Bio Pharma Dive
MAY 20, 2024
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.
Pharmaceutical Technology
MAY 20, 2024
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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pharmaphorum
MAY 21, 2024
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.
BioSpace
MAY 20, 2024
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.
Drug Patent Watch
MAY 21, 2024
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.
Pharma Times
MAY 20, 2024
Globally affecting 4% of the population, autoimmune diseases mistakenly attack healthy cells, tissues and organs in the body
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Rethinking Clinical Trials
MAY 22, 2024
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.
Bio Pharma Dive
MAY 23, 2024
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.
Pharmaceutical Technology
MAY 23, 2024
AstraZeneca has entered into a worldwide licence and option agreement with Nona Biosciences for a preclinical monoclonal antibody.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 21, 2024
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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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Fierce Pharma
MAY 23, 2024
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.
Bio Pharma Dive
MAY 23, 2024
Clinical trial abstracts posted by ASCO Thursday give a peek at anticipated datasets from Immunocore, Merck & Co., J&J and Arcus Biosciences.
Pharmaceutical Technology
MAY 22, 2024
As the nitrosamine scandal continues, we explore the advancements in parenteral packaging materials that are reducing the risk of this contaminant in modern injectables.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 23, 2024
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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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.
Fierce Pharma
MAY 24, 2024
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
Bio Pharma Dive
MAY 24, 2024
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.
Pharmaceutical Technology
MAY 24, 2024
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 22, 2024
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.
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.
Pharma Times
MAY 23, 2024
High-grade gliomas are rare, malignant tumours which account for up to 12% of all childhood brain tumours
Bio Pharma Dive
MAY 23, 2024
The findings, from two trials involving tens of thousands of women, could influence guidelines around the use of hormonal treatment for menopausal symptoms.
Pharmaceutical Technology
MAY 23, 2024
Merck KGaA’s MilliporeSigma has entered a definitive agreement for the acquisition of Mirus Bio in a deal totaling $600m (€500m).
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 19, 2024
Different types of brain cells could age at different speeds, and that may help explain the development of Alzheimer’s disease.
BioSpace
MAY 21, 2024
Despite weathering a difficult year, biopharma continues to see massive pay gaps between CEOs and their median employees, with top executives often earning hundreds of times more.
Bio Pharma Dive
MAY 21, 2024
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.
Pharmaceutical Technology
MAY 20, 2024
A recent study in England has shown that the HPV vaccine in teenagers reduced the rate of cervical cancer by up to 85%.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 22, 2024
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.
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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.
BioSpace
MAY 22, 2024
Amid its ongoing efforts to trim $4 billion in spending in 2024, Pfizer in an SEC filing on Wednesday said it is looking to save an additional $1.5 billion over the next several years.
Bio Pharma Dive
MAY 21, 2024
Since pivoting from oncology, the startup has raised close to $300 million and advanced an ulcerative colitis drug into mid-stage testing.
Pharmaceutical Technology
MAY 21, 2024
Roche announced an FDA breakthrough therapy designation for its inavolisib/Ibrance combination therapy.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 23, 2024
The Central Drugs Standard Control Organisation (CDSCO) has requested all stakeholders in the medical devices sector to deposit the requisite fee for retention of license or registration certificate under the Medical Devices Rules (MDR), 2017, well before the stipulated timeline in order to avoid cancellation of the approvals.
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