A pilot study evaluating an artificial pancreas in children with Type I diabetes found that the device helped kids control their condition, according to researchers at the University of Virginia. The artificial pancreas was developed at the UVA Center for Diabetes Technology and features a smartphone powered by algorithms that wirelessly link to a glucose monitor […]
Drug-Device Combinations
Boston Scientific looks to lead the drug-eluting PAD market
Angioplasty is not a new procedure – doctors have been widening obstructed arteries with balloons since the 1960s. But for years the medtech industry has been plagued with what Jeff Mirviss, president of Boston Scientific’s interventional peripheral biz, calls the procedure’s Achilles heel: Restenosis. For patients treated with bare balloons, half must have the procedure done again […]
United Therapeutics launches $250m share repurchase program
United Therapeutics (NSDQ:UTHR) said today that its board of directors approved the repurchase of up to $250 million of the biotech’s common stock. The share repurchase program is effective immediately and United said it will stay open until the end of 2017. The company can make purchases in the open market, accelerated share repurchases or in privately […]
Tandem misses on Q1 earnings, beats rev estimates
Shares in Tandem Diabetes (NSDQ:TNDM) fell today after the medical device maker missed earnings expectations on Wall Street with its 1st quarter results, but beat revenue estimates. The San Diego-based company posted losses of -$23.8 million, or -75¢ per share, on sales of $18.9 million for the 3 months ended March 31, for bottom-line loss of -13.9% […]
Nordisk wins label update for weight loss drug-device combo
Novo Nordisk (NYSE:NVO) said today that the FDA approved an updated label for its Saxenda liraglutide weight loss medicine. The therapy’s new label will include data showing that half of patients who received Saxenda and lost at least 5% of their weight after 56 weeks maintained their weight loss for 3 years. The update is based […]
Midazolam nasal spray trial meets primary endpoint in patients with seizure clusters
Proximagen Ltd. said today that its pivotal Phase III trial of intranasal midazolam met its primary efficacy endpoint as a treatment for patients with seizure clusters. The Cambridge-based company said it plans to begin talks with the FDA for a New Drug Application in the 2nd half of this year based on the trial’s findings. […]
Braeburn’s risperidone implant meets primary endpoint in schizophrenia trial
Braeburn Pharmaceuticals said yesterday that a 6-month study of its risperidone implant in patients with schizophrenia or schizoaffective disorder met its primary endpoint. Risperidone, the most commonly-prescribed therapy for schizophrenia, depends on consistent administration, but patients with schizophrenia sometimes stop taking their medication when their symptoms improve. Long-acting, injectable formulations of risperidone are on the market, […]
SurModics misses on Q2 earnings, narrows outlook
Shares in SurModics (NSDQ:SRDX) fell today after the medical device maker missed earnings expectations on Wall Street with its 2nd quarter results and narrowed its full-year outlook. The Eden Prairie, Minn.-based company posted profits of $506,000, or 4¢ per share, on sales of $17.5 million for the 3 months ended March 31, for bottom-line loss of […]
Bankrupt Unilife asks judge for $1m in bonuses for top execs
Unilife (NSDQ:UNIS), which filed for Chapter 11 bankruptcy earlier this month, reportedly asked a Delaware bankruptcy court yesterday to approve a “key employee retention plan” that would provide 4 top executives with nearly $1 million in bonuses, contingent upon a successful sale of the company. Unilife added it has already approved the plan with its debtor-in-possession lender. The […]
New GSK chief exec: Fewer, more focused drug programs as generic competition looms
In her 1st comments since taking the helm on April 1st, GlaxoSmithKline‘s (NYSE:GSK) new chief executive Emma Walmsley said that her priority is the company’s pharmaceuticals unit, where she wants to lead fewer but bigger new drug launches. “We’d like to have probably fewer and more focused priorities, to have bigger launches,” she told reporters, according […]