Sat.Jun 08, 2024 - Fri.Jun 14, 2024

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Global health leader critiques ‘ineptitude’ of U.S. response to bird flu outbreak among cows

STAT

LONDON — Seth Berkley, a longtime and widely respected global health leader , said Thursday that it has been “shocking to watch the ineptitude” of the U.S. response to the avian influenza outbreak among dairy cattle , adding his voice to a chorus of critics. In a presentation in London about vaccine development, Berkley, the former CEO of Gavi, the Vaccine Alliance, raised the issue of H5N1 bird flu when discussing whether the world was ready for another pandemic following i

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From Collision to Clarity: PECARN cervical spine injury prediction rule for injured children

ALiEM - Pharm Pearls

For years, adult literature has provided clear guidelines for cervical spine imaging through the NEXUS and Canadian C-spine Rule (CCR) tools. These have been invaluable in helping clinicians decide when to image the neck in trauma patients. Similarly, the Pediatric Emergency Care Applied Research Network (PECARN) has developed robust tools for assessing blunt head trauma in children.

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Behind Big Pharma’s layoffs — is there an end in sight?

PharmaVoice

A slew of major companies, including BMS, have announced cost-cutting measures in recent months. What will it take to turn the tide?

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Modifier gene therapy – clinical development and manufacturing considerations

European Pharmaceutical Review

Tell us about Ocugen’s lead programme, OCU400. What’s the latest and what’s next? OCU400 is a modifier gene therapy aimed at treating retinitis pigmentosa and Leber congenital amaurosis (LCA). In April 2024, Ocugen received US Food and Drug Administration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa.

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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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Supreme Court unanimously rejects challenge to mailed abortion pills

STAT

The Supreme Court ruled unanimously Thursday that anti-abortion doctors did not have standing to challenge the Food and Drug Administration’s regulation of the abortion pill mifepristone. The decision in FDA v. Alliance for Hippocratic Medicine reverses an appeals court order to require in-person prescribing of mifepristone , which had been available though telehealth and mail orders since 2021.

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2024 Commonwealth Pharmacists Day -Pharmacists developing resilient and sustainable health systems

Commonwealth Pharmacists Association

2024 Commonwealh Pharmacists Day -Pharmacists developing resilient and sustainable health systems About the Day Welcome to the official page for Commonwealth Pharmacists Day, celebrated every year on the 16th of June! This year, we have chosen the theme: “Pharmacists developing resilient and sustainable health systems”.

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Pharmacy closures nearly five times higher in more deprived areas

The Pharmacist

EXCLUSIVE The most deprived areas in England have lost nearly five times as many community pharmacy premises as the least deprived areas in the last five years, new analysis from The Pharmacist has found. The 10% most deprived areas saw a net loss of around 250 local pharmacies between March 2019 and April 2024, while […] The post Pharmacy closures nearly five times higher in more deprived areas appeared first on The Pharmacist.

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Michigan stands out for its aggressive bird flu response. Will other states follow its lead?

STAT

For weeks now, as the H5N1 bird flu has been spreading into dairy cattle herds in more and more places, one state continues to lead the pack. With reports of infections in 25 herds, Michigan currently accounts for about one-third of the country’s confirmed cases in livestock. And of the three people known to have contracted the H5N1 virus from sick cows since the outbreak began, two of them are farmworkers in Michigan, including one who experienced respiratory symptoms.

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EMCrit 377 – Breaking News – The PREOXI Trial changes everything about Preoxygenation for Intubations in the Critically Ill

EMCrit Project

the PREOXI trial validates what I have been saying for 15 years about preoxygenation for the critically ill patient EMCrit Project by Scott Weingart, MD FCCM.

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Launch Excellence: Moments of Truth

pharmaphorum

Explore the key moments of truth in launch excellence for MSLs and commercial teams in this informative white paper. Gain valuable insights and strategies for successful launches.

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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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Scrub-a-Dub-Dub: FTC is Cleansing the Orange Book of Device Patents

FDA Law Blog: Biosimilars

By Sara W. Koblitz — As we have noted for the last year or so, the FTC has been on a mission to clean up the Orange Book by removing what it deems to be “improper” patents. The FTC has put out policy statements, challenged patent listings, tapped Congress, appeared on talk shows, and filed amicus briefs all in the span of the last 8 months. It seems like all that work is paying off.

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Opinion: The J&J lawsuit should be a wakeup call to the PBM industry — and to companies everywhere

STAT

The ongoing legal dispute involving Johnson & Johnson has again thrust the topic of pharmacy benefit managers (PBMs) into the spotlight. Ann Lewandowski, a J&J employee, sued the company for overpaying for its employees’ prescription drugs through its PBM, Express Scripts, claiming that these overpayments resulted in higher health insurance premiums and out-of-pocket drug costs for employees.

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Our aim is to tailor our oncology portfolio to address the most pressing needs in India

Express Pharma

What are the therapeutic focus areas of Merck’s Oncology division? Do they match the unmet medical need in India for oncology treatment? WHO states that cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, or nearly one in six deaths and is set to increase. This drives us at Merck to develop innovations that matter most to people living with cancer.

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3rd to 7th June – This week in clinical trials

pharmaphorum

Get the latest updates on clinical trials from 3rd to 7th June involving companies like uniQure, Takeda, Otsuka, CatalYm, Agios, and Transgene. Stay informed on the latest developments in the field.

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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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Avidity drug for muscular dystrophy shows promise; Syntis takes new approach to weight loss

BioPharma Dive

Study results indicated Avidity’s medicine muted target genes. Elsewhere, Syntis revealed obesity drug plans and Nodthera chalked up more positive data for its NLRP3 inhibitor.

