Novo Nordisk wins FDA nod for fast-acting mealtime insulin

NordiskNovo Nordisk (NYSE:NVO) said today that the FDA approved its Fiasp insulin aspart injection.

The fast-acting mealtime insulin is designed to improve glycemic control for adults with Type I and Type II diabetes. The injection can be taken at the start of a meal or within 20 minutes after starting a meal, Novo Nordisk reported.

Get the full story at our sister site, Drug Delivery Business News.

The post Novo Nordisk wins FDA nod for fast-acting mealtime insulin appeared first on MassDevice.

Why Bigfoot Biomedical’s CEO thinks the diabetes industry has a data problem

Bigfoot BiomedicalBigfoot Biomedical‘s chief executive is excited about Abbott‘s (NYSE:ABT) latest regulatory win – and it’s not just because the two companies have an established partnership.

Yesterday, the FDA approved Abbott’s FreeStyle Libre Flash continuous glucose monitoring system. It’s the first device of its kind, allowing patients to track their blood glucose levels without the use of routine finger sticks.

“It’s a tremendous demonstration that the FDA understands the value of factory calibration and making usage of a sensor simpler and easier,” Bigfoot CEO Jeffrey Brewer told Drug Delivery Business News.

Get the full story at our sister site, Drug Delivery Business News.

The post Why Bigfoot Biomedical’s CEO thinks the diabetes industry has a data problem appeared first on MassDevice.

SteadyMed tops Q2 sales, EPS estimates

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 of 239.4% compared with the same period last year.

Get the full story at our sister site, Drug Delivery Business News.

The post SteadyMed tops Q2 sales, EPS estimates appeared first on MassDevice.

Cytori Therapeutics posts mixed Q2

Shares in Cytori Therapeutics (NSDQ:CYTX) fell today after the biotech missed sales expectations on Wall Street with its second quarter results, but topped EPS estimates.

The San Diego, Calif.-based company posted a net loss of -$6 million on sales of $1.5 million for the 3 months ended June 30, for bottom-line growth of 6% on sales loss of -47% compared with the same period last year.

Get the full story at our sister site, Drug Delivery Business News.

The post Cytori Therapeutics posts mixed Q2 appeared first on MassDevice.

MIT researchers developing device to pump drugs to the brain

Credit: Denis Paiste/Materials Processing Center

Researchers at the Massachusetts Institute of Technology are developing a pump to deliver drugs directly to the brain.

Alejandro Aponte, a mechanical engineering major at the University of Puerto Rico, has spent his summer working with Michael Cima, a professor of engineering, as part of MIT’s Summer Scholars program.

Get the full story at our sister site, Drug Delivery Business News.

The post MIT researchers developing device to pump drugs to the brain appeared first on MassDevice.

IntelGenx misses Q2 sales, earnings estimates

Drug delivery company IntelGenx (CVE:IGX) missed expectations on Wall Street yesterday with its second quarter results.

The Quebec-based company posted a net loss of -$550,000 on sales of $1.1 million for the 3 months ended June 30, paring its losses by 32% on sales growth of 64% compared with the same period last year.

Get the full story at our sister site, Drug Delivery Business News.

The post IntelGenx misses Q2 sales, earnings estimates appeared first on MassDevice.

Titan Pharmaceuticals misses estimates in Q2

Shares in Titan Pharmaceuticals (NSDQ:TTNP) fell yesterday after the pharmaceutical company missed expectations on Wall Street with its second quarter results.

The San Francisco, Calif.-based company posted a net loss of -$3.5 million on sales of $77,000 for the 3 months ended June 30. In the same period last year, Titan posted profits of $11.9 million on sales of $15 million, thanks to a one-time milestone payment following FDA approval of its buprenorphine implant, Probuphine.

Get the full story at our sister site, Drug Delivery Business News.

The post Titan Pharmaceuticals misses estimates in Q2 appeared first on MassDevice.

Novartis’ Ultibro Breezhaler tops corticosteroid for COPD in head-to-head study

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NovartisNovartis (NYSE:NVS) said today that a new analysis of its head-to-head Flame trial showed that inhaled corticosteroids may not be necessary in some chronic obstructive pulmonary disease patients with high blood eosiophil counts.

The data demonstrated that the company’s Ultibro Breezhaler provided better or similar benefits compared to Seretide, an inhaled corticosteroid, in COPD patients regardless of eosiophil count. These results contrast with previous work suggesting better outcomes with inhaled corticosteroids for patients with high eosinophil counts.

Get the full story at our sister site, Drug Delivery Business News.

Cerus lowers Intercept sales guidance after Fresenius Kabi supply snafu

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