XTalks
DECEMBER 10, 2024
Metabolic dysfunction-associated steatohepatitis (MASH), previously known as non-alcoholic steatohepatitis (NASH), is a growing health concern. In the US, MASH affects an estimated three to six percent of the population. This chronic liver disease results from fat accumulation that leads to liver cell damage and inflammation. It is often associated with obesity, type 2 diabetes and cardiovascular risks.
Drug Patent Watch
DECEMBER 10, 2024
The pharmaceutical industry has undergone significant changes over the past decade, with a growing trend towards outsourcing key aspects of research, development, and manufacturing to third-party vendors. This shift has led to the emergence of integrated contract development and manufacturing organizations (CDMOs), which provide end-to-end support for drug developers.
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Pharmaceutical Technology
DECEMBER 10, 2024
Seres Therapeutics has received US FDA breakthrough therapy designation for its SER-155, aimed at decreasing BSIs.
Drug Patent Watch
DECEMBER 10, 2024
The pharmaceutical and biotechnology industries are heavily regulated, and navigating these regulations can be a significant challenge for companies, especially those with limited experience. Contract Development and Manufacturing Organizations (CDMOs) play a crucial role in helping companies overcome these regulatory hurdles. Here, we will explore how CDMOs can provide support in regulatory compliance, ensuring that products meet the strict demands of safety, purity, and efficacy.
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
Pharmaceutical Technology
DECEMBER 10, 2024
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Pharma Times
DECEMBER 10, 2024
New cell therapy shows potential in treating advanced blood disorder
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
DECEMBER 10, 2024
New findings presented at international SCWD conference
Pharmaceutical Technology
DECEMBER 10, 2024
The respiratory syncytial virus (RSV) prophylaxis market across the eight major markets (8MM) - comprising the US, the five major European markets (France, Germany, Italy, Spain, and the UK), Japan, and Australia - is forecast to grow from $582m in 2020 to $6.2bn in 2030 at a compound annual growth rate of 26.7%, with the paediatric and adult segments accounting for $2.2bn and $4.0bn, respectively.
Drug Patent Watch
DECEMBER 10, 2024
Generic drug development is a complex process that involves not only scientific and medical expertise but also adherence to strict legal and ethical standards. Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts. This article will delve into the importance of scientific expertise in generic drug development, highlighting the key areas where scientific knowledge is essential.
Pharmaceutical Technology
DECEMBER 10, 2024
The EMA has validated Chiesi Global Rare Diseases and Protalixs submission to update the dosing regimen of pegunigalsidase alfa.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Drug Patent Watch
DECEMBER 10, 2024
Biosimilars have been transforming the pharmaceutical landscape by offering cost-effective alternatives to biologic drugs. As patents for these biologics expire, the market for biosimilars is expanding rapidly, with significant implications for manufacturing technologies. This article delves into the impact of biosimilars on biologic drug manufacturing technologies, highlighting the challenges, opportunities, and future directions in this field.
Pharmaceutical Technology
DECEMBER 10, 2024
An improved price discount and new evidence from Santhera has changed NICEs tune following a recommendation shun earlier this year.
Trialfacts
DECEMBER 10, 2024
Contents About the Study Why Participate? Your Rights Who Can Participate? More Study Details About the Research Center: Study Location Research Center: Purdue University Location: Lambert 08A, 800 W. Stadium Ave. West Lafayette, IN 47907, USA Lead Researcher: Dr. Igor A. Fernandes IRB: This study has been reviewed and approved by the Purdue University IRB About the Study Ever wonder how your body reacts to different levels of oxygen?
Pharmaceutical Technology
DECEMBER 10, 2024
The US FDA has accepted a submission from GSK to review a new indication of Nucala (mepolizumab) as an add-on maintenance treatment for COPD.
Pharmaceutical Commerce
DECEMBER 10, 2024
A panel uncovers how distribution channels are aligning commercialization efforts.
