United Therapeutics (Nasdaq:UTHR) announced today that the FDA granted premarket approval (PMA) for its LungFX perfusion device. The company designed LungFX for use in ex vivo lung perfusion (EVLP). This procedure enables the assessment of donor lungs outside the body after procurement and before transplantation. United Therapeutics’ wholly owned Lung Bioengineering subsidiary received the PMA […]
United Therapeutics
United Therapeutics touts study results for inhaled Tyvaso treatment
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 […]
FDA approves inhaled pulmonary hypertension treatment from United Therapeutics
United Therapeutics (NSDQ:UTHR) announced today that it received FDA approval 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 […]
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 […]
FDA clears RemUnity drug pump co-developed by Deka, United Therapeutics
United Therapeutics and Deka Research and Development have received FDA 510(k) clearance for the co-developed RemUnity system. The RemUnity system is a subcutaneous delivery system for Remodulin injections. The two companies have co-developed the device that is indicated to treat pulmonary arterial hypertension. “We developed the RemUnity system to address safety and patient convenience problems […]
Smiths Medical, United Therapeutics conspired to stifle generic Remodulin, Sandoz alleges
Smiths Medical allegedly conspired with United Therapeutics to stifle a generic version of pulmonary arterial hypertension drug Remodulin, according to a lawsuit filed this week by Novartis (NYSE:NVS) unit Sandoz. The Smiths Group (LON:SMIN) subsidiary, which is slated for a spinout as a separately traded company next year, makes the infusion pumps and single-use cartridges for the PAH drug treprostinil, sold […]
Medtronic wins FDA nod to deliver PAH therapy with implantable pump
Medtronic (NYSE:MDT) said today that it won FDA approval for its implantable drug-delivery system designed to administer United Therapeutics‘ (NSDQ:UTHR) pulmonary arterial hypertension drug, Remodulin. United Therapeutics is slated to take the lead on commercial promotion of the drug-device system, with support from Medtronic. Get the full story at our sister site, Drug Delivery Business News.
United Therapeutics $216m deal for SteadyMed clears HRS Act waiting period
United Therapeutics (NSDQ:UTHR) said today that it stepped closer to completing its $216 million acquisition of SteadyMed (NSDQ:STDY) after terminating the the HSR Act waiting period. The merger combines two companies that were in court as recently as last November, fighting over patents covering treprostinil, the active ingredient in both companies’ lead products. Read the whole story on our sister […]
United Therapeutics puts $216m on the table to buy rival SteadyMed
United Therapeutics (NSDQ:UTHR) today signed a deal to acquire competitor SteadyMed (NSDQ:STDY) for $4.46 per share in cash at closing and $2.63 per share in cash if the combined company can win approval for SteadyMed’s Trevyent drug-device combination therapy. The merger, valued at $216 million, combines two companies that were in court as recently as last November, fighting […]
United Therapeutics dishes out $210m to settle charity-kickback claims
United Therapeutics (NSDQ:UTHR) has agreed to pay $210 million to squash claims that it used a charity to illegally cover Medicare patients’ out-of-pocket costs in an attempt to boost sales. Drug companies are not allowed to subsidize co-pays for people enrolled in Medicare, but they can donate to independent non-profits that provide co-pay assistance. Get the […]
Appeals court affirms ruling in United Therapeutics, SteadyMed patent spat
A federal appeals court has affirmed an earlier ruling by the Patient Trial and Appeal Board of the U.S. Patent and Trademark Office, invalidating 22 claims of a patent owned by United Therapeutics (NSDQ:UTHR). The patent covered treprostinil, the active ingredient in both SteadyMed‘s (NSDQ:STDY) Trevyent and United Therapeutics’ Remodulin. The court’s ruling sent STDY shares up 8% today, trading […]
