The FDA today approved Sanofi‘s (NYSE:SNY) Admelog insulin lispro injection. The product is indicated to help adults and kids with Type I and Type II diabetes control their blood sugar levels. Admelog is the first short-acting insulin approved using the FDA’s 505(b)(2) pathway. Get the full story at our sister site, Drug Delivery Business News.
Drug-Device Combinations
Intersect ENT wins FDA nod for Sinuva polyp-disease-treating sinus implant
Intersect ENT (NSDQ:XENT) said today it won FDA approval for its Sinuva mometasone furoate sinus implant designed to treat recurrent nasal polyp disease in patients who have previously had ethmoid sinus surgery. The Sinuva device is designed to be implanted during a routine physician office visit and expands into the sinus cavity to deliver an anti-inflammatory steroid […]
Novo Nordisk inks outcomes-based contract with pharmacy benefit manager for Victoza
Novo Nordisk (NYSE:NVO) said today that it inked a value-based contract for its Type II diabetes drug, Victoza, with pharmacy benefit manager Prime Therapeutics. The agreement is part of Prime’s CareCentered Contract program. Under the terms of the deal, Prime will evaluate Victoza’s efficacy and will reimburse commercial clients if certain measures aren’t met, according to the company. […]
Novaliq’s NovaTears, Omega-3 combo approved in Europe for evaporative dry eye disease
Privately-held pharma company Novaliq GmbH said this week that its NovaTears+Omega-3 combo therapy for patients with evaporative dry disease was registered in Europe. The treatment uses Novaliq’s water-free EyeSol drug delivery tech and is available in a multi-dose bottle. The company touted its product as the first eye drop to contain high concentrations of Omega-3 ethyl ester. […]
Tandem’s finance chief to retire at year’s end | Personnel Moves – Dec. 8, 2017
Tandem Diabetes Care (NSDQ:TNDM) announced today that its EVP and chief financial exec, John Cajigas, will retire at the end of 2017. The company’s SVP of finance, Leigh Vosseller, is slated to take his place effective Jan. 1. Tandem noted that Cajigas’ retirement is not due to any disagreement or problem with the company’s accounting or […]
Aerogen, Lyomark ink inhaled surfactant deal
Aerogen and Lyomark Pharma said today that they inked a deal to develop an inhaled surfactant treatment for respiratory distress syndrome in pre-term infants. The pact calls for the duo to combine a compound called AP-002, a nasally inhaled surfactant based on a combination of Lyomark’s Alveofact bovine lung surfactant and Aerogen’s PDAP nasal delivery technology. Aerogen […]
Court dismisses class action suits against Novocure
Two class action lawsuits filed against Novocure (NSDQ:NVCR) and some of its directors and executives in January were dismissed after the court established that it lacked personal jurisdiction over any of the defendants. In mid-January, Joseph Donahue, Stephen Rosen and Susan Rosen filed two putative class action suits in a New Hampshire court against Novocure, its directors, […]
Acorda resubmits NDA for inhaled Parkinson’s disease therapy
Acorda Therapeutics (NSDQ:ACOR) said today that it resubmitted its new drug application for Inbrija, an inhaled therapy for people with Parkinson’s disease. The Ardsley, N.Y.-based company was dealt a setback in August when the FDA told Acorda that it wouldn’t review its application for Inbrija, a move that sent ACOR shares tumbling. Get the full story at […]
Lumicell aims $29m Series C at pivotal breast cancer trial and expansion into other cancers
With $28.7 million from a recently-closed Series C round, Lumicell reported today that it plans to launch a pivotal trial of its image-guided cancer surgery tech in breast cancer. The Wellesley, Mass.-based company added that it hopes to expand its clinical program into other solid tumor cancers, including lung, ovarian and brain cancer. Get the full story at our sister site, Drug Delivery Business […]
Sunovion wins FDA nod for inhaled COPD therapy
The FDA has approved Sunovion Pharmaceutical‘s Lonhala Magnair system for the long-term treatment of airflow obstruction in people with chronic obstructive pulmonary disease, the company reported today. The drug-device combo, also known as Sun-101/eFlow, is the first nebulized long-acting muscarinic antagonist approved for the treatment of COPD in the U.S. The system includes a portable nebulizer […]
Novo Nordisk’s once-weekly Type II diabetes injection wins FDA nod
Novo Nordisk‘s (NYSE:NVO) once-weekly semaglutide injection, Ozempic, has won FDA approval as a therapy for adults with Type II diabetes, the insulin-maker reported today. The injection, given in a pre-filled pen, is a GLP-1 analogue – a drug that trigger the production of insulin, while lessening appetite and food intake. Get the full story at […]