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.
Pharmaceutical Technology
JUNE 24, 2024
The osteoporosis market is expected to grow at a compound annual growth rate of 5.4% from 2023 to 2032, reaching $17.9bn across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) by the end of this forecast period, according to leading data and analytics company GlobalData’s recent report: Osteoporosis: Seven-Market Drug Forecast and Market Analysis.
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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.
Pharmaceutical Technology
JUNE 24, 2024
Big pharma and their packaging partners are collaborating to cut emissions and deliver more sustainable solutions for injectables.
Bio Pharma Dive
JUNE 24, 2024
Phase 3 trial results should support an approval application for the drug, which analysts view as a potential competitor to Roche’s blockbuster medicine Hemlibra.
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JUNE 24, 2024
The success of the Covid-19 messenger ribonucleic acid (mRNA) vaccines highlighted the major advantages of utilising mRNA technology in vaccine development.
Bio Pharma Dive
JUNE 24, 2024
Four critical components in which the right specialty pharmacy partner can bring rare and gene therapy manufacturers the scale, expertise and capabilities needed to drive enhanced patient access.
Pharmaceutical Technology
JUNE 24, 2024
Despite a difficult investing environment, major well-capitalised contract manufacturing organisations (CMOs) have been involved in recent acquisitions, as big pharma and private equity alike highly value the manufacturing capabilities and expertise these companies bring to the table.
Bio Pharma Dive
JUNE 24, 2024
Positive results from a Phase 3 trial of vutrisiran in transthyretin amyloidosis cardiomyopathy come eight months after the FDA rejected another medicine Alnylam developed for the condition.
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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
Pharmaceutical Technology
JUNE 24, 2024
The US FDA has approved argenx's VYVGART Hytrulo to treat adults with chronic inflammatory demyelinating polyneuropathy (CIDP).
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 24, 2024
Union government has now formed a committee to examine the matter of manufacturing of nutraceuticals within the drug manufacturing facility. This follows the implementation of revised Schedule M mandating dedicated areas for manufacture of nutraceuticals and pharmaceuticals.
Pharmaceutical Technology
JUNE 24, 2024
As the obesity drug development space gains traction, Altimmune shared positive data from a Phase II trial for pemvidutide.
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.
Pharmaceutical Technology
JUNE 24, 2024
Discover the key factors in selecting pharmaceutical consulting firms for regulatory compliance, strategic development, and market success.
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.
Pharmaceutical Technology
JUNE 24, 2024
Alimera Sciences shares have increased following a $5.50 per share buyout offer from ANI Pharmaceuticals.
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.
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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.
Pharmaceutical Technology
JUNE 24, 2024
Daiichi Sankyo has announced the receipt of approval from the Japan MHLW for EZHARMIA to treat peripheral T-cell lymphoma (PTCL).
Bio Pharma Dive
JUNE 24, 2024
Benefits of adopting the systems thinking approach in clinical trial design.
Pharmaceutical Technology
JUNE 24, 2024
The EC has approved Takeda’s Fruzaqla for adults with metastatic colorectal cancer (mCRC) who have exhausted standard therapies.
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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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
Pharmaceutical Technology
JUNE 24, 2024
Melodia Therapeutics has signed an exclusive licence agreement to obtain rights for Alivexis’ MDI-0151, a cathepsin C inhibitor.
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.
Pharmaceutical Technology
JUNE 24, 2024
The Phase III HELIOS-B study met its primary and secondary endpoints in the monotherapy and overall study populations.
Fierce Pharma
JUNE 24, 2024
Following Novo Nordisk’s recent Wegovy approval to cut heart risks in adults with obesity, Eli Lilly appears to be homing in on the next potential label expansion for its rival GIP/GLP-1 weigh | Late last week, Lilly shared detailed results from its phase 3 SURMOUNT-OSA study, which found that Zepbound at the 10 mg and 15 mg doses aced its primary and secondary endpoints in obese patients with obstructive sleep apnea (OSA).
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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.
Pharmaceutical Technology
JUNE 24, 2024
Novotech shines a light on the cutting-edge progress in epilepsy research in its latest in-depth disease analysis.
pharmaphorum
JUNE 24, 2024
Fenofibrate, a decades-old drug used to lower cholesterol levels, has been shown to reduce the progression of diabetic retinopathy in a large-scale trial.
Pharmaceutical Technology
JUNE 24, 2024
The KRAS inhibitor, Krazati, is expected to generate $1.3bn in global sales in 2029, as per GlobalData’s analysis.
pharmaphorum
JUNE 24, 2024
Daiichi Sankyo has a second approval in Japan for Ezharmia, its first-in-class dual EZH1 and EZH2 inhibitor, as a treatment for relapsed or refractory peripheral T-cell lymphoma (PTCL).Ezharmia (valemetostat tosylate) remains the first and only drug in the class to be approved for marketing around the world, having been cleared in Japan in 2022 for relapsed or refractory adult T-cell leukaemia/lymphoma (ATL).
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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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