Fierce Pharma
JULY 23, 2024
After making major manufacturing outlays in places like China and the United States earlier this year, Novo Nordisk is returning to its Danish roots. | Earlier this month, Novo Nordisk purchased a 200-acre site in Odense, Denmark’s third largest city, the company has confirmed. Novo is now set to kick off preparatory excavation work for a potential new production plant.
MedCity News
JULY 23, 2024
The National Community Pharmacists Association and providers argued that Change Healthcare didn’t take the needed precautions against the cyberattack that happened earlier this year. The post NCPA, Providers File Lawsuit Against UHG Over Change Healthcare Cyberattack appeared first on MedCity News.
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Fierce Pharma
JULY 23, 2024
Interim results from a phase 3 trial of AstraZeneca’s Imfinzi as a treatment before and after surgery in resectable non-small cell lung cancer (NSCLC) were head scratching as they failed to answer | An FDA advisory committee will discuss AstraZeneca’s application for Imfinzi in early-stage non-small cell lung cancer. The agency is asking external experts to weigh in on whether a new trial is needed to determine the contributions of the therapy on either end of surgery.
MedCity News
JULY 23, 2024
By prioritizing user-centric design, responsible data practices, and evidence-based solutions neurotech companies can not only drive user adoption but also foster long-term brand loyalty. The post Earning Trust in Neurotech appeared first on MedCity News.
Referral MD
JULY 23, 2024
ReferralMD, a leader in healthcare technology solutions, is excited to announce that Baptist Memorial Health Care, one of the nation’s largest not-for-profit health care systems and the largest Medicaid provider in the region, has significantly improved their referral management process with ReferralMD. The centralized Referral Center at Baptist Memorial sought a comprehensive referral management platform to replace their previous system.
MedCity News
JULY 23, 2024
The promise of these and other food allergy treatments is immense and research and development, in conjunction with clinical care facilities for food allergy patients, will continue to make more treatment options available for more people in the future. The post How Food Allergy Care Has Changed in the Last Decade appeared first on MedCity News.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
JULY 23, 2024
Abiologics develops biologic drugs from building blocks not found in nature, which it says confers these proteins with properties that make for better medicines. Founded by Flagship Pioneering, the startup is focusing on developing novel biologic treatments for cancer and immunology. The post Flagship Pioneering Launches Startup Abiologics to Advance New Class of Biologic Drugs appeared first on MedCity News.
pharmaphorum
JULY 23, 2024
Former Welsh rugby union captain Alum Wyn Jones is the face of a new awareness campaign launching in the UK today to draw attention to atrial fibrillation (AF), an irregular and potentially life-threatening heart rhythm abnormality.
MedCity News
JULY 23, 2024
As population health management becomes a vital element for long-term success, it’s time to take a closer look at what is holding providers and health plans from gaining the value they seek. The post Gaining the Right Value from Population Health Management: 3 Secrets to Success appeared first on MedCity News.
pharmaphorum
JULY 23, 2024
GSK has challenged Gilead's HIV behemoth Biktarvy, presenting data that its competing therapy Dovato is equally effective and associated with less weight gain.
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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
JULY 23, 2024
Johnson & Johnson is seeking approval for SPRAVATO for treatment-resistant depression with the submission of an sNDA to the US FDA.
pharmaphorum
JULY 23, 2024
Ionis plans phase 3 trial of its antisense therapy for Angelman syndrome, shortly after Biogen decided against exercising an option to license the drug
Healthcare Success
JULY 23, 2024
Entrepreneurial Insights from a Market Disruptor Market disrupters are drastically changing the healthcare industry, creating more accessible solutions and lucrative business models by addressing unmet needs with innovative solutions and scalable business models. Psych360 was one of the early disruptors to transform access to mental health care in long-term care facilities.
pharmaphorum
JULY 23, 2024
In today’s podcast, web editor Nicole Raleigh speaks with Carolyn Ward, director of clinical strategy at Particle Health Inc, a data transformation platform for healthcare, enabling organisations across the care continuum to turn medical records into actionable insights.
