Worldwide Clinical Trials

JULY 9, 2024

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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Clinical Research Research Clinical Trials Clinical Trials 130

Bio Pharma Dive

JULY 9, 2024

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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Scientist Research Vaccination Vaccine 294

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 9, 2024

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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Clinical Trials Clinical Trials Clinical Research Trials 184

Bio Pharma Dive

JULY 9, 2024

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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Gene Therapy Gene 164

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Clinical Supply

Rethinking Clinical Trials

JULY 9, 2024

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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Clinical Trials Clinical Trials Trials Research 130

Bio Pharma Dive

JULY 9, 2024

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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Marketing Regulation Drugs 139

Bio Pharma Dive

JULY 9, 2024

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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Protein Antibody Drugs 156

Pharmaceutical Technology

JULY 9, 2024

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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Vaccination Vaccine 130

pharmaphorum

JULY 9, 2024

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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Pharmacy Regulation Marketing 109

Pharmaceutical Technology

JULY 9, 2024

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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Trials Antibody Development 130

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

Clinical Trials

Fierce Pharma

JULY 9, 2024

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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Pharmaceutical Technology

JULY 9, 2024

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

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pharmaphorum

JULY 9, 2024

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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Gene Therapy Gene 114

Pharmaceutical Technology

JULY 9, 2024

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

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Clinical Supply

Intouch Solutions

JULY 9, 2024

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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Doctors Doctor Genetics Marketing 105

Pharmaceutical Technology

JULY 9, 2024

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

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pharmaphorum

JULY 9, 2024

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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Pharmaceutical Technology

JULY 9, 2024

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

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Development 130

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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.

Clinical Trials

Pharma Times

JULY 9, 2024

Myricx Bio’s therapies include treatments for breast, lung and colorectal cancer

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Clinical Development Development 145

Pharmaceutical Technology

JULY 9, 2024

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

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Trials 130

Pharma Times

JULY 9, 2024

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

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Medicine 141

Fierce Pharma

JULY 9, 2024

Ahead of an election in November—and amid a period of legislative uncertainty for the China-targeting BIOSECURE Act—U.S. | Ahead of an election in November—and amid a period of legislative uncertainty for the China-targeting BIOSECURE Act—U.S. House Speaker Mike Johnson has pledged to hold a vote for the controversial bill before the year is out.

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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

Clinical Research

Drug Patent Watch

JULY 9, 2024

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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Generic Drugs Drugs 104

BioSpace

JULY 9, 2024

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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Gene Therapy Gene Medicine 97

BioPharma Reporter

JULY 9, 2024

Her grandmother was in a marching band in the early 1900s and mom was only ond of two in her graduating class as a pharmacist and her dad, an inventor with more than 30 patents.

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Doctors Doctor Contract Manufacturing Manufacturing 96

BioSpace

JULY 9, 2024

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.

Pharmacy 93

Pharmacy Drugs 93

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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Clinical Trials

Drug Patent Watch

JULY 9, 2024

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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pharmaphorum

JULY 9, 2024

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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BioSpace

JULY 9, 2024

At the DIA Global 2024 Conference, Dr. Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA), and Lori Ellis, head of insights at BioSpace, discussed the advancements being made to help drive forward drug and medical device development. Not surprisingly, Dr. Marks stressed the need for regular communication between the FDA and the biopharma industry as science and technology continue to evolve.

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Drugs Development Research 91

pharmaphorum

JULY 9, 2024

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

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Sales Manufacturing 103

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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

Clinical Supply