CTTI (Clinical Trials Transformation Initiative)
DECEMBER 10, 2024
As 2024 draws to a close, we reflect on a busy year of collaboration at the Clinical Trials Transformation Initiative (CTTI). Thanks to your shared commitment to advancing clinical research, we have developed critical new resources to assist with registration and reporting of clinical trials as well as assessing the ability to embed trial elements into clinical practice.
Pharmaceutical Commerce
DECEMBER 10, 2024
Conference keynote speech examines the industrys critical developments of 2024 and offers a strategic outlook for next year.
Pharma Marketing Network
DECEMBER 10, 2024
In the ever-evolving healthcare marketing landscape, video advertising has emerged as a highly effective and influential medium for both publishers and advertisers. From capturing attention to driving conversions, video has become an essential tool in healthcare advertising. But what makes video so impactful for both publishers and advertisers in this industry?
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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 Commerce
DECEMBER 10, 2024
Our December analysis of the twists and turns in the Drug Supply Chain Security Act is a timely one, as the FDA recently again pushed back the deadline for complying with new mandates on tracking and tracing drugs at the package level.
Drug Channels
DECEMBER 10, 2024
This week, Im rerunning some popular posts while I prepare for Fridays Drug Channels Outlook 2025 live video webinar. Click here to see the original post. As you reread the article below, note that some manufacturers have already announced wholesale acquisition cost (WAC) list price declines for 2025. Last week, the Federal Trade Commission (FTC) released its interim report on pharmacy benefit managers (PBMs).
Pharmaceutical Commerce
DECEMBER 10, 2024
Click the title above for a link to open the Pharmaceutical Commerce December 2024 issue in an interactive PDF format.
CTTI (Clinical Trials Transformation Initiative)
DECEMBER 10, 2024
Presentation: Achieving Flexibility and Expanding Access while Preserving Data Quality Date: Tuesday, February 6, 12:25 p.m. Presenters: Wes Burian (Independent Patient/Caregiver), Lindsay Kehoe (CTTI), and Pamela Tenaerts (Medable) The post SCOPE Summit 2025 appeared first on CTTI.
Pharmaceutical Commerce
DECEMBER 10, 2024
Access Insights Conference delves into the latest obstacles, while mapping out potential solutions to address them.
XTalks
DECEMBER 10, 2024
Sanofis pivotal LUNA 3 Phase III study has delivered promising results for rilzabrutinib, marking an important advance for adults living with persistent or chronic immune thrombocytopenia (ITP). ITP is a rare autoimmune disorder that leads to dangerously low platelet counts. In this study, rilzabrutinib, an oral Brutons tyrosine kinase (BTK) inhibitor, demonstrated a durable platelet response in 23 percent of treated patients compared to none on placebo, indicating high statistical significance.
Pharmaceutical Commerce
DECEMBER 10, 2024
The value of this sometimes-unheralded technology to the pharma industryas well as potential use casesare starting to come to light.
Drug Patent Watch
DECEMBER 10, 2024
Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. Regulatory expertise plays a crucial role in ensuring that generic drugs meet the necessary standards for quality, safety, and efficacy. In this article, we will explore the importance of regulatory expertise in generic drug development, highlighting the key challenges and opportunities in this field.
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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 Commerce
DECEMBER 10, 2024
The latest news for pharma industry insiders.
Drug Patent Watch
DECEMBER 10, 2024
India has long been recognized as a significant player in the global pharmaceutical industry, particularly in the production of generic drugs. The country’s pharmaceutical sector has experienced substantial growth over the years, driven by both domestic and international demand for affordable and high-quality medicines. This article delves into India’s growing importance in generic drug API manufacturing, highlighting the key factors contributing to its success and the challenges it
Drug Patent Watch
DECEMBER 10, 2024
Patents play a crucial role in protecting intellectual property and fostering innovation. However, the increasing complexity of patent systems has given rise to a phenomenon known as “patent thickets.” These dense webs of overlapping patent rights can significantly impact innovation, market entry, and competition across various industries and countries.
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