Wed.Jan 22, 2025

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J&J joins Pfizer in detailing impact of Part D redesign

Bio Pharma Dive

The pharma expects a modest financial headwind this year from changes to Medicare prescription drug benefits under the Inflation Reduction Act.

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January 22, 2025: The HEALing Communities Study to Reduce Opioid Deaths, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Jeffrey Samet of Boston University will present “The HEALing Communities Study10 Million People, 67 Communities: A Community-Based Cluster Randomized Trial to Reduce Opioid Overdose Deaths.” The Grand Rounds session will be held on Friday, January 24, 2025, at 1:00 pm eastern. Samet is the John Noble Professor in General Internal Medicine at the Boston University Chobanian and Avedisian School of Medicine and and a professor of public health a

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J&J oncology sales grow, but shares slide on outlook

Bio Pharma Dive

CEO Joaquin Duato said the company is positioned for sustained growth in coming years even as competition batters Stelara, one of its top-sellers.

Sales 214
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The Big Three PBMs’ 2025 Formulary Exclusions: Humira, Stelara, Private Labels, and the Shaky Future for Pharmacy Biosimilars

Drug Channels

For 2025, the three largest pharmacy benefit managers (PBMs)Caremark (CVS Health), Express Scripts (Cigna), and Optum Rx (United Health Group)have again each excluded hundreds of drugs from their standard formularies. You can find our updated counting below. As youll see below, the combination of formulary exclusion and private labels is creating an increasingly confusing and crowded biosimilar marketplace.

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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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The Role of Good Manufacturing Practice (GMP) in Generic Drug Manufacturing: Ensuring Quality and Safety

Drug Patent Watch

The Unseen Heroes of Generic Drug Manufacturing: Good Manufacturing Practice (GMP) As we navigate the complex world of generic drug manufacturing, it's easy to overlook the unsung heroes that ensure the quality and safety of these life-saving medications. I'm talking about Good Manufacturing Practice (GMP), a set of guidelines that govern the production, testing, and packaging of generic drugs.

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Intellia makes progress on HAE study; 2 more China drug deals

Bio Pharma Dive

The biotech said it has dosed the first participant in a Phase 3 study of its in vivo gene editing treatment. Elsewhere, the FDA imposed a hold on Atara and lifted another on Amylyx.

More Trending

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Setting Up an Investigator-Initiated Research Program: Benefits and Lessons Learned

ACRP blog

Independent investigators play a vital role in advancing translational “bench to bedside” research to improve human health. Setting up an investigator-initiated research program (IIRP) can encourage and support these investigators while fostering an institutions high-quality research and compliance. The Hackensack Meridian Health (HMH) Research Institutes IIRP uses a structured, integrated team approach to support independent investigators.

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J&J’s Spravato receives FDA label expansion for depression monotherapy

Pharmaceutical Technology

The FDAs decision marks J&J's Spravato as the first monotherapy for adults with treatment-resistant depression.

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AstraZeneca receives positive recommendations for lung cancer treatments

Pharma Times

NICE endorses Imfinzi and Tagrisso for enhanced lung cancer care

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Glox to develop precision antibiotics for cystic fibrosis

Pharmaceutical Technology

Glox Therapeutics is set to receive a share of the 3m ($3.67m) Collaborative Discovery Programme (CDP) funding.

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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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Transformative Neuropsychiatric Therapies ft. Dr. Amit Etkin, Founder, President and CEO of Alto Neuroscience

XTalks

In this episode, Ayesha spoke with Amit Etkin, Founder, President and CEO of Alto Neuroscience , a company developing precision treatments for neuropsychiatric conditions. Alto Neuroscience is focused on designing candidates that target core brain processes in patient populations not adequately treated by currently available medications. Alto is currently pursuing candidates in major depressive disorder (MDD), bipolar depression and schizophrenia.

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AstraZeneca gains NICE nod for lung cancer drugs Tagrisso and Imfinzi

Pharmaceutical Technology

Tagrisso and Imfinzi are projected to generate global sales of $8bn and $7bn, respectively, by 2030, according to GlobalData.

Sales 147
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UK kicks off £150m tender process for healthcare AI

pharmaphorum

The UK government has launched a 150 million procurement drive for artificial intelligence tools that can be used by the NHS.

