Mon.Apr 21, 2025

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Intensive lowering of blood pressure tied to lower dementia risk

STAT

High blood pressure earned its reputation as the silent killer by causing heart attacks, heart failure, and strokes. It’s also been a suspect in dementia. Some studies have hinted at a correlation between lower blood pressure and fewer dementia cases, but they were too small and too short to lend statistical significance to the link. It’s also been noted that people with untreated high blood pressure carry a 42% higher risk of developing dementia.

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Reports Document FDA Review Delays: What Drugmakers Should Know Now

FDA Law Blog: Biosimilars

By John W.M. Claud & Michelle L. Butler Recent reductions in force (RIFs) and leadership changes at FDA are already affecting key agency functionsand as the administration plans a broader reorganization, the impact will likely grow. One area drawing increasing attention is how these changes will affect the drug development and review process. As reported by the Wall Street Journal last week , reviews of both innovative and follow-on drugs have been caught in a traffic jam, largely due to a

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Syngene collaborates with biotech firm to develop bile acid modulator for cholestatic disease treatment

Express Pharma

Disease overview Cholestatic liver disease is a condition that causes liver damage and fibrosis due to bile stasis. It is characterized by the slowing or stalling of bile flow through the hepato-biliary system (liver and bile duct). When bile flow is affected, it backs up into the organs and bloodstream, caus- ing inflammation. The disease is represented by primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC), but the pathophysiological pathways that cause bile stasis in bo

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Opinion: Physician groups need to become better advocates

STAT

Democrats recently unveiled a campaign to recruit and elect 100 doctors to public office. Democrats hope that by recruiting physicians to public office, they will be able to combat misinformation and restore trust in medicine and science.  Amid a full-blown measles outbreak, the U.S. plan to withdraw from the World Health Organization, the confirmation of Robert F.

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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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Enhancing Attendee Wellness at Events: Insights from the NHC Event Professionals Affinity Group Meeting

Putting Patients First Blog

Enhancing Attendee Wellness at Events: Insights from the NHC Event Professionals Affinity Group Meeting April 21, 2025 By Racquel Codling, Director, Meetings & Events Conferences and other events can be intense and demanding, leading to stress and burnout for attendees. However, incorporating wellness activities can help mitigate these effects, ensuring attendees feel energized, rejuvenated, and engaged.

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FDA approves novel therapy for chronic skin condition

European Pharmaceutical Review

For the first time in over ten years, the US Food and Drug Administration (FDA) has approved a new targeted treatment for chronic spontaneous urticaria. Sanofi and Regeneron Pharmaceuticals collaborated to develop Dupixent (dupilumab). Under the FDA’s new authorisation, the therapy is indicated for individuals aged 12 years and over with the chronic inflammatory skin disease, who still experience symptoms despite taking histamine-1 (H1) antihistamine medication.

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QbD for biopharmaceutical product lifecycle management

European Pharmaceutical Review

Quality-by-design (QbD) is a systemic risk-management strategy that facilitates the production of safe and consistent drugs. As pharma and biotech companies move towards more complex medicines, it is critical they have contract development and manufacturing organisation (CDMO) partners who can implement QbD principles while maintaining the accelerated timelines required for competitive business.

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AbbVie introduces Venetoclax in India for treatment of AML and CLL

Express Pharma

On the occasion of AML World Awareness Day, AbbVie, a global biopharmaceutical company, announced the launch of Venetoclax in India for the treatment of Acute Myeloid Leukaemia (AML) and Chronic Lymphocytic Leukaemia (CLL). This marks AbbVies entry into the Indian oncology market. AML is a type of blood cancer that progresses rapidly and affects the blood and bone marrow.

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US FDA clears Calidi’s CLD-201 for clinical development in solid tumours

Pharmaceutical Business Review

This clearance is intended for treating solid tumours in adults, with a focus on head & neck cancer, breast cancer and soft tissue sarcoma. Preclinical data included in the IND application has shown that CLD-201 has the potential to evade viral inactivation by the immune system of the subject. This allows it to target and destroy cancer cells. The forthcoming clinical trials will evaluate the tolerability, safety and preliminary efficacy of the therapy in patients with these challenging type

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FDA approves blockbuster Dupixent for chronic hives

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Morning. Today, we talk lots about tariffs — how they might impact drugmakers, patients, and even Ireland. Also, Novo Nordisk challenges Medicare over drug differentiation, and more.

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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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PADCEV™ (enfortumab vedotin) now available in India for locally advanced or metastatic urothelial cancer

Express Pharma

Astellas Pharma India today announced that PADCEV (enfortumab vedotin) is now available for prescription in India as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (LA/mUC) who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor 1.

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STAT+: Immunovant replaces CEO, makes other changes as Roivant tightens control

STAT

Immunovant on Monday announced changes to its management team, including the naming of a new chief executive, intended to give its majority owner, Roivant Sciences, greater control over the biotech company’s operations. Pete Salzmann, Immunovant’s current CEO and board member, is retiring. He will be replaced by Eric Venker, Roivant’s current president and chief operating officer.

