Dyve Bioscience touts proof-of-concept study for transdermal painkiller

Dyve Bioscience logoDyve Bioscience this week touted data from a human proof-of-concept pilot study of its transdermal sodium bicarbonate therapy for pain reduction in people with acute gout flare.

The study enrolled 24 people with a history of gout. Those in the active treatment group were given lotion containing sodium bicarbonate and menthol, while those in the placebo group were given lotion without sodium bicarbonate or menthol. Investigators told the participants to report to the clinic within 36 hours of flare onset.

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Novartis launches COPD inhalers in China

NovartisNovartis (NYSE:NVS) has launched its Ultibro Breezhaler and Seebri Breezhaler in China for the treatment of chronic obstructive pulmonary disease.

The Ultibro Breezhaler system is a once-daily fixed-dose combination of indacaterol and glycopyrronium bromide. Seebri Breezhaler is a fixed-dose formulation of glycopyrronium bromide.

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Novocure launches pivotal ovarian cancer trial

NovocureNovocure (NSDQ:NVCR) said today that it kicked off a Phase 3 pivotal trial testing its Tumor Treating Fields therapy combined with paclitaxel in people with recurrent, platinum-resistant ovarian cancer.

The 540-patient trial has a primary endpoint of overall survival, with secondary endpoints that include progression-free survival, objective response rate, severity and frequency of adverse events and quality of life.

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Novo Nordisk seeks FDA nod for oral diabetes pill

Novo Nordisk - updated logoNovo Nordisk (NYSE:NVO) said this week that it submitted applications to the FDA for its oral formulation of semaglutide, a once-daily glucagon-like peptide-1 receptor agonist therapy.

The company is hoping its pill will be approved as an adjunct to diet and exercise to improve blood sugar control in adults with Type 2 diabetes. Novo Nordisk also submitted for approval of an indication related to risk reduction of major adverse cardiovascular events.

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Sage wins historic FDA nod for postpartum depression therapy

Sage TherapeuticsSage Therapeutics (NSDQ:SAGE) this week won FDA approval for the first medicine indicated to treat postpartum depression.

The Cambridge, Mass.-based company’s injection therapy, Zulresso, is slated to be available in late June.

Postpartum depression is the most common medical complication of childbirth, according to Sage, and affects roughly one in nine women who have given birth in the U.S.

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Surmodics shares down following FDA’s paclitaxel device update

Surmodics (NSDQ:SRDX) shares fell last week after the FDA wrote a letter to doctors detailing a trend of heightened mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices.

In an SEC filing, the company said that it’s working with the FDA to clarify how the company should proceed with an ongoing clinical trial of its paclitaxel-coated SurVeil balloon.

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EOFlow wins breakthrough status for wearable closed-loop insulin delivery tech

EOFlowKorean medtech company EOFlow said last week that it won breakthrough status from the FDA for its closed-loop automated insulin delivery system for people with Type 1 diabetes.

The EOPancreas system features a wearable patch, continuous glucose monitoring systems and a closed-loop blood glucose control algorithm.

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Aptar Pharma touts FDA approval of nasal spray device

Aptar Pharma nasal spray deviceAptar Pharma said this week that its Bidose nasal spray device won FDA approval for use with a breakthrough depression therapy.

The Crystal Lake, Ill.-based company’s Bidose tech enables two-shot nasal drug delivery. Aptar touted its manufacturing facility in Congers, NY, which supports the manufacture of nasal and injectable drug delivery systems.

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FDA updates docs on review of paclitaxel devices for PAD

FDA-logo-newThe FDA said last week that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices compared to those treated with bare devices.

In a letter to healthcare providers, the U.S. regulatory agency reported that there was a 50% increased risk of mortality in people treated with paclitaxel-coated devices versus those treated with control devices in the three trials with five-year follow-up data.

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U.K., French regulators probe safety of paclitaxel devices

MHRATaking a note from the FDA, U.K. and French regulators are investigating the safety of paclitaxel devices for the treatment of peripheral artery disease.

Last week, the U.K. Medicines and Healthcare Products Agency said it ordered an inquiry into the safety of these devices following the publication of a meta-analysis that suggested a heightened risk of late mortality in people treated with paclitaxel devices compared to bare devices.

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