Johnson & Johnson and Pharmacyclics' new drug Imbruvica won the expanded approval it needed to go beyond a rare disease treatment and reach the blockbuster status it was conceived for. The FDA Wednesday gave Imbruvica accelerated approval for treating chronic lymphocytic leukemia in patients who have received at least one previous therapy.
Any industry that's undergoing as much change as biopharma is always looking for leadership. Old marketing practices are being blown apart, R&D is being subjected to emergency surgery, drug...
J&J has come up empty-handed after wrapping a mid-stage study of an experimental anti-depressant. The pharma giant had in-licensed the drug from Addex Therapeutics, a Geneva-based biotech which reported that the program is being scrapped as investigators ponder possible alternative targets for ADX71149.
Johnson & Johnson's Ethicon arm lost an early fight ahead of trials alleging that it sold faulty vaginal mesh implants that harmed women. Patients' attorneys had accused the company of inappropriately destroying or losing hundreds of thousands of product documents relating to the issue, and a judge has concluded the allegation is true.
One in three people in the U.S. either already have or are at high risk of developing diabetes, and analyzing genetic data for answers about how best to treat these patients is a daunting task. Now a collection of Big Pharma companies are teaming up to share the burden.
The National Institutes of Health has persuaded 10 rival drugmakers to briefly set aside their competitive spirits and collaborate on drug discovery projects in four major diseases, pooling their data and expertise to kick-start early-stage efforts.
Children as young as 2 years old can now use the latest in diabetes technology, even as the company that developed it is in a race to make it yesterday's news. The FDA announced Monday it has approved a pediatric version of DexCom's G4 Platinum. The San Diego med tech now has the first continuous glucose monitor (CGM) approved in the U.S. for toddlers.
GlaxoSmithKline, Pfizer and Roche have each taken steps to open up their clinical trial data, but each has faced criticism for leaving loopholes in their policies. Johnson & Johnson has now gone one step further by taking itself out of data-sharing decisions completely.
J&J is enlisting Yale University, which will provide an independent body to assess data requests and make the final calls on who sees what.
Medtronic generated more Class I recalls than any of its device company rivals in 2013. The FDA assigns that status--its most serious label--when problems behind a product can cause serious injury or death.