Mon.Nov 06, 2023

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Around 14% of Americans Have Experienced Long COVID Symptoms

Drug Topics

Although long COVID has emerged as a major public health concern, it has not yet been clearly identified as a clinical condition.

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AI in Biomedical Research Is Revolutionizing Drug Development, Clinical Innovation

Pharmacy Times

AI is expected to significantly quicken the pace of drug design and development, while improving the success rate of new medicines.

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Delta-8 THC Accessibility, Marketing to Minors Cause for Concern

Drug Topics

Unlike traditional THC, which is federally banned, D8 has managed to find a legal loophole, making it widely accessible.

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Benefits, Mechanisms of SGLT2 Inhibitors in Diabetic Kidney Disease, Other Communities

Pharmacy Times

Although SGLT2 inhibitors are not a cure of diabetic kidney disease, this treatment can help reduce the risk and manage the disease either alone or with complementary therapies.

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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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A new study maps the lasting effects of gun violence on children and teens who survive their injuries

STAT

When Christian Pulcini was a pediatric emergency fellow at Children’s Hospital of Philadelphia, he witnessed firsthand the ways that gun violence affected children who survived it. He still remembers one young boy who had been shot in the neck while playing outside his home. Pulcini did not remove the bullet — a routine practice, often safer than removal.

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The Ketogenic Diet Could Be an Effective Lifestyle Approach to Manage Advanced-Stage Chronic Kidney Disease, Diabetes

Pharmacy Times

A low carbohydrate diet plus a sodium glucose contransporter-2 (SGLT2) inhibitor was found to be safe and effective for weight loss and glycemic control in patients with diabetes and chronic kidney disease.

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Study: Risk of Atrial Fibrillation Remains High After 3 Years, Including Those With Heart Failure

Pharmacy Times

Risk of atrial fibrillation with 1 of the independent predictors, including congestive heart failure and left atrial enlargement, resulted in greater than a 4-fold increased detection.

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Opinion: There’s a real risk that harm reduction could be a fad

STAT

Harm reduction is having its moment in America. The doors of drug-related harm reduction have swung wide open after years of federal funding bans. Extensive opioid settlement payouts combined with an urgency to address the overdose crisis have allowed for harm reduction approaches to catch on like wildfire. But as renowned addiction author William White muses, “The fastest way to kill anything in America is to turn it into a superficial fad that dies from distortion and over-exposure.

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MA enrollees have fewer hospitalizations, Harvard study finds

Fierce Healthcare

Medicare Advantage (MA) beneficiaries have better quality of care and health outcomes than traditional fee-for-service counterparts, researchers from Harvard Medical School found. | Another white paper released by Inovalon and Harvard Medical School highlights the benefits Medicare Advantage enrollees enjoy over traditional Medicare counterparts.

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Staying Ahead of Headache Management: Tips for Pharmacists on Patient Recommendations

Pharmacy Times

Pharmacists can play a vital role in educating patients about headaches and can help to limit their impact on the patient.

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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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How to identify and treat an amoxicillin rash

The Checkup by Singlecare

Amoxicillin is one of the most commonly used antibiotics for treating bacterial infections. Known for its ability to stop the growth of bacteria, amoxicillin is also one of the most tolerable drugs for children and is prescribed by pediatric healthcare providers over others in the penicillin family, such as ampicillin or oxacillin. As a parent or patient, you may be concerned about reactions to a new medication, especially if they point toward an unknown drug allergy.

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Researchers Create App to Predict Whether Child in Acute Liver Failure Will Need Transplant

Pharmacy Times

Children with a score of higher than 30 on the CHALF Score scale will need an emergency transplant.

