Wed.Apr 12, 2023

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FDA should remain the authority on the safety and effectiveness of medicines

PhRMA

Recent district court rulings set an alarming precedent that calls into question the authority of the U.S. Food and Drug Administration (FDA) to determine the safety and effectiveness of new medicines.

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Solutions to Streamline Inventory Management

Drug Topics

Autofill programs and metrics reporting can help pharmacists streamline their inventory management.

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New global analysis shows patient access challenges around the world

PhRMA

Today PhRMA released a new report that analyzes the share of new medicines that are available in over 70 countries and how long patients wait to receive them. The Global Access to New Medicines Report includes comprehensive comparisons across countries in the G20, Organization for Economic Co-operation and Development (OECD) and several geographic regions.

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Study: Pandemic Shows Link to Increased Exposure of Opioids to Postpartum Women

Pharmacy Times

Analysis indicates that there was a larger increase of filled prescriptions for individuals who delivered by cesarean birth.

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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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Does Tirzepatide's Benefits in Patients with Type 2 Diabetes Make The Price Worth It?

Drug Topics

Tirzepatide was associated with a greater reduction in hemoglobin A1c and body weight when compared to semaglutide. But with a current list price of $1,023 for a one-month supply, is tirzepatide (Mounjaro; Lilly) worth it?

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12 Skills Pharmacy Students Can Apply to Become Leaders in Their Practice

Pharmacy Times

Pharmacists serve as advocates to optimize patient pharmaceutical care, advance the profession, and positively influence the community.

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More Trending

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FDA Approves Expanded Indication for Hyqvia to Treat Pediatric Primary Immunodeficiency

Pharmacy Times

During the 12-month trial period, Hyqvia was shown to be efficacious treating the occurrence of acute serious bacterial infections in children aged 2 through 16 years with primary immunodeficiency.

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Taking healing into your own hands

Drug Store News

The origin story of Element Apothec is like many other entrepreneurial endeavors, a product was developed and created because items available on the market didn’t meet the need.

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Hard Stops for EMRs Reduces Rates of Hospital-Acquired Clostridioides difficile Infection

Pharmacy Times

These are used to help reduce inappropriate testing, where an expert consults with medical directors of infection prevention and control for a test-order override.

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Opinion: Michael J. Fox: As a Parkinson’s patient, I felt a little left behind by biology’s century — until now

STAT

Last fall in STAT, Matt Herper questioned whether the biomedical research enterprise is really laying the necessary groundwork to gain the full benefit of innovation in “biology’s century.” “The biggest looming problem is that… new technologies in biology [could] outpace our ability to assess them,” he observed.

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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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Study: Participation in Clinical Trials Associated With Improved Overall Survival in Patients with Ovarian Cancer

Pharmacy Times

Availability of clinical trials in the gynecologic cancer care space are increasing, but it is important to be mindful of current racial disparities.

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A controversial hire at Arnold Ventures raises questions about the donor’s stance on addiction

STAT

A philanthropic giant’s recent hire of a researcher with controversial theories on naloxone access is raising alarms among public health advocates who worry the move marks a shift in major donors’ approach to addiction treatment. Arnold Ventures, one of the largest nonprofit funders of criminal justice reform projects and a major player in drug policy circles, announced last month that Texas A&M University economist Jennifer Doleac would take over its criminal justice portfolio

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There Are Two Significant Advantages to the Decriminalization of Psychedelics

Pharmacy Times

To build a brighter, healthier, and more equitable future for all US citizens, there is an indisputable need to decriminalize psychedelic medicines.

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Bad Sun Habits Increases Risk of Nonmelanoma Skin Cancer In Millennials, Gen Z

Drug Topics

A new survey found that neither generation is particularly good at maintaining healthy sun habits, and have low skin cancer awareness.

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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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Updates on 503A Compounding: The Impact of Drug Shortages

Pharmacy Times

The FDA’s temporary Guidance for 503A compounding of shortage drugs was meant to be temporary and withdrawn once COVID-19 ended.

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Menopause May Increase Risk of Glaucoma but Estrogen Therapy Could Help, Study Finds

Drug Topics

A recent study showed a link between menopause and increased glaucoma risk, with estrogen-based treatment being a possible solution.

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Help Patients Improve Glycemic Control for T2D

Pharmacy Times

Keeping blood glucose levels within a target range delays, prevents serious health complications associated with type 2 diabetes.

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A Parkinson’s ‘game changer,’ backed by Michael J. Fox, could lead to new diagnostics and, someday, treatments

STAT

NEW YORK — Michael J. Fox was sitting in his Upper East Side office surrounded by Emmys and an Oscar — one he received not for his acting but for his Parkinson’s philanthropy. (“Humanitarian stuff,” he said nonchalantly.) He wore blue trousers and a T-shirt, and Adidas sneakers with no socks. His hair, years ago always perfect, was a bit disheveled, and he was in constant movement in his chair, a hallmark of the Parkinson’s disease that has defined

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HRG’s five notable products from March 2023

Drug Store News

HRG reviewed 22 products in the health category, 169 in the wellness sector and 91 items in the beauty aisle to see which ones stood out as Products to Watch.

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LyGenesis and Imagine Pharma partner for type 1 diabetes therapies development

Pharmaceutical Technology

Clinical-stage biotechnology firm LyGenesis has formed a joint research collaboration with Imagine Pharma to develop new cell therapies for type 1 diabetes (T1D). The companies will develop new cell therapies for patients with T1D, using LyGenesis’ allogeneic cell therapy platform and Imagine Pharma’s Type 1 Diabetes Activated Islet Progenitor Cells (T1D AIPCs).

