Sat.Jan 28, 2023 - Fri.Feb 03, 2023

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STAT+: Medicare Advantage insurers to repay billions under final federal audit rule

STAT

The federal government will audit Medicare Advantage insurers aggressively under a rule finalized Monday, which is expected to result in billions of dollars in overpayments going back toward Medicare’s trust fund and patients over the next decade. However, federal officials watered down one of the auditing policies by giving insurers seven years of immunity from having the samples of their diagnosis coding errors extrapolated to their broader Medicare Advantage membership.

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Patients are using social media — clinical trial experts can learn from that

PharmaVoice

Why an alliance of industry leaders is exploring the potential of social media as a treasure trove of real-world patient experience insights.

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HIV vaccines suffer setbacks but new approaches could turn the tide

Pharmaceutical Technology

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections. This marks the second time one of Janssen’s HIV vaccines failed after another showed disappointing results in the Phase IIb Imbokodo trial in August 2021.

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Halting Europe’s essential medicines manufacturing exodus

European Pharmaceutical Review

While maintaining a healthy manufacturing industry for production of ‘high tech’ pharmaceuticals, Europe has stepped away from manufacturing essential medicines and active pharmaceutical ingredients (APIs) due to unrelenting price pressures and is now heavily reliant on the import of these critical ingredients. There is now a large regional concentration in the production of generic APIs in Asia with 66 percent of the world’s API production by volume manufactured in India and China. 1 Europe is

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Opinion: Disruptive science is leaping forward, not limping along

STAT

A recent study and accompanying news story in the preeminent journal Nature provocatively concludes that disruptive innovation in science has dramatically and mysteriously declined 90% since 1945. The study has prompted a wave of news coverage and tweets decrying the apparent languishing of modern science. We feel that the authors make interesting observations on publishing trends, but their conclusions seem to be quite disconnected from the valuable and transformative innovations that benefit h

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Vaxxinity eyes global COVID-19 vaccine market with ‘next-gen’ booster

PharmaVoice

The biotech aims to complete rolling submissions with regulators in the U.K. and Australia in the first half of 2023.

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More Trending

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Three-year patent strategy for greater medicine access announced

European Pharmaceutical Review

A new strategy for 2023-2025 by the Medicines Patent Pool (MPP) aims to reduce access inequities, by improving the availability and affordability of health products in low- and middle-income countries (LMICs). The MPP is a United Nations-backed public health organisation working to increase medicine access and facilitate the development of life-saving medicines for LMICs.

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Survey: A majority of Americans support banning all tobacco products

STAT

WASHINGTON — A majority of Americans support banning all tobacco products, according to a new poll published by researchers at the Centers for Disease Control and Prevention. The survey , which was published Thursday in the peer-reviewed journal Preventing Chronic Disease, asked 6,455 people nationwide: “To what extent would you support a policy to prohibit the sale of all tobacco products?

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This biotech CEO secured two billion-dollar Big Pharma deals during the pandemic

PharmaVoice

With the industry focused on cancer and COVID-19, Marc de Garidel made deals centered on cardio.

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US FDA approves GSK’s Jesduvroq to treat anaemia of CKD

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). It is claimed to be the only HIF-PHI approved in the country that offers a new oral treatment option for adult patients on dialysis with anaemia of CKD.

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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Clinical Trials Information System mandatory in EU

European Pharmaceutical Review

From 31 January 2023, all initial clinical trial applications in the European Union (EU) must be submitted via the Clinical Trials Information System (CTIS). According to the European Medicines Agency (EMA), CTIS is now the single-entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data. This follows a one-year transition, during which sponsors could choose whether to apply for a new clinical trial in the EU/EEA in line with the Clinical

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These blood-clot catching devices have been controversial for years. Why are doctors still relying on them?

STAT

Inferior vena cava filters are supposed to save lives. The spider-like devices catch blood clots before they can travel up to the lung and cause deadly pulmonary embolisms. But for over a decade, these devices have been dogged by questions about how well they work and the serious complications they can cause for patients. The latest data make clear they’re still causing problems: Researchers examined a Food and Drug Administration database and found that adverse event reports related to t

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Lessons from GoodRx’s “Guide to Successful Copay Programs”

PharmaVoice

Download the complimentary Guide to Successful Copay Programs that delivers actionable insights to pharma leaders.

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Pfizer reports 30% operational growth in full-year 2022 revenues

Pharmaceutical Technology

Pfizer has reported a 30% operational growth in revenues to $100.3bn in full-year 2022 compared with $81.2bn reported last year. The revenues grew 2% operationally excluding Paxlovid and Comirnaty’s contributions. In the fourth quarter (Q4) of 2022, they increased 13% operationally to $24.3bn compared to $23.8bn in the same quarter last year. On an operational basis, the revenues rose by 5%, omitting contributions from Paxlovid and Comirnaty.

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Best Practices to Streamline Compensation Management: A Foundation for Growth

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

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Milestone product launch for Kelso Pharma

Pharma Times

Acepiro tablets for respiratory diseases will be available across the UK prescription market

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MRI scans reveal disparate impact of poverty and other ‘toxic stress’ on brains of Black children

STAT

Stressful experiences during early childhood — particularly economic strife — appear to act as a toxic stressor that can alter regions of the brain tied to the processing of stress and trauma, according to a new study published Wednesday. The researchers found that Black children were impacted more than white children, largely because of the higher amounts of poverty and adversity they face.

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Antitrust watchdogs have pharma in their sights, and the landscape is getting thornier

PharmaVoice

The FTC and DOJ are heightening antitrust enforcement, and pharma deals are a prime target.

