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United Therapeutics

United Therapeutics touts study results for inhaled Tyvaso treatment

June 30, 2021 By Sean Whooley

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Pharmaceutical, Respiratory Tagged With: United Therapeutics

FDA approves inhaled pulmonary hypertension treatment from United Therapeutics

April 1, 2021 By Sean Whooley

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 […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance, Respiratory Tagged With: FDA, United Therapeutics

United Therapeutics launches Remunity pump for Remodulin

February 10, 2021 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Drug Pumps, Drug-Device Combinations, Featured, Vascular Tagged With: DEKA Research and Development Corp., United Therapeutics

FDA clears RemUnity drug pump co-developed by Deka, United Therapeutics

May 7, 2019 By Danielle Kirsh

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 […]

Filed Under: 510(k), Regulatory/Compliance Tagged With: DEKA Research and Development Corp., United Therapeutics

Smiths Medical, United Therapeutics conspired to stifle generic Remodulin, Sandoz alleges

April 19, 2019 By Brad Perriello

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 […]

Filed Under: Drug Pumps, Drug-Device Combinations, Featured, Legal News Tagged With: Novartis, sandoz, Smiths Group plc, Smiths Medical, United Therapeutics

Medtronic wins FDA nod to deliver PAH therapy with implantable pump

July 31, 2018 By Sarah Faulkner

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.

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance, Wall Street Beat Tagged With: Medtronic, United Therapeutics

United Therapeutics $216m deal for SteadyMed clears HRS Act waiting period

July 20, 2018 By Fink Densford

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Mergers & Acquisitions, Pharmaceutical, Vascular Tagged With: SteadyMed Therapeutics, United Therapeutics

United Therapeutics puts $216m on the table to buy rival SteadyMed

April 30, 2018 By Sarah Faulkner

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 […]

Filed Under: Drug-Device Combinations, Mergers & Acquisitions, Pharmaceutical, Vascular, Wall Street Beat Tagged With: SteadyMed Therapeutics, United Therapeutics

United Therapeutics dishes out $210m to settle charity-kickback claims

December 21, 2017 By Sarah Faulkner

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 […]

Filed Under: Drug-Device Combinations, Legal News, Pharmaceutical, Wall Street Beat Tagged With: Johnson and Johnson, Pfizer, United Therapeutics

Appeals court affirms ruling in United Therapeutics, SteadyMed patent spat

November 14, 2017 By Sarah Faulkner

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 […]

Filed Under: Drug-Device Combinations, Legal News, Patent Infringement, Pharmaceutical, Vascular, Wall Street Beat Tagged With: SteadyMed Therapeutics, United Therapeutics

United Therapeutics beats sales, earnings estimates in Q3

October 25, 2017 By Sarah Faulkner

Shares in United Therapeutics (NSDQ:UTHR) rose today after the biotech beat expectations on Wall Street with its third quarter results. The Silver Spring, Md.-based company posted profits of $267.3 million, or $6.28 per share, on sales of $445.5 million for the 3 months ended Sept. 30, for bottom-line growth of 71% on sales growth of 9.1% compared […]

Filed Under: Biotech, Drug-Device Combinations, MassDevice Earnings Roundup, Pharmaceutical, Wall Street Beat Tagged With: United Therapeutics

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