FDA to review Sanofi and Regeneron’s Dupixent sBLA for bullous pemphigoid
Pharmaceutical Technology
FEBRUARY 18, 2025
As Sanofi and Regeneron await the FDA decision, a legal dispute between the partners over commercialisation details continues.
Tue.Feb 18, 2025
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Healthcare Layoffs 2025: A Roundup
XTalks
FEBRUARY 18, 2025
Healthcare organizations have long used workforce adjustments to respond to changing market dynamics, regulatory pressures and the need to refocus on core patient care. In this blog, we detail the healthcare layoffs in 2025, examining the underlying factors and potential ramifications for the industry. In 2024, major players like CVS Health and BioRad Laboratories made headlines by trimming their staff.
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What to Expect When you are Expecting…a Government Shutdown
FDA Law Blog
FEBRUARY 18, 2025
By Richard A. Lewis, , Principal Regulatory Device and Biologics Expert The FDA is currently funded through March 1st, 2025. Come Monday March 3rd, if Congress does not pass a budget or continuing resolution, the FDA will enter a shutdown and shutter many offices and programs while Congress works out their inter-party squabbles on national priorities.
Regulatory considerations for biosimilar clinical efficacy trials
Drug Patent Watch
FEBRUARY 18, 2025
Unlocking the Potential of Biosimilars: Navigating Regulatory Considerations for Clinical Efficacy Trials As the pharmaceutical industry continues to evolve, biosimilars have emerged as a game-changer in the fight against high healthcare costs. These highly similar versions of biologic medications offer a more affordable alternative to their reference products, but their development requires careful consideration of regulatory requirements.
Bridging Innovation & Patient Care: The Growing Role of AI
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!
Gilead’s lenacapavir moves closer to FDA approval for HIV PrEP use
Pharmaceutical Technology
FEBRUARY 18, 2025
The FDA has accepted Gileads new drug application with a decision expected by 19 June 2025.
Biogen buys rights to Stoke’s rare epilepsy drug
Bio Pharma Dive
FEBRUARY 18, 2025
In exchange for $165 million, Biogen now has access to zorevunersen, a potential first-of-its-kind treatment for Dravet syndrome.
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Solid says early data suggest ‘differentiated’ Duchenne gene therapy
Bio Pharma Dive
FEBRUARY 18, 2025
The company raised $200 million after early findings hinted its therapy could be more potent than others like it, including Sarepta Therapeutics’ Elevidys.
FDA grants fast track status to Rznomics’ RZ-001 for HCC
Pharmaceutical Technology
FEBRUARY 18, 2025
The US FDA has granted fast track designation to Rznomics' RZ-001 for the treatment of hepatocellular carcinoma (HCC).
GSK’s 5-in-1 meningococcal shot wins FDA approval
Bio Pharma Dive
FEBRUARY 18, 2025
Penmenvy, which protects against five common types of disease-causing bacteria, is cleared for use in people aged 10 through 25 years old.
HMRI and Novartis Australia sign MoU to expedite medical research
Pharmaceutical Technology
FEBRUARY 18, 2025
HMRI has signed a memorandum of understanding (MoU) with Novartis Australia for expediting medical research to drive healthcare projects.
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
Sanofi Wins FDA Nod for Merilog, First Rapid-Acting Insulin Biosimilar
XTalks
FEBRUARY 18, 2025
The FDA has approved Sanofis Merilog (insulin-aspart-szjj) as the first rapid-acting insulin biosimilar product for the treatment of diabetes. Merilog is a biosimilar to Novo Nordisks NovoLog, a widely used rapid-acting insulin aspart. Merilog is approved for use in adults and pediatric patients six years of age and older. The approval includes both a 3 mL single-patient-use prefilled pen and a 10 mL multiple-dose vial of the biosimilar.
FDA Audits and Inspections: Preparation and Approaches to Addressing Consequences
ACRP blog
FEBRUARY 18, 2025
Although relatively rare, clinical investigator inspections by the U.S. Food and Drug Administration (FDA) can have a significant business impact. Audits are conducted more frequently than regulatory inspections, which are estimated to take place at fewer than 3% of sites, but adequate responses in either case are essential to successful outcomes. Clinical research professionals who deal with complex study issues need to understand requirements, including key areas of Good Clinical Practice and
Beyond copays: Redefining assistance for those with rare diseases and chronic conditions
Bio Pharma Dive
FEBRUARY 18, 2025
Accessia Health helps ease the burden of managing a rare disease or chronic condition.
