Tue.Jul 11, 2023

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New studies add to body of evidence questioning 340B efficacy

PhRMA

Recent studies add to the growing body of evidence questioning the value of the current 340B program and whether it’s benefiting patients as Congress intended.

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Moderna mounts 2 new patent lawsuits against mRNA rivals Pfizer, BioNTech: report

Fierce Pharma

Caught in a litigation crossfire, Moderna has reportedly opened two new fronts in its COVID-19 vaccine patent war with Pfizer and BioNTech. | Moderna has lodged two new lawsuits at the High Court in Dublin, Ireland, and the Brussels Commercial Court in Belgium, Juve Patent first reported. This adds to a complex web of ongoing mRNA patent litigation.

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Between hope and despair: Improving cancer outcomes

PhRMA

I can still see everything in the hospital room in my mind’s eye, the night — 13 days before Christmas — a neurologist delivered the news to my mother and me that she had non-Hodgkin’s lymphoma, an aggressive tumor lodged in her brain. It threw our little family into a panic and into a search for the best treatment available in the subsequent 8 months before her death.

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Lifestyle Medicine Presents Unexpected Opportunity for Pharmacists

Pharmacy Times

Pharmaceuticals are a critical and often lifesaving tool for managing disease, but we will never solve our chronic disease crisis through a mindset of mere management.

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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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Many Patients With COPD Have Poor Adherence to Long-Acting Inhalers

Drug Topics

Researchers encourage physicians to personalize care plans to ensure that more patients adhere to their inhalers.

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PrEP Initiation, Continuation Feasible in Range of Clinical Settings

Pharmacy Times

Wide-ranging options for HIV pre-exposure prophylaxis initiation in different settings and though different providers should be maintained to ensure underserved populations get adequate treatment options.

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Pharma Not the Only Ones Upset with PBM Practices

Pharmaceutical Commerce

The National Alliance of Healthcare Purchaser Coalitions releases resources for employers/health plan purchasers to offer insights on PBMs role in high prescription drug costs.

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Economic Burden of Pediatric Influenza in Europe: Urgent Need for Vaccination Policies

Drug Topics

Vaccination can minimize health care costs associated with influenza.

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Senate proposal would give hospitals $385M for emergency preparedness. The AHA is pushing for double that amount

Fierce Healthcare

Hospitals told a major Senate panel that a $385 million bucket of annual emergency preparedness funding up for reauthorization should “be at least doubled” if the country’s healthcare system is to | A flat reauthorization of the money spent preparing hospitals for public health emergencies is insufficient "to help rebuild the program after years of underfunding," the hospital lobby told lawmakers Monday.

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Takeda withdraws application for dengue vaccine from FDA

STAT

Takeda announced Tuesday that it has voluntarily withdrawn its application to the Food and Drug Administration for its dengue vaccine, making it unclear when or if the vaccine will be licensed in this country. The company said in a press release that it will review whether to proceed with trying to bring the vaccine to the U.S. market. The vaccine has already been approved in the European Union, the United Kingdom, Brazil, Argentina, Indonesia, and Thailand.

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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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Providers rarely screen for maternal mental health. Are new guidelines enough to move the needle?

Fierce Healthcare

Mental health conditions are the leading cause of maternal mortality, and most pregnancy-related deaths are | Mental health conditions are the leading cause of maternal mortality. Yet despite national guidance, addressing them remains complicated.

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Top Clinical Services for Boosting Your Pharmacy’s Revenue

Digital Pharmacist

With reimbursements dwindling and the so-called “ DIR Apocalypse ” or “DIR Armageddon” on the horizon, no explanation is needed as to why independent pharmacies are seeking innovative ways to expand their revenue streams beyond traditional prescription dispensing. By diversifying services and embracing a patient-centered approach, independent pharmacies can position themselves as vital healthcare hubs within their communities.

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Can price transparency drive down health costs? The jury is still out

Fierce Healthcare

Price transparency has been a key focus for policymakers looking to address rising health costs, but experts say breaking through that black box won't solve the problem wholesale. | Price transparency has been a key focus for policymakers looking to address rising health costs, but experts say breaking through that black box won't solve the problem wholesale.

