Pharmaceutical Technology
APRIL 16, 2024
The price ceiling policy has been in place for more than 20 years, but it has neither been very successful nor free of consequences for pharma companies.
Bio Pharma Dive
APRIL 16, 2024
Joel Marcus, the longtime head of Alexandria Real Estate Equities, sees few near-term challengers to the established biotech hubs of Boston, San Diego and San Francisco.
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Pharmaceutical Technology
APRIL 16, 2024
Norgine has sought approval for eflornithine (DFMO) for the treatment of patients with high-risk neuroblastoma (HRNB).
Bio Pharma Dive
APRIL 16, 2024
Shares of the biotech rose 25% after a large trial found adding its drug Caplyta onto antidepressant therapy significantly helped people with major depression.
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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
APRIL 16, 2024
XXB-750 is a monoclonal antibody commercialized by Novartis, with a leading Phase II program in Systolic Heart Failure.
Bio Pharma Dive
APRIL 16, 2024
The biotech says a dual-pronged antibody it’s developing could become an “off-the-shelf” alternative to cell therapies in development for lupus and other inflammatory conditions.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
APRIL 16, 2024
Tecvayli sales, which J&J broke out for the first time, surpassed Wall Street forecasts and offset underperformance from Carvykti, which J&J attributed to the "phasing and timing of orders.
Pharmaceutical Technology
APRIL 16, 2024
Sanofi has signed an agreement with IDT Australia for preclinical formulation development of its messenger RNA (mRNA) vaccines.
Fierce Pharma
APRIL 16, 2024
Intra-Cellular Therapies has unveiled another positive late-stage trial readout for Caplyta, taking another step toward a potential blockbuster label expansion for the depression drug. | Intra-Cellular Therapies has unveiled another positive late-stage trial readout for Caplyta, taking another step toward a potential blockbuster label expansion for the depression drug.
Pharmaceutical Technology
APRIL 16, 2024
The US FDA placed the clinical hold based on the preclinical data that showed that Neumora’s NMRA-266 triggered convulsions in rabbits.
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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
pharmaphorum
APRIL 16, 2024
A smart sensor developed by Adherium has been cleared by the FDA for use with AstraZeneca's asthma inhaler Airsupra and Breztri for COPD.
Pharmaceutical Technology
APRIL 16, 2024
Artificial intelligence (AI) has the potential to revolutionize drug development through improved efficiency, accuracy, and speed.
Fierce Pharma
APRIL 16, 2024
Despite a pair of clinical misfires in 2023, argenx has stuck by the thesis that its star drug Vyvgart, also known as efgartigimod, could tackle a wide array of autoimmune diseases linked to immuno | Argenx is bolstering its case for Vyvgart’s CIDP potential and preparing for a possible launch later this year—all while the company continues to prove the medication’s worth in its inaugural generalized myasthenia gravis indication.
Pharmaceutical Technology
APRIL 16, 2024
The FDA has cleared Spinogenix’s Phase II trial of SPG601, as the European Commission grants orphan drug status to zatolmilast.
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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.
pharmaphorum
APRIL 16, 2024
Researchers from the UK have developed an endoscopic device that uses 3D imaging to look at the stiffness of cells and could diagnose cancer earlier.
Pharmaceutical Technology
APRIL 16, 2024
Acorda’s closure date is set for 15 June, as Merz Therapeutics looks set to acquire the biotech’s once-prolific assets.
XTalks
APRIL 16, 2024
The 18th Annual Canadian Summit on Food Safety , happening on Wednesday, April 24, and Thursday, April 25, is an unrivaled platform for exploring the latest trends and innovations in food safety. This year’s summit promises to be an essential event for anyone involved in food safety and quality assurance. It offers opportunities to update regulatory understanding, network with industry leaders and learn about cutting-edge technologies and methods.
Pharmaceutical Technology
APRIL 16, 2024
Qureight has secured $8.5m in a Series A funding round led by Hargreave Hale AIM VCT to accelerate drug development.
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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.
pharmaphorum
APRIL 16, 2024
FDA starts review of GSK’s 5-in-1 meningitis vaccine, cueing up a decision early next year, as it tries to chase down Pfizer's recently-approved Penbraya
Pharmaceutical Technology
APRIL 16, 2024
NovelMed has received ODD status from the US FDA for NM5072 for treating paroxysmal nocturnal hemoglobinuria (PNH).
BioSpace
APRIL 16, 2024
With Wednesday’s readout showing symptom improvements in obstructive sleep apnea patients, Eli Lilly is preparing to file for a label expansion for its top-selling weight-loss drug Zepbound.
Pharmaceutical Technology
APRIL 16, 2024
Boehringer Ingelheim announced consistent growth across its human pharma sales and R&D investments in 2023.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
Pharma Times
APRIL 16, 2024
Solid organ transplantation is used to treat end-stage organ failure, including the kidneys
Pharmaceutical Technology
APRIL 16, 2024
ELVN-002 is a small molecule commercialized by Enliven Therapeutics, with a leading Phase I program in Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer).
BioSpace
APRIL 16, 2024
At this week’s American Academy of Neurology annual meeting, Amylyx provided additional data from its Phase III amyotrophic lateral sclerosis study showing the full extent of Relyvrio’s failure.
Pharmaceutical Technology
APRIL 16, 2024
NN-9931 is a recombinant peptide commercialized by Novo Nordisk, with a leading Phase III program in Metabolic Dysfunction-Associated Steatohepatitis (MASH).
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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.
BioSpace
APRIL 16, 2024
GSK’s antibiotic eliminated the bacterial cause of gonorrhea in 92.6% of patients in a Phase III study, while its Shingrix vaccine’s efficacy in shingles remained above 70% over 11 years of follow up.
Pharmaceutical Technology
APRIL 16, 2024
LY-3972406 is a small molecule commercialized by Eli Lilly and Co, with a leading Phase II program in Plaque Psoriasis (Psoriasis Vulgaris).
Pharma Times
APRIL 16, 2024
Liver cirrhosis, caused by long-term liver damage, is estimated to affect around 100 million people worldwide
Pharmaceutical Technology
APRIL 16, 2024
ABBV-400 is a monoclonal antibody conjugated commercialized by AbbVie, with a leading Phase II program in Metastatic Colorectal Cancer.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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