Sat.May 18, 2024 - Fri.May 24, 2024

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Therapies designed to dismantle cancer’s escape mechanisms show promise for patients

Bio Pharma Dive

Hear from IO Biotech CEO Dr. Mai-Britt Zocca about the potential of therapeutic vaccines to strip the defenses used by cancer cells to keep the immune system at bay.

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Final report says UK infected blood scandal “should have been avoided”  

Pharmaceutical Technology

Nearly 30,000 people, including children in clinical trials, were infected with hepatitis C and HIV from contaminated blood products in the 1970s and 1980s.

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FDA competition seeks digital endpoints for Parkinson’s

pharmaphorum

FDA is asking artificial intelligence teams to develop a digital endpoint tool to study freezing of gait, a symptom of Parkinson’s that can have a serious impact on patients.

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Sanofi, Regeneron Post Strong Phase III COPD Data for Dupixent as FDA Decision Looms

BioSpace

Late-stage results from the NOTUS trial showed Sanofi and Regeneron’s Dupixent lowered moderate to severe chronic obstructive pulmonary disease exacerbations by 34% and led to significantly better lung function.

Trials 116
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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New patent for Merck Sharp drug BELSOMRA

Drug Patent Watch

Annual Drug Patent Expirations for BELSOMRA Belsomra is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from one supplier.

Drugs 105
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KCL researchers identify key features of autoimmune diseases present in the gut

Pharma Times

Globally affecting 4% of the population, autoimmune diseases mistakenly attack healthy cells, tissues and organs in the body

Research 105

More Trending

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AstraZeneca, on fast track of growth, sets revenue target at $80B by 2030

Fierce Pharma

A decade ago, with AstraZeneca in decline and some investors urging the drugmaker to sell out to Pfizer, new CEO Pascal Soriot presented an audacious plan to hike revenue to $45 billion by 2023. | After AstraZeneca achieved Pascal Soriot's ambitious $45-billion-by-2023 revenue goal, the CEO is thinking big again. On Tuesday morning, AZ unveiled its new plan to swell its revenue to $80 billion by 2030.

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May 22, 2024: In TSOS Study, Clinical and Demographic Characteristics Predict Response to PTSD Interventions

Rethinking Clinical Trials

Dr. Doug Zatzick In a secondary analysis of data from the TSOS study pooled with data from 2 other comparative effectiveness trials, baseline patient clinical and demographic characteristics were associated with persistent symptoms of posttraumatic stress disorder (PTSD) symptoms and diminished treatment response. The report was published online ahead of print in Psychiatry.

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Orna, a circular RNA specialist, acquires a buzzy startup

Bio Pharma Dive

After laying off staff late last year, Orna is expanding through the purchase of ReNAgade Therapeutics, which was built around technology designed to more effectively deliver RNA-based medicines.

RNA 294
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AstraZeneca and Nona Biosciences sign agreement for monoclonal antibody

Pharmaceutical Technology

AstraZeneca has entered into a worldwide licence and option agreement with Nona Biosciences for a preclinical monoclonal antibody.

Antibody 288
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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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Eerie Personality Changes Sometimes Happen After Organ Transplants

AuroBlog - Aurous Healthcare Clinical Trials blog

The idea that the heart contains the very ‘essence’ of a person might be more than just a spiritual concept. Ever since the first human heart transplants back in 1967, patients have reported, often reluctantly, some eerie and inexplicable changes to their personalities.

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Researchers combine herpes virus with cancer vaccine to treat brain cancer in children

Pharma Times

High-grade gliomas are rare, malignant tumours which account for up to 12% of all childhood brain tumours

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ASCO24: An early look at cancer drug study results

Bio Pharma Dive

Clinical trial abstracts posted by ASCO Thursday give a peek at anticipated datasets from Immunocore, Merck & Co., J&J and Arcus Biosciences.

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No nitrosamines: How parenteral packaging is evolving to meet today’s E&L challenges

Pharmaceutical Technology

As the nitrosamine scandal continues, we explore the advancements in parenteral packaging materials that are reducing the risk of this contaminant in modern injectables.

Packaging 243
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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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Ozempic Could Be Good For Your Heart Even If You Don’t Lose Weight

AuroBlog - Aurous Healthcare Clinical Trials blog

The medicine behind Ozempic and Wegovy, called semaglutide, could have significant benefits for heart health, reducing the risk of stroke or cardiac arrest even in those who don’t lose weight. The data comes from the largest and longest clinical trial on semaglutide use amongst those without diabetes, called the Semaglutide and Cardiovascular Outcomes (SELECT) trial.

