Fri.Mar 08, 2024

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STAT+: In stunning outcome, Amylyx’s ALS drug fails large clinical trial

STAT

Amylyx Pharmaceuticals said Friday that its treatment for ALS, called Relyvrio, failed to provide any benefit for patients in a large clinical trial — a stunning outcome that now has the company considering a voluntary withdrawal of the approved medicine from the market. “This is really hard for us, and it’s really hard for our team who care so much, but it’s so much harder for people with ALS and their families, and we have to keep that perspective,” said a so

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FDA Takes Steps to Ensure Safety of Cinnamon Products Sold in the US

LifeProNow

March 06, 2024: “The U.S. Food and Drug Administration is taking several additional steps to address concerns about elevated lead levels in cinnamon following the recent incident associated with certain cinnamon apple sauce pouches that resulted in lead poisoning in young children. The agency sent a letter to all cinnamon manufacturers, processors, distributors and facility operators in the U.S., reminding them of the requirement to implement controls to prevent contamination from potentia

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STAT+: Amylyx ALS drug failure leaves patients, advocates, and researchers reeling — and wondering what’s next

STAT

The latest disappointment in amyotrophic lateral sclerosis research brought crushing news for patients and physicians, forcing the community to consider just what to do with an approved medicine that doesn’t appear to work. Amylyx Pharmaceuticals’ announcement Friday that its drug, marketed as Relyvrio, failed to beat placebo in a pivotal study marks “a sad day for us, but we have to believe the data,” said Mary Catherine Collet, an ALS advocate.

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Amylyx ALS drug fails crucial study, putting company’s future in doubt

PharmaVoice

The results have led Amylyx to pause promotion of Relyvrio and potentially pull it from the market in the coming weeks, a major blow to the company and ALS patients.

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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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STAT+: Obesity drug Wegovy gets FDA approval to add cardiovascular benefits on its label

STAT

U.S. regulators approved a label expansion for Novo Nordisk’s obesity drug Wegovy to tout its benefits for the heart, a move that could boost demand and insurance coverage for the already highly popular treatment. The new label indicates that Wegovy can reduce the risk of major heart complications — including heart attack, stroke or cardiovascular-related deaths — for people with overweight or obesity and existing heart disease, Novo said in a statement Friday.

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Into the unknown: Tarsus’ CEO on its launch strategies in a new disease category

PharmaVoice

The company scored a first-in-class nod for its eye med last year, which treats a common but frequently undiagnosed condition.

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Amylyx ALS drug fails crucial study, putting company’s future in doubt

BioPharma Dive

The results have led Amylyx to pause promotion of Relyvrio and potentially pull it from the market in the coming weeks, a major blow to the company and ALS patients.

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STAT+: In surprise move, FDA calls for advisory committee on Lilly’s Alzheimer’s drug

STAT

In a surprise move, the Food and Drug Administration has called for a meeting of outside advisers to discuss whether an Alzheimer’s drug from Eli Lilly should be approved, even as many outsiders expected the medicine to receive regulatory clearance this month. The drug, donanemab, succeeded in its Phase 3 trial , resulting in a 35% slowing of Alzheimer’s disease progression versus placebo.

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How Women of the CPA are Accelerating Healthcare Progress Across the Commonwealth

Commonwealth Pharmacists Association

International Women’s Day 2024: Invest in women—accelerate progress Leading with Impact: How Women of the CPA are Accelerating Healthcare Progress Across the Commonwealth At the Commonwealth Pharmacists Association, we believe that investing in women leaders is a catalyst for transformative change in healthcare worldwide. Our leadership team, predominantly composed of women, exemplifies this commitment.

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STAT+: UnitedHealth gives timeline for Change restoration: payments up by late next week

STAT

Change Healthcare’s parent company said it’ll have its electronic payment function up and running by late next week after a February cyberattack took many of its systems offline. Its claims network and software will take longer. UnitedHealth Group said clients will be able to reconnect to Change’s electronic payment system on March 15.

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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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Women in pharmacy: overcoming imposter syndrome and inspiring inclusion

The Pharmacist

This International Women’s Day focuses on the theme ‘Inspire Inclusion’: championing diversity in leadership and highlighting the experiences of women from all walks of life. The Pharmacist spoke to four female pharmacy leaders to hear how their different experiences of being women and pharmacists have influenced their work and leadership within the profession.

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A disabled artist’s journey from ‘Oh, sorry’ to social justice activism

STAT

Sonya Rio-Glick was born three months and six days premature, alongside her twin, in the summer of 1997. Both had health complications. Sonya had cerebral palsy but wasn’t formally diagnosed until she was 2, after a physical therapist approached her parents at a party. That’s when her family learned what had made Rio-Glick move differently since infancy.

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FDA delays decision on Lilly’s closely watched Alzheimer’s drug

BioPharma Dive

The agency expects to convene a group of outside experts to more closely scrutinize the safety and efficacy of the medicine, donanemab, pushing back the timing of its potential approval.

