Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Indian company says compulsory license use has cost country $10B in potential investments

Hetero Pharma's director adopted a heretical position in the local pharmaceutical industry when he said use of the compulsory licensing process has cost India $10 billion in potential investments.

Chi-Med's fruquintinib meets metastatic colorectal cancer Phase II primary endpoint

Hutchison China MediTech has met the primary endpoint of progression-free survival in a Phase II clinical trial for its metastatic colorectal cancer candidate fruquintinib (HMPL-013), putting it one step closer to China approval.