Fierce Pharma
FEBRUARY 14, 2024
FDA unleashes multiple warning letters targeting insanitary manufacturing and online sales of unapproved Mounjaro, Ozempic fkansteiner Wed, 02/14/2024 - 05:10
MedCity News
FEBRUARY 14, 2024
Ipsen’s Onivyde is now FDA approved as a first-line treatment for metastatic pancreatic cancer, triggering a milestone payment to Merrimack Pharmaceuticals, the drug’s original developer. Merrimack plans to dissolve operations but its shareholders will receive payouts from the Ipsen payment.
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Fierce Pharma
FEBRUARY 14, 2024
Over the last month, for those watching HBO’s macabre “True Detective Night Country”—a TV series set in a harsh, sunless winter in a fictional Alaskan town—a continual theme is frostbite. | The FDA has approved the first medicine for severe frostbite. The U.S. regulator has signed off on Johnson & Johnson’s Aurlumyn (iloprost), an injected treatment to reduce the risk of amputation of the fingers or toes.
MedCity News
FEBRUARY 14, 2024
When striving for health equity, organizations need to adopt new methods and a new mindset in order to steer clear of using SDoH as a buzzword, and instead hit the mark of health equity results.
Fierce Pharma
FEBRUARY 14, 2024
With another quarter exceeding analysts’ expectations, Blueprint Medicines has raised its peak sales estimate for rare disease drug Ayvakit to $2 billion. | With another quarter exceeding analysts’ expectations, Blueprint Medicines has raised its peak sales estimate for rare disease drug Ayvakit to $2 billion.
MedCity News
FEBRUARY 14, 2024
Most hospitals and payers have publicly posted their pricing information, but experts think that data will remain mostly useless for consumers for at least another five years. Now that the data is available, healthcare software companies must step in and build tools that are personalized and easy to use. That way, consumers can eventually use price transparency data to shop for care.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
FEBRUARY 14, 2024
2024 presents an exciting yet challenging landscape for global pharma marketers. Prioritizing digital transformation, adopting patient-centric strategies, navigating regulatory complexities, investing in innovative content marketing, and fostering global collaboration position pharmaceutical marketers to make a lasting impact in an ever-evolving industry.
Fierce Pharma
FEBRUARY 14, 2024
Even as Australia’s CSL continues to grow, the company’s ambitions for its kidney disease and iron deficiency outfit Vifor Pharma—now known as CSL Vifor—have become more muted. | Even as Australia’s CSL continues to grow, the company’s ambitions for its kidney disease and iron deficiency outfit Vifor Pharma—now known as CSL Vifor—have become more muted.
MedCity News
FEBRUARY 14, 2024
Omada’s newly expanded GLP-1 Care Track provides tailored exercise plans, support for getting off of GLP-1s and calorie tracking. It also offers insight into who is responding to GLP-1s and who is engaging in Omada’s program.
Fierce Pharma
FEBRUARY 14, 2024
Sage Therapeutics and Biogen may not have the broad label that they had hoped for with Zurzuvae, but the two companies are still touting the med’s initial launch performance in postpartum depressio | Sage Therapeutics and Biogen may not have the broad label that they had hoped for with Zurzuvae, but the two companies are touting the med’s initial launch performance in postpartum depression.
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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.
PharmaTimes
FEBRUARY 14, 2024
The aggressive type of cancer accounts for 13% of all lung cancer cases worldwide
MedCity News
FEBRUARY 14, 2024
Here’s the audio of Episode 1 of the newly-launched show Debunked: Slaughtering Myths, Bad Practices and Sacred Cows in Healthcare.
pharmaphorum
FEBRUARY 14, 2024
Ipsen has won FDA approval for first-line use of its pancreatic cancer therapy Onivyde, saying it is now part of a potential new “standard-of-care” for patients
European Pharmaceutical Review
FEBRUARY 14, 2024
Gilead Sciences has agreed to acquire CymaBay Therapeutics for a total equity value of $4.3 billion. Gilead confirmed that CymaBay’s lead product candidate seladelpar has a best-in-disease profile for second-line primary biliary cholangitis (PBC). This is based on data from the Phase III RESPONSE trial. The company shared that seladelpar is an oral, selective peroxisomeproliferator-activated receptor delta (PPARδ) agonist.
