Sat.Jul 13, 2024 - Fri.Jul 19, 2024

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New HIV Prevention Drug Shows 100% Efficacy in Clinical Trial

AuroBlog - Aurous Healthcare Clinical Trials blog

A large clinical trial in South Africa and Uganda has shown that a twice-yearly injection of a new pre-exposure prophylaxis drug gives young women total protection from HIV infection. The trial tested whether the six-month injection of lenacapavir would provide better protection against HIV infection than two other drugs, both daily pills.

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Will Eli Lilly Overtake Novo Nordisk in Weight-Loss Drug Race?

BioSpace

Some analysts say so, and a recent study suggested Lilly’s tirzepatide beat Novo’s semaglutide at inducing weight loss, but there are other factors in the market race.

Drugs 103
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FDA proposes cell and gene therapy site tours to help regulators learn from industry

Fierce Pharma

It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become increasingly popular in recent years. | It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become increasingly popular in recent years. Now, the FDA is proposing to work directly with industry through a series of facility tours that could enable both sides to learn something from each other.

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Revolution Medicines firms up Phase 3 trial plans with latest cancer drug data

Bio Pharma Dive

Updated results show the biotech's RAS inhibitor shrank pancreatic tumors in 20% to 25% of study participants, but with high rates of side effects like rash and nausea.

Medicine 300
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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July 16, 2024: OS-PCORTF Report Focuses on Building Data Capacity for Patient-Centered Outcomes Research

Rethinking Clinical Trials

A recent report from the Assistant Secretary for Planning and Evaluation in the US Department of Health and Human Services outlines 36 projects funded by the Office of the Secretary Patient-Centered Outcomes Research Trust Fund (OS-PCORTF). OS-PCORTF was created to build national data capacity and infrastructure and leverage existing clinical data and federal data for patient-centered outcomes research.

Research 147
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AstraZeneca completes Amolyt Pharma acquisition

Pharmaceutical Technology

AstraZeneca has closed the acquisition of Amolyt Pharma, a company specialising in treatments for rare endocrine diseases.

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Novo leads $100m financing for Alzheimer's player Asceneuron

pharmaphorum

Novo Holdings leads $100m financing for Swiss biotech Asceneuron, which is developing an oral tau therapy for Alzheimer's disease

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Treating Rheumatoid Arthritis Patients With Biosimilars Versus Leflunomide: An Economic Evaluation

Pharmaceutical Commerce

A study explores the cost-effectiveness of combining methotrexate with various drugs as a way to combat failed methotrexate monotherapy.

Drugs 98
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KCL leads first guidelines on immune monitoring for hard-to-treat blood cancer

Pharma Times

Myelodysplastic syndromes are a group of blood cancers that currently affect more than 7,000 people in the UK

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Artiva prices $167M IPO, riding optimism for autoimmune cell therapy

Bio Pharma Dive

The offering comes days after the publication of a paper showing what analysts said was early proof that “off-the-shelf” cell therapies can treat inflammatory diseases.

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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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Johnson & Johnson’s Q2 2024 net earnings drop 12.8% to $4.6bn

Pharmaceutical Technology

Johnson & Johnson has reported a 12.8% decrease in net earnings for Q2 2024, with figures falling to $4.6bn from $5.3bn in Q2 2023.

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Does Walking to Work Burn The Same Calories as Running? Here’s The Science.

AuroBlog - Aurous Healthcare Clinical Trials blog

It’s Monday morning, the alarm goes off and it’s already 7:30 a.m. – and you’re 30 minutes late. Normally you need 45 minutes to walk the 3 kilometres to work, but this morning you’ll be running for 20 minutes.

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July 17, 2024: In This Week’s PCT Grand Rounds, Lessons From the PRECIDENTD Comparative Effectiveness Trial

Rethinking Clinical Trials

Dr. Brendan Everett and Dr. Deborah Wexler In this Friday’s PCT Grand Rounds, Brendan Everett and Deborah Wexler of Harvard Medical School will present “Lessons From PRECIDENTD: A Pragmatic Comparative Effectiveness Trial.” The Grand Rounds session will be held on Friday, July 19, 2024, at 1:00 pm eastern. The PRECIDENTD study (Prevention of Cardiovascular and Diabetic Kidney Disease in Type 2 Diabetes) is comparing SGLT2 inhibitors and a GLP-1 receptor agonist to treat type 2

Trials 147
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Sionna revives AbbVie’s cystic fibrosis drugs, eyeing a shot at Vertex

Bio Pharma Dive

The well-funded startup says drugs AbbVie abandoned last year could form a combination regimen with “superior efficacy” to Vertex’s market-leading medicines.

Drugs 273
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How Machine Learning Drives Clinical Trial Efficiency

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.

