Archive

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Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

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Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Scrip, or if you love it how it is, now is the time to have your voice heard.

Galapagos Expands Point-Of-Care CAR-T Study To The US

 

CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.

Analysts Split On Eisai’s Chances Of Changing EU Regulator’s Mind On Leqembi

 

A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand


GSK Looks To Catch Up In mRNA Vaccines With New CureVac Deal

 

GSK will assume full control of mRNA shots in infectious disease, allowing CureVac to cut costs and pivot its research to oncology.

Better Tolerability Could Make Zealand’s Amylin Drug A Future Obesity Leader

 

The Danish company’s amylin analog looks like a match for GLP-1 agonists on efficacy, and better on tolerability, and is now moving quickly into Phase II.

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Podcast: Navigating IND Applications & Pre-IND Meetings: Key Considerations And Misconceptions

In this podcast, glean insights from an experienced regulatory leader at Allucent and an expert currently navigating the complexities of the pre-IND stage at Ridgeline Therapeutics. They dive into best practices for pre-IND meetings and IND applications, helping you develop strategies to succeed in this increasingly challenging environment.

In Partnership with EDQM

Scrip Asks...What Does 2024 Hold For Biopharma? Transformative Technology

Discover what’s on the horizon for the pharma industry as truly transformative technologies revolutionize the way drugs are developed, delivered and manufactured.


The Scrip Awards Podcast, Episode 1: Genmab: The Ongoing Evolution Of Europe’s Antibody Powerhouse

 

A new podcast series marking 20 years of the Scrip Awards and their recognition of biopharma sector innovation.

In Partnership with Cerba Research

Infectious Disease Clinical Trials: Navigating Innovation & Rising Complexity

Stay current with trends in infectious disease clinical trials, with fresh insights from a recent roundtable event. Discover how the landscape is evolving and what to expect in the future, with key takeaways from industry experts.

Amylyx Resets As A Clinical-Stage Company, Withdrawing Relyvrio

 

The ALS treatment Relyvrio was removed from the market as expected following a Phase III trial failure.

Publisher’s Spotlight: Citeline News And Insights App

 
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Introducing the all-new Citeline News and Insights app, providing seamless access to all your favorite award-winning publications. Explore the latest articles from Pink Sheet, Scrip, In Vivo, Medtech Insight, Generics Bulletin and HBW Insight, all in one stylish, intuitive and user-friendly platform.


Idorsia Asset Sell Off Continues But Future Still Up In The Air

 

A new outlicensing deal with Viatris will keep it afloat for now but Idorsia needs more time, money and R&D success to secure its long-term future.

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Competence And Fairness At One Of Europe’s Dynamic API Producers

Read the article to learn more about how fostering a culture of competence and fairness is allowing CF Pharma to deliver on its API and CMO capabilities.

Quick Listen: Scrip's Five Must-Know Things

 
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In this week's podcast edition of Five Must-Know Things podcast: US Medicare price negotiations get soft landing; Medicare negotiations and patent cliff acceleration; Novo Nordisk steps into heart failure; PCSK9s and the convenience battle; and an investor’s view of Korean biotech potential.

Big Rebates Already A Big Factor For Drugs On Medicare Negotiation List

 
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Long-awaited list has a couple of surprises that are expected to face biosimilar competition either before negotiated prices are implemented in 2026 or during that year.


Podcast: Diversity, Equity, and Inclusion Measures Continue to Evolve in the Clinical Space

 
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Listen to expert perspectives from Tracey Parker, Vice President, Biometrics, Advanced Clinical and Rebecca Starkie, Senior Global Patient Engagement Director, Advanced Clinical on the recent history of DEI in clinical trials and the barriers to patient participation. Examine the key drivers that have influenced the development of diversity, equity, and inclusion programs for clinical trials.

Mazdutide Consolidates Potential Efficacy Lead In China GLP-1 Obesity Race

 

Higher-dose mazdutide showed superiority over placebo after 24 weeks of treatment in a Phase II trial in Chinese adults with obesity. The potential best-in-class efficacy profile of the Lilly-originated GLP-1 receptor agonist is expected to help it gain the upper hand in the race for the leadership of the country's obesity market, estimated at $5.5bn in 2030.

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UDI Requirements: The Fear of the Unknown

In recent years, global regulatory requirements have evolved in many areas of the MedTech product life cycle management.

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Navigating The Regulatory Landscape - Enhancing Spectroscopy Validation And Compliance In The Pharmaceutical Lab

Fourier-transform infrared (FTIR) spectroscopy is one of the most common forms of infrared spectroscopy and one of the most popular analytical techniques for quality assurance (QA), quality control (QC), and materials identification in the pharmaceutical industry.