Sat.Feb 25, 2023 - Fri.Mar 03, 2023

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Opinion: How physician wellness programs keep doctors captive

STAT

The American College of Surgeons recently announced its new well-being initiative for surgeons. This wellness program has lofty goals: [The ACS] recognizes the need to foster well-being, resilience, and work-life integration for all surgeons, regardless of their career stage. Fostering the growth of both the surgical expertise and the person as a whole is paramount.

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11 Tips to Improve Epistaxis Management in the Emergency Department

ALiEM - Pharm Pearls

Managing epistaxis is often challenging, time-consuming, and takes practice. Even under the best circumstances, epistaxis often results in return visits for rebleeding and poor outcomes. Rarely should you do “nothing” for adults who present to the ED with or following epistaxis. If it produced enough blood to seek care (even without hemodynamic compromise), epistaxis frequently recurs even if currently resolved.

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As clinical trials face a hiring crunch, here’s how research organizations can pivot

PharmaVoice

Staffing shortages are causing inefficiencies in clinical trials, but one leading CRO is finding ways to adapt.

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Why Congress should prioritize fixing the 340B program

PhRMA

Nearly all Americans nationwide agree: Lowering out-of-pocket costs for health care should be a top priority for policymakers. Luckily, there are commonsense policies Congress could implement to meaningfully address the cost burdens Americans face. These include things like making sure patients aren’t paying more for their medicines than their health insurance company or requiring first-dollar coverage, so insurance companies cover the cost of certain lifesaving medicines from day one of the pla

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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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Report: Obesity could cost the world over $4 trillion a year by 2035

STAT

The costs of obesity are projected to soar globally, in step with rising prevalence, according to a new report from the World Obesity Federation, the only group focused solely on tracking global obesity trends and a partner of the World Health Organization. Over half the world’s population will be either overweight or have obesity by 2035, the report projected, while the economic impact of a high BMI could reach $4.32 trillion annually, if current trends continue and policy inertia around

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SAEM Clinical Images Series: A Rare Cause of Post-traumatic Neck Pain

ALiEM - Pharm Pearls

A 15-year-old male presents to the pediatric Emergency Department (ED) for evaluation of neck pain for three weeks. The patient is vague as to the development of his symptoms, but his mother reveals patient was assaulted by peers three weeks ago and has had progressively worsening neck pain and stiffness. The patient states symptoms have gotten to the point where he is unable to turn his head but denies fevers, chills, nausea, vomiting, focal weakness, or sensory changes.

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Celebrating 40 years of the Orphan Drug Act on Rare Disease Day

PhRMA

For over a decade, Rare Disease Day has been celebrated on February 28 to raise awareness and generate change for the more than 30 million patients in the U.S. living with a rare disease. This year’s Rare Disease Day is particularly special because this year also marks the 40 th anniversary of the Orphan Drug Act (ODA), allowing us to celebrate all the progress that’s come to patients because of it.

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How policymakers could tweak HIPAA to better protect abortion records

STAT

WASHINGTON — Patient privacy law offers little protection if law enforcement requests a person’s medical records — an issue that’s fueled concern as states impose restrictions on abortion after the Supreme Court overturned Roe v. Wade. “I think it’s important to know that right now, your health records aren’t necessarily protected.

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New workflow for the analysis of mRNA therapeutics

European Pharmaceutical Review

Large RNA is rapidly emerging as a new class of therapeutics. Nowhere is this more publicly evident than in the development, regulatory approval, and efficacious use of mRNA‑based vaccines for COVID-19. Beyond the high-profile COVID-19 vaccines, mRNA therapeutics are crucial in applications such as protein replacement therapies and regenerative medicine.

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Woman of the Week: Denali Therapeutics’ Cindy Dunkle

PharmaVoice

As chief people officer, Dunkle is harnessing the company’s unique culture to foster innovation.

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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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US FDA approves Reata Pharmaceuticals’ SKYCLARYS for Friedreich’s ataxia

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Reata Pharmaceuticals ’ oral, once-daily medication SKYCLARYS (omaveloxolone) to treat Friedreich’s ataxia patients. SKYCLARYS is indicated to treat the ultra-rare, inherited neurodegenerative disorder in 16 years and above-aged adults and adolescents in the US. SKYCLARYS is the first approved treatment in Friedrich’s Ataxia and marks a milestone for drug development in this complex disease.

