Sat.Aug 19, 2023 - Fri.Aug 25, 2023

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The 2023-2024 Flu Season: What Pharmacists Need to Know

Digital Pharmacist

As we gear up for the upcoming flu season of 2023-2024, it’s important to reflect on the lessons of the previous year , and understand how the coming year may look different. In this article, we’ll delve into a comprehensive breakdown of the past season’s dynamics and provide valuable insights to equip you for the challenges and opportunities that lie ahead.

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U.S. health officials lay out plans to cope with respiratory virus season

STAT

With last fall’s chaotic early start to the respiratory virus season still fresh in the public memory, federal health authorities are trying to move quickly to convey the impression that this year will be different. In a briefing for reporters Thursday, senior officials of the Centers for Disease Control and Prevention and the Food and Drug Administration detailed the various countermeasures available to combat Covid-19, RSV, and influenza, and discussed the expected timing on the rollout

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Henrietta Lacks’ immortal cells put biopharma profits under a microscope

PharmaVoice

The HeLa cell line’s contributions to medical science were obtained without permission, and now biotechs profiting from its use are answering for it.

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Apellis finds faulty needles in probe of rare eye drug side effects

BioPharma Dive

The company doesn’t know if the needles have caused retinal vasculitis in some people receiving its geographic atrophy drug Syfovre, but is no longer recommending their use.

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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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AstraZeneca’s Soliris approved in Japan for paediatric gMG patients

Pharma Times

The drug is the first to be approved in Japan to treat children and adolescents with& generalised myasthenia gravis - News - PharmaTimes

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Krystal Cascetta, Lindsay Clancy, and the impossibility of being a mom in American medicine

STAT

In Igbo-Nigerian culture, new moms receive exquisite care from their own mothers, mothers-in-law, or surrogate mothers for the first few months postpartum. After each of my daughters was born, I was blessed to participate in this tradition, called omugwo, which allowed me to be nurtured by the mothers who came before me. They cooked and cleaned. Massaged my belly and taught me how to breastfeed.

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More Trending

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Foundery, a new biotech venture firm, sets out to speed early immune drug research

BioPharma Dive

Billing itself as both a scientific and investment partner, Foundery aims to provide research grants and drug development support to researchers developing new immunotherapies.

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Fourteen HP&M Attorneys Recognized by Best Lawyers® in 2024 in America

FDA Law Blog: Biosimilars

Hyman, Phelps & McNamara, P.C. (“HP&M”) is is proud to announce that 14 of the Firm’s attorneys have been selected to the 2024 edition of The Best Lawyers in America®. Newly recognized this year are attorneys Josephine M. Torrente (FDA Law), Michelle L. Butler (FDA Law), Sara W. Koblitz (FDA Law), Allyson B. Mullen (FDA Law), and Anne K. Walsh (FDA Law), as well as McKenzie E.

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New study suggests people who tested negative for Covid-19 can still develop long Covid

STAT

Of the 103 million confirmed cases of Covid-19 in the U.S., an estimated one-third have led to long Covid — a condition that ranges in severity, but can be debilitating. A new study suggests that even more people may be suffering from the post-viral syndrome without having ever received an official diagnosis of Covid-19. The study , published Wednesday in Neurology, Neuroimmunology & Neuroinflammation , was small, examining only 29 patients.

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A rare disease research aims to tackle disability discrimination in new lawsuit

PharmaVoice

How a pediatric neurologist is advocating for herself and the disabled community in a legal battle with the Howard Hughes Medical Institute.

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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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Pharmaceutical migration study sampling procedure reported

European Pharmaceutical Review

A paper published in Molecules has detailed a strategy and evaluation approach for acceptable classification of species usually detected in migration studies. This can therefore support extractable and leachable (E&L) studies. Migration studies are one of the few domains of QA/QC pharmaceutical analysis employing wide-scope screening methodologies, the paper noted.

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Pfizer’s first-ever bispecific antibody Elrexfio holds promise in multiple myeloma

Pharmaceutical Technology

The US Food and Drug Administration's recent accelerated approval of Pfizer's Elrexfio for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) has made a significant impact in the oncology community.

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Kellogg’s is going to war over Mexico’s nutrition label rules. A similar fight is coming to the U.S.

STAT

MEXICO CITY — Kellogg’s is waging a war here over Tigre Toño and Sam el Tucán. A 2019 policy requires companies that make unhealthy foods to include warning labels on the front of any boxes they sell in Mexico to educate consumers about things like excess sugar and fat. Any food with a warning label — like Kellogg’s Fruit Loops or its Frosted Flakes, which typically contain more than 37 grams of added sugar in a 100-gram serving — is also banned from

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Brii Biosciences aims to come up big where Sage and Biogen fell short

PharmaVoice

The depression space recently got a stinging FDA rebuke — but Brii thinks it can break through with improved formulations.

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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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Revised Annex 1 now effective

European Pharmaceutical Review

The European Commission (EC)’s revised Annex 1 – Manufacture of Sterile Medicinal Products is now effective in the EU. As of 25 August 2023, pharmaceutical manufacturers are required to implement the GMP regulation into cleaning and bio-decontamination procedures for these products. What is included in the new revision? According to the EC, revision to the document has been made to reflect changes in regulatory and manufacturing environments.

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The Missing Link to Thyroid Fatigue

The Thyroid Pharmacist

Sometimes we can get stuck on our healing journey. We may be on a seemingly great diet, taking the right supplements, and doing everything in our power to feel better, but still feel like we’re making no progress. But, many times, we’re only one small change away from seeing a huge difference. In my case, I was well on my way to feeling better with Hashimoto’s after changing my diet and incorporating key supplements.

