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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In dribs and drabs, USDA reports suggest containing bird flu outbreak in dairy cows will be challenging

STAT

The U.S. Department of Agriculture released two reports Thursday that lay out what has been learned about how H5N1 bird flu is moving among dairy cow herds in the United States. The reports do not shed much new light on the situation. Instead, they sum up what is known: that the outbreak was probably the result of a single “spillover” of the virus from wild birds into a dairy herd, likely late last year, and that movement of cows, farmworkers, and shared equipment appears to be res

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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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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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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.

Hospitals 364
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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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New polymer-based drug delivery system developed for tuberculosis

European Pharmaceutical Review

Researchers have reported the successful formulation of clofazimine spray-dried poly (lactic acid-co-glycolic acid) (PLGA) microparticles as an “efficient” treatment for tuberculosis (TB). In treating this bacterial infection, the paper highlighted that oral therapy often fails to achieve therapeutic concentrations at the primary infection site, the lungs.

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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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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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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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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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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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Developing the EU’s first intestinal microbiota-based biologic

European Pharmaceutical Review

Since 2018, biotech company Mikrobiomik has been researching, development and producing innovative biological medicines based on the human microbiome. We are proud to be the first company planning to market MBK-01, the EU’s first biologic based on intestinal microbiota, full spectrum purified intestinal microbiota (FSPIM), in the form of lyophilised capsules for oral administration.

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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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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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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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STAT+: The inside story of how Lykos’ MDMA research went awry

STAT

At a heated advisory committee meeting convened by the Food and Drug Administration last week, regulators repeatedly expressed frustration that Lykos, a company seeking approval of MDMA-assisted therapy to treat PTSD , failed to follow instructions and track positive feelings such as “euphoria” that could be used to inform understanding of the drug’s addiction potential.

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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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Lilly’s Alzheimer’s drug set to join Leqembi after FDA vote

pharmaphorum

An FDA advisory committee has delivered a strong endorsement to Eli Lilly’s Alzheimer’s disease therapy donanemab, voting unanimously that the safety and efficacy of the amyloid-busting drug support its approval. The independent advisors on the Peripheral and Central Nervous System Drugs Advisory Committee voted by 11 to zero that donanemab’s benefits outweigh its risks, and by the same margin that the data submitted by Lilly to support its efficacy was convincing.

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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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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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STAT+: Moderna says data show its combination Covid-flu vaccine generates a strong immune response

STAT

Moderna announced Monday that, in a Phase 3 clinical trial, its combination Covid-19 and influenza vaccine generated stronger immune responses in older adults than individual vaccines that target those viruses. The findings, disclosed in a press release, suggest the company may be on track to bring a combination flu and Covid vaccine to the market, potentially as early as autumn 2025.

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Pfizer shares update on DMD gene therapy clinical trial

Pharmafile

Pfizer has announced an update from its phase 3 randomised, multicentre, double-blind, placebo-controlled CIFFREO trial, which assessed the investigational mini-dystrophin gene therapy, gordadistrogene movaparvovec, in ambulatory patients with Duchenne muscular dystrophy (DMD). The post Pfizer shares update on DMD gene therapy clinical trial appeared first on Pharmafile.

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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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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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New paediatric blood test to prevent sudden death from hereditary heart condition

Pharma Times

Hypertrophic cardiomyopathy is a rare condition that affects up to 1,000 children in the UK

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Melinda French Gates, going solo, aims to influence reproductive rights in the U.S.

STAT

Last week, Melinda French Gates officially left the Bill & Melinda Gates Foundation with a $12.5 billion check from Bill Gates, per the terms of their separation. Her departure from the foundation she co-founded in 2000 had been announced in May , and on Friday she published a parting memo thanking all who worked with her during her tenure at the foundation.

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CCA pharmacies have delivered over 200,000 Pharmacy First consultations

The Pharmacist

Large multiple pharmacies have delivered around 200,000 Pharmacy First consultations in under six months. Since 31 January, Company Chemists’ Association (CCA) member pharmacies have delivered 209,200 Pharmacy First consultations, the CCA said on Wednesday. CCA chief executive Malcolm Harrison said the strong patient interest demonstrated ‘that the service is here to stay’.

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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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New study reveals how brain cell communication is linked to Alzheimer’s disease

Pharma Times

Two support cells, microglia and astrocytes, were found to communicate with each other