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AstraZeneca’s Tagrisso gains approval in Canada for NSCLC

Pharmaceutical Technology

AstraZeneca has obtained Health Canada’s Notice of Compliance (NOC) for Tagrisso (osimertinib) to treat NSCLC.

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Scientists Identify a Speech Trait That Foreshadows Cognitive Decline

AuroBlog - Aurous Healthcare Clinical Trials blog

Can you pass me the whatchamacallit? It’s right over there next to the thingamajig. Many of us will experience “lethologica”, or difficulty finding words, in everyday life. And it usually becomes more prominent with age.

Scientist 200
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Amgen, BMS and Merck have the most exposure as Big Pharma eyes $183B patent cliff: analyst

Fierce Pharma

While patent cliffs are looming for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a research note f | While patent cliffs loom for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a July 11 research note from Morgan Stanley.

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Obesity pill from Roche shows promising weight loss in small study

Bio Pharma Dive

Treatment led to "clinically meaningful" weight loss over four weeks, but longer studies will be needed to compare it to Wegovy and Zepbound.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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The US Biosecure Act threatens to destabilise the pharmaceutical industry 

Pharmaceutical Technology

In January, the US House Select Committee on the Strategic Competition between the US and the Chinese Communist Party introduced the Biosecure Act.

Marketing 230
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ICMR to hold workshop on measuring oxidative stress in pre-clinical mouse models to boost pre-clinical research

AuroBlog - Aurous Healthcare Clinical Trials blog

Home Editorial Services Interview Q&A Chronicle Specials Pharma Mart ePharmail Archives Join Pharma | Login Home > TopNews you can get e-magazine links on WhatsApp.

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Pfizer's ATTR heart disease drug needs hefty discount, says ICER draft report. What about Alnylam's Amvuttra?

Fierce Pharma

Pfizer’s blockbuster drug tafamidis for the treatment of the rare heart disease transthyretin amyloid cardiomyopathy (ATTR-CM) needs at least a 96% discount off its list price to be considered cost | Pfizer’s blockbuster tafamidis for the treatment of the rare heart disease ATTR-CM needs at least a 96% discount off its list price to be considered cost-effective under common benchmarks, a draft report by ICER has found.

Drugs 121
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Lilly alone in bidding for Morphic; Novartis won’t yet file MorphoSys drug

Bio Pharma Dive

Federal filings showed no companies other than Lilly made an offer to buy Morphic, while Novartis executives said they’re still waiting for more data on pelabresib.

Drugs 164
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Kyverna wins RMAT designation for stiff-person syndrome for cell therapy candidate

Pharmaceutical Technology

Kyverna’s CEO Peter Maag said the biotech is “eager to start generating data” from a Phase II trial.

Trials 221
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Clinical Trial Shows One Drug Performs Better Than Ozempic For Weight Loss

AuroBlog - Aurous Healthcare Clinical Trials blog

Patients taking Eli Lilly’s new drug Mounjaro achieved significantly greater weight loss than those on Novo Nordisk’s Ozempic, a head-to-head study published Monday showed.

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Novartis CEO sees IRA impact ‘manageable’ in short run, maintains midterm growth goal

Fierce Pharma

As biopharma companies and the U.S. | As biopharma companies and the U.S. government near the deadline of their drug price talks under the Inflation Reduction Act, Novartis CEO said the cost cuts “might be manageable” in the short term for the firm’s first few products to be included.

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Vertex sues US over limits on providing fertility services to Casgevy patients

Bio Pharma Dive

In the suit, Vertex argues HHS’ stance forces a “Hobson’s choice” on people with sickle cell seeking to undergo the potentially curative treatment.

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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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Exploring Melbourne’s booming life sciences sector

Pharmaceutical Technology

Australia is fast becoming the place to be for innovative life sciences companies, as proved by Melbourne’s latest FDI wins from the likes of BioNTech and Moderna.

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New Alzheimer’s Nasal Spray Clears Toxic Tangles in Human Neurons And Mice

AuroBlog - Aurous Healthcare Clinical Trials blog

Twisted and tangled proteins are found in the brains of many of those who die with Alzheimer’s disease. Some scientists suspect these neural knots can harm and even kill brain cells, but so far in clinical trials, drugs that have tried to target the tangles have shown limited success.

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J&J, BMS and AstraZeneca strike back in appeals after IRA litigation losses

Fierce Pharma

Despite a string of high-profile losses this year, at least three major drugmakers continue to fight back against the Medicare price negotiations being rolled out under the Inflation Reduction Act. | Despite a string of high-profile losses this year, at least three major drugmakers continue to fight back against the Medicare price negotiations being rolled out under the Inflation Reduction Act.

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Asceneuron raises another $100M for Alzheimer’s drug development

Bio Pharma Dive

The Merck KGaA spinout has a tau-regulating medicine it claims could be an “ideal therapy” for Alzheimer’s. The pitch has intrigued both healthcare investors and pharma venture arms.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.