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At long last, AstraZeneca, Pfizer, J&J, Roche and others have an ally in Biden

Fierce Pharma

Over the last four years, with President Joe Biden milking a popular cause as an opponent of Big Pharma drug pricing, the industry has rarely seen good news coming from the White House. | Over the last four years, with President Joe Biden milking a popular cause as an opponent of Big Pharma's pricing, the industry has rarely seen good news coming from the White House.

Drugs 124
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With Duchenne decision ahead, FDA’s Marks pushes for speedy gene therapy approvals

Bio Pharma Dive

But the head of the FDA’s CBER office didn’t tip where the agency stands on potentially broadening use of Sarepta’s Duchenne gene therapy Elevidys.

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FDA advisory committee reviews Novo Nordisk insulin icodec for T1D

Pharmaceutical Technology

The US FDA's EMDAC is set to hold a meeting to assess the benefit-risk profile of Novo Nordisk's insulin icodec, to treat type 1 diabetes.

Insulin 246
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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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Scientists Warn Brain Diseases Are Getting Worse as Climate Change Intensifies

AuroBlog - Aurous Healthcare Clinical Trials blog

Climate change is making the symptoms of certain brain conditions worse, our new review has found. Conditions that can worsen as temperature and humidity rise include stroke, migraines, meningitis, epilepsy, multiple sclerosis, schizophrenia, Alzheimer’s disease and Parkinson’s.

Scientist 193
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Latest Ozempic results 'move the needle' for treating patients with diabetes, chronic kidney disease: Novo exec

Fierce Pharma

While it’s hard to overstate the success Novo Nordisk’s GLP-1 franchise has already achieved, the company’s latest deep dive into semaglutide data in chronic kidney disease (CKD) could help set a n | Early Friday, Novo shared full, positive results from the FLOW trial assessing the ability of once-weekly semaglutide 1.0 mg to help combat major kidney outcomes such as kidney failure, loss of kidney function and death from kidney or cardiovascular causes in people with Type 2 diabetes and chronic

Trials 123
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Certain menopausal hormone therapy could raise ovarian cancer risk, study finds

Bio Pharma Dive

The findings, from two trials involving tens of thousands of women, could influence guidelines around the use of hormonal treatment for menopausal symptoms.

Hormones 286
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Merck’s MilliporeSigma agrees to acquire Mirus Bio for $600m

Pharmaceutical Technology

Merck KGaA’s MilliporeSigma has entered a definitive agreement for the acquisition of Mirus Bio in a deal totaling $600m (€500m).

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Alzheimer’s Could Be Caused by Brain Cells That Age Too Fast

AuroBlog - Aurous Healthcare Clinical Trials blog

Different types of brain cells could age at different speeds, and that may help explain the development of Alzheimer’s disease.

Engineer 219
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Unlocking biotech insights: Top 10 podcasts you need to listen to

pharmaphorum

Unlocking biotech insights: discover the latest advancements in biotech with our top picks for podcasts. Stay informed and up-to-date with industry trends and news by listening to some of the best biotech podcasts featuring expert analysis, discussions of ethical issues, and interviews with industry leaders.

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AstraZeneca sets sights on $80B in revenue by 2030

Bio Pharma Dive

The U.K. pharma expects to launch 20 new drugs by then, among them complex medicines for cancer as well as treatments for weight loss.

Medicine 298
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Cervical cancer elimination in the UK is within sight with HPV vaccine

Pharmaceutical Technology

A recent study in England has shown that the HPV vaccine in teenagers reduced the rate of cervical cancer by up to 85%.

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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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CDSCO calls for timely reporting of adverse events related to medical devices to MvPI

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has requested stakeholders to take appropriate action for timely reporting of adverse events related to medical devices to the Materiovigilance Programme of India (MvPI), in the backdrop of shifting the segment to licensing regime.

In-Vitro 172
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Big Pharma Layoffs by the Thousands: Are Bayer and BMS Harbingers of More?

BioSpace

Patent cliffs and other factors may lead other large drugmakers to embrace similar cost-cutting measures, experts tell BioSpace.

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AltruBio lands up to $225M after shift to immune drug research

Bio Pharma Dive

Since pivoting from oncology, the startup has raised close to $300 million and advanced an ulcerative colitis drug into mid-stage testing.

Drugs 278
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Roche’s PI3K inhibitor secures breakthrough status in breast cancer

Pharmaceutical Technology

Roche announced an FDA breakthrough therapy designation for its inavolisib/Ibrance combination therapy.

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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.