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NICE's Trikafta snub could portend another pricing standoff between Vertex and UK officials

Fierce Pharma

History may repeat for Vertex Pharmaceuticals in the U.K., where a new decision by the country’s cost-effectiveness gatekeeper threatens to spark another dispute over the cost of lifesaving cystic | Last week, the U.K.'s National Institute for Health and Care Excellence unveiled draft guidance that acknowledged the effectiveness of Vertex’s cystic fibrosis drugs Trikafta, Symkevi and Orkambi.

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What Pharmacies Can Expect From Medication Synchronization Programs

Drug Topics

Tiffany Capps, CPhT, pharmacy operations manager at Galloway-Sands Pharmacy in North Carolina and marketing communications manager at CPESN, discusses how pharmacies can utilize med sync programs and what they can expect when implementing one.

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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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STAT+: Data backing prescription digital therapeutics found lacking in rigor, inclusivity

STAT

The fast-evolving world of digital therapeutics offers the promise of lowering barriers to accessing health care, but the companies behind these software-based tools face an uphill battle in convincing clinicians and insurers that their products can complement traditional medicine. That debate has largely focused on the quality of evidence backing these prescription digital therapies.

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Navigating a Complicated Pediatric COVID-19 Case With Immunomodulatory Therapies

Drug Topics

A poster session at the 2023 American Academy of Pediatrics National Conference & Exhibition, featured a complex pediatric case involving SARS-CoV-2, bacterial coinfection, multiorgan failure, thrombotic microangiopathy, and systemic hyperinflammation.

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STAT+: Vertex may face another battle in the U.K. over the value of its cystic fibrosis medicines

STAT

Once again, Vertex Pharmaceuticals and a U.K. government agency are at odds over the value of life-saving cystic fibrosis medicines. In draft guidance published late last week, the National Institute for Health and Care Excellence stated that a groundbreaking treatment called Trikafta and two other cystic fibrosis medications sold by the company offer notable clinical benefits, but are not cost-effective.

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Cigna explores selling Medicare Advantage business: report

Fierce Healthcare

Cigna is looking into the possibility of selling its Medicare Advantage (MA) business, according to a report from Reuters. | Cigna may decide to sell off its Medicare Advantage business. The insurer is reportedly in early discussions with an investment bank to go over its options.

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Krystal's topical gene therapy gains steam, prompting analyst group to boost sales projection

Fierce Pharma

At the start of its first-ever conference call to present its quarterly numbers, Krystal Biotech CEO Krish Krishnan was quick to point out that the company’s positive earnings for the third quarter | Krystal Biotech's launch of Vyjuvek, the world's first topical gene therapy, has been so promising that analysts with Evercore ISI increased their 2024 sales projection to $273 million.

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STAT+: Astellas shows enough data for eye treatment to support expanded use, but still lags competitor

STAT

Astellas on Saturday presented study results showing an increased treatment effect over time for its approved medicine for a common type of vision loss. The new data are probably enough to convince the Food and Drug Administration to remove restrictions on the drug’s use, but they still don’t measure up to a competing treatment from Apellis Pharmaceuticals.

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Kaiser Permanente logs $239M net income, 0.6% operating margin in Q3 2023

Fierce Healthcare

Kaiser Permanente pulled in $239 million in net income during the third quarter of 2023, a turnaround from the $1.5 billion net loss the integrated system had seen a year prior. | The massive integrated nonprofit's $156 million operating income turns around the $75 million operating loss of the third quarter of 2022 but is a slight pullback from 2023's prior quarters.

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Clinical Overview: Treatment Options for Premenstrual Syndrome (PMS)

Pharmacy Times

Treatment options for individuals impacted with PMS can vary and include lifestyle modifications, medication treatments, and herbal products.

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Apellis parries Astellas' long-term Izervay data with 3-year results on its rival GA med Syfovre

Fierce Pharma

After this summer’s FDA approval of Iveric Bio’s Izervay—the drug at the center of the $5.9 billion buyout by Japanese pharma Astellas—the battle for the geographic atrophy (GA) crown is on in the | After this summer’s approval of Iveric Bio’s Izervay—the drug at the center of the $5.9 billion buyout by Japanese pharma Astellas—the battle for the geographic atrophy crown is on in the U.S.

