Bio Pharma Dive
JUNE 26, 2024
The findings provide early proof that multiple doses of a gene editing medicine can be safely administered with additive effects, overcoming a key constraint of the complex therapies.
Pharmaceutical Technology
JUNE 26, 2024
AstraZeneca has received Japanese approval for Tagrisso plus chemotherapy as first-line treatment for non-small cell lung cancer (NSCLC).
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AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 20, 2024
(VioletaStoimenova/Getty Images) To better treat and prevent depression, we need to understand more about the brains and bodies in which it occurs. Curiously, a handful of studies have identified links between depressive symptoms and body temperature, yet their small sample sizes have left too much room for doubt.
Rethinking Clinical Trials
JUNE 24, 2024
Dr. Margaret Kuklinski and Dr. Stacy Sterling In an analysis of behavioral health data from the GGC4H study, researchers observed a significant increase in the rate of depression among early adolescents during the first year of the COVID-19 pandemic in the United States. The results extend findings on adolescent mental health during the pandemic to younger adolescents, a relatively understudied population.
Fierce Pharma
JUNE 20, 2024
For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. | For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. For Gilead, it serves as one of two pieces for a potential FDA filing. For GSK, it means a major competitor could be looming around the corner.
Bio Pharma Dive
JUNE 21, 2024
Peter Marks’ decision to override the objections of agency staff and broaden use of Elevidys could have a “lasting impact” on gene therapy as well as the FDA, one analyst wrote.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 24, 2024
For many, catching SARS-CoV-2 means an unpleasant few weeks of aches, coughs, and fatigue. In roughly one in every five cases, however, the discomfort endures for months on end. What puts some individuals at greater risk of an acute infection lingering as long COVID has been far from clear.
Rethinking Clinical Trials
JUNE 26, 2024
Dr. Fatima Mirza In this Friday’s PCT Grand Rounds, Fatima Mirza of the Warren Alpert Medical School of Brown University will present “Using ChatGPT to Facilitate Truly Informed Medical Consent.” The Grand Rounds session will be held on Friday, June 28, 2024, at 1:00 pm eastern. Mirza is chief resident in the Department of Dermatology at the Warren Alpert Medical School of Brown University.
pharmaphorum
JUNE 24, 2024
Explore how digital twins are transforming healthcare and drug discovery, with success stories showcasing their impact in the biopharma industry. Learn about their journey from concept to real-world applications.
Bio Pharma Dive
JUNE 20, 2024
The agency has lifted a partial trial suspension based on one-year data showing PTC’s pill suppressed a key protein associated with the disorder.
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Pharmaceutical Technology
JUNE 25, 2024
Novo Nordisk has unveiled a significant investment plan, committing $4.1bn to construct a second fill and finishing facility in Clayton.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 25, 2024
Artificial intelligence (AI) is transforming healthcare customer experience as healthcare organisations are uniquely challenged to provide great customer service in stressful and highly personal situations, says Vasudeva Rao Munnaluri, regional vice president (RVP) for India & SAARC at Zendesk while discussing the role of AI in healthcare customer experience (CX) and the unique challenges faced […]
Fierce Pharma
JUNE 24, 2024
After losing round one of its respiratory syncytial virus (RSV) vaccine bout with GSK, Pfizer is rallying. | After losing round one of its respiratory syncytial virus (RSV) vaccine bout with GSK, Pfizer is rallying. And what better way to do it than to win a major contract in your rival’s home country? The U.K. government has selected Pfizer to supply 5 million doses of its RSV shot Abrysvo over the next two years.
BioSpace
JUNE 24, 2024
If approved, ensifentrine would be the first non-steroidal, anti-inflammatory drug for patients with chronic obstructive pulmonary disease, offering an option with potentially fewer side effects.
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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.
Bio Pharma Dive
JUNE 20, 2024
Researchers recommended Gilead end testing early as lenacapavir proved 100% effective in protecting cisgender women in the Phase 3 trial.
