Topic:

Regulatory

Latest Headlines

Latest Headlines

China allows trial of investigators of GSK sex-tape scandal to go public

China has abruptly changed course on its plans to prosecute private investigator Peter Humphrey and his wife Yu Yingzeng in a closed trial. Now Humphrey and Yu, who were arrested last summer as part of China's investigation of bribery charges involving GlaxoSmithKline, will be tried in a public proceeding.

InterMune bags a 'breakthrough' nod of its own in a race with Boehringer

InterMune secured the FDA's breakthrough therapy designation for an in-development treatment for a rare lung disease, evening the regulatory score with rival Boehringer Ingelheim as the two angle for position on the U.S. market.

Salix wins FDA approval for a rare disease drug

Salix Pharmaceuticals picked up FDA approval for an orphan therapy, giving the company another revenue source as it plots a tax-saving move to Ireland.

Wearable biosensor for assessing back injuries wins FDA clearance

Australia's dorsaVi just received 510(k) clearance from the FDA for its wearable biosensor for assessing movement in the spine and lower back.

Salix scores another FDA green light with approval for angioedema med Ruconest

In its second FDA nod this week, Salix Pharmaceuticals won the go-ahead for Ruconest, its first-in-class treatment for a rare genetic disease, hereditary angioedema.

Medtronic could face legislative pushback in tax-inversion deal with Covidien

The Obama administration is cracking down on companies moving operations overseas for tax-inversion purposes, a move that could hold negative implications for Medtronic in its $43 billion proposed deal with Covidien.

France's AB Science warned by FDA for its canine cancer drug promotion

With a slap to French animal health company AB Science, the FDA is sending out a poignant reminder that there are no exceptions to its rules when it comes to marketing medications. It issued the company a warning letter regarding its Kinavet-CA1 canine drug, intended for canine mast cell tumors, for allegedly boasting its off-label uses without approval.

Boehringer's lung drug wins FDA 'breakthrough' tag

Boehringer Ingelheim's treatment for a rare and deadly lung disease picked up the FDA's coveted breakthrough therapy designation, a mark that guarantees a speedy regulatory review and could help the company beat its nearest rival to market.

FDA rejects petition to ban transvaginal mesh

The FDA formally rejected a 2011 citizen petition calling for the ban of all nonabsorbable surgical mesh products for transvaginal repair of pelvic organ prolapse in a letter to the Dr. Michael Carome, then deputy director of Public Citizen's Health Research Group, sent out this week. The agency expressed sympathy and agreement with the petitioner's concerns, but did not agree with the proposed remedy.

Concert's spasticity drug gets out from under an FDA hold

The FDA has lifted a partial clinical hold on Concert Pharmaceuticals' treatment for spasticity, allowing the biotech to resume dosing in a Phase I trial.