Novartis is “actively” managing its existing relationships with Chinese service providers to mitigate risks if the Biosecure Act passes.
Enforcement Report - Week of April 3, 2024
The FDA has legal clearance to approve Liquidia’s pulmonary arterial hypertension treatment Yutrepia after two recent court developments.
Par Issues Voluntary Nationwide Recall of One Lot of Treprostinil Injection
Par Pharmaceutical Issues Voluntary Nationwide Recall of One Lot of Treprostinil Injection Due to Potential for Silicone Particulates in the Product Solution
United Therapeutics starts litigation with FDA over rival Liquidia`s drug application
Actavis's Generic Treprostinil Approval in the U.S.
MORRISVILLE, N.C., Dec. 05, 2022 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) announced today a collaboration with Sandoz Inc. (Sandoz) and Mainbridge Health Partners LLC (Mainbridge) to support the development of a new subcutaneous pump for infusion of Treprostinil Injection, a generic form of Remodulin®, for which Liquidia has the exclusive rights to promote and commercialize with Sandoz.
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that a preliminary analysis of the EXPEDITE study in patients suffering from World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) demonstrated that 79% of patients in the study achieved an Orenitram (treprostinil) extended-release tablet dose of at least 4 mg three times daily (TID), for a 12 mg total daily dose at 16 weeks, after an up to eight week induction treatment period with Remodulin (treprostinil) injection. Detailed study results will be made available through scientific disclosure at upcoming medical conferences and in peer-reviewed publications.
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the first patient has enrolled in the phase 3 TETON 2 study which will evaluate Tyvaso in 396 adult patients with idiopathic pulmonary fibrosis (IPF) at sites outside the United States and Canada. This second registration study is part of the broader global TETON program evaluating Tyvaso for the treatment of IPF. The 52-week study will evaluate the impact of Tyvaso on a key prognostic indicator for IPF known as forced vital capacity (FVC). IPF is a progressive lung disease characterized by the loss of the ability of the lungs to transfer oxygen into the blood, ultimately resulting in respiratory failure and death.