Medtronic (NYSE:MDT) said this month that it won approval for a change to its problematic SynchroMed II implantable drug infusion pump designed to address motor shaft wear issues. The Fridley, Minn.-based medical device titan said the change is aimed at improving the long-term rate of non-recoverable motor stall in the SynchroMed II devices, estimating that pump […]
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Boston Scientific takes a $3B hit on latest Lotus valve delay
Boston Scientific (NYSE:BSX) saw its market capitalization lose $3 billion after yesterday revealing another delay for its Lotus replacement heart valve. The Marlborough, Mass.-based company, which recalled the Lotus transcatheter aortic heart valve in February over issues with its locking mechanism, said it no longer expects the ensuing manufacturing and design specification changes to get the […]
One Drop wants to help lead a healthcare revolution for people with diabetes – here’s how
When Jeff Dachis was diagnosed with Type I diabetes four years ago, he remembers leaving the doctor’s office with a sinking feeling in his chest. “I had about six minutes with a nurse practitioner and was given an insulin pen and a prescription and a pat on the back – and I was out the […]
Egalet’s extended-release, abuse-deterrent opioid succeeds in Ph3 trial
Shares in Egalet Corp. (NSDQ:EGLT) soared this morning in pre-market activity after the company reported that its abuse-deterrent, extended-release oxycodone candidate met the primary endpoint of a Phase III pain relief trial. The Wayne, Penn.-based company compared the efficacy and safety of its product to a placebo in opioid-experienced and opioid-naïve patients with moderate-to-severe chronic low back […]
Kala Pharmaceuticals taps biopharma exec as chief operating officer | Personnel Moves – Nov. 27, 2017
Kala Pharmaceuticals (NSDQ:KALA) this month expanded its team of C-suite executives, naming Todd Bazemore as chief operating officer. Bazemore has spent more than 20 years in the biopharmaceutical industry, most recently working as EVP and COO for Santhera Pharmaceuticals. He has also spent time at Dyax Corp., Sunovion Pharmaceuticals, and Muro Pharmaceuticals. “We welcome Todd to […]
GSK to use Owlstone’s breath biopsy device in Phase II COPD trial
GlaxoSmithKline (NYSE:GSK) is slated to use Owlstone Medical‘s breath biopsy device in a phase II trial of its drug for chronic obstructive pulmonary disease, danirixin. The diagnostics company’s breathalyzer will be used to help GSK identify which patients will most benefit from the drug, as well as evaluate the effects of danirixin, according to the pharma company. Get […]
Bayer’s antibiotic drug-device combo fails in late-stage trial
Bayer (ETR:BAYN) reported last week that its antibiotic drug-device combination product failed in a phase III trial. In the 725-patient Inhale trial, Bayer’s Amikacin Inhale did not out-perform a placebo as a treatment for Gram-negative pneumonia in patients on ventilators. Get the full story at our sister site, Drug Delivery Business News.
Philips snaps up imaging workflow provider Analytical Informatics
Royal Philips (NYSE:PHG) said last week that it spent an unspecified sum to acquire imaging workflow solutions provider Analytical Informatics to beef up its PerformanceBridge portfolio. Founded in 2011 and spun out of the University of Maryland, Baltimore-based Analytical Informations offers vendor-agnostic workflow tools and applications based on technology licensed from the university’s medical school, Philips […]
GSK, Innoviva seek expanded label for triple inhaler
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) have submitted data from the landmark Impact trial to the FDA in the hopes of landing an expanded label for the Trelegy Ellipta triple inhaler. The two companies are hoping that their therapy could be used to treat airflow obstruction and to reduce exacerbations in people with chronic obstructive pulmonary disease. Get the […]
FDA wants to improve access to generic abuse-deterrent opioids: here’s how
The FDA commissioner, Dr. Scott Gottlieb, has made the opioid crisis a priority in his time at the agency. Yesterday, the regulatory body issued guidance to help promote the development of generic opioids designed to prevent abuse. To date, the FDA has approved 10 of these products, called abuse-deterrent opioids. But, as Gottlieb noted in a statement, […]
CHF Solutions prices $18m offering
CHF Solutions (NSDQ:CHFS) said today that it prices an offering of Series F stock and warrants worth $18.0 million. Eden Prairie, Minn.-based CHF Solutions, formerly known as Sunshine Heart, said the Series F shares are convertible to common stock at $4.50 per share. The Series F shares also carry a one-year Series 1 warrant for 223 shares […]