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After the FDA released draft guidance on increasing diversity in clinical trials, companies have been left to figure out the details.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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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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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.

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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.

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More Trending

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mRNA Drugs: Pros, Cons, and Prospects

Pharma Mirror

by Carrie Taylor, Director of Research & Development of BOCSCI. Globally, the COVID-19 pandemic has significantly accelerated the development of mRNA technology platforms and mRNA industry chains. The first mRNA drug (BNT162b2 vaccine) was granted emergency use authorization by the FDA in December 2020 and approved for marketing in August 2021. mRNA drugs mRNA drugs encode mRNA based on the selection of targets or antigens and enter the cytoplasm through specific delivery systems (such as LN

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

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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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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.

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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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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 290
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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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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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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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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.

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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 278
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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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Parkinson’s UK grants £400,000 to research projects in Scotland

Pharma Times

The two projects will investigate the potential causes of Parkinson’s disease - News - PharmaTimes

Research 147
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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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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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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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New £30m initiative launched to support innovation against antimicrobial resistance

Pharma Times

Global innovators can apply to PACE to receive up to £1m per project - News - PharmaTimes

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EC expands Takeda’s Adcetris label for advanced Hodgkin lymphoma treatment

Pharmaceutical Technology

Adcetris/AVD is already approved as a first-line treatment for patients with CD30+ Stage IV Hodgkin lymphoma.

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Indian Pharmacopoeia Commission becomes member of Pharmacopoeial Discussion Group

AuroBlog - Aurous Healthcare Clinical Trials blog

The Pharmacopoeial Discussion Group (PDG), with the Pharmacopoeia Commissions from US, Europe and Japan as members to harmonise pharmacopeial standards globally, has announced the Indian Pharmacopoeia Commission (IPC) as a PDG member.

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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 195
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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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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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NIPER underscores applications of AI in pharma research to enable faster, cost-effective drug discovery

AuroBlog - Aurous Healthcare Clinical Trials blog

The National Institute of Pharmaceutical Education and Research (NIPER) has underlined indispensability of artificial intelligence in pharmaceutical research. The applications of AI have enabled faster, more cost-effective, and data-driven approaches across the drug discovery and development lifecycle.

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J&J again bumps forecasts on strong immune drug sales

Bio Pharma Dive

Tuesday’s earnings were the first since J&J officially split off its consumer drug business, now the publicly traded company Kenvue.

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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.