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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
MedCity News
FEBRUARY 14, 2024
A comprehensive approach to obesity management goes beyond prescribing medications for a quick fix.
European Pharmaceutical Review
FEBRUARY 14, 2024
The development of drug products containing live anaerobic bacterial strains as the active pharmaceutical ingredient and where potency and shelf-life is typically associated with viable cell quantification, poses unique challenges when compared to both small and large molecule development therapeutics. It is the uniqueness of the strain and perceived inter-cellular variations (sub-populations) resulting from high viable cell densities during growth (fermentation) and the subsequent harvest and d
pharmaphorum
FEBRUARY 14, 2024
Eicos Sciences' Aurlumyn has become the first FDA-approved drug treatment to prevent amputations in cases of severe frostbite
European Pharmaceutical Review
FEBRUARY 14, 2024
A report by Allied Market Research predicts that the global pharmaceutical suspension market will reach $83.8 billion by 2032. Having valued $55.5 billion in 2022, the research expected that the market will reach a CAGR of 4.2 percent between 2023 and 2032. Factors driving the global pharmaceutical suspension market One of the main factors anticipated to propel the growth of the pharmaceutical suspension market is the availability of generic pharmaceutical suspensions, the research asserted.
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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 Technology
FEBRUARY 14, 2024
A bipartisan group of lawmakers is seeking an investigation and sanctions against WuXi given alleged connections to the Chinese military.
PharmaTimes
FEBRUARY 14, 2024
The report includes five recommendations for the government to address these issues
pharmaphorum
FEBRUARY 14, 2024
Venture capital group Earlybird has launched its second health fund with $185 million to fund companies in the health technology area
Clarivate
FEBRUARY 14, 2024
In an increasingly digital world, the amount of data generated around the use of medical devices provides opportunities for medtech companies to gain valuable insights about patients and their physicians. However, without context, those data are not sufficient to recognize what is actually happening in the market and why. To understand the environment in which these devices are functioning and provide a high-touch, personalized experience, marketers require a combination of robust external, comp
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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.
Nixon Gwilt Law
FEBRUARY 14, 2024
Tracking technologies (pixels, cookies, etc.) are invisible and everywhere. Offered by Meta’s Pixel and Google Analytics, and by many social media platforms like Instagram and TikTok, tracking technologies are the workhorse behind tailored advertising (e.g., behavioral advertising) and marketing analytics on consumer-facing websites. Tracking technologies capture static and behavioral information about webpage visitors, such as click-through rate, location, and other user input, including person
Pharmaceutical Commerce
FEBRUARY 14, 2024
Onivyde (irinotecan liposome injection) in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) was found to improve overall survival in metastatic pancreatic adenocarcinoma.
PM360
FEBRUARY 14, 2024
Public Health Leader, Dr. Dave A. Chokshi, Becomes New Board Member of Yuvo Health Dr. Dave A. Chokshi Dr. Dave A. Chokshi, a nationally renowned public health leader, practicing primary care physician, and Sternberg Family Professor of leadership at the City College of New York, has joined the board of Yuvo Health, a leading technology, operational, and administrative solution uniquely designed to give community health centers an advantage in value-based care.
Pharmaceutical Commerce
FEBRUARY 14, 2024
Bruce Phelan of Blue Fin discusses Novo Nordisk's purchase of Catalent manufacturing sites to increase its ability to meet the demand for the popular weight loss drug Wegovy.
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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
PharmaVoice
FEBRUARY 14, 2024
The pharma giant’s leader of a collective devoted to health equity discusses how companies can put their money where their mouth is to reach communities in need.
Pharmaceutical Technology
FEBRUARY 14, 2024
The US FDA has granted fast track designation to Edgewise Therapeutics’ EDG-5506 aimed at treating Duchenne muscular dystrophy.
PharmExec
FEBRUARY 14, 2024
Augtyro is a potential best-in-class tyrosine kinase inhibitor that targets ROS1- or NTRK-positive locally advanced or metastatic solid tumors.
Pharmaceutical Technology
FEBRUARY 14, 2024
A panel at the 2024 SCOPE Summit shared their experiences of setting up and running clinical trials that are more inclusive of the LGBTQIA+ community.
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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.
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