Pharmaceutical Technology
JUNE 24, 2024
Big pharma and their packaging partners are collaborating to cut emissions and deliver more sustainable solutions for injectables.
pharmaphorum
JUNE 23, 2024
Netherlands biotech Argenx has a second FDA approval for its FcRn inhibitor Vyvgart Hytrulo, adding a new indication in chronic inflammatory demyelinating polyneuropathy (CIDP) for a drug that it hopes could find a use in more than a dozen diseases.
Fierce Pharma
JUNE 25, 2024
A little over a year after being slapped with an FDA rejection, AbbVie has hit another regulatory wall in its bid to debut a more convenient Parkinson’s disease successor to its established fo | A little over a year after being slapped with an FDA rejection, AbbVie has hit another regulatory wall in its bid to debut a more convenient Parkinson’s disease successor to its established formulation of carbidopa and levodopa.
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.
BioSpace
JUNE 20, 2024
While Thursday’s label expansion and traditional approval for the gene therapy is an important milestone, many challenges still face the Duchenne muscular dystrophy community.
Bio Pharma Dive
JUNE 20, 2024
Interim study data suggest the Danish drugmaker can remain in the race to develop new kinds of weight loss drugs as doctors seek alternatives to the now dominant GLP-1s.
Pharmaceutical Technology
JUNE 21, 2024
Trial investigators anticipate that the FDA will decide on approval for linvoseltamab in relapsed/refractory multiple myeloma by the end of 2024.
Drug Patent Watch
JUNE 25, 2024
DrugChatter is an innovative AI-powered search and answer engine designed to revolutionize how we access and comprehend information. Harnessing the power of advanced natural language processing, DrugChatter provides concise, accurate, and contextually relevant answers to a wide array of questions, making information retrieval faster and more intuitive than ever before.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Fierce Pharma
JUNE 24, 2024
In one of the most closely watched biotech trial readouts of the year, Alnylam Pharmaceuticals said its RNA interference drug reduced the risk of death or recurrent cardiovascular events in patient | In one of the most closely watched biotech trial readouts of the year, Alnylam Pharmaceuticals said its RNA interference drug reduced the risk of death or recurrent cardiovascular events.
BioSpace
JUNE 24, 2024
Merck KGaA’s drug candidate xevinapant in a late-stage trial was unable to significantly improve event-free survival in patients with locally advanced head and neck cancer.
Bio Pharma Dive
JUNE 26, 2024
Obesity drugs like Wegovy are proving useful in many other diseases. Polycystic ovary syndrome, a chronic condition that can cause infertility, may be one.
Pharmaceutical Technology
JUNE 21, 2024
Both Novo Nordisk and Eli Lilly have filed lawsuits against unapproved sellers of their diabetes and weight loss drugs.
Drug Patent Watch
JUNE 24, 2024
The 505(b)(2) regulatory pathway provides an attractive avenue for drug developers to bring new products to market by leveraging existing data on approved drugs. This pathway allows modifications and improvements to be made to existing drugs, while potentially reducing development costs and timelines compared to the traditional new drug application (NDA) route.
Fierce Pharma
JUNE 25, 2024
On the market for three years in China, Novo Nordisk’s diabetes drug Ozempic (semaglutide) is racing toward blockbuster sales in the world’s second most populous country. | China’s National Medical Products Administration (NMPA) has blessed Novo Nordisk's Wegovy with marketing approval to treat people with a body mass index (BMI) of at least 30 or between 27 and 30 for those with one weight-related risk factor.
BioSpace
JUNE 20, 2024
Jazz Pharmaceuticals’ calcium channel modulator suvecaltamide in a mid-stage trial was unable to significantly lower tremor burden in patients with essential tremor, the company reported Thursday.
Bio Pharma Dive
JUNE 20, 2024
The decision makes Elevidys available to Duchenne patients at least 4 years of age, despite mixed trial results that have led to skepticism about its effectiveness.
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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.
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