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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ACMT Toxicology Visual Pearls: On the Mark

ALiEM - Pharm Pearls

What potential terrorism agent could be treated with the pictured antidote? Anthrax Botulism Dioxin Ricin Soman Reveal the Answer 5. Soman The pictured autoinjector is a MARK-1 kit containing 2 mg of atropine and 600 mg of pralidoxime. This kit has historically been issued to US service members for treating nerve agent toxicity from agents such as soman, sarin, tabun, and VX, all of which are organophosphates and cause a cholinergic toxidrome.

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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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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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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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2023 Nobel Prize in Medicine: Karikó, Weissman awarded prize for mRNA research

STAT

LONDON — Two pioneers of mRNA research — the technology that helped the world tame the virus behind the Covid-19 pandemic — won the 2023 Nobel Prize in medicine or physiology on Monday. Overcoming a lack of broader interest in their work and scientific challenges, Katalin Karikó and Drew Weissman made key discoveries about messenger RNA that enabled scientific teams to start developing the tool into therapies, immunizations, and — as the pandemic spread in 2020 &

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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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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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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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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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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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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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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+: Nobel Prize, in a rarity, celebrates a fruitful and durable partnership

STAT

The most noteworthy aspect of awarding the Nobel Prize in medicine or physiology to two pioneers of mRNA research was not who won Monday — Katalin Karikó and Drew Weissman were widely expected to get the accolade for discoveries that made it possible to deliver the finicky molecule to cells and enabled the record-breaking development of vaccines that tamed the Covid-19 pandemic.

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5 FDA decisions to watch in the fourth quarter

BioPharma Dive

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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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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2024 BCPS Exam – What’s Changing?

Med Ed 101

It’s hard to believe that I have been following pharmacist board certifications and helping pharmacists pass the BCPS exam for over 10 years since I first passed it in 2013! Each year in updating and creating our study materials, I review the content outline and any possible changes in the BCPS exam. There are definitely […] The post 2024 BCPS Exam – What’s Changing?

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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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WHO recommends second malaria vaccine

European Pharmaceutical Review

The World Health Organization ( WHO ) has recommended a new vaccine, R21/Matrix-M, to prevent malaria in children. The R21 vaccine is the second malaria vaccine recommended by WHO. This follows the WHO’s recommendation of the RTS,S/AS01 vaccine for the disease in 2021. Novavax’s President and Chief Executive Officer, John Jacobs, declared that the company is “proud” of the role of its saponin-based Matrix-M adjuvant plays in the R21/Matrix-M malaria vaccine.

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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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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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Orchard sells to Kyowa Kirin in gene therapy buyout

BioPharma Dive

Kyowa will pay nearly $400 million to acquire Orchard, which sells the gene therapy Libmeldy in Europe but has struggled to find paths to market for other experimental treatments.

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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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mRNA researchers awarded 2023 Nobel Prize

European Pharmaceutical Review

The Nobel Assembly has awarded Hungarian biochemist Katalin Karikó and US immunologist Drew Weissman the Nobel Prize in Physiology or Medicine 2023 for their breakthrough findings in RNA vaccine development. The discoveries by the two Nobel Laureates have revolutionised science’s understanding of how messenger RNA (mRNA) interacts with the immune system.

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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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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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Sanofi shares new data for long-term efficacy of Nexviazyme for Pompe disease treatment

Pharmafile

Sanofi has shared new data for the long-term efficacy of Nexviazyme (avalglucosidease alfa) for the treatment of Pompe disease at the 28th Annual Congress of the World Muscle Society (WMS) in Charleston, South Carolina, US. Nexviazyme is approved in the US and elsewhere as a monotherqapy for the treatment of late-onset Pompe disease, and is […] The post Sanofi shares new data for long-term efficacy of Nexviazyme for Pompe disease treatment appeared first on Pharmafile.

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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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Will novel antibiotic become front-line for C. difficile?

European Pharmaceutical Review

Due to observed clinical success, Acurx Pharmaceuticals, Inc. has discontinued the Phase IIb clinical trial of its lead antibiotic candidate, ibezapolstat, for Clostridioides difficile infection (CDI). In the trial, ibezapolstat and the control antibiotic vancomycin, a standard treatment for C. difficile infection, delivered high rates of clinical cure without any emerging safety concerns.

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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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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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What Pharma Fears Most About AI

PharmExec

In this Q&A with Pharmaceutical Executive®, Andrew Hopkins, founder and CEO of Exscientia, reveals how artificial intelligence (AI) is currently being utilized in the pharma industry, predictions for where AI can be implemented in the future, and what pharma fears most about AI.

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Opinion: The next frontier in biomedicine: AI models of the human immune system

STAT

If the Covid-19 pandemic has shown us one thing, it is how little we really know about how the human immune system works. Despite the remarkable success in development of vaccines to prevent severe disease from SARS-CoV-2, it remains unclear how SARS-CoV-2, a newly emerging virus, causes such a broad spectrum of disease , ranging from asymptomatic and mild cases to severe disease and death.

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Moderna reveals optimistic data for influenza-COVID-19 vaccine

European Pharmaceutical Review

Positive interim results from Moderna’s Phase I/II trial of mRNA-1083 , an investigational vaccine designed to immunise against both influenza and COVID-19, have been released. There are several benefits of the combination vaccine as a preventative measure against these respiratory conditions, according to the pharmaceutical company. For example: higher patient compliance, easier administration and greater convenience.

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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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