Tue.Jul 09, 2024

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Current Clinical Research Trends in GLP-1 (Glucagon-Like Peptide 1) Treatment

Worldwide Clinical Trials

The recent surge in GLP-1 treatments has ignited a profound shift in the pharmaceutical landscape, with more studies being announced than ever before. Due to this meaningful change, the first-ever GLP-1-Based Therapeutics Summit took place in Philadelphia on May 15-16th, 2024, serving as a platform for industry decision-makers to provide invaluable insights for therapeutic strategies.

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Pfizer research chief Dolsten to step down, with company at a crossroads

Bio Pharma Dive

The company has begun searching for a successor to Dolsten, who oversaw more than 35 drug and vaccine approvals but also some notable setbacks during his time as Pfizer’s top scientist.

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It’s Official: WHO Warns Talc Is ‘Probably Carcinogenic’ For Humans

AuroBlog - Aurous Healthcare Clinical Trials blog

The World Health Organization‘s cancer agency on Friday classified talc as “probably carcinogenic” for humans, however an outside expert warned against misinterpreting the announcement as a “smoking gun” The decision was based on “limited evidence” talc could cause ovarian cancer in humans, “sufficient evidence” it was linked to cancer in rats and “strong mechanistic evidence” […]

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UniQure stock surges on data for Huntington’s gene therapy

Bio Pharma Dive

The biotech’s stock rose more than 60% as fresh data appeared to alleviate some investor concerns about the therapy’s effectiveness and reliability.

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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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IPC-MvPI awarded provisional approval as certification body for ICMED 9000 and ICMED 13485

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian Pharmacopoeia Commission – Materiovigilance Programme of India (IPC-MvPI) has received provisional approval from the Quality Council of India (QCI) to operate as a certification body for the ICMED 9000 and ICMED 13485 certification schemes.

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SciRhom pulls in $70M for a new type of immune disease drug

Bio Pharma Dive

The Series A round will help the startup bring its lead candidate, an antibody aimed at the protein iRhom2, into human testing by the end of 2024.

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FTC criticizes PBM power over prescription drug market

Bio Pharma Dive

On Tuesday, regulators updated the public on their yearslong probe of PBM's business practices. The report faults PBMs for profiting at the expense of patients and independent pharmacists.

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SMC accepts Boehringer/Lilly’s Jardiance for CKD within NHS Scotland

Pharma Times

The serious, progressive kidney disease affects nearly 850 million people worldwide

Medicine 150
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iTeos and GSK hit enrolment milestone with Phase III TIGIT lung cancer trial 

Pharmaceutical Technology

iTeos will receive $35m from GSK as the first patient is dosed in the Phase III trial of the jointly developed monoclonal antibody EOS-448.

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July 9, 2024: Health Equity Core Updates Terminology Guide

Rethinking Clinical Trials

The NIH Pragmatic Trials Collaboratory’s Health Equity Core published a new version of the Equitable Language Guide , which offers guidance on inclusive language and terms to use when referring to specific people, groups, and communities. The Equitable Language Guide is available on the Health Equity Core webpage. The new version of the guide includes updated and expanded recommended terminology, an easy-to-use organization, and additional sources.

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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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iOnctura expands PI3K inhibitor programme to NSCLC

Pharmaceutical Technology

iOnctura will evaluate roginolisib in combination with GSK’s Jemperli in a Phase II trial.

Trials 130
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Opportunity costs of gene therapies. Where do we go from here?

pharmaphorum

Learn about the opportunity costs of gene therapies like Beqvez. Discover the obstacles and potential paths forward in the evolving field of gene therapy.

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Roche relaunches refillable wet AMD implant two years after recall

Pharmaceutical Technology

The Susvimo eye implant is filled with Lucentis, which delivers the therapy continuously and eliminates the need for multiple injections.

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FTC report finds PBM power has “dire consequences”

pharmaphorum

A long-awaited report from the US Federal Trade Commission (FTC) on pharmacy benefit managers (PBMs) is out – and will make uncomfortable reading for the pharma supply chain middlemen.Its central message is clear. The six largest PBMs in the US manage nearly 95% of all prescriptions filled in the US, a “concentrated market structure” that has allowed them to “profit at the expense of patients and independent pharmacists,” according to the financial regulator.