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The Active Ingredient Stands Alone

The FDA Law Blog

By Sara W. Koblitz — One of the most important questions FDA has to answer is whether a given product is appropriately characterized as a drug, biologic, device, food, cosmetic, or something entirely different. As we have explained before , that distinction is critical to assigning a particular product to the appropriate regulatory scheme. While it is exceedingly obvious that some products, like eyeshadow for example, are cosmetics, or a pacemaker is a device, it can get thorny where the disti

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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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Drug shortages drive up prices for consumers. Here's how they can be avoided

Fierce Healthcare

Drug shortages can drive up costs for patients, and a new analysis suggests ways these issues could be avoided. | Prior research about drug shortages looked at frequency and intensity. New Rand research looks at how they affect consumers.

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Superbugs, antibiotic resistance get renewed scrutiny in Congress

STAT

Melanie Lawrence doesn’t think she’ll live long enough to see her son graduate college. Lawrence, a patient with cystic fibrosis from Massachusetts, has been on antibiotics almost her whole life. Throughout her childhood and early teenage years, the antibiotics were “highly effective,” but with Lawrence now in her 40s, “the bacteria in my lungs are resistant to nearly all antibiotics,” she told the Senate HELP subcommittee on primary health & retirem

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Baby feeding support startup SimpliFed now in network for female veterans in eastern US

Fierce Healthcare

SimpliFed, a national provider of lactation and baby feeding support, is now in network with Optum’s VA Community Care Network. | The new deal grants female veterans in the eastern half of the U.S. access to virtual baby feeding support, available seven days a week, at no cost to the patient and no limits on number of appointments.

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Study Finds Psyilocybin Reduces Alcohol Cravings, Diminishes Shame-Based Thought Patterns in AUD

Pharmacy Times

The use of psilocybin and psychedelic therapy can be a helpful tool for individuals with AUD and could have a positive outcome that can result in self compassion.

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Digital health funding settles down in 2023 with fewer deals, lower check sizes

Fierce Healthcare

After a wild ride in 2020 and 2021, the digital health funding market is entering a new reality with fewer deals and smaller average check sizes. | After a wild ride in 2020 and 2021, the digital health funding market is entering a new reality with fewer deals and smaller average check sizes.

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Takeda yanks FDA filing for dengue vaccine, citing data disagreement with regulator

Fierce Pharma

U.S. travelers and healthcare providers looking for another—and potentially safer—dengue vaccine will have to keep waiting. | U.S. travelers and healthcare providers looking for another—and potentially safer—dengue vaccine will have to keep waiting. After an ominous delay, Takeda has decided to withdraw the FDA application for its dengue vaccine candidate after the agency raised concerns about data collection.

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UVA Health, Riverside Health System partner on care coordination, medical education in eastern Va.

Fierce Healthcare

Virgina providers Riverside Health System and UVA Health have cut a strategic partnership deal that expands complex care access and coordination for patients in the eastern part of the state. | The new strategic agreement gives the academic health system a 5% ownership stake in nonprofit Riverside Health System. With that, UVA Health has committed to expanding care in Riverside's markets as well as to a bidirectional sharing of expertise on clinical program development, medical research and

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Last Chance: Register Now for the Total Pharmacy Solutions Summit

Drug Topics

Join industry experts on Saturday, June 15, to completely transform and revolutionize how you approach front- and back-end solutions within your pharmacy.

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Making Strategic Sense of Pharma’s New Race for Competitive Advantage

Fierce Pharma

The race for competitive advantage for pharma today is about far more than just innovative new molecules. | Pharma's new race for competitive advantage requires embracing transformation across product, company, and market categories and addressing the needs of patients and health systems by developing new products, services and digital ecosystems.

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Short- and Long-Term Exposure to Air Pollution Increase Risk of Heart Failure

Pharmacy Times

The risk of heart failure was higher in low- and middle-income countries when compared to high-income countries.

