Every week there is some news, recall or event that reminds us that the give and take with the FDA over manufacturing often means poor GMPs give companies major headaches and take a lot of time and money to resolve. The examples you will find in our 2012 FDA Red Flags Report are not all tipping point examples, but many are.
Biolex Therapeutics is calling it quits after burning through $190 million of venture cash from a slate of top-tier biopharma players on a once-promising hepatitis C drug.
Johnson & Johnson ($JNJ) is pulling nearly 70,000 packages of its K-Y Liquibeads Vaginal Moisturizer lubricant product off the market. It is not that there are any safety issues, the company says. It is just a matter of it not being approved by the FDA.
As FierceMedicalDevices looks at CEO compensation for 2011 at the top 10 medical device companies, we see that it very much reflects an industry in transition. In many cases, the corporate titans on our list didn't even finish out the year, as new leadership took the stage to address controversies over quality or sluggish revenue. Some executives retired abruptly, defying expectations for longer tenures.
With hundreds of millions of diabetes patients around the globe, the market for insulin delivery is vast and, according to the National Institutes of Health and others, ever-expanding. Couple that with healthcare reforms in the developing world that are bringing treatment to underserved populations, and it's no surprise that biotechs and drug delivery firms are turning their eyes to insulin as a possible cash cow.
Johnson & Johnson's sordid vaginal mesh implant saga continues, as Bloomberg reports that the company continued to sell Gynecare Prolift for 9 months after the FDA ordered the company to pull the product and address safety concerns.
So much for a speedy review of Eliquis, the new anticoagulant from Bristol-Myers Squibb and Pfizer. Best expectation for an approval? Next spring.
Bristol-Myers Squibb and Pfizer have hit another costly snag in their quest to gain an FDA approval for Eliquis (apixaban), their blockbuster anti-clotting hopeful.
The expected news on Xarelto has been delivered to Johnson & Johnson ($JNJ) and Bayer. In its complete response letter, the FDA turned down their request that it be approved to prevent heart attacks and strokes in patients with acute coronary syndrome, a common heart ailment, a use that would have significantly enhanced the drug's financial value.
The The Wall Street Journal reports that J&J and the Justice Department are coming to terms, aiming to wrap up whistleblower suits, state claims and federal probes with a $1.5 billion-plus deal.