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 […]
United Therapeutics
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 […]
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. The system includes Medtronic’s SynchroMed II implantable pump and a new intravascular […]
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. In the deal, United Therapeutics will pay […]
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, […]
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. The settlement […]
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 […]
United Therapeutics beats sales, earnings estimates in Q3
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% […]
United Therapeutics wins FDA nod for third-gen Tyvaso TD-300/A nebulizer
United Therapeutics (NSDQ:UTHR) said today that its third-generation inhalation device designed for use with its Tyvaso treprostinil inhalation solution won FDA approval. Tyvaso first won FDA approval in 2009 as a treatment for pulmonary arterial hypertension, the company said, with an ultrasonic nebulizer. United Therapeutics touted its drug-device combo as the most-prescribed inhalation therapy for PAD […]
United Therapeutics logs Q2 beat
Shares in United Therapeutics (NSDQ:UTHR) fell today even though the biotech beat expectations on Wall Street with its second quarter results. The company recorded a net loss for the quarter and revealed that it has set aside $210 million for a possible settlement with the Dept. of Justice, according to United’s quarterly regulatory filing. The DOJ […]
