Sat.Oct 14, 2023 - Fri.Oct 20, 2023

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5 steps to help increase the odds of clinical trial success

Bio Pharma Dive

There are many common reasons clinical trials fail, including failure to demonstrate efficacy, safety concerns, issues with inclusion and exclusion criteria and patient recruitment. Follow these five steps to increase the odds of clinical trial success.

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How Companies Are Upping Diversity Among Clinical Trial Participants

BioSpace

After the FDA released draft guidance on increasing diversity in clinical trials, companies have been left to figure out the details. Here’s what experts say is working.

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How generative AI Is transforming healthcare

pharmaphorum

How generative AI Is transforming healthcare Mike.

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Ultragenyx to spin out new company around Alzheimer’s gene therapy

Bio Pharma Dive

CEO Emil Kakkis says the company's findings are too exciting to ignore, but the “high-risk, high-return” venture needs to be pursued outside the organization.

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

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This Protein May Protect Against Alzheimer’s, Scientists Say

AuroBlog - Aurous Healthcare Clinical Trials blog

In the search for a treatment for Alzheimer’s disease, researchers have zeroed in on a protein with protective effects. A new study reveals how cholesterol and inflammation in different types of human brain cells interact with a protein called ABCA7, which regulates how molecules pass through cell membranes.

Protein 227
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Novo Nordisk stops trial of Ozempic in kidneys as interim analysis shows success

Pharmaceutical Technology

In October 2023, Novo Nordisk announced that its trial studying Ozempic (semaglutide) in diabetic CKD patients, will come to a halt almost a year prior to its planned completion.

Trials 279

More Trending

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Hyloris wins painkiller approval amidst amplified anti-opioid efforts

Pharmaceutical Technology

The FDA approved Hyloris’s non-opioid painkiller as the agency increases efforts to mitigate an opioid crisis.

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Antidepressants Can Take Weeks to Work, And We Finally Know Why

AuroBlog - Aurous Healthcare Clinical Trials blog

The most widely prescribed class of antidepressant has – at long last – been shown to increase connections in the human brain. The discovery offers a plausible biological explanation for the medication’s delayed treatment response and could help develop new targeted treatments.

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October 18, 2023: In This Friday’s PCT Grand Rounds, Ending Hepatitis C in the United States

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Rachael Fleurence of the NIH and Joshua Sharfstein of Johns Hopkins University will present “A National Initiative to Eliminate Hepatitis C in the United States – Why This Matters to Clinical Trialists.” The Grand Rounds session will be held on Friday, October 20, 2023, at 1:00 pm eastern. Fleurence is a senior advisor at the NIH.

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BrainStorm, after setbacks, withdraws approval application for ALS drug

Bio Pharma Dive

A panel of FDA advisers last month found BrainStorm’s data unconvincing. The company now says a Phase 3b study will be needed for its NurOwn cell therapy to have a shot at an approval.

Drugs 284
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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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Lisata receives orphan drug designation for pancreatic cancer therapy

Pharmaceutical Technology

Lisata has received orphan drug designation from the EMA's Committee for Orphan Medicinal Products for LSTA1 to treat pancreatic cancer.

Drugs 286
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World-First Study Finds Immune Cells Crucial to Stopping Bowel Cancer

AuroBlog - Aurous Healthcare Clinical Trials blog

In a medical first, scientists have hindered the growth of bowel cancers in mice by harnessing immune cells in the large intestine. One of the most exciting new cancer treatments is immunotherapy, which works by training the body’s immune system to identify and destroy cancer cells.

Scientist 186
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With COVID sales in free-fall, Pfizer slashes revenue forecast by $9B and preps for major cost cuts

Fierce Pharma

As the coronavirus outbreak has shifted to the endemic phase, drugmakers have warned of a drop in demand for COVID-19 products, with the impact coming into focus during the fall vaccination season. | Pfizer has slashed its 2023 revenue projection by $9 billion because of declining demand for COVID products. The company now expects sales to reach between $58 billion and $61 billion, down from a prior range of $67 billion to $70 billion.

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With $56M, a Mayo Clinic-backed startup takes aim at radiopharmaceutical roadblocks

Bio Pharma Dive

Nucleus RadioPharma, a contract developer and manufacturer, is expanding at a time when investment is pouring into the radiopharmaceutical drug field.

