Lumicell said today that it is launching clinical studies in breast cancer and prostate cancer with its Lum image-guided cancer surgery system. The breast cancer trial is a pivotal study following an initial training period with surgeons, the Wellesley, Mass.-based company reported, and the prostate cancer study is a first for Lumicell and its technology. […]
Drug-Device Combinations
Nordisk settles DOJ’s Victoza marketing suit for $59m
Novo Nordisk (NYSE:NVO) said yesterday afternoon that it inked a $58.7 million deal with the U.S. Dept. of Justice to settle an investigation into the company’s marketing practices for Victoza – its Type II diabetes drug. The agreement settles eight different lawsuits alleging that the drugmaker misled doctors by dressing salespeople as medical educators, paying physicians […]
Bellerophon Therapeutics touts Ph2 COPD trial of inhaled nitric oxide
Bellerophon Therapeutics (NSDQ:BLPH) touted data today from a Phase II trial of pulsed, inhaled nitric oxide in patients with pulmonary hypertension associated with chronic obstructive pulmonary disease. The 10-patient trial was designed to evaluate the effects of pulsed, inhaled nitric oxide on targeted vasodilation and the chronic effect on hemodynamics and exercise capacity. The data showed […]
Sanofi wins tentative FDA nod for Admelog insulin lispro injection
Sanofi (NYSE:SNY) said today that the FDA granted the company tentative approval for its Admelog insulin lispro injection. The decision is based on physicochemical, non-clinical and clinical similarity to another, already-approved insulin lispro injection. The compound is contraindicated during hypoglycemia episodes and in patients with hypersensitivity to insulin lispro or one of its other ingredients, […]
Diabetes orgs send insulin, glucose meters to Texas
Thousands of people in Texas have been displaced from their homes after Hurricane Harvey landed there last week, leaving many without life-saving medication and supplies. People with diabetes are especially vulnerable, since many require daily insulin injections and regular monitoring of their blood glucose levels. In what they have described as a ‘landmark partnership’, the […]
Adherium wins 510(k) clearance for smart inhaler monitoring device
Adherium Ltd. (ASK:ADR) said today that it won 510(k) approval from the FDA for its inhaler monitoring device, SmartTouch for Symbicort. The device was cleared for use with AstraZeneca‘s (NYSE:AZN) Symbicort aerosol inhaler. The Melbourne, Australia-based company’s product installs directly onto a patient’s inhaler to monitor and boost medication adherence. The device records the time and […]
SteadyMed shares tumble after FDA refuses to review Trevyent NDA
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 […]
Express Scripts, other PBMs named in lawsuit over pricey EpiPens
Express Scripts (NSDQ:ESRX) and other pharmacy benefit managers have been accused of giving Mylan‘s (NSDQ:MYL) EpiPens favorable placement on drug formularies in exchange for kickbacks, according to a proposed class action filed in Kansas federal court this week. The suit was brought by people covered under Employee Retirement Income Security Act benefit plans. These consumers claim […]
Smiths Medical wins 510(k) approval for wireless ambulatory infusion pump
Smiths Medical said yesterday that it won 510(k) clearance from the FDA for its CADD-Solis wireless ambulatory infusion pump. The device can connect wirelessly with Smiths’ PharmGuard Server infusion management software, enabling clinicians to deploy updates and drug libraries to all pumps simultaneously, as well as remotely manage device performance and monitor drug dosing. The […]
Acorda shares plunge -30% after FDA refuses to review NDA
Shares in Acorda Therapeutics (NSDQ:ACOR) dropped nearly -30% today after the FDA told the company that the new drug application for its inhaled Parkinson’s disease treatment is incomplete. The FDA’s refusal to file letter surprised analysts. The note from the regulatory agency had to do with the date when the manufacturing site would be ready for […]