STAT

MARCH 8, 2024

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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LifeProNow

MARCH 8, 2024

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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Labelling 130

STAT

MARCH 8, 2024

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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PharmaVoice

MARCH 8, 2024

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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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.

STAT

MARCH 8, 2024

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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Labelling 333

The Pharmacist

MARCH 8, 2024

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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Hospitals 140

PharmaVoice

MARCH 8, 2024

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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STAT

MARCH 8, 2024

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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The Pharmacist

MARCH 8, 2024

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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Community Pharmacies Vaccines 128

STAT

MARCH 8, 2024

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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Hospitals 271

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Pharmacy Management

Commonwealth Pharmacists Association

MARCH 8, 2024

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

MARCH 8, 2024

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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BioPharma Dive

MARCH 8, 2024

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

MARCH 8, 2024

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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Drug Development 234

BioPharma Dive

MARCH 8, 2024

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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STAT

MARCH 8, 2024

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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The Pharmacist

MARCH 8, 2024

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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pharmaphorum

MARCH 8, 2024

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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Pharmaceutical Technology

MARCH 8, 2024

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

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pharmaphorum

MARCH 8, 2024

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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Quality Matters

MARCH 8, 2024

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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Labelling 98

pharmaphorum

MARCH 8, 2024

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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European Pharmaceutical Review

MARCH 8, 2024

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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Diabetes Labelling 94

pharmaphorum

MARCH 8, 2024

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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Pharmaceutical Technology

MARCH 8, 2024

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

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pharmaphorum

MARCH 8, 2024

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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Pharmaceutical Technology

MARCH 8, 2024

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

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pharmaphorum

MARCH 8, 2024

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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Pharma Times

MARCH 8, 2024

The gamma treatment also shows potential for treating patients living with neurological diseases

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pharmaphorum

MARCH 8, 2024

The UK government plans to link the NHS App to data generated by smart devices, including step counts and heart rate, according to Health Secretary Victoria Atkins.

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Express Pharma

MARCH 8, 2024

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

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Communication 90

Pharma Times

MARCH 8, 2024

The rare epileptic seizure disorder currently affects around one in 42,000 people in the UK

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European Pharmaceutical Review

MARCH 8, 2024

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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Drug Development 85

Welltopia Pharmacy

MARCH 8, 2024

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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EMCrit Project

MARCH 8, 2024

NephMadness hits EMCrit with RRT for the Poisoned Patient EMCrit Project by Scott Weingart, MD FCCM.

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