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Dollar General appoints two leadership roles

Drug Store News

Kelly Collier has been promoted to senior vice president, assistant general counsel, while Peggie Fort has joined the company as vice president, inventory and demand management.

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Wireless pacemakers may work for children with slow heart rhythms — but first, doctors need child-sized catheters

STAT

Pacemakers, relied upon by many patients with irregular heart rhythms, are not built for children. Scrambling up trees, hanging from monkey bars, and even the simple act of growing make the device more likely to fail.  Roughly 1 in 15,000 children are born with congenital heart block , which causes an abnormally slow heart rate. The condition leads to lightheadedness, shortness of breath, and in serious cases, heart failure.

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See the most important savings tip, according to a pharmacist

The Checkup by Singlecare

After nearly four decades working in pharmacy, Vicki O’Connor, R.Ph., understands the unique needs of the community she serves at Jewel-Osco in Huntley, Illinois, a suburb of Chicago. With a large older adult population, O’Connor is an expert at navigating the ins and outs of Medicare coverage and finding creative solutions to help her patients save money on their prescription medications.

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Juul agrees to pay $462 million to 6 states and D.C., and to share documents

STAT

WASHINGTON — The e-cigarette maker Juul has agreed to pay six states and Washington, D.C., $462 million for its alleged role in fueling the recent significant rise in youth vaping, New York Attorney General Letitia James announced Wednesday. The settlement, which includes California and New York, is the largest to date between Juul and state attorneys general, and will also require Juul to disclose a number of previously secret documents, which will be housed in an academic archive.

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A Closer Look at Paperless Validation’s Impact on Biotech

ISPE

A Closer Look at Paperless Validation’s Impact on Biotech Trudy Patterson Wed, 04/12/2023 - 07:34 iSpeak Blog iSpeak A Closer Look at Paperless Validation’s Impact on Biotech Steven Thompson 12 April 2023 The impact of paperless validation on the biotechnology industry is massive, and the overall effect is growing as adoption increases. Paperless validation is applicable to every type of validation in biotech: cleaning, process, equipment, facilities, utilities, and many others.

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Large European study underlines power of genomic sequencing to diagnose diseases

STAT

LONDON — Using genome sequencing greatly expanded the number of diagnoses researchers could provide for children with developmental disorders from thousands of families across the United Kingdom and Ireland, researchers reported in a new study Wednesday. The study , published in the New England Journal of Medicine, focused on children with severe developmental disorders who hadn’t received diagnoses through other standard methods.

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Healthy sleep pattern reduces risk of developing asthma

Hospital Pharmacy Europe

Having a healthy sleep pattern reduces the risk of adults developing asthma even among those with a high genetic risk for the disease Chinese researchers analysing data held in the UK Biobank, found that those with a healthy sleep pattern have a reduced risk of developing asthma, even among those with an increased genetic susceptibility to the disease.

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White House designates xylazine, better known as ‘tranq,’ as an emerging drug threat

STAT

The White House on Wednesday issued an unprecedented warning about xylazine , the veterinary tranquilizer increasingly found in the illicit opioid supply. Beginning today, the substance will be classified as an “emerging drug threat” — the first designation of its kind. The announcement and accompanying notification to Congress from Rahul Gupta, the White House’s top drug policy official, comes as xylazine — also known as “tranq” — continue

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Clinical Excellence in Cardiovascular Care: a new event

Hospital Pharmacy Europe

Hear the latest developments and innovations in cardiovascular care at a new free event being held in May 2023 In support of our mission to provide high-quality clinical education, Hospital Healthcare Europe , together with Hospital Pharmacy Europe, is proud to announce a new series of events in 2023: the HHE Clinical Excellence programme. Kicking off with cardiovascular care and developed in conjunction with an expert advisory board of renowned key opinion and thought leaders from UK Centres of

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White House moves to protect some abortion patients’ records

STAT

WASHINGTON — The White House on Wednesday proposed a new federal rule to limit how law enforcement and state officials collect medical records if they investigate women who flee their home states to seek abortions elsewhere. The proposal, prompted by a string of blows to abortion access across the country, follows a federal judge’s ruling on Friday that threatens to pull the most commonly used abortion pill, mifepristone, off the market.

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What’s pharma doing wrong to improve trial diversity? ‘Everything’

PharmaVoice

Pharma’s missing the mark when it comes to recruiting Black patients, and Ricki Fairley, CEO of The Black Breast Cancer Alliance, reveals what’s needed.

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AACR: AstraZeneca offers first look at Imfinzi's resectable lung cancer showing, fueling a key debate

Fierce Pharma

AACR: AstraZeneca offers first look at Imfinzi's resectable lung cancer showing, fueling a key debate aliu Wed, 04/12/2023 - 15:37

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A majority of payers used outcomes-based contracting last year: survey

Fierce Healthcare

A majority of payers used outcomes-based contracting last year: survey pminemyer Wed, 04/12/2023 - 13:04

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Moderna nabs a win in Arbutus patent case as appeals court upholds prior invalidation

Fierce Pharma

Moderna nabs a win in Arbutus patent case as appeals court upholds prior invalidation zbecker Wed, 04/12/2023 - 11:16

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