Infusion device issues sink Supernus’ Parkinson’s filing

This Week

Oct 12, 2022

Merck KGaA extends smart drug delivery pact with Biocorp

Eisai cuts the ribbon on $69M injectable drug delivery facility

Two years after FDA refusal, infusion device issues sink Supernus’ Parkinson’s filing

NIH awards $15M contract to Intravacc's nasal gonorrhea vaccine

scPharmaceuticals finally wins FDA nod for its on-body infusor for congestive heart failure

The Top Line Podcast: don’t miss out on the newest episode where we discuss ASCO data, rising health tech stars, and more. Listen now.

 

Featured

Merck KGaA extends smart drug delivery pact with Biocorp

Merck KGaA has extended its collaboration with Biocorp. The German drugmaker has signed up to work with Biocorp to develop a version of a Bluetooth enabled clip-on device that is specific to one of its drug delivery devices.
 

Top Stories

Eisai cuts the ribbon on $69M injectable drug delivery facility

Eisai’s ¥10 billion ($69 million) bet on injectable drug delivery is complete. The Japanese drug developer plowed the money into the construction of an injectable formulation research building, positioning it to continue its expansion beyond oral drug delivery.

Two years after FDA refusal, infusion device issues sink Supernus’ Parkinson’s filing

Questions about an infusion device have scuttled Supernus Pharmaceuticals’ attempt to win approval of a Parkinson’s disease therapy. The complete response letter marks the second time in two years that the FDA has knocked back a filing for approval of the continuous treatment of motor fluctuations.

NIH awards $15M contract to Intravacc's nasal gonorrhea vaccine

The NIH has agreed to fund development of a nasally administered gonorrhea vaccine. Intravacc secured the financial support, landing a $14.6 million contract as it works to move its NGoXIM candidate into a phase 1 trial.

scPharmaceuticals finally wins FDA nod for its on-body infusor for congestive heart failure

After five years and two unsuccessful attempts, scPharmaceuticals has finally pushed its on-body infusor for the treatment of congestive heart failure across the FDA finish line. Furoscix becomes the first self-administered, subcutaneous loop diuretic for those with worsening HF.
 
Fierce podcasts

Don't miss an episode

'The Top Line': Eisai's Alzheimer’s drug, Pfizer's COVID ads

This week on "The Top Line," we talk about trial results for Eisai and Biogen's Alzheimer’s drug, which were surprisingly good, and we dig into what comes next. We also discuss how Pfizer is ramping up its DTC ad campaign for its COVID shots, most recently spending big on a booster ad for the NFL season.

 

Resources

eBook

The Essential Components of a Successful Remote Patient Monitoring Program

Looking to implement a remote patient monitoring (RPM) program at your organization? Download the eBook from Health Catalyst to learn the essential components of successful RPM programs.
eBook

How the Cloud Puts Precision Medicine Within Reach for Startups

In this free guide, explore how Cloud Computing is enabling emerging biopharma organizations to decrease time-to-discovery in pursuit of breakthrough treatment modalities.
Whitepaper

Navigating the Data Deluge: Turning Data Into Insight Across the Health Care and Life Sciences Industries

Learn the benefits of unlocking data insights across the healthcare and life sciences ecosystem.
eBook

Optimize the value and impact of your real-world data

With real-world data playing a significant role in health care decisions, life sciences leaders need to maximize their data investments. The best place to start is right here, with our e-book on the four steps to a more coordinated, connected real-world data strategy.
Whitepaper

Commercializing Gene Therapies, Part I - Introduction

This paper is the first in a 4-part series focused on developing commercial models for gene therapies
Whitepaper

A Guide to Pre-Validated Software-as-a-Service LIMS

SaaS LIMS from LabVantage Solutions Is Pre-Validated for Regulated Industries, Delivering Maximum Flexibility, Uptime, and Security.
Whitepaper

Achieving faster formulation for First In Human supplies

Supporting your product development programme through experience, expertise, and efficiency.

Video

Improve Life Sciences Research with AI Workflow Automation

Can an optimized research process--including AI-powered workflow and process automation tools--help get breakthrough drugs to market faster?
Video

Building a Broader Tissue Research Ecosystem

Learn how a centralized platform for pathology images, metadata, and analysis results can connect previously siloed research initiatives and advance our collective understanding of tissue.
Whitepaper

The Most Suitable Dosage Form Technologies for the Oral Delivery of Lipid-Based Formulations

What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations?
Research

Versatility of Softgel Technology - Encapsulation of a Volatile Compound

Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound.
Whitepaper

Lipid-Based Drug Delivery System to Bring Poorly Soluble Drugs to Market

How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market?
Webinar

The Faster Path From Pre-Filled Syringe to Auto-Injector

Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar.

Whitepaper

Formulation Strategies When Transitioning From Vial to PFS

Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.

Custom Resource Center

Scaling life sciences companies: Discover resources to support growth and innovation

Read through this library of resources to find out how you can strengthen innovation and efficiency, improve safety and quality, and prioritize resources to support your long-term goals.

Whitepaper

Softgel Formulation Enables Oral Delivery of Testosterone

Clarus Therapeutics (Clarus) is a men’s specialty pharmaceutical company that partnered with Catalent to develop a unique and convenient drug delivery form for their hormone replacement therapy.

Whitepaper

Strategies for the Optimal Scale-up & Tech Transfer of Oral Small Molecules

Learn more about how the transition from early to late phase of a small molecule program plays a pivotal role in a program’s ultimate success.

Whitepaper

Plan for scalable process liquid and buffer preparation

Explore how Thermo Scientific’s Process Liquid Preparation Services can help you plan for scalable buffer preparation.