Tue.Dec 10, 2024

article thumbnail

MASH Clinical Trials: New Approaches and Methodologies

XTalks

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.

article thumbnail

UniQure shares soar on chance of speedy approval for Huntington’s therapy

Bio Pharma Dive

199
199
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

ASH 2024: Regeneron’s Ordspono faces challenges, but positive results signal hope

Pharmaceutical Technology

While 88.

147
147
article thumbnail

ASH24: Leukemia drug sequencing, sickle cell questions and a new kind of CAR-T

Bio Pharma Dive

Drugs 120
article thumbnail

From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

article thumbnail

New Amsterdam stock jumps as LDL-C lowering drug scores again at Phase III

Pharmaceutical Technology

The results from the Phase III trial found the LDL-C treatment to be well tolerated with a reduction in low-density lipoprotein cholesterol.

Trials 147
article thumbnail

NewAmsterdam drug shows ‘unexpected’ signs of protecting the heart in latest study

Bio Pharma Dive

Drugs 120

More Trending

article thumbnail

CatalYm shows potential of visugromab for treating cachexia

Pharma Times

New findings presented at international SCWD conference

112
112
article thumbnail

EMA validates Chiesi and Protalix’s dose variation for Fabry disease

Pharmaceutical Technology

The EMA has validated Chiesi Global Rare Diseases and Protalixs submission to update the dosing regimen of pegunigalsidase alfa.

147
147
article thumbnail

How do patent thickets vary across different countries

Drug Patent Watch

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.

article thumbnail

Santhera’s DMD therapy Agamree approved for NHS use after new price deal

Pharmaceutical Technology

An improved price discount and new evidence from Santhera has changed NICEs tune following a recommendation shun earlier this year.

147
147
article thumbnail

Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

article thumbnail

Rilzabrutinib Sets a New Benchmark in Immune Thrombocytopenia Trials

XTalks

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.

Trials 82
article thumbnail

FDA to review GSK’s Nucala for COPD

Pharmaceutical Technology

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.

147
147
article thumbnail

High-flying Eli Lilly plots $15B share buyback plan

Fierce Pharma

81
article thumbnail

Seres’ SER-155 gains breakthrough status for BSIs reduction

Pharmaceutical Technology

Seres Therapeutics has received US FDA breakthrough therapy designation for its SER-155, aimed at decreasing BSIs.

147
147
article thumbnail

The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

article thumbnail

ASH: Stem cell transplant study exposes US zip-code lottery

pharmaphorum

81
article thumbnail

Cellenkos presents promising phase 1b data for CK0804 in myelofibrosis

Pharma Times

New cell therapy shows potential in treating advanced blood disorder

80
article thumbnail

Suspect in UnitedHealth CEO killing charged with murder

pharmaphorum

78
article thumbnail

CSL Vifor floats £23M offer, doctor outreach campaign in bid to resolve UK antitrust probe

Fierce Pharma

Doctor 65
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

ConTIPI starts rollout of pelvic organ prolapse device in US

pharmaphorum

78
article thumbnail

The Benefits of Integrated CDMO Services: Streamlining Drug Development and Manufacturing

Drug Patent Watch

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.

article thumbnail

ASH: Blenrep ups survival by 42% in multiple myeloma trial

pharmaphorum

Trials 75
article thumbnail

Trade & Channel Strategies 2024: Evolving with the Times

Pharmaceutical Commerce

A panel uncovers how distribution channels are aligning commercialization efforts.

52
article thumbnail

The New Age of Decentralized Clinical Trials

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.

article thumbnail

MSD gets first positive trial of Keytruda/Lynparza combo

pharmaphorum

Trials 74
article thumbnail

Trade & Channel Strategies 2024: Access and Channel 2024 Year-in-Review and Preview of 2025

Pharmaceutical Commerce

Conference keynote speech examines the industrys critical developments of 2024 and offers a strategic outlook for next year.

article thumbnail

The Role of Scientific Expertise in Generic Drug Development

Drug Patent Watch

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.

article thumbnail

Traceability's Latest Curve

Pharmaceutical Commerce

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.

article thumbnail

Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

article thumbnail

The Importance of Regulatory Expertise in Generic Drug Development

Drug Patent Watch

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.

article thumbnail

Pharmaceutical Commerce - December 2024 Issue (PDF)

Pharmaceutical Commerce

Click the title above for a link to open the Pharmaceutical Commerce December 2024 issue in an interactive PDF format.

52
article thumbnail

Analyzing the impact of biosimilars on biologic drug manufacturing technologies

Drug Patent Watch

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.

article thumbnail

Conference Connect: Tackling the Issues that Matter in the Access Space

Pharmaceutical Commerce

Access Insights Conference delves into the latest obstacles, while mapping out potential solutions to address them.

52
article thumbnail

How Machine Learning Drives Clinical Trial Efficiency

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.