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Lights Lacquer gets in holiday spirit via Cabin Fever collection

Drug Store News

Inspired by the rustic allure of a cozy cabin retreat, the line’s color palette draws inspiration from the serene beauty of a vintage winter wonderland, the brand stated.

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Alliance for mRNA Medicines Officially Launched in Germany

BioPharm

The Alliance for mRNA Medicines (AMM) was officially launched at the 11th International mRNA Health Conference in Berlin, Germany.

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STAT+: Government looks to tinker with new caps on Medicare Advantage broker payments

STAT

The federal government is proposing to rein in health insurance companies that entice brokers with lavish bonuses to sell their Medicare Advantage plans by placing a firmer cap on broker compensation. However, even with new guardrails in place, agents and brokers will still have strong financial incentives to move people into Medicare Advantage plans instead of pitching supplemental coverage for the traditional Medicare program.

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FDA approves Wezlana for inflammatory conditions

The Checkup by Singlecare

Those on immunosuppressive drugs for psoriasis or ulcerative colitis may soon breathe a little easier when they get to the pharmacy counter: The U.S. Food and Drug Administration (FDA) just approved Wezlana (ustekinumab-auub), a biosimilar for the popular drug Stelara. Manufactured by Amgen, the biosimilar—which is like a generic for biologic medications—was approved to treat inflammatory conditions like plaque psoriasis or ulcerative colitis.

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STAT+: Ventyx stock craters after lackluster mid-stage trial results for psoriasis drug

STAT

SAN DIEGO — Ventyx Biosciences reported on Monday that it was ending development of an experimental drug for treating plaque psoriasis though it proved safe and moderately effective in a mid-stage trial. Within hours, the company’s stock tanked by more than 80%. That’s because the company announced that the small molecule, VTX958, had not met the biotech’s internal goals to advance to the next phase of clinical development.

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BioNTech cuts 2023 revenue guidance by 20%, but touts its financial position

Fierce Pharma

Following suit with other companies that produce COVID-19 vaccines, BioNTech has discovered demand for its Pfizer-partnered, omicron-adapted shot has not met expectations this fall and has had to a | BioNTech has slashed its estimate of 2023 revenue by 20%, now expecting it to reach 4 billion euros ($4.3 billion) versus its previous estimate of 5 billion euros ($5.4 billion).

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Will holiday sales be ho, ho, ho or ho hum?

Drug Store News

This year’s early holiday season appears off to a slow start, per a Placer.ai analysis, which notes that retailers might need to get creative to convince shoppers to walk through their doors.

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Lots of FDA Guidance, But Few Drug Manufacturing “Remote Interactive Evaluations” (We Would Call Them “Virtual Inspections”)

The FDA Law Blog

By Douglas B. Farquhar & Richard A. Lewis, Senior Regulatory Device & Biologics Expert — We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something. A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections.

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As Vertex preps for exa-cel launch, exec touts 'very large' opportunity but tempers early expectations

Fierce Pharma

As Vertex preps for exa-cel launch, exec touts 'very large' opportunity but tempers early expectations zbecker Mon, 11/06/2023 - 20:59

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In experiment, electrical stimulation of the spinal cord helps a patient with Parkinson’s to walk

STAT

An experimental treatment that delivers an electrical current to the spinal cord appeared to notably improve the ability of a man with Parkinson’s to keep his balance and walk without freezing up, a development that experts say could be a dramatic advance if it is found to deliver similar benefits in larger studies. The volunteer, identified as Marc, a 62-year-old who has had Parkinson’s for 30 years, spoke on a call with reporters last week.

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CVS Pharmacy expands OTC hearing aid offerings

Drug Store News

Three OTC hearing aids are now available at more than 1,000 locations across 39 states, with select models also available for purchase online.

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