Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Nasal version of naloxone for opioid overdose gets on FDA's fast track

The first nasally administered naloxone-based therapy to treat emergency cases of opioid overdose from heroin or prescription painkillers received a Fast Track Designation from the FDA, product developer AntiOp said in a July 15 statement.

Boston Scientific wins expanded European approval for Lotus transcatheter valve system

Boston Scientific won expanded European approval for its Lotus transcatheter valve system, adding to the company's current aortic valve offerings and bolstering its presence in overseas markets. 

Fifth Circuit backs shield against branded pharma's liability for generic harms

The court fight over Pfizer's stomach drug Reglan (metoclopramide) has yielded another ruling in Big Pharma's favor. Once again, a U.S. court has ruled that branded drugmakers can't be sued for damages allegedly caused by generic versions of their drugs.

Titan Spine wins 510(k) for spinal fusion implant

Wisconsin's Titan Spine announced today that it received 510(k) clearance from the FDA for its Endoskeleton TL System implant for spinal fusion.

FDA cites Italian API maker for deleting all analytics

FDA inspections have uncovered a number of Indian companies that have manipulated data on their active pharmaceutical ingredients and deleted test results that didn't conform to specifications, an issue that has led to warning letters and contributed to import alerts. Many of those makers have been in India, but a warning letter posted today for an Italian company shows the problem is universal.