United Therapeutics Archives - Medical Design Sourcing

MannKind shares slide 22% as FDA delays review of Tyvaso DPI new drug application

Inhalable insulin specialist MannKind Corp. (NASDAQ:MNKD) announced that the FDA is extending its deadline to review United Therapeutics’ (NASDAQ:UTHR) new drug application (NDA) for Tyvaso DPI from February to May.

MannKind is developing Tyvaso DPI (treprostinil) in collaboration with United Therapeutics.

The drug candidate Tyvaso DPI would potentially treat pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.

MNKD shares fell 22.54% to $2.84 in afternoon trading, while UTHR shares dipped 13.81% to $166.45.

FDA has asked for additional information about the pulmonary safety of Tyvaso DPI related to a pending citizen petition filed in July 2021. The petition questions the safety of fumaryl diketopiperazine (FDKP), an excipient used in Tyvasson DPI. The excipient is also used in MannKind’s inhalable insulin product Afrezza.

The petition requests that FDA require additional testing …

Gilead Sciences, Merck near the top of Newsweek’s most responsible companies list

A handful of big names in drug discovery and development are among the 500 “most responsible,” according to Newsweek.

The outlet published its “America’s Most Responsible Companies 2022” list, marking the third installment of the compilation (in partnership with Statista), this time expanded to include 500 of the largest public corporations around. Companies were judged with an overall score out of 100 that combined assessments on environmental, social and corporate governance performance.

Gilead Sciences (NSDQ:GILD), Merck (NYSE:MRK) and Pfizer (NYSE:PFE) were among the pharmaceutical companies to land a spot in the top-500, with a number of other drug development, pharmaceutical processing and manufacturing companies included.

The highest-ranking company was Gilead in sixth, landing an overall score of 89.9 points (90.6 environmental, 81.1 social and 98.2 corporate governance).

Merck was next-best in ninth at 89.3 points (94.6, 81.4, 92.…

United Therapeutics touts study results for inhaled Tyvaso treatment

Image from United Therapeutics

United Therapeutics (NSDQ:UTHR) today announced positive results from an analysis of forced vital capacity (FVC) change with its Tyvaso treatment.

Research Triangle Park, N.C.-based United Therapeutics developed Tyvaso (treprostinil) as an inhalation solution for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The FDA approved the treatment in April 2020.

Get the full story at our sister site, Drug Delivery Business News.

FDA approves inhaled pulmonary hypertension treatment from United Therapeutics

Image from United Therapeutics

United Therapeutics (NSDQ:UTHR) announced today that it received FDA clearance for its Tyvaso inhalation solution for pulmonary hypertension.

Research Triangle Park, N.C.-based United Therapeutics’ Tyvaso (treprostinil) inhalation solution is designed to treat patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability, according to a news release.

Get the full story at our sister site, Drug Delivery Business News.

United Therapeutics launches Remunity pump for Remodulin

United Therapeutics (NSDQ:UTHR) announced today that it launched its Remunity pump for Remodulin in patients with pulmonary arterial hypertension (PAH).

Research Triangle Park, N.C.-based United Therapeutics’ Remunity pump initially received FDA clearance in May 2019 for patient filling, adding another 510(k) clearance in February 2020 to enable cassettes to be prefilled with Remodulin by contracted specialty pharmacies in an effort to increase convenience for patients, according to a news release.

Get the full story at our sister site, Drug Delivery Business News.

United Therapeutics launches Remunity pump for Remodulin

United Therapeutics (NSDQ:UTHR) announced today that it launched its Remunity pump for Remodulin in patients with pulmonary arterial hypertension (PAH).

Research Triangle Park, N.C.-based United Therapeutics’ Remunity pump initially received FDA clearance in May 2019 for patient filling, adding another 510(k) clearance in February 2020 to enable cassettes to be prefilled with Remodulin by contracted specialty pharmacies in an effort to increase convenience for patients, according to a news release.

The Remunity pump for Remodulin injection is indicated for the continuous subcutaneous delivery of Remodulin in adults greater than 22 years of age.

Remunity’s cassettes contain enough drug for up to three days and arrive from the specialty pharmacy prefilled to eliminate the need for a patient to mix or fill. The water-resistant, small device is programmed using a wireless remote to increase safety and simplicity of use.

“We are excit…