Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Roche's Avastin up for another lift with fast-track cervical cancer review

Roche's cancer blockbuster Avastin has yet another shot at boosting sales. The FDA put Avastin up for priority review in cervical cancer, with a decision date of Oct. 24.

Roche's Avastin steps on FDA fast track for new cervical cancer use

When it comes to expanding Avastin into new cancer territories, Roche has a win-some, lose-some record. Now, Roche is closer to adding cervical cancer to its arsenal of indications in the U.S.

Boston Scientific wins CE mark for next-generation drug-coated balloon catheter

Boston Scientific won a CE mark for its next-generation drug-coated balloon catheter for peripheral artery disease, expanding its presence in the endovascular market and continuing its push to reinvigorate sales.