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SteadyMed Therapeutics

Appeals court affirms ruling in United Therapeutics, SteadyMed patent spat

November 14, 2017 By Sarah Faulkner

SteadyMed Therapeutics

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 […]

Filed Under: Drug-Device Combinations, Featured, Legal News, Pharmaceuticals, Vascular, Wall Street Beat Tagged With: SteadyMed Therapeutics, United Therapeutics

SteadyMed requests meeting with FDA over rejected application for drug-device combo

September 28, 2017 By Sarah Faulkner

SteadyMed Therapeutics

Shares in SteadyMed (NSDQ:STDY) fell last month after the FDA decided it would not review the new drug application for the company’s drug-device combination product, Trevyent. SteadyMed received a refused to file letter, indicating that its NDA is incomplete and that the regulatory agency will not look it over. The company submitted its application to the […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Vascular, Wall Street Beat Tagged With: SteadyMed Therapeutics

SteadyMed shares tumble after FDA refuses to review Trevyent NDA

August 31, 2017 By Sarah Faulkner

SteadyMed Therapeutics

Shares in SteadyMed (NSDQ:STDY) fell more than -35% today after the company announced that the FDA will not review the new drug application for its drug-device combo product, Trevyent. The company received a refused to file letter, indicating that its NDA is incomplete and that the regulatory agency will not look it over. This is the […]

Filed Under: Cardiovascular, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: SteadyMed Therapeutics

BioDelivery Sciences president, CEO Sirgo to retire | Personnel Moves – Aug 29, 2017

August 29, 2017 By Sarah Faulkner

BioDelivery Sciences International

BioDelivery Sciences (NSDQ:BDSI) said last week that its president & CEO, Mark Sirgo, plans to retire at the end of this year. Sirgo has held the corner office at the Raleigh, N.C.-based company since 2005. He will stay on as vice chairman of the board and will help determine his successor, BioDelivery Sciences reported. “After thirteen […]

Filed Under: Drug-Device Combinations, Featured, Personnel, Pharmaceuticals, Wall Street Beat Tagged With: Aerie Pharmaceuticals, BioDelivery Sciences International, Insulet, Merrimack Pharmaceuticals, Novartis, Ocular Therapeutix, pierispharmaceuticals, Proteus Digital Health, Shire, SteadyMed Therapeutics

SteadyMed tops Q2 sales estimates

August 11, 2017 By Sarah Faulkner

SteadyMed Therapeutics

Shares in SteadyMed (NSDQ:STDY) fell today after the pharmaceutical company beat sales expectations on Wall Street with its second quarter results, but missed EPS estimates. The San Ramon, Calif.-based company posted a net loss of -$8.1 million on sales of $319,000 for the 3 months ended June 30, for bottom-line loss of -14% on sales growth […]

Filed Under: Cardiovascular, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), MassDevice Earnings Roundup, Pharmaceuticals, Wall Street Beat Tagged With: SteadyMed Therapeutics

SteadyMed seeks FDA nod for Trevyent drug-device combo

July 3, 2017 By Sarah Faulkner

SteadyMed Therapeutics

SteadyMed (NSDQ:STDY) said today that it submitted a new drug application to the FDA for its drug-device pulmonary arterial hypertension therapy. The San Ramon, Calif.-based company’s lead product candidate is a combination of treprostinil and the PatchPump prefilled, disposable infusion system. “The submission of our NDA for Trevyent is the latest in a series of significant […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Vascular, Wall Street Beat Tagged With: Cardiome Pharma Corp, SteadyMed Therapeutics

SteadyMed raises another $5m from key shareholder

May 26, 2017 By Sarah Faulkner

SteadyMed Therapeutics

SteadyMed (NSDQ:STDY) said today that 1 of its largest institutional shareholders exercised warrants to purchase additional shares of the company that the investor got in conjunction with the 1st tranche of a previous private placement. Thanks to the exercise, San Ramon, Calif.-based SteadyMed received an additional $5 million in proceeds. The company said it is slated […]

Filed Under: Cardiovascular, Featured, Funding Roundup, Pharmaceuticals, Wall Street Beat Tagged With: SteadyMed Therapeutics

SteadyMed raises $30m for Trevyent commercial launch

April 21, 2017 By Sarah Faulkner

SteadyMed Therapeutics

Shares in SteadyMed (NSDQ:STDY) rose 6% today after the company said it inked a $30 million private placement with Adage Capital Management, OrbiMed, Deerfield Management and Kingon Capital Management. The San Ramon, Calif.-based company plans to use its newly-acquired funds to prepare for the commercial launch of its pulmonary arterial hypertension treatment, Trevyent. The therapy is […]

Filed Under: Cardiovascular, Drug-Device Combinations, Featured, Funding Roundup, Wall Street Beat Tagged With: SteadyMed Therapeutics

SteadyMed studies accuracy and precision of PatchPump infusion system for Trevyent

April 6, 2017 By Sarah Faulkner

SteadyMed Therapeutics

SteadyMed (NSDQ:STDY) said yesterday that it finished a clinical study for its lead drug candidate, Trevyent. The pulmonary arterial hypertension treatment is a combination of treprostinil and the PatchPump prefilled, disposable infusion system. The San Ramon, Calif.-based company said it is on track to submit a New Drug Application for Trevyent in the 2nd quarter […]

Filed Under: Cardiovascular, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Wall Street Beat Tagged With: Cardiome Pharma Corp, SteadyMed Therapeutics

More trouble for United’s Remodulin

April 4, 2017 By Sarah Faulkner

United Therapeutics

The Patent Trial and Appeal Board of the U.S. Patent and Trademark Office ruled yesterday that the claims of United Therapeutics‘s (NSDQ:UTHR) patent, which covers Remodulin, are unpatenable due to obviousness. SteadyMed (NSDQ:STDY) challenged the patent in October last year. The patent, No. 8,497,393, relates to the process to purify prostacyclin derivatives, including treprostinil, which is […]

Filed Under: Cardiovascular, Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance, Vascular, Wall Street Beat Tagged With: SteadyMed Therapeutics, United Therapeutics

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