| 03.23.22 | Argenx’s subcut Vyvgart hits goal in phas e 3; Ipsen starts $66M Somatuline autoinjector project

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Webinar: Key Challenges & Opportunities in the Process Scale-Up of Oral Solid Dosage Forms

Tuesday, April 5 | 11am ET / 8am PT

Join this webinar to hear experts share insights into faster drug product manufacturing in a large-scale setting and discuss upcoming trends in oral solid dose form manufacturing. Register Now.

Today's Rundown

Argenx's subcutaneous Vyvgart matches IV sibling in phase 3, clearing path to FDA filing this year Facing generic rivals, Ipsen starts $66M Somatuline autoinjector project Vallon's abuse-resistant Adderall fails clinical trial, causing stock to crater With midphase data in hand, MediPrint lands investment to take drug delivery contact lens deeper into the clinic Alnylam sues Pfizer and Moderna claiming infringement on its delivery technology for COVID shots

Featured Story

Argenx's subcutaneous Vyvgart matches IV sibling in phase 3, clearing path to FDA filing this year

By Nick Paul Taylor

Argenx’s subcutaneous Vyvgart has hit the primary endpoint in a phase 3 trial, clearing the biotech to file for approval of a formulation it expects to become the most popular version of the autoimmune drug.

This week's sponsor is MASS.

Facing generic rivals, Ipsen starts $66M Somatuline autoinjector project

By Nick Paul Taylor

Ipsen is investing €60 million ($66 million) in an electronic autoinjector for its blockbuster cancer drug Somatuline. Facing generic competition, the French drugmaker has partnered with Phillips-Medisize on a delivery device it expects to enable patients to administer the drug independently at home.

Vallon's abuse-resistant Adderall fails clinical trial, causing stock to crater

By Nick Paul Taylor

Vallon Pharmaceuticals’ abuse-resistant Adderall has flunked a key test. ADAIR performed no better than the reference formulation of the stimulant dextroamphetamine on a measure of abuse liability, causing the trial to miss its primary endpoint and Vallon’s share price to collapse.

With midphase data in hand, MediPrint lands investment to take drug delivery contact lens deeper into the clinic

By Nick Paul Taylor

Investors have bought into MediPrint Ophthalmics’ vision for drug delivery contact lenses. With a phase 2b of its lead glaucoma asset looming into view, MediPrint has pulled together a series A to bankroll its next steps.

Alnylam sues Pfizer and Moderna claiming infringement on its delivery technology for COVID shots

By Kevin Dunleavy

Alnylam has filed lawsuits claiming COVID-19 vaccine producers Moderna and Pfizer infringed on its patent for a delivery technology employed by both shots. The moves come after Arbutus and Genevant sued Moderna, claiming infringement on the same technology.

Webinar: Inside the Pharmacodynamic Toolbox: Developing CNS-Active Drugs Faster

Thursday, April 7, 2022 | 11:00 am ET / 8:00 am PT

Find out how to strategically include validated models of pain, anxiety, and other psychiatric conditions as part of a battery of tests for cognition and safety to evaluate a drug’s potential for abuse or dependence, as well as its ability to enhance or impair performance. Register now.

Resources

Industry Report: The Top Four Barriers to Successful KOL Engagement

eBook: Leveraging Clinical Data for Study Success

Sponsored by: Medidata, a Dassault Systèmes company

The landscape of clinical trials has been permanently changed. Today's trials require sponsors to modernize their use of technology and data to adapt. This eBook provides an overview of how sponsors can empower trials with real-time performance data to improve study integrity, reduce risks, optimize patient safety, and increase trial success rates.