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STAT Madness 2023

STAT

Welcome to STAT Madness, a bracket-style contest to find the best innovation in science and medicine. Click on each matchup for a short summary of each school’s pioneering research. Then pick your favorites. Help us crown a champ!

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Will Face to Face Communication Fade in a Digital World?

Pulses

By: Jaclyn Boyle, MS, MBA, BCACP and Jonathan Lang, PharmD Candidate 2023 With the technological advances of today’s age, will students lose the ability to communicate face to face (F2F)? The newly revised AACP Curriculum Outcomes and Entrustable Professional Activities (COEPA) stress the importance of communication. COEPA 2.2 states that students should “actively engage, listen, and communicate verbally, nonverbally, and in writing when interacting with or educating an individual, group,

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Launched with a ‘pioneer’ in RNA, aTyr Pharma is charting a new course in immunology

PharmaVoice

With a focus on rare and hard-to-treat diseases, aTyr is banking on its head start in tRNA and vast IP portfolio to build a billion-dollar company.

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FDA panel backs GSK RSV vaccine ahead of approval

Pharmafile

Yesterday, GSK shared that an advisory committee from the FDA voted in support of its respiratory syncytial virus (RSV) vaccine candidate for older adults. This support is ahead of an official FDA approval for the company’s vaccine. GSK has shared that a final decision is expected to be made by the FDA ahead of the 3 May.

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The FDA has cleared the first home flu and Covid test — but its maker just declared bankruptcy

STAT

On Friday, the Food and Drug Administration issued an emergency authorization for the first at-home test that can detect flu and Covid-19 — but for the test’s maker, Lucira, the long-anticipated authorization may have taken too long. The company filed for bankruptcy on Feb. 22, directly blaming the “protracted” FDA authorization process for the over-the-counter combination test for its financial troubles.

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What The NAPLEX 2022 Pass Rate Tells Us About 2023

Med Ed 101

I’ve followed the NAPLEX exam since I graduated in 2009. The NAPLEX was relatively easy from my experience and the experience of many of my classmates. The pass rate that year was an indicator that the NAPLEX was not very difficult. That is not the case anymore. Just looking at the California Board of Pharmacy […] The post What The NAPLEX 2022 Pass Rate Tells Us About 2023 appeared first on Med Ed 101.

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The ‘recovering academic’ leading Allogene to the next stage of cell therapy

PharmaVoice

Zachary Roberts joined Allogene at the beginning of this year to lead the company's R&D and bring allogeneic cell therapy to the forefront.

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Double win for StudyKIK's oncology and cash apps helping trial patients

Outsourcing Pharma

Year on year, the SCOPE summit brings thousands of people working in the pharma field together and the last one attracted more than 2,300 leaders in clinical operations and research.

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Same patient, same drug, same insurer — coverage denied

STAT

Janice Morales-Ferrer is a planner. It’s helped her get ahead in her career and in raising three young kids. But it’s hard to plan when you’ve got a rare disease, especially one with no standard treatment regimen or predictable outcome. “I’m a data-driven person,” said the 46-year-old Boston area resident. “It’s frustrating for me to not be able to plan how long I can live for my kids.

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US FDA approves Regeneron-Sanofi’s Kevzara to treat polymyalgia rheumatica

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Regeneron Pharmaceuticals and Sanofi ’s Kevzara (sarilumab) to treat polymyalgia rheumatica (PMR) in adult patients. Kevzara has been approved as the first and only biologic indicated for PMR adult patients who did not respond to corticosteroids or who cannot tolerate corticosteroid taper.

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PharmaVoice 100 honorees: Where are they now?

PharmaVoice

How some of our past PharmaVoice 100 honorees are transforming the life sciences industry in new roles.

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New patent for Optinose Us drug XHANCE

Drug Patent Watch

Annual Drug Patent Expirations for XHANCE Xhance is a drug marketed by Optinose Us Inc and is included in one NDA. It is available from one supplier. There are thirteen… The post New patent for Optinose Us drug XHANCE appeared first on DrugPatentWatch - Make Better Decisions.