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Licensing Agreements in the Pharmaceutical Sector

Drug Patent Watch

"The Secret to Unlocking the Pharmaceutical Industry's Hidden Goldmine As a seasoned pharma professional, I've seen it time and time again: a promising new treatment, stifled by patent restrictions and licensing agreements that seem to favor the big players. But what if I told you that there's a way to level the playing field? A way to tap into the lucrative world of pharmaceutical licensing agreements, and come out on top?

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STAT+: Pharmalittle: We’re reading about a Novo challenge to Medicare talks, a scuttled FDA office, and more

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of deadlines, online meetings, and phone calls has predictably returned. But what can you do? The world, such as it is, continues to spin. So time to give it a nudge in a better direction by brewing cups of stimulation.

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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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Can anything threaten Novo and Lilly’s obesity market dominance?

PharmaVoice

Five GLP-1 products will collectively bring in $470 billion by 2030, and the market leaders are working to hold back competition.

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STAT+: In Ireland, a global hub for the pharma industry, Trump tariffs are a source of deep worry

STAT

The hulking factories are tucked away off the roads around the village of Ringaskiddy — operated by the likes of Pfizer, Johnson & Johnson, and BioMarin, whose plant featured signs last week touting a new facility “coming Q1 2027.” The nearby town of Carrigtwohill crows that it’s grown “+400% over the past 20 years,” a surge driven by sites run by GSK, AbbVie, and Gilead.

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How a scrapped Pfizer drug became a winner for SpringWorks

PharmaVoice

SpringWorks Therapeutics and the Children’s Tumor Foundation salvaged a shelved asset for neurofibromatosis and got it over the regulatory finish line.

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STAT+: NIH moving to ban all future grants to universities with DEI programs or Israel boycotts, document suggests

STAT

The National Institutes of Health appears to be preparing to prohibit the awarding of new grants to any institutions that have DEI programs or boycott Israeli companies, in what would be an escalation of the Trump administration’s use of research funding as leverage to dismantle activities at universities that it deems discriminatory or antisemitic.

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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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Novo says it’s submitted obesity pill for FDA approval

BioPharma Dive

A spokesperson confirmed the Danish drugmaker has asked U.S. regulators to clear an oral version of its weight loss drug Wegovy two years after reporting initial Phase 3 results.

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The NIH puts a further chokehold on universities, and Ireland braces for pharma tariffs

STAT

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Good morning, Jason Mast here filling in for Theresa. The Morning Rounds editor has informed me that she has tired of all this debate over potato chips and the curious case of the vanishing sour cream and onion. Therefore, I will move on to french fries.

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Sanofi's Dupixent gets FDA nod for chronic hives indication

pharmaphorum

Sanofi's Dupixent gets FDA nod for chronic hives indication Jonah.

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STAT+: ACA marketplace worries, and a UNH stock chart

STAT

This is the online version of STAT’s email newsletter Health Care Inc., delivered to your inbox every Monday.  Sign up here.  Hello, everyone! My inane thought of the moment: A basketball player with 15-foot-long arms would surely have some major vascular problems, right? Don’t forget to send your thoughts, inane and serious, here: bob.herman@statnews.com or bobjherman.09 on Signal.

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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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Enhertu poised to move first line in HER2+ breast cancer

pharmaphorum

New data could make HER2-directed antibody-drug conjugate (ADC) Enhertu an option for previously untreated breast cancer for the first time

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Global divide emerges among physicians over patient choice in biologics vs. biosimilars, reveals GlobalData

Express Pharma

Physician attitudes toward patient choice between the use of biologics and biosimilars vary widely across global markets, revealing deep-rooted cultural and systemic differences. While nearly half of (49 per cent) physicians support patient involvement in treatment decisions, enthusiasm ranges from strong backing in China to notable skepticism in Germany and Franceunderscoring the growing but uneven shift toward shared decision-making in modern healthcare, finds GlobalData.

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FDA grants breakthrough status to uniQure’s Huntington’s disease therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has awarded breakthrough therapy designation to uniQure's AMT-130 for Huntington's disease.

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Trodelvy-Keytruda pairing hits the spot in breast cancer

pharmaphorum

Gilead Sciences has cemented the role of its TROP2 drug Trodelvy in triple-negative breast cancer with a study win in combination with MSD's Keytruda.

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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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Enhertu combo tops standard drugs in first-line HER2 breast cancer

BioPharma Dive

The data could help the Enhertu regimen overtake a drug combination that’s been used as the initial treatment for HER2-positive breast tumors for more than a decade.

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Thermo Fisher Scientific Unveils Advanced Therapies Collaboration Center

Pharmaceutical Commerce

The Carlsbad plant is expected to accelerate both the development and commercialization of cell therapies.

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UK’s MHRA authorises GSK’s Blenrep for multiple myeloma treatment

Pharmaceutical Technology

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has authorised GSKs Blenrep for treating multiple myeloma (MM).

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Strengthening Your Compendial Strategy

PharmaTech

Webinar Date/Time: Tue, May 13, 2025 11:00 AM EDT

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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.