Understanding Patient Expectations and Preferences in Clinical Trials
Antidote
FEBRUARY 18, 2025
Clinical trials are fundamental to the development of new therapies, but engaging patients effectively remains one of the most significant challenges for research organizations. As competition among similar trials intensifies, understanding patient expectations and preferences has never been more important. For stakeholders in the clinical trial ecosystem, aligning recruitment and retention strategies with these insights can not only drive patient enrollment but also improve retention rates and
Can Dupixent plug treatment gap in bullous pemphigoid?
pharmaphorum
FEBRUARY 18, 2025
The FDA is scheduled to deliver a verdict on Sanofi and Regeneron's Dupixent for rare autoimmune skin disorder bullous pemphigoid in June
NHS England launches first-ever breast cancer screening campaign
Pharma Times
FEBRUARY 18, 2025
New data has shown that around a third of women do not attend screenings after being invited
Four more drugs in keenly watched ALS trial miss the mark
pharmaphorum
FEBRUARY 18, 2025
ALS candidates from Biohaven, Prilenia, Clene, and UCB were unable to slow disease progression in the study, but two showed signs of efficacy
The Role of Collaborative Supply Chains in Improving Patient Outcomes
Pharmaceutical Commerce
FEBRUARY 18, 2025
In the first part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Laura Johnson, senior director of sales, life sciences, Loftware, comments on why she believes supply chain collaboration is becoming increasingly critical today.
The New Age of Decentralized Clinical Trials
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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
First biosimilar fast-acting insulin reaches US market
pharmaphorum
FEBRUARY 18, 2025
Sanofi has claimed FDA approval for the first biosimilar of Novo Nordisk's rapid-acting insulin analogue Novolog
IQED Information Meeting audit 9
Sciensano
FEBRUARY 18, 2025
Event type: closed meeting Audience: health professionals Description: You are kindly invited to the IQED Information Meeting of audit 9, organised by Sciensano in collaboration with the Group of Experts IQECAD , on behalf of the National Institute of Health and Disability Insurance ( NIHDI ). Programme 18.30 : Registration and walking dinner 20.00-22.15 : Presentations and discussion 22.30 : End Registration Participation is free but registration is mandatory.
Shionogi gets approval in Japan for ADHD digital therapeutic
pharmaphorum
FEBRUARY 18, 2025
Shionogi will market the EndeavorRide app, originally licensed from Akili, in Japan following its approval by the MHLW regulator
Do You Have Type 2 Diabetes? Your Participation Could Make a Difference
Trialfacts
FEBRUARY 18, 2025
Contents About the Study Why Participate? Your Rights Who Can Participate? More Study Details About the Research Centre: Location: Research Centre: University of Adelaide Location: Clinical Research Facility, Level 4, Adelaide Health and Medical Sciences Building, Corner North Tce and George St Adelaide SA 5005 Lead Researcher: Professor Karen Jones HREC: This study has been reviewed and approved by the Central Area Local Health Network Human Research Ethics Committee (CALHN HREC) and the Univer
Annapolis, MD, Site Recognized as Top U.S. Enroller for Phase 3 Respiratory Trial
Velocity Clinical Research
FEBRUARY 18, 2025
Congratulations to our Annapolis, MD, site for being recognized as the top U.S. enroller in a Phase 3 respiratory trial. Established in partnership with Luminis Health, this site also marked Velocitys entry into oncology in the U.S. The post Annapolis, MD, Site Recognized as Top U.S. Enroller for Phase 3 Respiratory Trial appeared first on Velocity Clinical Research.
3rd Obesity & Weight Loss Summit
pharmaphorum
FEBRUARY 18, 2025
Join us at the 3rd Obesity & Weight Loss Summit by Hanson Wade on July 14-16, 2025, in Boston, MA. This event brings together experts and professionals in the field of obesity and weight loss to share insights and advancements in the industry. Register now to secure your spot!
Clinical Research Industry Insights: SCOPE Summit 2025
Imperical Blog
FEBRUARY 18, 2025
Get insights on current trends within the clinical research industry from the Imperial team, who recently returned from SCOPE Summit 2025 held in Orlando, Florida. Political, economic, and environmental changes and concerns appeared to preoccupy the minds and energy of many people we encountered daily.… The post Clinical Research Industry Insights: SCOPE Summit 2025 appeared first on Imperial Clinical Research Services Blog.
2nd ADC Payload Summit
pharmaphorum
FEBRUARY 18, 2025
Join us at the 2nd ADC Payload Summit from May 6-8 in Boston, MA, organised by Hanson Wade. This event will feature industry experts and thought leaders sharing insights on the latest trends and developments in the field.
The New Age of Decentralized Clinical Trials
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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.
Dairy-Free Done Right: The Rise of Faba Bean Ingredients
XTalks
FEBRUARY 18, 2025
A vast number of consumers are focusing on eating fewer animal products and more plant-based alternatives, but they are not willing to compromise on taste, texture and nutritional aspects such as protein content. However, replacing dairy in recipe development can cause technical challenges. BENEO offers solutions for these challenges with the help of functional ingredients.
Pharma Pulse 2/18/25: PharmExec's 20th Annual 2025 Pipeline Report, Patient Journey and the Role of the Pharmacist & more
Pharmaceutical Commerce
FEBRUARY 18, 2025
The latest news for pharma industry insiders.
The UK can’t just be a life sciences lab – we need manufacturing success too
pharmaphorum
FEBRUARY 18, 2025
Discover why it's important for the UK to not only excel in life sciences, but also focus on manufacturing success. Learn how these industries can work together for economic growth.
Impact of Telehealth Reimbursement Policies on Federally Qualified Health Centers
Pharmaceutical Commerce
FEBRUARY 18, 2025
A qualitative study examines how Medicaid telehealth reimbursement policies affect staffing and patient-centered care.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
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