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

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Understanding of effects of microplastics on human health urgently needed: Expert

AuroBlog - Aurous Healthcare Clinical Trials blog

Understanding of the effects of microplastics on human health is urgently needed, according to Dr. LeepikaParulekar, consultant, general medicine, Holy Family Hospital, Mumbai. Dr. Parulekar further explained that the health risks of exposure to micro plastics are just beginning to be understood.

Medicine 134
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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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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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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 99
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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 95

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Advent of decentralised clinical trials spurs need for robust rules like USFDA’s Cancer Clinical Trial Eligibility Criteria

AuroBlog - Aurous Healthcare Clinical Trials blog

As India sees the emergence of decentralised clinical trials driven by digital health technologies remote patient monitoring, Electronic Health Records andpatient data capture, it also sees robust rules like the US FDA’s Cancer Clinical Trial Eligibility Criteria as an advantage.

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

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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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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 206
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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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Lilly to pour $5B more into expanding Zepbound, Mounjaro production

Bio Pharma Dive

The planned spending on new facilities in Lebanon, Indiana, brings its total commitment to the site to $9 billion, the largest single manufactuing investment in company history.

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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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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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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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King’s Doctoral Training Centre to investigate MS symptom management

Pharma Times

The lifelong autoimmune disease affects more than 150,000 people living in the UK

Doctors 149
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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 302
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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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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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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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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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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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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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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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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 181
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Vicore and Endeavor’s therapies show promise in treating IPF

Pharma Times

Both drugs have the potential to offer a disease-modifying approach to the lung disease

Drugs 139
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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 297
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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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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 162
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UK MRC and AstraZeneca partner for translational clinical research

Pharma Times

The partnership will provide six MRC clinical fellows with industry placement opportunities

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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 290
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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.