NovaDel NDA: Longs May Finally Get a Good Night’s Sleep

The FDA has accepted Flemington, NJ-based NovaDel Pharma’s New Drug Application for ZolpiMist. ZolpiMist is an oral spray for the short-term treatment of insomnia. The company anticipates the FDA will complete its review by the end of the year consistent with PDUFA guidelines. Following NovaDel’s...

Nanomaterial Coatings Help Drugs Bypass Bodily Defenses

A new study published in the January issue of ACS Nano offers insight into cutting edge world of drug delivery research. In the study, UCLA and Northwestern University researchers used nanoscale polymer film coatings to circumvent typical bodily defenses while delivering a drug payload. An inert nanoscale...

Laser Battles Reach Fever Pitch

A quick glance at the Diomed’s recent press releases might lead you to believe the company is a law firm, rather than a provider of minimally invasive varicose vein treatments. Diomed vs. Total Vein Solutions The Andover-based company headed to court again today to voice its request today for a...

FDA Puts Brakes on Expanded Indication for PreMD’s Skin Sterol Diagnostic

Company to decrease spending to ensure its ability to execute. Tortono, Ontario-based PreMD received a non-substantially equivalent letter from the FDA regarding its 510(k) submission for an expanded regulatory claim on its skin cholesterol test. The company’s PREVU Skin Cholesterol Test non-invasively...

New Study Highlights Promising Gene-Based Predictor of Prostate Cancer Risk

Test to be commercialized by Proactive Genomics, LLC In the past few years, novel research tools have emerged which scientist to systematically and objectively evaluate genetic variants in the genome. These new techniques have improved researchers’ ability to identify risk variants in the genome that...

Private Equity Firm Warburg Pincus to Acquire Lifecore Biomedical

Even as access to cheap debt has dried up and the rate of deals flow has dwindled, Warburg Pincus seems to show no sign of slowing down. Since 1989, Warburg has invested more than $1 billion in the medical device space, with equity spread across 20 companies and a focus on diabetes, interventional...

First Annual Meeting a Success

Over 200 attended the first annual meeting of OneMedPlace, its 2008 Finance Forum in San Franscisco January 7th and 8th. Audio presentations by many of the companies can be seen at www.onemedplace.com/meeting/companies.php. Located less than a block from the very crowded JP Morgan Healthcare conference,...

Novo Nordisk Loses Faith in AERx, Takes a $260 Million Hit

Denmark-based Novo Nordisk discontinued its experimental AERx insulin inhaler triggering a hefty one-time charge of $260 million. Novo, the world’s biggest insulin producer, said that while the AERx inhaler was safe, the system offered little upside when compared to the company’s suite of injection...