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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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AI startup Leucine raises $7m for drug manufacturing digital twin platform

Pharmaceutical Technology

As AI applications in drug manufacturing widen, Leucine’s digital twin of the shop floor helps automate compliance and improve safety.

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Spicy Food Can Be Extremely Painful, But Is It Actually Dangerous?

AuroBlog - Aurous Healthcare Clinical Trials blog

Everyone has a different tolerance for spicy food — some love the burn, while others can’t take the heat. But the scientific consensus on whether spicy food can have an effect — positive or negative — on your health is pretty mixed.

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Merck’s Keytruda wins coveted FDA nod around surgery for early lung cancer—with a surprise

Fierce Pharma

Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery. | Thanks to a new FDA approval for Merck's Keytruda, a continuous immunotherapy regimen around surgery is now available for patients with early-stage non-small cell lung cancer. The drug's label already includes an overall survival win from a key trial.

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The top biopharma conferences in 2024

Bio Pharma Dive

A few key meetings remain this year, like ESMO and ASH, while next year’s events are already being planned. Here’s a list of conferences to keep in mind.

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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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Pfizer and BioNTech face 2023 revenue hits amid Covid product write-offs

Pharmaceutical Technology

Pfizer is launching a $3.5bn cost-saving programme and BioNTech expects 2023 revenues to decrease as demand for Covid treatments wanes.

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‘Long Cold’: A Hidden Form of Chronic Sickness Has Just Been Identified

AuroBlog - Aurous Healthcare Clinical Trials blog

At least 10% of people infected with SARS-CoV-2, the virus that causes COVID, have symptoms that last more than four weeks after the infection.

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Health Literacy Month: How industry communication can impact patient health literacy

Antidote

Since 1999, October has been designated as Health Literacy Month , a month dedicated to promoting patient-centricity in healthcare communications across the industry. Health literacy refers to a person’s ability to find, understand, and use health-related services and make informed decisions for themselves and others.

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Merck cancer drug deal caps pharma investment influx into ‘ADC’ field

Bio Pharma Dive

With the alliance, Merck joins Pfizer, AstraZeneca and Gilead in staking major bets on the potential for antibody-drug conjugates to reshape cancer treatment.

Drugs 273
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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NVIDIA banks on generative AI to pursue partnerships with biotechs

Pharmaceutical Technology

NVIDIA’s vice-president of healthcare, Kimberly Powell, discussed GenAI in pharma and the importance of partnerships.

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AI/ML-enabled Medical Devices Have Everyone’s Attention, Including FDA’s

FDA Law Blog

By Gail H. Javitt & Steven J. Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. The first article—“Is the Eye the Window to Alzheimer’s?

Radiology 119
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Podcast: The British start-up taking psychedelic therapy mainstream

BioPharma Reporter

In our first podcast interview of 2023, BioPharma Reporter spoke with Dr Sarah Bateup, therapy lead at Clerkenwell Health, about the potential of psychedelic medicine and her work within the psychedelic therapy training space.

Medicine 119
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Novo’s Uli Stilz on biotech innovation and the future of diabetes drugs

Bio Pharma Dive

The Danish drugmaker's innovation hub in Boston has teamed up with the Broad Institute, Mass General Brigham, Harvard and Yale, expanding its research into cardiometabolic diseases.

Drugs 190
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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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Ardelyx wins FDA approval for phosphate absorption inhibitor

Pharmaceutical Technology

The company also secured $50m in debt financing to support the commercial launch of Xphozah in November 2023.

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UCL study suggests changes to improve MRI scans for prostate cancer

Pharma Times

The research aims to make MRIs more available to men and improve treatment decisions - News - PharmaTimes

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ESMO: Seagen, Astellas and Merck knock it out of the park with Padcev-Keytruda combo in bladder cancer

Fierce Pharma

Editor's Note: Please check back on Oct. 22 when the full data of EV-302 are presented at ESMO 2023. | The results are in for a phase 3 bladder cancer trial assessing the combination of Seagen and Astellas' Padcev, plus Merck's Keytruda, versus standard of care chemotherapy. The figures indicate that the combo can be transformative in the indication.

Trials 119
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Roche is stuck on molecular glue

Bio Pharma Dive

One month after Roche’s Genentech inked a similar deal, the Swiss pharma is now paying $50 million to work with Monte Rosa on molecular glue medicines for cancer and neurological diseases.

Medicine 157
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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.