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Opinion: STAT+: It’s time to rethink everything about our approach to psychiatric drug development

STAT

In many ways, psychiatry is still flying blind. People experiencing mental health conditions are prescribed various drugs until one (or a combination) finally works — a painful process that can take years. As a psychiatrist and neuroscientist, I became increasingly impatient and frustrated with this ineffective way of treating patients. This guided the core question behind my research: Can biology explain how people with the same psychiatric disorder respond differently to the same treatm

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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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Women in life sciences: Miruna Sasu

pharmaphorum

Celebrate International Women’s Day by learning about Miruna Sasu, a prominent female figure in the life sciences field and CEO of COTA. Explore how the company uses AI in the oncology space.

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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Community pharmacy delivers first private covid jabs

The Pharmacist

EXCLUSIVE A community pharmacy in Scotland has delivered what is believed to be the UK’s first private Covid vaccination, ahead of the service’s planned launch date in April. Dear Pharmacy & Travel Clinic was among a number of community pharmacies that received stock of the Pfizer’s private Covid mRNA vaccine earlier than expected, and so […] The post Community pharmacy delivers first private covid jabs appeared first on The Pharmacist.

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Bridging the gap: Uniting stakeholders through a digital ecosystem for holistic maternity care

pharmaphorum

Discover how a digital ecosystem can unite stakeholders in providing holistic maternity care, enhance maternal and postpartum care outcomes, and bridge the gap in healthcare services.

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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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Vaginal Health For Postmenopausal Women | 5 Benefits Of Hormone Therapy

Welltopia Pharmacy

Vaginal Health can significantly impact a woman's quality of life and sexual well-being, menopause marks a significant transition in a woman's life, signaling.

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Women in life sciences: Angie Franks

pharmaphorum

Angie Franks is a prominent female figure in the life sciences industry and perfect to highlight on International Women's Day. Learn more about her contributions and achievements in healthcare and technology.

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AD/PD 2024: TauRx’s HMTM promising despite lacking primary endpoint data

Pharmaceutical Technology

Participants cannot remain blind to their treatment arm due to the properties of TauRx's drug, which causes urinary discoloration.

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Accelerating inclusion in innovation: Gender diversity in clinical research

pharmaphorum

Clinical research continues to struggle with a lack of representation within trial populations, and gender diversity in clinical trials remains a critical issue. Learn about the importance of gender diversity in clinical research trials and how it can accelerate inclusion in innovation.

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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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Pharmacists need endometriosis education amid slow diagnoses, charity suggests

The Pharmacist

Community pharmacists need better education about endometriosis given that pharmacies are often the first port of call for many experiencing symptoms, a national charity has suggested. In a new report, Endometriosis UK called on professional bodies to provide more education about endometriosis and menstrual health for community pharmacists and other healthcare professionals.

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Navigating “Trending” Supplements

Quality Matters

Navigating “Trending” Supplements Last year, we witnessed growing interest in consumer health and wellness products that were trending on social media. The rise of third-party online shopping platforms – think TikTok Shop, Amazon and sponsored content on Meta-owned platforms – has fostered a culture where consumers are comfortable trusting influencer recommendations, often purchasing items without critical examination of a product and its claims.

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Semaglutide could provide novel dual benefit in diabetes and kidney disease

European Pharmaceutical Review

Headline results from Novo Nordisk AS’s kidney outcomes FLOW trial reveal that injectable semaglutide 1.0mg demonstrated a statistically significant and superior reduction in kidney disease progression as well as cardiovascular and kidney death of 24 percent. This was based on treatment policy estimand: treatment effect regardless of treatment adherence, Novo Nordisk confirmed.

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Johnson & Johnson acquires Ambrx Biopharma for $2bn

Pharmaceutical Technology

Johnson & Johnson (J&J) has concluded the acquisition of Ambrx Biopharma in a transaction valued at approximately $2bn.

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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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The role of GAMP 5, data integrity and QbD in pharmaceutical quality assurance

European Pharmaceutical Review

Researchers have described the impact of data integrity, GAMP 5 and quality by design (QbD) principles on pharmaceutical quality assurance (QA) , highlighting the importance of data integrity through various case studies. The authors explained first that “a robust quality assurance framework” is needed to ensure medicinal products are safe and efficient.

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Novo Nordisk’s oral amycretin tops Wegovy in obesity trial

pharmaphorum

Amongst Novo Nordisk's comprehensive business update to investors, attention latched onto early data for an oral obesity therapy that outperformed the company’s big-selling GLP-1 agonist Wegovy in a clinical trial. The drug, called amycretin and codenamed NN9487, is a dual agonist that targets both GLP-1 and amylin and is being developed in both oral and subcutaneous injection formulations.

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BeiGene secures accelerated FDA approval for follicular lymphoma treatment

Pharmaceutical Technology

The FDA has already granted accelerated approvals to several third-line treatments, with big pharma being prominent in the landscape.

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MindMed gets FDA breakthrough tag for LSD in anxiety

pharmaphorum

In another inflection point for the psychedelic medicines category, Mind Medicine (MindMed) has claimed breakthrough status from the FDA for its LSD-based treatment candidate MM120 as a treatment for anxiety.

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Fostering inclusion: Empowering women in STEM

Express Pharma

Sridevi Khambhampaty, VP – Biopharmaceutical Development, Syngene International , gives an overview of the evolving landscape of STEM, emphasises the importance of gender diversity and inclusion in this field and spotlights both progress and persistent challenges. She advocates addressing systemic barriers and promoting awareness through mentorship, scholarships, and proactive hiring practices With over two decades in life sciences, I’ve witnessed an encouraging increase in initiativ