Wed.Jan 15, 2025

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January 15, 2025: Designing for Diversity, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Christopher Lindsell In this Friday’s PCT Grand Rounds, Chris Lindsell of Duke University will present “Design for Diversity.” The Grand Rounds session will be held on Friday, January 17, 2025, at 1:00 pm eastern. Lindsell is professor and cochief of biostatistics and bioinformatics, director of data science and biostatistics at the Duke Clinical Research Institute, and director of biostatistics and bioinformatics at the Duke Clinical and Translational Science Instituteall

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IMVARIA’s FDA-Cleared ScreenDx Brings AI-Powered Screening to Interstitial Lung Disease

XTalks

Known for its AI-driven diagnostic tools, IMVARIA, a Berkeley-based health tech company, recently earned the FDAs 510(k) clearance of ScreenDx, a first-of-its-kind algorithm designed to identify potential interstitial lung disease (ILD) cases. This follows their earlier success with Fibresolve , a tool for idiopathic pulmonary fibrosis (IPF) that became the first FDA Breakthrough-designated AI diagnostic for lung fibrosis.

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Why Google Patents Is Not a Good Solution to Identify Drug Patents

Drug Patent Watch

Identifying drug patents is crucial for various stakeholders, including researchers, legal professionals, and business strategists. While Google Patents is a widely used tool for searching patent information, it may not be the most effective solution for identifying drug patents. This article explores the limitations of Google Patents in this context and suggests alternative approaches.

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Federal watchdog cites concerns with FDA’s accelerated approval process

Bio Pharma Dive

The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency procedures.

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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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Can a Technology Reboot Help Sites, Sponsors, Patients, and Others Talk Seamlessly?

ACRP blog

In this season of wish lists and resolutions, moving seamlessly cross-communicative clinical trials technologies that can be utilized across sites and sponsors on an ongoing basis from the nice to have category into the must-have one doesnt have to be dismissed as a miracle that will never see the light of day, an industry observer of trends in technology says.

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At JPM, Biogen CEO tries to take down the deal temperature

Bio Pharma Dive

While Biogen has made an opportunistic bid for partner Sage, its top executive seemed to play down the urgency for his company to go after larger deals.

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Oxford Drug Design achieves in vivo validation for novel cancer treatment

Pharma Times

Promising results from mouse study lead to expanded trials

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JP Morgan 2025: AbbVie counts on Skyrizi and Rinvoq to fill Humira-sized hole

Pharmaceutical Technology

AbbVie executives said they have high hopes for Skyrizi and Rinvoq in the inflammatory bowel disease market after Humira sales drop.

Sales 147
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Owlstone Medical announces $27 million USD first close in Series E financing round

Pharma Times

Funds to accelerate commercialisation and clinical trials of diagnostic tests

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Regenxbio and Nippon Shinyaku forge $810m gene therapy deal

Pharmaceutical Technology

Regenxbio will receive $110m upfront from Nippon Shinyaku and is eligible to get up to $700m in development, regulatory, and sales milestones.

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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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Pioneering Cancer Treatment with Alpha Radiation Technology

XTalks

In this episode, Vera spoke with Dr. Robert Den, Chief Medical Officer (CMO) of Alpha Tau Medical , a company developing cancer treatment with its highly potent alpha radiation technology. Dr. Den shared his journey to becoming CMO at Alpha Tau Medical and discussed the companys mission to bring innovative cancer therapies to patients worldwide. Learn how Alpha Taus technology differs from traditional radiation therapies, the types of cancers it has shown promise in treating and the impact this

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Charles River CEO reveals drop in 2025 revenue outlook at JP Morgan

Pharmaceutical Technology

At the JP Morgan Healthcare Conference 2025, Charles River CEO blamed low client spending, loss of a contract and other reasons for lower 2025 projections.