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FDA approves Pfizer’s RSV vaccine designed to protect newborns by immunizing parent

STAT

The Food and Drug Administration on Monday approved a Pfizer vaccine that aims to protect newborns against RSV by vaccinating pregnant people in the latter part of pregnancy. The vaccine, Abrysvo, has also been approved for use in adults 60 and older to protect them against respiratory syncytial virus.

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‘Eris’ and other new COVID strains accelerate vaccine push from Pfizer, Moderna, Novavax

PharmaVoice

New variants drive a need for another round of shots, and biopharma companies are stepping up to the plate.

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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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FDA grants first approval for multiple sclerosis biosimilar

European Pharmaceutical Review

The first US Food and Drug Administration (FDA)-approved biosimilar has been authorised to treat multiple sclerosis. Tyruko (natalizumab-sztn) is a biosimilar to Tysabri (natalizumab) injection for adults with relapsing forms of MS. Approval of Tyruko has been granted to Sandoz Inc. It is indicated for the following relapsing forms of MS: Clinically isolated syndrome – a single, first occurrence of MS symptoms Relapsing-remitting disease – in this type of MS, episodes of new neurological symptom

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FDA approves Novartis’ copycat of blockbuster Biogen drug

BioPharma Dive

According to one analyst, the approval was the last hurdle keeping Sandoz’s Tyruko from directly competing in the U.S. market against Biogen’s inflammation-regulating medicine Tysabri.

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STAT+: Obesity specialists are scarce. Here’s how that’s starting to change

STAT

Treatment of obesity has never been more prominent, with the advent of medications like Ozempic and Mounjaro generating both excitement and concern. Overlooked, however, is a severe shortage of doctors who actually specialize in treating obesity. Across the United States, fewer than 100 doctors have completed a fellowship in obesity medicine and are actively practicing, according to a STAT analysis.

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Leveraging data to drive efficiency and patient-centricity in clinical trials

PharmaVoice

Using real-time data, patient centricity and personalized medicine to accelerate clinical trials.

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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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GSK shingles vaccine achieves 100 percent efficacy in China trial

European Pharmaceutical Review

GSK’s Shingrix (Recombinant Zoster Vaccine or RZV) vaccine has been shown to offer 100 percent efficacy against shingles in adults 50 years old and over in China. The Phase IV trial (ZOSTER-076) is the first-ever efficacy trial of the shingles vaccine Shingrix in China. Almost 6,000 participants were enrolled in the trial, which was conducted between 2021 and 2023.

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Roche’s surprise study results spur new optimism for TIGIT drugs

BioPharma Dive

Data inadvertently published from a closely watched lung cancer study suggest a drug blocking the protein TIGIT may help extend survival, a finding that boosted shares of other developers.

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Covid-19, a disease with tricks up its sleeve, hasn’t fallen into a seasonal pattern — yet

STAT

To most people on the planet, the Covid-19 pandemic is over. But for many scientists who have been tracking the largest global infectious disease event in the era of molecular biology, there is still a step that the virus that caused it, SARS-CoV-2, hasn’t yet taken. It has not fallen into a predictable seasonal pattern of the type most respiratory pathogens follow.

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FDA Offers GDUFA III Insight

PharmExec

The Generic Drug User Fee Amendments, designed to facilitate the delivery of safe and effective generic drugs to the public and improve the predictability of the ANDA assessment process, has undergone changes that will impact the pre-ANDA and ANDA approval process—and ultimately the path for generic drugs to approval.

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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 Parkinson’s drug formulation “nearly doubles” exposure

European Pharmaceutical Review

A new drug formulation of a protein kinase inhibitor therapeutic designed to modify the course of Parkinson’s diseas e has been developed. The Abelson Tyrosine Kinase (c-Abl) inhibitor risvodetinib (IkT-148009), “nearly doubles” drug exposure, according to Inhibikase Therapeutics’ CEO. Dr Milton Werner, President & CEO of Inhibikase explained that the company “recently completed characterisation of a novel tablet formulation that mimics the oral drug formulation we used to evaluate eff

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Academic Pharmacy Fellowships: Is it the defined path into Academia?

Pulses

By : Victoria L. Williams, PharmD, BCCCP “Dr. Williams, what do I have to do if I want to pursue a career in academia? ” a curious student asked me after class. As a clinical faculty member with 50% of my appointment dedicated to direct patient care and the other 50% to teaching, research/scholarship, and service, my answer started off strong with tried-and-true advice on pursuing residency training to prepare for the practice component of my role.

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CDC says it’s too soon to assess risk posed by new Covid subvariant

STAT

The Centers for Disease Control and Prevention said Wednesday it’s too early to tell whether a new version of the SARS-CoV-2 virus that has triggered some international concern will actually prove to be disruptive. In a preliminary statement about the BA.2.86 subvariant, the CDC also revealed that updated Covid-19 vaccines should be available across the country as early as mid-September, earlier than previous estimates have placed the start of the fall booster campaign.

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Elevating Health Through Medication Adherence

assurecare

In my previous blog, I expressed my profound passion for medication adherence and my dedication to helping people improve their lives. Proper medication adherence is essential, as it can significantly enhance the well-being of numerous individuals. As a refresher, let's define adherence again based on the U.S. Food and Drug Administration (FDA) definition: "Medication adherence, or taking medications correctly, refers to the extent to which patients follow their doctors' prescribed medication re

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Eli Lilly therapeutic shows potential in thyroid cancer

European Pharmaceutical Review

Eli Lilly and Company ’s highly selective and potent RET kinase inhibitor for advanced medullary thyroid cancer (MTC) has demonstrated superior progression-free survival (PFS) compared to approved multikinase inhibitors. These topline results are from an interim efficacy analysis of a Phase III study that compared Retevmo ® (selpercatinib) against multikinase inhibitors (MKIs) cabozantinib or vandetanib.