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

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Taiho exercises option for Arcus Biosciences’ quemliclustat in Asia

Pharmaceutical Technology

Taiho has exercised an option for an exclusive licence for Arcus Biosciences’ quemliclustat (AB680) in Japan and Asian territories.

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Digital health financing shows signs of recovery in H1

pharmaphorum

After languishing in the doldrums for a few quarters, there are signs that the winds of investment are starting to blow again in the US digital health sector.

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SciRhom secures $70m for autoimmune diseases treatments

Pharmaceutical Technology

SciRhom has secured €63m ($70m) in a Series A funding round to develop iRhom2-targeting therapeutics for autoimmune diseases.

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Mikael Dolsten exits Pfizer, putting R&D leadership in flux

pharmaphorum

Mikael Dolsten exits Pfizer, putting R&D leadership in flux Phil.

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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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Moderna and Mitsubishi Tanabe link on mRNA vaccines in Japan

Pharmaceutical Technology

Moderna and Mitsubishi Tanabe have entered into a collaboration to jointly promote the former’s mRNA respiratory vaccine portfolio in Japan.

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Agios Pharmaceuticals’ “Do You See It?” Campaign Featured in MM+M

Intouch Solutions

MM+M recently named Agios Pharmaceuticals’ “Do You See It?” campaign as their Campaign of the Week! The campaign focuses on the hidden dangers of thalassemia, a rare genetic condition affecting an estimated 8,000 Americans. The disease can result in anemia-like symptoms, with severe cases requiring regular blood transfusions, while milder cases often go untreated.

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Ligand Pharmaceuticals to acquire APEIRON Biologics for $100m

Pharmaceutical Technology

Ligand Pharmaceuticals has announced a definitive agreement for the acquisition of APEIRON Biologics in a deal worth $100m in cash.

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Roche will relaunch AMD implant Susvimo after update

pharmaphorum

Roche will reintroduce its Susvimo implant wet AMD, which was withdrawn from sale in 2022 due to manufacturing defects.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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How to find low-competition generic drug opportunities

Drug Patent Watch

To find low-competition generic drug opportunities, focus on drugs with limited competition due to small patient populations, complex formulations, or […] Source

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Pharma Pulse 7/9/24: Technology Designed to Support Infertility, Patients with Type 1 Diabetes Have Higher Risk of Epilepsy & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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The impact of biosimilars on biologic drug distribution models

Drug Patent Watch

The introduction of biosimilars has significantly altered the landscape of biologic drug distribution models.

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A spectrum of obesity requires precision

pharmaphorum

In this latest pharmaphorum podcast, web editor Nicole Raleigh speaks with Michael Kyle, chief medical officer at Currax Pharmaceuticals – a company working to advance a greater understanding of how to effectively treat obesity – about perceptions and options beyond the bounds of GLP-1s, including evolution of hypertension treatments.

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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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Unified Patent Court Reshapes European Patent Landscape

Drug Patent Watch

In a seismic shift for European intellectual property, the Unified Patent Court (UPC) is rapidly transforming how businesses approach patent […] Source

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UniQure Wins First FDA RMAT in Huntington’s Disease After Strong Phase I/II Data

BioSpace

Following a disappointing readout last year, uniQure on Tuesday posted promising Phase I/II data for its investigational gene therapy AMT-130 and nabbed the first-ever Regenerative Medicine Advanced Therapy designation from the FDA in Huntington’s disease.

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Bayer to largely complete layoffs within pharma commercial team in 2024, exec says

Fierce Pharma

Bayer’s massive reorganization championed by CEO Bill Anderson is bringing major changes to the German company’s pharma commercial team, shaking up its structure, personnel and operations. | Bayer’s massive reorganization championed by CEO Bill Anderson is bringing major changes to the German company’s pharma commercial team. And the division’s newly named commercial chief Christine Roth is among those changes.

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PBMs ‘Wield Enormous Power’ Over Patient Access to Affordable Drugs: FTC

BioSpace

The Federal Trade Commission on Tuesday issued an interim report on the top pharmacy benefit managers, showing that they are generating massive profit at the expense of patients by inflating prescription drug costs.

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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