Topic:

Regulatory

Latest Headlines

Latest Headlines

J&J's Ethicon gets FDA OK on new tissue sealer

Ethicon, a division of Johnson & Johnson, is expanding its Enseal line of tissue sealers, securing FDA clearance for the Enseal G2.

South Korea's Dong-A, dozens of doctors caught up in kickback probe

In what has been termed the worst pharmaceutical kickback scandal in years, 7 former and current executives of Korea's largest drugmaker, Dong-A Pharmaceutical, have been indicted for paying 4.8 billion won ($4.4 million) in kickbacks

Covidien ticks toward pharma spinoff

Covidien is just about ready to spin out its drug business, Mallinckrodt, filing with the SEC and planning to split into two publicly traded companies next quarter.

Feds grab Shire's attention on Adderall marketing

Federal authorities were interested in the way Shire was pushing many of its drugs and the company has now disclosed that an agreement is close. It said it will take a $57.5 million charge to its fourth-quarter earnings to settle up for its missteps.

Yogurt, pacemakers compel conflict-of-interest issues in Florida

Hollywood cardiologist Mark Sabbota and St. Jude Medical ($STJ) sales rep Charles Lodowski are partners in two corporations that run frozen yogurt shops, and some industry observers told the Miami Herald  that patients deserve to know about a doctor's financial relationship with companies.

UPDATED: Loss of Actos weighs heavily on Takeda

Takeda Pharmaceutical last week nailed down FDA approval for three new diabetes drugs--DPP-4 inhibitors--and it was none too soon, as today's earnings report makes crystal clear.

Indian clinical trials: Private group steps in to increase transparency

As India's government churns over the idea of tightening clinical trial regulations, a private industry group is entering the fold and launching a committee designed to improve transparency.

U.S. finally gets payment rule published

It is 15 months overdue and it will be more than a year before information is public, but at last the government has set out its rule for how it will publish payments from drugmakers to doctors.

FDA stamps approval on Hyperion's new orphan drug

Hyperion has won its first FDA approval. The South San Francisco-based company grabbed the agency's nod for its drug Ravicti, a treatment for managing genetic conditions known as urea cyclic disorders.

Endosense eyes FDA nod with ablation trial

Fresh off raising $40.3 million in venture cash, Endosense has treated its first American patient in a study of its cardiac catheter ablation device, and the company is amassing data to support an FDA application.