the Underlying Causes, Challenges of Treating Obesity

Pharmacy Times

Guidelines from the American Academy of Pediatrics recommend treating obesity as a chronic illness.

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Labor marketplace company CareRev launches new tool to build flexible staffing pools within health systems

Fierce Healthcare

Workforce challenges continue to be front of mind for health system executives as the industry contends with ongoing staff shortages, nurse retention issues and clinician burnout. | CareRev has created what it calls the largest on-demand workforce and a technology platform to build and manage it. The company believes it can leverage this technical know-how to help health systems more effectively manage their own flexible staffing resources.

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Placer.ai takes stock of how superstores are faring amid economic headwinds

Drug Store News

Placer.ai analyzed traffic data for Walmart, Target, Costco Wholesale, BJ’s Wholesale Club and Sam’s Club to see how the sector is faring as consumer sentiment improves.

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CHMP to review MAA for geographic atrophy treatment

European Pharmaceutical Review

The European Medicines Agency (EMA) has accepted for regulatory review the marketing authorisation application (MAA) for avacincaptad pegol (ACP) to treat geographic atrophy (GA). “This acceptance of our EU Marketing Authorisation Application is a key milestone in our global effort to help patients living with GA, a leading cause of blindness worldwide.

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Wakefern expands engagement with Simbe to more ShopRite stores

Drug Store News

Following a pilot in 20 stores, Wakfern is expanding its use of Simbe's business intelligence solution to additional ShopRite stores.

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In A Post-Dobbs World, Pharmacists Still Face Uncertainty

Drug Topics

Legal challenges have made dispensing abortion medications more difficult than ever.

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Bruker to buy cell biology company PhenomeX for $108m

Pharmaceutical Technology

Bruker has entered into a definitive agreement to acquire functional cell biology company PhenomeX for a total equity value of $108m.

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???????Wolters Kluwer survey: Pharmacies face headwinds on children’s vaccinations

Drug Store News

The survey found that there is a strong acceptance for adult immunizations, but only 36% prefer pharmacies for children’s shots.

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AbbVie achieves win for migraine prevention drug Aquipta in Europe

Pharmaceutical Technology

The decision brings the first daily oral migraine prophylactic to Europe, with plans to rollout the treatment as soon as possible.

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Empowering women with eco-friendly products

Drug Store News

Alexandra Fennell, co-founder of Attn: Grace, shares the brand’s momentum and the importance of sustainably sourced incontinence products.

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EMA accepts for review Iveric Bio’s MAA for geographic atrophy therapy

Pharmaceutical Technology

Astellas Pharma has announced that EMA has accepted the MAA from its subsidiary Iveric Bio for the review of ACP to treat GA.

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Former Covid medical officer Van-Tam takes role at vaccine maker Moderna

The Guardian - Pharmaceutical Industry

One of UK’s public faces of pandemic, ‘JVT’ was known for football-related metaphors in No 10 briefings Sir Jonathan Van-Tam, the UK’s former deputy chief medical officer who became a household name during the pandemic, has become a senior medical consultant to the Covid-19 vaccine maker Moderna. Known by the initials JVT and remembered for the striking metaphors he used during Downing Street briefings on the progress of the virus, he took up the role as part-time clinical adviser to the America