PharmaTimes
JULY 23, 2024
The life-threatening medical condition affects 100,000 people in the UK every year
pharmaphorum
JULY 23, 2024
Johnson & Johnson has filed for FDA approval of its antidepressant nasal spray Spravato, hoping to make it the first standalone treatment for adults with treatment-resistant depression (TRD).Spravato (esketamine) is already approved in the US as an add-on to oral antidepressant therapy for TRD, as well as for depressive symptoms in adults with major depressive disorder (MDD) and suicidal thoughts or behaviours.
Pharmaceutical Commerce
JULY 23, 2024
The deal exponentially grows the CDMO’s biopharma capabilities.
PharmaTech
JULY 23, 2024
The addition of BIOVECTRA’s biologics capabilities to accelerate drug development and manufacturing will allow Agilent to expand its end-to-end offerings for biopharma services.
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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.
Pharmaceutical Commerce
JULY 23, 2024
The latest news for pharma industry insiders.
PharmaTimes
JULY 23, 2024
The neurological disease is estimated to affect more than ten million people globally
PharmaTech
JULY 23, 2024
Lipid-based formulations (LBFs) and softgels can offer numerous advantages in terms of clinical and commercial potential. Integrating formulation and manufacturing to enhance drug solubility and market speed can help unlock these benefits.
PharmExec
JULY 23, 2024
The trial is expected to include 40 patients across the United States who haven’t responded adequately to standard hypovolemic septic shock treatments and are on vasopressors.
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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
PharmaTech
JULY 23, 2024
The increasing number of breakthroughs in small molecule drug development are exciting, but corresponding workflows are complex and require much more tailored approaches to ensure successful upstream and downstream processing, drug approvals and commercialization.
Prognos Health
JULY 23, 2024
The landscape of Non-Small Cell Lung Cancer (NSCLC) treatment is constantly evolving, with personalized medicine playing an increasingly vital role. In this pursuit, advanced diagnostic tools like FISH (Fluorescence In Situ Hybridization) panels have become instrumental. Recently, we’ve had a chance to assess exciting new data from a major laboratory's FISH panel, offering valuable insights for pharmaceutical companies working to target clinicians and patients.
PharmaTech
JULY 23, 2024
Speed to market is a critical aspect of developing new pharmaceutical products, and scale-up-or scale-down-can play a key part in that process. Significant interest has been focused on the science of scale for spray drying, since this process is the leading technology for formulating drugs with slow dissolution rates or poor solubility, which results in low bioavailability.
Nixon Gwilt Law
JULY 23, 2024
In the recently released 2025 Medicare Physician Fee Schedule Proposed Rule (the “Proposed Rule”), the Centers for Medicare & Medicaid Services (CMS) created a new reimbursement pathway for “Digital Mental Health Treatment” (DMHT) devices and services. As we mentioned in our overview of the Proposed Rule , this new pathway is a major step in the right direction for reimbursement of digital therapeutics (DTx) interventions more broadly.
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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
PharmaTech
JULY 23, 2024
While the document does not address treatment or prevention of the long-term complications of ulcerative colitis or Crohn’s disease in children, it aims to help sponsors developing drugs for pediatric patients currently affected.
European Pharmaceutical Review
JULY 23, 2024
A collaborative study involving several pharmaceutical companies has proposed reconsideration of employing naturally occurring endotoxins (NOEs) in endotoxin recovery studies. Following up on their initial research, in this part 2 of their study, the research team evaluated naturally occurring endotoxins prepared in high and low nutrient conditions in two common monoclonal antibody (mAb) buffer formulations.
PharmExec
JULY 23, 2024
In this part of his Pharmaceutical Executive video interview, Joshua M. Cohen, MD, MPH, FAHS, Chief Medical Officer, Braeburn discusses how the findings from this study contribute to addressing treatment gaps and improving patient outcomes for those struggling with fentanyl dependence, ensuring broader patient access to BRIXADI®, and more.
PharmaVoice
JULY 23, 2024
BARDA director Gary Disbrow explains the agency’s focus, how companies can get their “foot in the door” and why platforms are so important for preparedness.
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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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