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.
MedCity News
APRIL 16, 2024
Intra-Cellular Therapies reported its drug Caplyta met the main and secondary goals in the first of three pivotal studies in major depressive disorder. Success in two of them could support expanding the label of the drug, which is currently approved in schizophrenia and bipolar depression. The post Depression Trial Win Moves Intra-Cellular Drug Closer to Label Expansion & Blockbuster Status appeared first on MedCity News.
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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.
MedCity News
APRIL 16, 2024
AHIP, the AMA and NAACOS released a playbook last week that provides the best practices for value-based care. It is based on experiences from physicians, value-based care entities and payers. The post AHIP, AMA, NAACOS Release Playbook for Value-Based Care appeared first on MedCity News.
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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
APRIL 16, 2024
For the first time, Johnson & Johnson has reported sales numbers for its novel multiple myeloma treatment Tecvayli and they indicate that the bispecific, which was approved in October 2022, is | For the first time, Johnson & Johnson is reporting sales of its multiple myeloma drug Tecvayli, which is off to a strong launch and contributing to the company's overall strength in treating the disease.
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.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
APRIL 16, 2024
Two Chairs, a startup offering hybrid behavioral health care, closed a $72 million Series C funding round. The company’s focus on measuring outcomes and dedication to care quality assurance are two key factors that differentiate it from other mental health startups, CEO Alex Katz said. The post Two Chairs Rakes In $72M For Its Hybrid Therapy Platform appeared first on MedCity News.
Fierce Pharma
APRIL 16, 2024
After getting a fat check worth $30.5 million for joining Biogen as the CEO in late 2022, Chris Viehbacher saw his 2023 pay drop to $4.1 million as the Big Biotech continues to struggle. | After getting a fat check worth $30.5 million for joining Biogen as the CEO in late 2022, Chris Viehbacher saw his 2023 pay drop to just $4.1 million as the Big Biotech continues struggling.
MedCity News
APRIL 16, 2024
In vulnerable moments when employees need it most, virtual specialty care delivers a human connection that offers empathy, support, and guidance. The post Guidance and Education For Employees Facing a Cancer Journey appeared first on MedCity News.
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.
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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.
MedCity News
APRIL 16, 2024
Former U.S. CTO Aneesh Chopra will moderate a webinar on April 16 at 1pm ET on eConsent, The post EConsent Workflows Must Evolve to Support Interoperability and Health Equity appeared first on MedCity News.
Copyright Clearance Center
APRIL 16, 2024
In a publishing environment buffeted by digital disruption and calls for open access, university presses in 2024 must manage to remain relevant and sustainable even as their audiences grow.
pharmaphorum
APRIL 16, 2024
Boehringer Ingelheim says the strongest R&D pipeline in its history is set to deliver 25 new product launches between now and 2030
Pharmaceutical Technology
APRIL 16, 2024
Norgine has sought approval for eflornithine (DFMO) for the treatment of patients with high-risk neuroblastoma (HRNB).
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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.
European Pharmaceutical Review
APRIL 16, 2024
Novartis has released new data from the first and only Phase III study to demonstrate significant proteinuria reduction by targeting the complement system in patients with the rare kidney disease IgA nephropathy (IgAN). Pre-specified interim analysis results from the Phase III APPLAUSE-IgAN clinical trial were presented at the 2024 World Congress of Nephrology (WCN).
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
European Pharmaceutical Review
APRIL 16, 2024
A new global licensing agreement is set to advance development of an oncology biosimilar candidate. Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. and Spain-based biopharmaceutical company mAbxience, have entered into a strategic deal for a drug candidate that is in development for treating multiple indications in the oncology space.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
pharmaphorum
APRIL 16, 2024
Shares in Intra-Cellular Therapies rose after it reported Caplyta was effective for major depressive disorder (MDD), in a phase 3 trial.
European Pharmaceutical Review
APRIL 16, 2024
A new bilateral prospective harmonisation project between the European Pharmacopoeia (Ph. Eur.) and the Japanese Pharmacopoeia (JP) will focus on pharmacopoeial standards for active substance and medicinal product monographs. Through the harmonisation, alignment of the pharmacopoeial standards in different regulatory jurisdictions, is aimed at decreasing the burden on drug manufacturers to do different compendial tests, according to the organisation European Directorate for the Quality of Medici
PharmaTimes
APRIL 16, 2024
Solid organ transplantation is used to treat end-stage organ failure, including the kidneys
PharmaTech
APRIL 16, 2024
At INTERPHEX, Bill Whitford, Strategic Solutions leader at Arcadis, discusses the progress made in 3D bioprinting toward commercial biologics production.
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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.
PharmaTimes
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
XXB-750 is a monoclonal antibody commercialized by Novartis, with a leading Phase II program in Systolic Heart Failure.
Spotio
APRIL 16, 2024
If you want your team to succeed in the industrial sales sector your reps need to become more than order-takers. They need to take a proactive approach to find quality buyers for themselves. This is much easier said than done, of course. Thankfully, there are plenty of effective industrial sales training programs available. Each one will teach your reps to close more deals—often in less time and with less effort than before.
PharmExec
APRIL 16, 2024
Amid lingering questions and uncertainty, a look at ways pharma companies can prioritize incorporating the Inflation Reduction Act into their strategic planning process—and do it now.
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
Clarify Health
APRIL 16, 2024
Although price transparency files are available, the volume and complexity of available data makes it difficult for healthcare organizations to clearly understand their competitive rate position—where their negotiated rates may be significantly above or below market rates. Finding insights in price transparency data can be like finding a needle in a haystack.
PharmExec
APRIL 16, 2024
In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, discusses what to expect from the obesity space in the next five years.
PharmaTech
APRIL 16, 2024
WMFTS has launched WMArchitect, a single-use product line that offers ready-to-use single-use assemblies and custom-designed workflows for biopharma fluid management.
Pharmaceutical Technology
APRIL 16, 2024
NNC0519-0130 is commercialized by Novo Nordisk, with a leading Phase II program in Type 2 Diabetes.
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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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