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J&J files a potential blockbuster; Lykos shakes up its board

Bio Pharma Dive

The pharma began submitting its TAR-200 bladder cancer treatment to the FDA. Elsewhere, Sarepta and Madrigal reported strong revenue numbers, while Bausch + Lomb made an acquisition.

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Insmed’s gene therapy poised to challenge DMD landscape after IND clearance

Pharmaceutical Technology

Insmed is set to challenge the Duchenne muscular dystrophy (DMD) treatment space with its innovative gene therapy asset, INS1201.

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

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Keros pulls study of Winrevair rival after safety signal

pharmaphorum

Adverse events have led Keros to abandon a phase 2 trial of pulmonary arterial hypertension drug cibotacept, a would-be rival to MSD's Winrevair

Trials 105
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AbbVie and Simcere Zaiming link to develop trispecific antibody

Pharmaceutical Technology

AbbVie and Simcere Zaiming have announced an option-to-license agreement for the development of an investigational drug candidate, SIM0500.

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Obesity needs a new definition, says global commission

pharmaphorum

Experts think the current way of defining obesity based on BMI isn't nuanced enough to gauge health and the need for weight-loss therapies.

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Acadia submits MAA to EMA for Rett syndrome therapy

Pharmaceutical Technology

Acadia Pharmaceuticals has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for trofinetide

Medicine 147
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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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FTC doubles down on PBM criticism in new report

pharmaphorum

A new FTC report claims that pharmacy benefit managers generated $7.3bn by marking up specialty generics used to treat diseases like cancer and HIV.

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JP Morgan 2025: Eli Lilly misses 2024 revenue estimate by $400m

Pharmaceutical Technology

Eli Lillys CEO Dave Ricks cited stocking levels and unexpected market dynamics in Q4 2024 in the GLP-1RA market.

Marketing 147
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Sling shoots at thyroid eye disease with its oral therapy

pharmaphorum

Amgen's thyroid eye disease blockbuster Tepezza, given by infusion, is facing competition from an oral alternative from Sling Therapeutics

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WHO reports eight deaths from suspected Marburg outbreak in Tanzania

Pharmaceutical Technology

Eight people have likely died from an outbreak of Marburg virus disease (MVD) in a northwestern region of Tanzania, according to the WHO.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Lilly trims sales forecast on weaker obesity/diabetes growth

pharmaphorum

Eli Lilly has revised its revenue forecast for 2024 after seeing weaker-than-expected growth for its diabetes and obesity therapies.

Sales 97
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JP Morgan 2025: Incyte expects period of ‘defining catalysts’

Pharmaceutical Technology

Incyte told JP Morgan attendees of plans for four launches in 2025, beginning with its FDA-approved Niktimvo for chronic GvHD.

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Pharma trends and predictions for 2025: An incoming CEO’s perspective

pharmaphorum

Explore the latest pharmaceutical trends and predictions for 2025 from an incoming CEO's perspective. Stay ahead of the curve and prepare your organisation for the future.

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Umoja secures $100m to advance CAR-T cell therapy pipeline

Pharmaceutical Technology

Umoja Biopharma has announced the closing of an oversubscribed $100m Series C financing round to progress CAR-T cell therapy pipeline.

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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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JP Morgan Week 2025 - Day 3

pharmaphorum

pharmaphorum's JPM Week live blog finishes strong with panels on AI, funding, and a conference wrap-up.

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Aggressive protection of Stelara may indicate J&J’s immunology strategy

Pharmaceutical Technology

J&J will protect the branded anti-interleukin (IL)-12/23 biologic Stelara against sales erosion from biosimilars.

Branding 147
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Register Now for the AAPS National Biotechnology Conference

pharmaphorum

Register Now for the AAPS National Biotechnology Conference Mike.

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How a Fresh Approach to Supply Chains Can Unlock Scaling in Personalized Medicine

Pharmaceutical Technology

Personalized medicine is on the rise in the biomanufacturing industry, and supply chains will need to adapt.

Medicine 130
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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