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With placenta-on-a-chip, researchers hope to gauge how drugs and toxins impact pregnancy

STAT

Early in her pregnancy in 2015, Nicole Hashemi wanted to know how much caffeine was safe for her to consume. “I was actually advised not to drink a lot of caffeine,” Hashemi, an associate professor of mechanical engineering at Iowa State University, told STAT. The American College of Obstetrics and Gynecologists, for instance, advises that pregnant people consume no more than 200 milligrams per day  to reduce the risk of miscarriage or preterm birth.

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OTC Hearing Aids: “Nothing to See Here” Says GAO Report

FDA Law Blog: Biosimilars

By Sara W. Koblitz & Jeffrey N. Gibbs — It’s been over a year and a half since Over-the-Counter (“OTC”) hearing aids became legal, and it’s not clear that they’ve made the difference in hearing loss treatment that Congress anticipated. (FDA once estimated that OTC hearing aids would save patients over $3000.) A recent GAO Report hasn’t found that OTC hearing aids have had much impact.

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What can pharma companies do to quicken the pace of digital disruption?

pharmaphorum

Discover how pharmaceutical companies can leverage digital technologies to accelerate innovation and disrupt the industry. Learn about regulatory considerations and engagement with healthcare professionals (HCPs) for successful digital transformation.

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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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DoH expands research partnership with Penn Medicine

Pharmaceutical Business Review

This partnership will focus on developing a translational medicine ecosystem and launching innovative research initiatives in Abu Dhabi. The second MoU outlines plans to design and develop a translational medicine ecosystem inspired by Penn’s Institute for Translational Medicine and Therapeutics (ITMAT). The aim is to utilise Abu Dhabi’s advanced infrastructure alongside Penn Medicine’s expertise to foster new treatments and discoveries within the region.

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Four Tops singer’s lawsuit says he visited ER for chest pain, ended up in straightjacket

STAT

When Alexander Morris, a member of the Motown group The Four Tops , visited a Detroit-area Ascension hospital with chest pain and trouble breathing, he said the staff assumed he was mentally ill after he told them he was a famous singer. Instead of treating Morris, a white security guard told him to “sit his Black ass down” and he was placed in a straightjacket, Morris claims in a new lawsuit.

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Knock, Knock – FDA Issues Guidance on Best Processes and Practices During BIMO Inspections

FDA Law Blog: Biosimilars

By Sarah Wicks & Anne K. Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In an effort to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance aimed at providing recommendations on how to handle inspections under FDA’s Bioresearch Monitoring (BIMO) program.

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The B2C prescription: Marketing lessons for B2B pharma companies

pharmaphorum

Learn valuable marketing lessons for B2B pharma companies by examining successful strategies used in the B2C prescription market, including over-the-counter (OTC) products and interactions with healthcare professionals (HCPs).

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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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J P Nadda appointed as Minister of Chemicals and Fertilisers

Express Pharma

Jagat Prakash Nadda takes charge as the Minister of Chemicals and Fertilisers, following his induction into Prime Minister Narendra Modi’s cabinet. Additionally, he also holds the portfolio of the Ministry of Health and Family Welfare. Nadda holds a law degree and previously served as the Health Minister during the Modi government’s first term, from 2014 to 2019.

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Opinion: Empathy should guide responses to reported vaccine injuries

STAT

As a co-leader of the team at the National Institutes of Health that developed technologies powering a number of Covid-19 vaccines, I often speak publicly about vaccine science, even though I no longer work for the government. After my talks, people often approach me, almost always thanking me for my work. There is no denying the millions of lives that Covid-19 vaccines saved. sometimes, though, they relate stories of vaccine injuries.

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Ipsen drug for rare liver disease approved by FDA

BioPharma Dive

The medicine will join Intercept’s Ocaliva as a treatment option for primary biliary cholangitis. Another drug, from the now Gilead-owned CymaBay, could be cleared for the condition by August.

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FDA wants to make the home a healthcare hub

pharmaphorum

The FDA is exploring ways to transform the home into a healthcare hub, bringing healthcare services closer to individuals. This article discusses the potential impact of this trend on the future of healthcare.

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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 expands approval to GSK’s Arexvy for adults aged 50-59, at increased risk

Express Pharma

GSK announced that the US FDA has approved Arexvy (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 to 59 years of age who are at increased risk. In the US, the vaccine is currently approved for use in adults aged 60 and older and recommended by CDC/ACIP using shared clinical decision-making.

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Millions fewer people may need statins, a new study suggests. But guidelines have yet to agree

STAT

It’s a familiar scene for patients during a routine primary care visit. The doctor scans blood test results, notes high cholesterol flagged by a standard calculator to assess risk of heart attack or stroke, then decides — and ideally discusses — whether to recommend taking a statin to cut the risk over time. That conversation may happen less often if changes in the risk model presented by the American Heart Association in November translate into new guidelines for prescribin

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Pfizer gene therapy for Duchenne fails to meet goals of key trial

BioPharma Dive

The negative results from the Phase 3 study, called Ciffreo, come a little more than a month after Pfizer said a patient died in another trial of the gene therapy.

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10th to 14th June – This week in clinical trials

pharmaphorum

Stay up-to-date with the latest news in clinical trials with highlights from NMD Pharma, Minoryx Therapeutics, Moonlake Immunotherapeutics, and Ipsen. Discover the groundbreaking developments from 10th to 14th June.

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Lupin announces closure of US FDA inspection

Express Pharma

Lupin announced that the United States Food and Drug Administration has completed an inspection of its injectable facility in Nagpur, India. The inspection of the facility was carried out from June 10 to June 13, 2024 , and concluded with zero 483 observations. Nilesh Gupta, Managing Director, Lupin said, “We are pleased to have a successful outcome of the U.S.

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