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Atara’s T cell programmes hit with clinical hold after third-party site woes

Pharmaceutical Technology

The FDA placed a clinical hold on two Atara assets, following an inspection at a third-party site that also led to a CRL for Ebvallo.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Could an AI-powered eye test spot dementia early on?

pharmaphorum

A UK alliance between data scientists, clinical researchers, and community opticians hopes to develop an AI to predict dementia during an eye test.

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Catalent backs decentralised manufacture of Galapagos’ CAR-T therapy

Pharmaceutical Technology

Catalent has entered a strategic partnership with Galapagos to facilitate decentralised manufacturing for the latters GLPG5101.

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The Regulatory Pathway for Generic Drugs Explained

Drug Patent Watch

The Unseen Journey of Generic Drugs: A Look into the Regulatory Pathway Have you ever wondered how generic drugs make it to the market? It's a complex process that involves navigating a series of regulatory hurdles. As a healthcare professional or a pharmaceutical enthusiast, understanding the pathway to generic drug approval can be fascinating. The journey begins with the original patent holder filing for a new drug application (NDA) with the FDA.

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FDA breakthrough status for Bluejay’s CHD therapy brelovitug

Pharmaceutical Technology

The US FDA has granted breakthrough therapy designation to Bluejay Therapeutics brelovitug, to treat chronic hepatitis delta (CHD).

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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J&J's Spravato gets another lift with new FDA approval

pharmaphorum

Johnson & Johnson's Spravato has become the first standalone drug to be cleared by the FDA for adults with treatment-resistant depression

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Focusing on the Patient

Pharmaceutical Commerce

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Donald Prentiss, founder and CEO, Qualthera, describes the importance of the patient within the pharma supply chain.

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2025: The year ahead in pharma and life sciences

pharmaphorum

Discover the key trends and innovations shaping the pharma and life sciences industries in 2025, focusing on efficiency, patient care, customer experience, and advancements in rare disease treatments.

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Pharma Pulse 1/22/25: How Politics Impact Investors, Pharmacies Struggle Amid California Wildfires & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Support Research From Home: Join a Study on Quitting Smoking

Trialfacts

Contents About the Study Why Participate? Your Rights Who Can Participate? More Study Details About the Research Center Research Center: Florida International University Location: This is a virtual research study in Miami Lead Researcher: Dr. Olatokunbo Osibogun IRB: This study has been reviewed and approved by the Florida International University Institutional Review Board About the Study Why is quitting cigarettes so challenging for those who also use e-cigarettes?

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5 takeaways from JP Morgan 2025

pharmaphorum

Explore the top 5 key takeaways from JP Morgan's 2025 report, covering market access, IRAs, China, AI, and women's health. Stay informed on the latest trends and developments in the financial and healthcare industries.

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The Association Between Semaglutide Initiation and Obese Individuals Without Diabetes

Pharmaceutical Commerce

What factors influence their likelihood of receiving this form of obesity treatment?

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JP Morgan Week 2025 – Marianne De Backer

pharmaphorum

Explore the in-depth video interview with Marianne De Backer during JP Morgan Week 2025 where she discusses her insights and perspectives on the future of the financial industry.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Top 10 Heart and Vascular Medications Based on Recent Sales Data

XTalks

The heart and vascular medication market continues to be a critical focus area for pharma companies, with billions of dollars in sales generated annually. These medications play a vital role in managing conditions such as heart failure, atrial fibrillation, stroke prevention and cholesterol reduction, improving patient outcomes and quality of life worldwide.

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The future of precision psychiatry

pharmaphorum

Discover how EEG technology is shaping the future of precision psychiatry and revolutionising mental health treatment. Explore the latest advancements and possibilities in this cutting-edge field.

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Prehabilitation Demonstrates Potential for Enhancing Health and Minimizing Surgical Complications

Bioengineer

A groundbreaking study published in The BMJ has revealed that prehabilitationa proactive approach aimed at enhancing a patients physical and mental condition before surgeryholds significant promise in improving surgical outcomes. The research, led by Dr. Daniel McIsaac, an anesthesiologist and senior scientist at The Ottawa Hospital, compiles data from over 15,000 patients involved in 186 randomized clinical trials internationally.

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HPV self-collection: A step closer to eliminating cervical cancer

pharmaphorum

Learn more about HPV self-collection, a step closer to eliminating cervical cancer, and its importance in early detection and prevention. Find out how this simple test can save lives.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud