Drug Discovery World

JULY 13, 2023

Following the death of a cancer patient after they were given an unlicensed drug, Diana Spencer unpacks the practice of prescribing unlicensed and off-label medicines. This month, a cancer patient died and three others were hospitalised in the UK after they were administered an unlicensed version of the chemotherapy drug cabazitaxel. In a statement, the company at fault claimed the problem was caused by an issue at its medicines manufacturing unit.

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Drugs Medicine Regulation Licensing 94

Bio Pharma Dive

JULY 13, 2023

The oral contraceptive’s maker, Perrigo, said the pill will be available in drug and grocery stores early next year, but did not disclose its planned price.

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Drugs 246

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 11, 2023

Being surrounded by people who don’t see the world quite like you do increases your risk of feeling lonely, even if you’re friends with them. Neuroimaging tests on 66 young adults discovered significant contrasts in the way lonely people’s brains process information compared to their peers.

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Pharmaceutical Technology

JULY 12, 2023

To that end, the company presented positive top-line Phase III results for its once-daily stimulant for ADHD.

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FDA Approval 245

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Clinical Supply

Pharmaceutical Technology

JULY 13, 2023

The company aims to start two trials in H1 2024 based on its current timeline, depending on if it closes its Series B round soon.

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Trials 130

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 9, 2023

Finding new drugs – called “drug discovery” – is an expensive and time-consuming task. But a type of artificial intelligence called machine learning can massively accelerate the process and do the job for a fraction of the price.

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Drugs Clinical Trials Clinical Trials Clinical Research 202

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 12, 2023

Researchers in Japan found a connection between tooth loss, gum disease, and shrinkage in a region of the brain involved in memory and Alzheimer’s disease called the hippocampus.

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Bio Pharma Dive

JULY 12, 2023

Backed by F-Prime Capital and Sofinnova Partners, the company claims to have technology that could allow it replace eye cells destroyed in age-related and inherited ocular conditions.

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Pharmaceutical Technology

JULY 13, 2023

NVIDIA signed an investment and collaboration agreement with Recursion to create AI models to accelerate drug discovery.

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Drugs 246

Rethinking Clinical Trials

JULY 13, 2023

Dr. Adrian Hernandez At the NIH Pragmatic Trials Collaboratory Steering Committee Meeting in May, we interviewed Dr. Adrian Hernandez about how to better promote data sharing. Hernandez is a co–principal investigator of the program’s Coordinating Center and the executive director of the Duke Clinical Research Institute. “We have to change the incentive structure because we still have barriers for sharing data.

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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

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 13, 2023

The world changed for all of us when we were suddenly plunged into a pandemic in 2020. COVID sent us into a series of lockdowns in a bid to control the spread of the virus until a vaccine could be developed.

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Development Vaccination Vaccine Clinical Trials 188

Bio Pharma Dive

JULY 10, 2023

Three reports from Iceland spurred the EMA to evaluate whether certain Novo Nordisk drugs, including Ozempic, might cause thoughts of self harm.

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Regulation Drugs 280

Pharmaceutical Technology

JULY 12, 2023

Innovate UK’s New Cancer Therapeutics programme awarded the grant to the Imperial College spinout to support pre-clinical development.

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Clinical Development Development 243

Rethinking Clinical Trials

JULY 12, 2023

Dr. Stephanie Morain At the NIH Pragmatic Trials Collaboratory Steering Committee’s annual meeting in May, Dr. Stephanie Morain discussed the results of a recent bioethics initiative to explore ethical considerations for data sharing in the context of pragmatic clinical trials. The project was supported by a supplemental grant award from the NIH through the NIH HEAL Initiative.

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Trials Clinical Trials Clinical Trials Research 130

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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

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 9, 2023

Karnataka government has given a booster shot to health & startups in lifesciences with focus on infrastructure and innovation. Announcing an allocation of Rs. 14,950,496 crore for healthcare, state has called for the re-introduction of Yashashwini scheme to provide medical facilities to rural farmers with a grant of Rs. 300 crore.

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Clinical Trials Clinical Trials Clinical Research Trials 159

Bio Pharma Dive

JULY 12, 2023

The decision to explore “strategic alternatives” comes about six weeks after the company sold its most advanced treatment to Novartis for nearly $90 million.

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Gene Therapy Sales Gene Research 246

Pharmaceutical Technology

JULY 12, 2023

The EMA is reviewing data on the potential effects of high-profile GLP-1RAs in causing suicidal thoughts and thoughts of self-harm.

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Drugs 242

Fierce Pharma

JULY 11, 2023

Caught in a litigation crossfire, Moderna has reportedly opened two new fronts in its COVID-19 vaccine patent war with Pfizer and BioNTech. | Moderna has lodged two new lawsuits at the High Court in Dublin, Ireland, and the Brussels Commercial Court in Belgium, Juve Patent first reported. This adds to a complex web of ongoing mRNA patent litigation.

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Vaccination Vaccine 138

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.

Clinical Research

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 10, 2023

As most new parents can attest, sleepless nights don’t exactly make for the most cheerful mornings. This is why it makes little sense that total sleep deprivation temporarily resets the mood of nearly half of people with a major depressive disorder.

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Clinical Trials Clinical Trials Trials 156

Bio Pharma Dive

JULY 12, 2023

The European drug regulator says it now has 150 reports of possible cases involving self-injury and suicidal thoughts among people taking GLP-1 medicines like Ozempic.

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Drugs Regulation Medicine 245

Pharmaceutical Technology

JULY 11, 2023

Iovance Biotherapeutics completes a preliminary analysis after the US' FDA found the trial design acceptable for accelerated approval.

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Trials 189

Fierce Pharma

JULY 10, 2023

Two cases of suicidal thoughts and one case of self-harm from users in Iceland of Novo Nordisk’s diabetes and obesity drugs have prompted the European Medicines Agency (EMA) to review the blockbust | Two cases of suicidal thoughts and one case of self-harm from users in Iceland of Novo Nordisk’s diabetes and obesity drugs have prompted the European Medicines Agency (EMA) to review the blockbuster products.

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Drugs Regulation Medicine Production 123

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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

Antidote

JULY 14, 2023

For medical research to advance, the participation of individuals in a clinical trial is essential. However, accessing trial sites can present an undue burden. A survey about barriers to clinical trial participation found that the primary reason patients declined to enroll in a study was due to the inconvenience associated with travel. This is backed up by research from Deloitte, which reveals that 70% of potential clinical trial participants in the United States live at least two hours away fro

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Clinical Trials Clinical Trials Trials Research 98

Bio Pharma Dive

JULY 14, 2023

The pharma will pay up to $1.9 billion to acquire the private biotech and its experimental antibody, which Lilly plans to pair with its own weight loss medicines.

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Antibody Drugs Medicine 246

Pharmaceutical Technology

JULY 11, 2023

Study shows patients taking abatacept, cenicriviroc, or Remicade in addition to SOC do not recover quicker compared to placebo.

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Drugs 186

Pharmaceutical Commerce

JULY 11, 2023

The National Alliance of Healthcare Purchaser Coalitions releases resources for employers/health plan purchasers to offer insights on PBMs role in high prescription drug costs.

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Drugs 98

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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

XTalks

JULY 13, 2023

Diagnostic test maker Quanterix has launched LucentAD, a biomarker-based prescription Alzheimer’s disease (AD) test to help in the diagnosis of the disease. The test is intended to help diagnose Alzheimer’s disease with other diagnostic tools. It is not intended as a standalone screening or diagnostic assay, according to Quanterix. LucentAD is designed to evaluate patients experiencing cognitive symptoms that indicate early signs of Alzheimer’s disease.

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Protein FDA Approval Clinical Trials Clinical Trials 98

Bio Pharma Dive

JULY 11, 2023

While the shot is approved in the EU, Takeda wasn’t able to address data collection issues raised by the US regulator in its current review cycle.

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FDA Approval Vaccination Vaccine Regulation 246

Pharmaceutical Technology

JULY 14, 2023

Vistagen has received a Canadian Notice of Allowance for patent that is related to the use of AV-101 in Parkinson's disease (PD) patients.

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Pharma Marketing Network

JULY 13, 2023

When it comes to marketing your pharma business on Facebook, you may be wondering whether you should boost a post or create an ad. Both have their own advantages and disadvantages, so it’s important to choose the right option for your needs. Boosting a post is a quick and easy way to get more exposure for your content. When you boost a post, you’re essentially paying to increase its reach and visibility.

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Marketing Branding Sales 98

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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.

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