| 03.02.22 | FDA delays decision on United Therapeutics inhaler; COPD Foundation backs antiviral nasal spray

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Webinar: Advancements of Delayed Release Technology

Join this webinar to learn how softgel capsules, formed by both pectin and gelatin, are used in OptiGel® DR, a new delayed release delivery technology for pharmaceutical applications. Register today!

Today's Rundown

Lung safety review delays FDA decision on United's Tyvaso DPI COPD Foundation links arms with Ena on antiviral nasal spray ahead of phase 2 trials in COVID-19, flu Trevi revs up extended-release opioid cough program, exiting phase 2 early and racing into next stage Hovione allies with Zerion to boost oral drug bioavailability After raking in billions with its COVID shot, Moderna faces patent infringement suit related to vaccine delivery tech

Featured Story

Lung safety review delays FDA decision on United's Tyvaso DPI

By Nick Paul Taylor

The FDA has delivered another twist in United Therapeutics’ long-running effort to win approval for the dry powder version of pulmonary hypertension drug Tyvaso. After rejecting the drug last year, the FDA has delayed its decision on the resubmission to review data on the safety of an excipient.

Webinar: Harnessing Parallel Workstreams to Speed Your Biologic into Phase 1-3 Clinical Trials

Wednesday, March 16 | 11am ET / 8am PT

This webinar will explore the feasibility of integration and how taking parallel approach enables each activity to be fully executed within a typical vs compressed timeframe, yet enables the overall project timeline to be shortened, often significantly. Register Now.

COPD Foundation links arms with Ena on antiviral nasal spray ahead of phase 2 trials in COVID-19, flu

By Nick Paul Taylor

The COPD Foundation has stepped up to support development of Ena Respiratory’s antiviral nasal spray for use in people with chronic lung diseases. Ena is preparing to run phase 2 studies to test the ability of the nasal spray to prevent COVID-19 and influenza.

Trevi revs up extended-release opioid cough program, exiting phase 2 early and racing into next stage

By Nick Paul Taylor

Trevi Therapeutics has linked its oral, extended-release formulation of the opioid analgesic nalbuphine to reduced cough frequency in idiopathic pulmonary fibrosis patients, prompting it to wrap the phase 2 trial up early and push deeper into the clinic.

Hovione allies with Zerion to boost oral drug bioavailability

By Nick Paul Taylor

Hovione has expanded its oral drug delivery toolkit. Working with Zerion Pharma, the company plans to commercialize technology for overcoming the common problem of low drug solubility.

After raking in billions with its COVID shot, Moderna faces patent infringement suit related to vaccine delivery tech

By Fraiser Kansteiner

Last last year, Moderna lost a legal bid to invalidate two Arbutus Biopharma patents tied to the delivery of its COVID-19 vaccine. At the time, it wasn’t so much a question of whether Arbutus would sue the mRNA vaccine giant for infringement, but when. Now, the other shoe has dropped.

Webinar: Strategies to Optimize the Dosage Form Design Process to Create Better Treatments

Watch this webinar to hear from experts as they use case studies to demonstrate how the right guidance, at the right time, can help drug developers create better treatments.