XTalks
SEPTEMBER 25, 2024
Patient-centricity isn’t a catchphrase in clinical trials—it’s a guiding principle for improving patient experiences. One of the most critical aspects of this is how patients are compensated for their participation in trials. While payment may seem like a simple transactional matter, it has far-reaching effects on patient satisfaction and trial engagement.
Bio Pharma Dive
SEPTEMBER 25, 2024
The financing will support a technology designed to make delivery of lentiviral gene therapies, which are typically administered through a complex process, more convenient.
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Rethinking Clinical Trials
SEPTEMBER 25, 2024
In this Friday’s PCT Grand Rounds, Tom Lietman of the University of California, San Francisco, will present “Azithromycin for Childhood Mortality: Randomizing Entire Countries.” The Grand Rounds session will be held on Friday, September 27, 2024, at 1:00 pm eastern. Lietman is the Ruth Lee and Phillips Thygeson Distinguished Professor in the Department of Ophthalmology and the Department of Epidemiology and Biostatistics at the University of California, San Francisco, and the d
Bio Pharma Dive
SEPTEMBER 25, 2024
The offering, which was upsized twice, will support development of a drug the company believes can boost the effects of popular weight loss medicines like Eli Lilly’s Zepbound.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 25, 2024
(Science Photo Library/Getty Images) Has your doctor asked you to stick out your tongue and say “aaah”? While the GP assesses your throat, they’re also checking out your tongue, which can reveal a lot about your health. The doctor will look for any changes in the tongue’s surface or how it moves.
Bio Pharma Dive
SEPTEMBER 25, 2024
The biotech expects that stopping enrollment for KarMMa-9, a trial evaluating early use of the multiple myeloma cell therapy Abecma, should save it $80 million in the near term.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
SEPTEMBER 25, 2024
Medicines the company is developing for eczema and myasthenia gravis met their objectives in Phase 3 trials. But analysts weren’t convinced they can compete with available alternatives.
Pharmaceutical Technology
SEPTEMBER 25, 2024
Discover the leading Biotechnology Equipment Manufacturers, Companies and Suppliers. Download the free Buyer's Guide today for full details.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 25, 2024
Since the Pharmacovigilance Programme of India (PvPI) is taking momentum in the health sector today, the PvPI and the Adverse Drug Reaction (ADR) monitoring and reporting should be made part of the curriculum of the pharmacy education.
Pharmaceutical Technology
SEPTEMBER 25, 2024
The epigenetic drugs space has witnessed a two-fold increase in Series A venture funding, with total deal value increasing to $342m in 2024.
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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
Rethinking Clinical Trials
SEPTEMBER 25, 2024
Speaker John Fortney, PhD Professor Department of Psychiatry and Behavioral Sciences University of Washington Senior Research Career Scientist HSR Center of Innovation for Veteran-Centered and Value-Driven Care VA Puget Sound Health Care System Slides Keywords Pragmatic; Implementation; Hybrid-Effectiveness; Trial Types Key Points Pragmatic trials are primarily designed to determine the effectiveness of a clinical intervention under the usual condition
Pharmaceutical Technology
SEPTEMBER 25, 2024
Bavarian Nordic has received a $63m US contract to produce bulk product and final freeze-dried doses of the JYNNEOS smallpox/mpox vaccine.
Fierce Pharma
SEPTEMBER 25, 2024
Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to a $5.4 billion acquisition the New York pharma made two years ago. | Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to its $5.4 billion acquisition of Global Blood Therapeutics two years ago.
Pharmaceutical Technology
SEPTEMBER 25, 2024
Some counterfeits contain bacteria and have high impurity levels or different chemical structures to Lilly's FDA-approved medicines.
pharmaphorum
SEPTEMBER 25, 2024
Novo Nordisk chief executive Lars Fruergaard Jørgensen was taken to task by US lawmakers over the price of the company's semaglutide drugs for diabetes and obesity at a congressional hearing yesterday – but would not commit to reducing them. Jørgensen danced around the topic of price cuts, saying Novo Nordisk supported "anything that helps patients get access and affordability […] we will look into.
