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Post by Clement on Jul 24, 2019 7:16:32 GMT -5
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Post by mytakeonit on Jul 24, 2019 12:10:31 GMT -5
OH NO !!! If UTHR even mentions Afrezza and MNKD ... then I won't get the pricing that I want when I return from Vegas !!! Gotta find more $$$ by July 30th !!!
But, that's mytakeonit
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Post by Omega on Oct 10, 2019 12:25:28 GMT -5
Respira Therapeutics Regains North America Rights from United Therapeutics to Phase 2 Inhaled Drug-Device Product, RT234, for Pulmonary Hypertension Indications ALBUQUERQUE, N.M., October 10, 2019— Respira Therapeutics, a clinical-stage specialty pharmaceutical company developing next-generation cardiopulmonary disease-targeted inhalation products, has regained full worldwide research, development, and licensing rights to the company’s novel inhaled drug-device combination product, RT234, following a decision by United Therapeutics Corporation (Nasdaq: UTHR) to conclude its collaboration with Respira based on a strategic prioritization of assets within United Therapeutics’ product development portfolio. RT234 recently concluded successful Phase 1 clinical studies and is currently in Phase 2 studies for a pulmonary arterial hypertension (PAH) indication. Respira and United Therapeutics entered into a strategic collaboration in April 2017 for the co- development and exclusive license of RT234 for pulmonary hypertension indications in North America markets. The research and development costs of this drug-device candidate were supported by United Therapeutics. As a result of the conclusion of the collaboration, Respira has no further obligation to United Therapeutics regarding the RT234 program, and United Therapeutics has no future development funding obligations. All development, commercialization, and licensing rights to the RT234 program, including intellectual property rights and all program information generated under the collaboration, have reverted to Respira. United Therapeutics will retain its minority preferred equity stake in Respira.
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Post by uvula on Oct 10, 2019 12:50:30 GMT -5
Good or bad for mnkd? Was this done because uthr would rather focus on the drug being developed with mnkd? Thank you
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Post by boca1girl on Oct 11, 2019 7:58:11 GMT -5
Good or bad for mnkd? Was this done because uthr would rather focus on the drug being developed with mnkd? Thank you Looks to me to be GOOD. UTHR signed that deal back in 2017 and now will strategically focus on products in it’s pipeline (TreT).
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Post by kite on Oct 22, 2019 10:58:09 GMT -5
United Therapeutics Announces FDA Approval Of Updated Label For Orenitram Reflecting Results Of FREEDOM-EV Study ir.unither.com/file/Index?KeyFile=400498356SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Oct. 21, 2019 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplement to the New Drug Application for Orenitram® (treprostinil) Extended-Release Tablets reflecting data from the FREEDOM-EV study in patients with pulmonary arterial hypertension (PAH). The FDA-approved labeling has now been updated to indicate that Orenitram delays disease progression when used in conjunction with an approved oral background PAH therapy. The primary efficacy endpoint of the FREEDOM-EV study was time to first clinical worsening (morbidity or mortality) event. The new label notes that treatment with Orenitram resulted in a significant increase in the time to first clinical worsening event compared with patients who received placebo, which was associated with a reduction in the risk of an event. The treatment effect on time to first clinical worsening due to disease progression was consistent across subgroups. "We are pleased that the FDA has approved the updated Orenitram label, which should bolster the competitive positioning of this important prostacyclin analogue therapy," said Leigh Peterson, Ph.D., United Therapeutics' Vice President, Product Development. "We believe this improved label will provide physicians and patients with even more confidence in the efficacy and benefit of Orenitram." "Data from the FREEDOM-EV study have already been well-received by the PAH community throughout the course of scientific and medical discourse," said Michael Benkowitz, President and Chief Operating Officer of United Therapeutics. "We believe this FDA approval will continue to expand the commercial opportunity for Orenitram." Orenitram was originally approved by FDA in 2013, with a label indicating that it improves PAH patients' exercise capacity when used as a monotherapy.