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What the dogs of Chernobyl can teach us about life at the edge

STAT

You’d think an irradiated wasteland would be a poor place to make a home, but some animals beg to differ. Since the Chernobyl nuclear meltdown 37 years ago, both wild animals and free-roaming domesticated dogs have, to the surprise and delight of environmentalists, flocked to and flourished in the evacuated,1,000 square mile zone surrounding the plant.

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Merck reports rise in group net sales in fiscal 2022

Pharmaceutical Technology

Merck has reported an increase in group net sales by 12.9% to €22.23bn in fiscal 2022 against €19.68bn in 2021. The growth in sales was driven by all regions and business sectors, particularly Life Science. Organically, the company generated an increase of 6.4% in group sales in fiscal 2022. Favourable foreign exchange effects of 6.1% resulted primarily from the development of the US dollar and the Chinese renminbi.

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Insurer and PBM tactics are shifting higher costs to patients with chronic and complex conditions

PhRMA

Health plans are increasingly using deductibles and coinsurance to shift more of the cost of care to chronically ill patients taking brand medicines. As data from IQVIA show, this alarming trend is especially burdensome for patients with cancer, who pay nearly 10X more on average per year for their medicines when they face deductibles and coinsurance versus patients with only fixed copays.

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New patent expiration for Dialysis Sups drug NORMOCARB HF 25

Drug Patent Watch

Annual Drug Patent Expirations for NORMOCARB+HF+25 Normocarb Hf 25 is a drug marketed by Dialysis Sups and is included in one NDA. There is one patent protecting this drug. This… The post New patent expiration for Dialysis Sups drug NORMOCARB HF 25 appeared first on DrugPatentWatch - Make Better Decisions.

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STAT+: CRISPR patent fight redux? A new battle is brewing among biotechs over next-gen gene-editing tools

STAT

Genome editing summits are generally friendly, nerdy affairs, but for a moment at a Lisbon hotel last June, the conversation at the FASEB genome engineering conference grew tense. Tessera Therapeutics chief scientist Michael Holmes had just finished presenting a much-anticipated peek at a technology the company had previously said could “ revolutionize genetic medicine ” and “cure nearly any genetic disease.

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Amniotics’ PulmoStem receives positive safety data

Pharma Times

Treatment is a lung-specific stem cell therapy designed for hospitalised patients with respiratory infections

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Double win for StudyKIK's oncology and cash apps helping trial patients

Outsourcing Pharma

Year on year, the SCOPE summit brings thousands of people working in the pharma field together and the last one attracted more than 2,300 leaders in clinical operations and research.

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Justification of Using Weight Variation Instead of Content Uniformity for Release of Relevant OSD Forms

PharmaTech

This article discusses the evaluation of paired content uniformity and weight variation data sets using F and T tests to ensure that batches meet compendial requirements.

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Opinion: Adoption is not a simple or easy alternative to abortion

STAT

“But aren’t you grateful to be alive”? That’s a question adoptees like me are often asked when we speak out against the Supreme Court’s decision to overturn Roe v. Wade. Like other adoptees, I hesitate to answer, feeling the pressure to respond as we’ve been trained to by society, “Yes, I’m grateful, so very grateful.

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Hope for Parkinson’s disease and Lewy body dementia patients

Pharma Times

Research into modified RNA messages could help treat diseases and develop new therapies

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New purification method could enhance protein drug manufacturing

European Pharmaceutical Review

In a recent study, Massachusetts Institute of Technology (MIT) researchers developed a new purification method to cut the costs of manufacturing protein drugs. The engineers used bioconjugate-functionalised nanoparticles to quickly and inexpensively isolate proteins from a bioreactor. Producing biologics by isolating proteins Biologics like antibodies and other protein-based drugs are produced by living cells such as yeast in large bioreactors.

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PioneerRx Fills Crucial Gap in COVID-19 Vaccine Reporting for North Carolina

PioneerRx

Irving, TX - PioneerRx Pharmacy Software is the first and only independent pharmacy management system to feature a direct reporting capability with North Carolina’s