Sat.Sep 30, 2023 - Fri.Oct 06, 2023

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5 FDA decisions to watch in the fourth quarter

PharmaVoice

The regulator is considering approval of what would be the first CRISPR medicine, as well as important clearances for Alnylam, Bristol Myers, Amgen and Pfizer.

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FDA authorizes Novavax’s updated Covid-19 vaccine

STAT

The Food and Drug Administration on Tuesday authorized Novavax’s updated Covid-19 vaccine, giving Americans seeking to update their protection against the SARS-CoV-2 virus another option. Though the FDA’s green light came three weeks after the approvals for the updated Moderna and Pfizer-BioNTech shots, it contained some welcome news for the Gaithersburg, Md.

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Fewer MS patients are prescribed DMTs in UK compared to Europe

Pharma Times

The study analysed and compared information from 65,000 MS patients - News - PharmaTimes

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Sodium valproate reclassification ushers in full pack dispensing

The Pharmacist

All licensed medicines containing sodium valproate, valproic acid and semisodium valproate have been reclassified as special containers, meaning they are subject to full pack dispensing. The change, effective since 1 October, means that where the prescription quantity is not available in an original pack size or multiple of pack sizes, the nearest number of full […] The post Sodium valproate reclassification ushers in full pack dispensing appeared first on The Pharmacist.

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Navigating Payroll Compliance: Future-Proofing Payroll in an Evolving Regulatory Landscape

Speaker: Jennifer Hill

Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.

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The ALS therapy keeping the human pig heart transplant pumping

PharmaVoice

Eledon’s investigational ALS drug tegoprubart could also help prevent organ transplant rejections, the company says.

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FDA expert panel endorses idea of removing a component from flu vaccine

STAT

The Food and Drug Administration’s expert vaccine advisory panel on Thursday unanimously endorsed the idea of taking a strain of influenza viruses that no longer appears to circulate out of flu shots as quickly as possible, pressing the FDA and manufacturers to try to get the work done on an expedited timeline. While a representative of vaccine manufacturers warned it may not be possible to remove the influenza B/Yamagata component from the flu vaccines that will be made for the Northern

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Meet The Recipients Of The 2023 CVS Health Minority Scholarship

Pharmacy Is Right For Me

The CVS Health Minority Scholarship for Pharmacy Students was awarded to five outstanding underrepresented minority (URM) student pharmacists who are currently pursuing their PharmD degree. Selected awardees demonstrated outstanding leadership, academic success, and a commitment to advancing the profession of pharmacy and patient care. This scholarship will support them in their goal of becoming pharmacists by reducing financial barriers.

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Where have all the unicorns gone? A look at 4 billion-dollar biotechs

PharmaVoice

Not every unicorn company lives up to its $1 billion promise. Here are four worth watching.

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GLP-1 drugs are transforming diabetes, obesity and more. Could a Nobel be next?

STAT

Next week, 50 medical experts from the Karolinska Institutet in Stockholm will meet to award the 2023 Nobel Prize for Physiology or Medicine. The vote takes place on Oct. 2, but betting-minded scientists are already beginning to make their picks for who might take home the gold. Seasoned Nobel prognosticators will point out that the medicine prize often cycles between super-basic molecular biology and inventions that actually cure people.

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AstraZeneca reveals new research to improve drug discovery

Pharma Times

The study used data from 50,000 people in the UK Biobank - News - PharmaTimes

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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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NIH funds research for three experimental ALS drugs

BioPharma Dive

The funding, which is part of ACT for ALS, will support expanded access studies of drugs developed by Prilenia Therapeutics, Clene Nanomedicine and Rapa Therapeutics.

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FDA’s ‘ivory tower thinking’ ignores promising biomarkers, says a rare disease CEO

PharmaVoice

The FDA wouldn’t review a drug that was 90% effective. In rare diseases, this is too common, said the UltraGenyx CEO and a leading rare disease researcher.

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STAT+: Cigna to pay $172 million in Medicare Advantage fraud settlement

STAT

Health insurer Cigna is paying more than $172 million to settle allegations that it committed fraud by knowingly submitting inaccurate diagnoses of its Medicare Advantage members, the company and Department of Justice announced Saturday. The settlement stems from a wide-ranging government investigation into the coding practices of Medicare Advantage insurers, as well as a specific whistleblower lawsuit against Cigna that the DOJ joined last year.