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Post by Clement on Oct 23, 2019 7:19:11 GMT -5
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Post by rfogel on Dec 14, 2019 8:44:45 GMT -5
www.bizjournals.com/washington/news/2019/12/13/united-therapeutics-stalled-in-launching-drug.html"United Therapeutics Corp. (NASDAQ: UTHR) will look to launch its implantable pump for Remodulin, the company’s flagship pulmonary arterial hypertension drug, later than planned. The Maryland company announced Friday a potential rollout of the device is now expected in 2021 rather than 2020 because Minneapolis medical equipment company Medtronic (NYSE: MDT) — which developed the system with United Therapeutics — hasn’t yet satisfied conditions required by the Food and Drug Administration. The regulatory agency first approved Medtronic’s premarket approval application for the implantable system in December 2017, then greenlighted United Therapeutics’ new drug application in July 2018. “Medtronic has indicated that these conditions will not be satisfied during 2020,” United Therapeutics reported in a federal filing Friday. “UT has no control over when or whether these conditions will be met.” United Therapeutics’ stock fell nearly 4% to $90.29 per share by Friday afternoon, falling as low as $89.19 per share earlier in the day. It’s a setback for the Silver Spring biotech, which has been working to innovate and carve out new revenue streams as patents for key drugs expire and generic competitors enter the market. The implantable system for Remodulin would bring to patients a new intravenous delivery method for the drug — and would help United Therapeutics maintain its edge over growing threats to its top line, analysts told us last year. This system and other implantable pumps can’t dispense generics, so patients using them must continue to take branded Remodulin. And doctors often don’t like to prescribe generics for patients with late-stage pulmonary arterial hypertension, because there’s variability in generic formulations; they’re not exact copies of the branded drugs, analysts have said. The impact of generic competition has already manifested in revenue to a degree, with third quarter revenue decreasing from $412.7 million in 2018 to $401.5 million in 2019 — an $11.2 million drop from a $44.3 million year-over-year decrease in sales of PAH drug Adcirca, after a generic form of it was released in August 2018. Revenues from United Therapeutics’ four other commercial products softened the blow, and net product sales also increased year-over-year: by $14.7 million for Remodulin, $8.2 million for Orenitram, $7.2 million for Unituxin and $3 million for Tyvaso. For the system Medtronic manufactures, “We rely heavily on Medtronic for the success of our program,” United Therapeutics said in recent filings. “Medtronic’s failure to comply with the ongoing obligations under the consent decree could adversely impact Medtronic’s ability to manufacture and supply the Implantable System for Remodulin,” the filings read. “In the event Medtronic is unwilling or unable to supply the system for any reason, our ability to meet patient demand and generate additional revenues will be materially adversely impacted; any delays in supply could also adversely impact our ability to meet patient demand and generate revenues.” It’s one of three systems United Therapeutics CEO Martine Rothblatt highlighted on an October earnings call, when she said she expects “no fewer” than three FDA approvals in 2020. The other two were RemUnity, a Remodulin pump with disposable cartridges that it’s developing with New Hampshire-based DEKA Research & Development Corp., and Trevyent, a product from SteadyMed that United Therapeutics acquired along with the company last year. In the first quarter of 2020, the company plans to open its first xenotransplantation facility and move toward filing for FDA approval for two drugs: a neuroblastoma therapy Unituxin in small cell lung cancer and PAH treatment Tyvaso in patients with interstitial lung disease and pulmonary fibrosis. Within the next year, the company also plans to begin clinical development for a less painful form of Remodulin and a once-daily form of Orenitram, another PAH drug that recently earned approval for another use."
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Post by uvula on Dec 14, 2019 10:04:27 GMT -5
Are "we" the less painful form of remodulin mentioned at the end of the article?
It sounds like medtronic is sanofi-ing uthr.
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Post by kite on Dec 19, 2019 16:14:11 GMT -5
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Post by mytakeonit on Dec 19, 2019 17:02:26 GMT -5
Only about $1.75M ... so I hope I'm on the Xmas list.
But, that's mytakeonit
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Post by kite on Jan 6, 2020 7:50:18 GMT -5
ir.unither.com/file/Index?KeyFile=402038529SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Jan. 6, 2020 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) announced today that Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics, will provide an overview and update on the company's business at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco, California. The presentation and the immediately following Q&A session will take place on Monday, January 13, 2020, from 1:30 PM to 2:25 PM Pacific Standard Time, and can be accessed via a live webcast on the United Therapeutics website at www.unither.com under the "Investors" tab in the "Events and Presentations" section. An archived, recorded version of the presentation and the Q&A session will be available approximately twenty-four hours after the Q&A session ends and can be accessed at the same location for 30 days.
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Post by Clement on Jan 9, 2020 9:01:14 GMT -5
1:30 PM to 2:25 PM Pacific Standard Time
55 minutes
a lot to talk about?
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Post by uvula on Jan 9, 2020 18:31:14 GMT -5
If anyone listened to this could you please provide a summary of any mnkd stuff?
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Post by uvula on Jan 10, 2020 9:16:29 GMT -5
If anyone listened to this could you please provide a summary of any mnkd stuff? Oops, isn't until Jan 13.
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