Topic:

Regulatory

Latest Headlines

Latest Headlines

Sanofi, Merck win EMA nod for Gardasil 9

Merck's new-and-improved Gardasil is making headway in Europe with the word late last week that the European Medicines Agency has recommended the jab against 9 types of human papillomavirus and will send its blessing to the European Commission.

Medtronic gets FDA go-ahead to use CoreValve in additional heart patients

In a big win for Medtronic, the FDA expanded the indication of the company's transaortic valve replacement device permission to include replacement of patients' failed artificial aortic valve. The novel use of the device gives Medtronic a leg up on rival Edwards, whose Sapien XT TAVR does not have permission to be used for what's called "valve-in-valve" replacement.

Mylan recalling two injectable drugs made in India

Mylan is recalling two sterile injectable drugs made in India, including 6 lots of an injectable blood pressure med that it began retrieving after testing found that it might be subpotent and that it missed specifications for impurities and degradation. The second drug is being recalling over a packaging issue.

Judge tosses Abilify kickback claims, but puts BMS on notice for firing whistleblowers

Bristol-Myers Squibb and Otsuka won't have to fight claims that they promoted Abilify for off-label uses or used kickbacks to persuade doctors to prescribe the antipsychotic drug. A U.S. judge tossed out those allegations, leveled by a couple of whistleblowers in 2011, for lack of specific evidence.

Watch out, Pomalyst: Amgen gets quick FDA review for lucrative new Kyprolis use

Amgen's hoping its blood cancer med Kyprolis can win an FDA bump-up from third-line treatment to second-line, and it won't have to wait long to find out whether its hopes pay off.

Europe bans Chinese API maker over contamination issues

The European Directorate for the Quality of Medicines has banned products from a Chinese maker of iodine after an inspection at its plant by French inspectors turned up contamination issues in its manufacturing processes, issues with its purified water system and a piece of testing equipment that may have been put in the facility just for show.

Federal authorities raid Internet pharmacy operator CanadaDrugs.com

Federal authorities in Canada last week raided the Winnipeg headquarters of CanadaDrugs.com but declined to say what prompted the raid, citing a court-ordered confidentiality order.

'Japanese NIH' launches April 1 with focus on devices and drugs

Japan is set to launch its version of the U.S. National Institutes of Health, calling it the Japan Agency for Medical Research and Development, or AMED.

China puts stem-cell clinical trial regulation in play with draft for comment

China health authorities have proposed some new regulations for conducting stem-cell clinical trials in the country, one requiring that a 30-year archive of the clinical records of stem-cell donors and patients be maintained.

Australia's reimbursement cost battle hits cancer drug access

Australia's reimbursement agency has lagged developed country counterparts in paying for newly approved new cancer therapies, highlighting problems at the tail end of a system that patients and industry complain is broken.