Pharmaceutical Technology
SEPTEMBER 25, 2024
The funds will advance Genespire’s gene therapy for methylmalonic acidemia, a group of rare metabolic disorders, to Phase I/II trials.
pharmaphorum
SEPTEMBER 25, 2024
Aurion Biotech has launched its cell therapy Vyznova for serious eye disorder bullous keratopathy in Japan, its debut market, becoming an alternative to corneal replacement using donor tissue.Vyznova (neltependocel, formerly AURN001) is the world's first allogeneic cell therapy for corneal endothelial disease, according to the Seattle, Washington-based company.
Pharmaceutical Technology
SEPTEMBER 25, 2024
Generate:Biomedicines and Novartis have partnered for the discovery and development of protein therapeutics in multiple disease areas.
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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.
Fierce Pharma
SEPTEMBER 25, 2024
As private equity firms reportedly place their bids, Sanofi may soon follow in the footsteps of GSK and Johnson & Johnson with the separation of its consumer health unit. | Sanofi has received two private equity offers for its consumer health business, which could be valued at 15 billion euros ($16.7 billion) or more, Bloomberg reported Tuesday, citing people close to the matter.
Pharmaceutical Technology
SEPTEMBER 25, 2024
Eli Lilly has received approval in Japan for Kisunla (donanemab-azbt) to treat early symptomatic Alzheimer's disease.
pharmaphorum
SEPTEMBER 25, 2024
Flagship Pioneering-backed artificial intelligence startup Generate:Biomedicines has attracted another big pharma partnership, this time with Novartis.The wide-ranging deal, worth up to $1 billion, covers multiple targets and disease areas and focuses on the discovery and development of protein-based therapeutics using Generate's generative AI (genAI) platform.
Pharmaceutical Technology
SEPTEMBER 25, 2024
AllazoHealth has introduced AI-enabled dynamic modular content to enhance initiation and adherence to medications.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Fierce Pharma
SEPTEMBER 25, 2024
Bristol Myers Squibb’s struggling CAR-T therapy Abecma has hit a major setback. | Bristol Myers Squibb’s CAR-T therapy Abecma has hit a major setback. Bristol and its partner 2seventy bio have decided to pull the plug on the phase 3 KarMMa-9 trial in first-line myeloma after struggling to enroll patients.
Pharmaceutical Technology
SEPTEMBER 25, 2024
The tracker, currently available via a pilot scheme, could save pharmacists hours by reducing patient queries.
Fierce Pharma
SEPTEMBER 25, 2024
While it was just last week that Zevra Therapeutics’ Miplyffa became the first FDA-approved treatment for the lysosomal storage disorder Niemann-Pick disease type C (NPC), IntraBio has already one- | While it was just last week that Zevra Therapeutics’ Miplyffa became the first FDA-approved treatment for the lysosomal storage disorder Niemann-Pick disease type C, IntraBio has already one-upped its rare disease rival.
Drug Patent Watch
SEPTEMBER 25, 2024
Generic drug manufacturers face significant challenges when attempting to navigate around REMS (Risk Evaluation and Mitigation Strategies) imposed by brand-name drug companies. These strategies, intended to ensure drug safety, are sometimes misused to delay generic competition.
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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
SEPTEMBER 25, 2024
Three months after Amgen revealed that Uplizna had aced a phase 3 trial in immunoglobulin G4-related disease (IgG4), the company said the anti-CD-19 antibody has excelled in a study against another | Three months after Amgen revealed that Uplizna had aced a phase 3 trial in IgG4, the company said the anti-CD-19 antibody has excelled in a study against another neurologic disorder, myasthenia gravis.
pharmaphorum
SEPTEMBER 25, 2024
Pfizer is voluntarily withdrawing its sickle cell drug Oxbryta after a review revealed an imbalance of deaths in clinical trials
Drug Discovery World
SEPTEMBER 25, 2024
Antibody drug conjugates (ADCs) are among the hottest properties in pharma, powerful anticancer drugs that target tumours and deliver a lethal payload that destroys them, while leaving healthy tissues untouched. But there’s much more to come from this technology. DDW’s Megan Thomas explores the topic and speaks with experts in the industry. Early days of ADC drug development The first ADC was approved around the turn of the century, with Pfizer’s Mylotarg (gemtuzumab ozogamicin) becoming the fi
pharmaphorum
SEPTEMBER 25, 2024
Eli Lilly has opened up a second market for its new Alzheimer's disease therapy Kisunla, after Japan followed the US in approving the drug
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
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