In a preview of their panel discussion at AAPS PharmSci 360 2026, Alfred Rumondor, PhD, AbbVie, and Swita Singh, PhD, Bristol Myers Squibb, discuss the implementation of risk-based approaches for CMC.
News|Articles|December 30, 2013
Supernus Announces FDA Approval of Orenitram
Author(s)Melanie Sena
Supernus Pharmaceuticals receives FDA approval of Orenitram for the treatment of pulmonary arterial hypertension.
Advertisement
Supernus developed the extended release formulation of Orenitram under a development and license agreement with United Therapeutics Corporation. The product uses EnSoTrol, Supernus' osmotic technology platform. Per the license agreement between Supernus and United Therapeutics, United Therapeutics will pay Supernus certain milestone fees and royalties associated with the commercialization of the product worldwide.
Source:
Advertisement
Related to this article
Merck licenses SciBrunch's preclinical KRAS G12D inhibitor for $2.13B, raising tech transfer and scale-up questions for oral cancer drug development.
Ronald Piervincenzi, USP, urges drugmakers and purchasers to act on supply chain resilience to curb drug shortages and shape better policy.
Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
This article discusses risk-based lifecycle governance, system implementation considerations, and the progression of batch record control from paper-based to fully electronic systems.
Ronald Piervincenzi, USP, explains why manufacturers should act now and how benchmarking could reward reliable generic drug suppliers.
The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.
Florin Muraru, Gourav Pandey, and Richard Jaenisch explain where human sign-off belongs as multi-agent AI and document-parsing models reach GxP.
Advertisement
Advertisement