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France gets new sterile liquid drug manufacturing facility

European Pharmaceutical Review

Switzerland-based contract development and manufacturing organisation (CDMO) CARBOGEN AMCIS has opened a new facility in France, dedicated to the custom development and production of sterile injectable drug products. The facility forms two new fully-automated production lines for liquid and freeze-dried drugs, including highly potent compounds and advanced therapies such as antibody drug conjugates (ADCs).

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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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Magazine: CRISPR gene therapies cut through in 2023

Pharmaceutical Technology

If things go as per plan, in a few months, the US Food and Drug Administration (FDA) will deliberate on the first-of-its-kind CRISPR-based gene therapy for sickle cell disease (SCD) and transfusion-dependent beta thalassemia. Having made significant advances in a relatively short period of time, CRISPR research is now edging closer to reaching the clinic , and this month’s cover story takes a look at the major players in this field and the big events that could break through this year.

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STAT+: Biden administration floats major 2024 pay cut for Medicare Advantage plans

STAT

Medicare Advantage insurers could face an average 2.3% cut to baseline payments in 2024, the Biden administration said Wednesday. If the proposal stands, it would be a net cut of more than $3 billion to the industry. The major reason behind the proposed pay cut: Medicare officials want to update data and coding systems that are used to explain the health conditions of an insurance company’s enrollees.

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Boost returns from social strategies with new channels and tactics

PharmaVoice

Emerging channels offer new ways to reach key targets and improve campaign ROI.

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Top 10 Drug Interactions – My List

Med Ed 101

There are literally thousands of drug interactions so I had my work cut out to try to narrow down the list to the top 10. In this post, I outline my list of the top 10 drug interactions. This is based on a combination of my experience, the frequency of the interaction, the severity of […] The post Top 10 Drug Interactions – My List appeared first on Med Ed 101.

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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What Does an NFL Team Physician Do?

Board Vitals - Pharmacist

On February 12, the Philadelphia Eagles and Kansas City Chiefs will duke it out in Super Bowl LVII. In addition to the players on the field, there are teams of NFL team doctors and sports medicine specialists who keep the offenses, defenses, and special teams in top shape. According to the NFL Physicians Society (NFLPS), 192 team physicians (as of 2023) provide care to the 32 NFL teams and their players – on and off the field, and long before and after game time.

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STAT+: ‘Everybody has blood on their hands’: A decade-long battle over Medicare Advantage audits is coming to a head

STAT

The federal government and health insurance companies have been clashing for more than a decade over how Medicare Advantage plans should be audited and how the well-documented overpayments to those plans should be clawed back. That fight is about to hit an inflection point this week, when Medicare makes a final determination about how aggressively it will probe the industry.

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Woman of the Week: Bayer’s Dr. Yesmean Wahdan

PharmaVoice

The VP of medical affairs and women's health is focused on an audacious goal — to meet the needs of 100 million women in lower income countries.

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Gut Health & My Favorite Probiotic

The Luxe Pharmacist

As many of you know I’ve been on a bit of a health kick since the end of October, so I’m not necessarily creating new resolutions for 2023 when it comes to health. Instead, this year is about continuing my commitment to physical and mental wellness. As a whole this involves obviously many different aspects of my life and daily habits but today I wanted to talk about one area in particular, gut health.

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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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First medicine approved in EU for eosinophilic esophagitis

European Pharmaceutical Review

The European Commission (EC) has expanded the marketing authorisation for Dupixent® (dupilumab) in the European Union (EU) to treat eosinophilic esophagitis (EoE). It is the “… first and only targeted treatment option clinically proven to reduce both oesophageal inflammation and damage,” explained Dr Naimish Patel, Head of Global Development, Immunology and Inflammation at Sanofi.

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STAT+: No more ‘playing God’: How the longevity field is trying to recast its work as serious science

STAT

SAN FRANCISCO — “Why is it in popular culture, if you want to live forever, you are evil and you want to kill babies on the side?” says Martin Borch Jensen. It’s fast approaching 10 p.m. on the first night of the J.P. Morgan Healthcare Conference , and among a couple stragglers at a dinner for longevity CEOs, scientists, and investors, the conversation has turned from the practical or merely social to the philosophical.

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Astria Therapeutics’ edge in an ultra-rare disease

PharmaVoice

With positive early phase data, CEO Jill Milne is aiming to bring an improved preventative option to patients with hereditary angioedema.

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Merck reports 2% increase in worldwide sales in Q4 2022

Pharmaceutical Technology

Merck (MSD outside North America) has reported a 2% increase in worldwide sales to $13.83bn in the fourth quarter (Q4) of 2022 from $13.52bn in the previous year’s quarter. The company’s pharmaceutical sales recorded a 1% rise to $12.18bn compared to $12.03bn in the prior-year quarter. For the quarter, GAAP earnings per share (EPS) from continuing operations was $1.18, indicating a 22% decline from $1.5 in the same quarter last year.

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First biosimilar to HUMIRA® available in US

European Pharmaceutical Review

AMJEVITA (adalimumab-atto), a biosimilar to Humira ® (adalimumab), is now available in the US. Amgen’s AMJEVITA was the first biosimilar to Humira approved by the US Food and Drug Administration (FDA), in 2016. The active ingredient in the anti-TNF-α monoclonal antibody has the same amino acid sequence as Humira. The Humira biosimilar will be available in prefilled syringe and autoinjector presentations to support dosing in each of the approved indications.