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Bristol Myers' Opdivo stages comeback in bladder cancer, teeing up 2 'Merck' showdowns

Fierce Pharma

After one combination’s failure, Bristol Myers Squibb is celebrating a new triumph in bladder cancer. But a showdown with the two “Merck” companies likely lies ahead. | After one combination’s failure, Bristol Myers Squibb is celebrating a new triumph in bladder cancer. But a showdown with the two “Merck” companies likely lies ahead.

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Infectious Disease Focus: Hepatitis C Treatment Options

Pharmacy Times

HCV infection is mostly curable and treated with antiviral medications, which can clear the virus from the body.

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Hepatitis B Coinfection with HIV Requires Vigilant Screening, Treatment

Drug Topics

A new study has been published in which researchers attest to the importance of screening vigilance in regards to HIV and HBV.

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These 3 supplements can help manage heat intolerance

The Checkup by Singlecare

You may avoid being outside when it’s brutally hot. But when overwhelming heat comes from your own body, there’s no escaping its intensity. Here’s what you need to know about heat intolerance, its causes, and heat-regulating supplements that may prevent or minimize symptoms of heat intolerance. What is heat intolerance? Heat intolerance is when your body and skin are hypersensitive to a rise in temperature.

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STAT+: How UnitedHealth’s acquisition of a popular Medicare Advantage algorithm sparked internal dissent over denied care

STAT

Frustration was boiling into open conflict within NaviHealth, a company that uses computer predictions to help control the cost of caring for millions of older and disabled Americans on privatized Medicare plans. The source of the outrage was not a customer or a salesperson, but an algorithm — specifically one that was being used to predict the amount of care needed by seriously ill patients.

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Do fish oil supplements increase the risk of atrial fibrillation?

Hospital Pharmacy Europe

Fish oil supplements offer cardiovascular benefits in randomised trials, but is this advantage undermined by an increased risk of atrial fibrillation, and do these risks also apply to eating oily fish? Rod Tucker finds out more. A study by Danish scientists in 1976 first observed how Greenland Eskimos had a fatty acid plasma profile that showed a higher content of long-chain polyunsaturated fatty acids – known as omega-3 fatty acids – derived from marine mammals.

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White House announces new plan to address the growing threat of xylazine in overdose crisis

STAT

The White House on Tuesday unveiled a new plan to address the growing presence of xylazine, a veterinary tranquilizer, in the country’s illicit drug supply. In recent years, xylazine, which is commonly known as “tranq,” has helped to accelerate the already-deadly U.S. drug crisis. The drug is increasingly being mixed into illicit opioids like fentanyl, contributing to overdose spikes across the country, particularly in northeastern cities like Philadelphia and New York.

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Can Post-Exposure Doxycycline Prevent Sexually Transmitted Infections?

Drug Topics

A study examined STI rates following doxycycline post-exposure prophylaxis to see if it could reduce infection rates.

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STAT+: Eisai executive who helped lead development of Alzheimer’s drug to retire

STAT

Japanese drugmaker Eisai said Tuesday that Ivan Cheung, chairman of its U.S. operations and global head of its Alzheimer’s disease unit, will retire at the end of the month. The surprise announcement comes just days after Eisai won final approval in the U.S. for its Alzheimer’s drug Leqembi. Cheung will be replaced in his capacity as head of the Alzheimer’s unit by his brother-in-law Keisuke Naito, 34, who is currently chief ecosystem officer and chief strategy officer.

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Eisai's US CEO and Alzheimer's lead Ivan Cheung telegraphs retirement days after Leqembi's full FDA nod

Fierce Pharma

Right after Leqembi's full approval from the U.S. FDA, Eisai’s global Alzheimer’s disease officer is getting ready to hang up his hat. | Ivan Cheung, Eisai's American CEO and global Alzheimer's disease officer, will retire at the end of the month. With Cheung headed for the exit, Keisuke Naito—the 34-year-old son of Eisai’s CEO Haruo Naito—has taken up the lead Alzheimer’s mantle, the company said Tuesday.

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