Bio Pharma Dive
APRIL 30, 2024
Supply continues to be tight, however, and the company anticipates further sales growth to be limited by how quickly it can bring on additional production capacity.
Pharmaceutical Technology
APRIL 30, 2024
Dengue fever is now found in over 120 countries compared to nine that experienced severe epidemics in the 1970s given the spread of infectious diseases due to climate change.
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Pharmaceutical Technology
APRIL 28, 2024
Artificial intelligence tools can be used for infection control through facial recognition systems designed to identify proper face mask use within hospitals.
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 29, 2024
A unique genetic mutation in two siblings – that has never been seen in anyone else – has been discovered by UK researchers at the University of Exeter, pointing the way towards new treatment options for type 1 diabetes.
BioSpace
APRIL 28, 2024
As the Phase III amyotrophic lateral sclerosis pipeline thins out, the ALS community is placing its hopes on earlier-stage trials sponsored by Denali Therapeutics, PTC Therapeutics and more.
pharmaphorum
APRIL 30, 2024
California will start selling its own generic of overdose reversal agent naloxone in another example of the use of government-level purchasing power to reduce drug prices
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
APRIL 24, 2024
Pfizer and its Germany partner BioNTech have urged London’s High Court to invalidate competitor Moderna's patents over technology instrumental in the Covid-19 vaccines development as the latest phase of a global legal fight that started yesterday (23 April), reported Reuters.
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 29, 2024
Clinical trial companies see immense relevance on US FDA Electronic Submission Safety Reports. The guidance provides instructions about how the individual case safety reports (ICSRs) from investigational new drug (IND) need to be supported with Adverse Event Reporting System (AERS).
Fierce Pharma
APRIL 29, 2024
The price tag includes both the approved cancer drug Qinlock and another Deciphera candidate heading to the FDA’s desk in the coming months.
BioSpace
APRIL 28, 2024
With GLP-1 agonists slated to become the best-selling drugs in 2024, the biopharma industry is already pivoting to explore treatments that preserve muscle mass as patients shed pounds.
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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
Bio Pharma Dive
APRIL 29, 2024
The drug benefited people whose tumors have “ultralow” levels of HER2 protein, a result that could extend its reach in HER2-positive breast cancer.
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 24, 2024
The constant ebb and flow of hormones that guide the menstrual cycle don’t just affect reproductive anatomy. They also reshape the brain, and a study has given us insight into how this happens.
Pharma Times
APRIL 30, 2024
GPT-4 is trained on datasets to offer eye-related advice, diagnosis and management suggestions
pharmaphorum
APRIL 29, 2024
Patients in the US with the ultra-rare disease WHIM syndrome now have their first approved treatment, after X4 Pharma’s Xolremdi was given a green light by the FDA. Oral CXCR4 antagonist Xolremdi (mavorixafor) can be used in patients aged 12 and over with WHIM (warts, hypogammaglobulinemia, infections, and myelokathexis) syndrome, a congenital immunodeficiency characterised by low neutrophil counts that affects fewer than 1,000 people in the US.
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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
APRIL 26, 2024
The Food and Drug Administration approval of Beqvez comes as other gene therapies for the bleeding condition that were approved earlier struggle to gain traction.
Pharmaceutical Technology
APRIL 29, 2024
Pfizer has received approval from the US Food and Drug Administration (FDA) for its one-time gene therapy BEQVEZ for haemophilia B.
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 25, 2024
Researchers have identified dysfunctions in two specific brain systems in people who have psychosis – systems that help us filter attention to important internal and external information and predict or anticipate rewards.
BioSpace
APRIL 28, 2024
Bristol Myers Squibb’s deal announced Monday will see the pharma pay $65 million upfront to Repertoire Immune Medicines, which will develop autoimmune disease vaccines using its Decode discovery platform.
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.
pharmaphorum
APRIL 30, 2024
Prime Medicine has been given the go-ahead by the FDA for the first human trial of its prime editing technology, which promises to deliver one-shot therapies for a range of severe genetic diseases.
Bio Pharma Dive
APRIL 25, 2024
The layoffs will impact some 2,200 employees, the company said, as it repositions its business ahead of looming patent expirations for top-selling products.
Pharmaceutical Technology
APRIL 29, 2024
Experts hold scalability challenges and high costs accountable for market failures within the cell and gene therapy landscape.
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 29, 2024
The implementation of Revised Schedule M is set to revolutionize the pharma industry landscape by not only enhancing quality standards but also by streamlining regulatory processes, notably by minimizing duplicative inspections by various regulatory bodies of different countries, according to a senior Central Drugs Standard Control Organisation (CDSCO) official.
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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
APRIL 29, 2024
For Novo Nordisk to gain approval in the United States for its groundbreaking Awiqli (insulin icodec), it will have to first pass muster with a panel of experts next month,
pharmaphorum
APRIL 29, 2024
Japan’s Ono Pharma has bolstered its cancer pipeline with a $2.4 billion agreement to buy Deciphera Pharma of the US and its fast-growing gastrointestinal stromal tumour (GIST) therapy Qinlock. Ono is offering $26.50 per share in cash for the Waltham, Massachusetts-based company, saying the deal will enable it to “build a robust presence in oncology,” one of the group’s key priority areas.
Bio Pharma Dive
APRIL 25, 2024
“With each passing year, we're more committed to becoming a serious player in the genetic medicine space,” a Regeneron executive said.
Pharmaceutical Technology
APRIL 30, 2024
The FDA granted accelerated approval for the drug back in September 2021 following positive Phase II trial data.
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AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 30, 2024
The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies of In-vitro Diagnostic Medical Device (IVDMD) to aid manufacturers in the preparation of premarket review documents for the import or manufacturing license applications.
BioSpace
APRIL 28, 2024
Phase II data indicate Larimar Therapeutics’ injectable therapy nomlabofusp could go head-to-head in the market with Biogen's Skyclarys.
pharmaphorum
APRIL 28, 2024
Report from Evaluate shows growth in the orphan drugs sector is slowing down, in part as pharma and payers’ attention has refocused on treatments for more widespread conditions like obesity
Bio Pharma Dive
APRIL 30, 2024
Large and small drugmakers are vying for a piece of what analysts view as one of the biggest market opportunities in the pharma industry's history. Here’s what’s coming next.
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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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