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Evonetix installs first DNA synthesis development platform at ICL

Pharma Times

It will be the company’s first platform to be installed in an external scientific setting - News - PharmaTimes

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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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Cipla Foundation, NIMHANS partner to set up neuro-palliative care unit

Express Pharma

Cipla Foundation in partnership with National Institute of Mental Health and Neuro-Sciences (NIMHANS) has set up a neuro-palliative care unit in Bengaluru. The company informed that this unit has provided support to over 2,000 individuals with neurological conditions such as Alzheimer’s, Dementia, and Parkinson’s, through in-patient, out-patient, home care, and has offered teleconsultation services to patients as well as their families and caregivers. it also informed that at this ne

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Drugmakers face uphill battle in Medicare negotiation suits

PharmaVoice

Judges have found fault with drug manufacturers’ First and Fifth Amendment arguments against the IRA’s drug pricing measures.

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STAT+: Gene therapy makers wonder if they can make a profit in Europe. Patients fear being left behind — again

STAT

LONDON — It was when she was 12 that doctors first raised the prospect of a medicine that could transform the disease Stella Pelteki had inherited into an afterthought. Pelteki was born with beta thalassemia, a disorder that inhibits oxygen’s flow through the blood. Ever since she was a few years old, she’d needed frequent blood transfusions.

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Kate Therapeutics and Capsida Biotherapeutics collaborate on gene therapies

Pharma Times

The companies aim to bring gene therapies to patients sooner than traditional approaches - News - PharmaTimes

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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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Roche app relieves diabetes distress in clinical trial

pharmaphorum

Roche app relieves diabetes distress in clinical trial Phil.

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3 marketing tips for biotechs emerging from stealth

PharmaVoice

In a crowded biotech market, here’s how your company can stand out to investors.

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Can the world still invent an HIV vaccine? Progress in one area creates new problem

STAT

Louis Picker is nervous. Last month, the first volunteer was injected with an HIV vaccine he spent over 20 years designing. It’s prototype No. 2. The last shot they tested, in 2021, didn’t do much of anything, and the 66-year-old worries that if this fails, he might not get another chance to redesign it.  Truthfully, though, Picker isn’t sure his HIV vaccine stands much of a chance.

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King Faisal Specialist and Research Centre achieves world-first fully robotic liver transplant

Pharma Times

The approach reduces recovery times and lowers rates of complications - News - PharmaTimes

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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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Digital therapeutics at a turning point: What we heard at DTx East

pharmaphorum

Digital therapeutics at a turning point: What we heard at DTx East Mike.

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Key upcoming events for pharma execs

PharmaVoice

Trade shows and events focused on the industry’s hot-button topics, technologies and trends.

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STAT+: Colombia set to issue a compulsory license for an HIV medicine sold by GSK’s ViiV

STAT

In the latest battle over access to medicines, Colombian authorities have decided to issue a compulsory license for a needed HIV treatment, a step that underscores ongoing friction between the pharmaceutical industry and cash-strapped governments around the world. By issuing such a license, the Colombian government hopes to obtain lower-cost generic versions of an HIV medicine called dolutegravir, which is made by ViiV Healthcare, a company that specializes in HIV treatments and is largely contr

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NERA Economic Consulting raises concerns over DHSC’s Statutory Scheme

Pharma Times

The proposed changes could limit patients’s access to treatments and clinical trials - News - PharmaTimes

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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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LogiPharma USA 2023: Tracy Nasarenko Provides a Synopsis of “DSCSA—Final Checks to Have Before Deadlines.”

Pharmaceutical Commerce

In an interview at LogiPharma USA 2023 with Pharma Commerce Editor Nicholas Saraceno, Tracy Nasarenko, Sr. Director of Community Engagement for Pharmaceuticals, GS1 US highlights her “DSCSA—Final Checks to Have Before Deadlines.

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The PharmaVoice 100: Brand and commercialization pros

PharmaVoice

Leaders decoding the complex language of drug development to push treatments past the finish line and into patients’ hands.

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STAT+: J&J agrees not to enforce patents on a key tuberculosis drug in dozens of poor countries

STAT

In an unexpected turnabout, Johnson & Johnson announced it would not enforce any of its patents for a key tuberculosis medicine in 134 low- and middle-income countries, the second time in recent weeks that a manufacturer has agreed to widen access to products needed to combat the infectious disease. The move comes after the health care giant has recently faced accelerating demands to alter its pricing and patenting policies for the drug, which is called bedaquiline and is considered the back

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Signant Health launches Signant Biotech for emerging biopharma organisations

Pharma Times

The research approach will help small- to mid-sized organisations to advance their clinical studies - News - PharmaTimes

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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.