Topic:

Regulatory

Latest Headlines

Latest Headlines

Pfizer drops effort to make Lipitor an OTC med

Millions of Americans take statins to help control their cholesterol and try to stay heart healthy. You just can't count on them to handle that on their own, Pfizer has found. And so the maker of Lipitor, the most successful statin of them all, has given up on its efforts to move the drug to an over-the-counter treatment.

Bio-Rad Labs grabs FDA approval for next-gen HIV test

Bio-Rad Laboratories snagged FDA approval for its next-generation HIV Ag-Ab test for early detection of the virus. The Hercules, CA-based company's BioPlex 2200 HIV Ag-Ab assay distinguishes between HIV-1 and HIV-2 markers in human blood samples, making it the first diagnostic approved by the agency that can differentiate the infections.

Progenics' orphan cancer drug picks up the FDA's 'breakthrough' tag

Progenics Pharmaceuticals' in-development treatment for an ultrarare form of cancer secured the FDA's breakthrough-therapy designation, promising a smoother path through the regulatory process.

EU ban on more than 700 drugs set for Aug. 21

The European Union will impose a ban starting Aug. 21 on more than 700 drugs that were bioequivalency tested by India's GVK BioSciences after inspectors raised questions about its procedures.

EU-wide ban starts Aug. 21 on 700-plus drugs tested by India's GVK Bio Sciences

A European Union-wide ban on more than 700 drugs that were bioequivalency tested by India's GVK BioSciences will come into effect on Aug. 21 in a move that New Delhi had tried to head off with diplomatic efforts.

AbbVie CEO: Viekira approval expected this year in Japan

For the second quarter AbbVie on a July 24 earnings call saw Rick Gonzalez, chairman and CEO put Bristol-Myers Squibb and Gilead on notice that approval for hepatitis C therapy in Japan is expected in the second half of the year.

Eli Lilly execs on Q2 call discuss Japan opportunities, China slowdown

For the second quarter Eli Lilly on a July 23 earnings call heard John Lechleiter, chairman, president and CEO, and his team provided upbeat talk about opportunities in Japan. But there was also some of the same comments heard from Johnson & Johnson, Abbott and Novartis on China's slowdown.

Roche COO O'Day highlights 'good growth' in emerging markets on Q2 call

For the second quarter Roche on a July 23 earnings call saw CEO Severin Schwan speak about the cancer immunotherapy pipeline at some length, but his two chief operating officers provided details on emerging markets.

FDA launches probe into safety of common MRI contrast agent

Amid a growing body of research that shows deposits of gadolinium-based contrast agents (GBCAs) remain in the brain after repeat MRI procedures, the FDA is investigating the products' safety and risks.

Trans-Pacific Partnership impasse on data exclusivity for biologics softens

Negotiations in Hawaii to reach agreement on the Trans-Pacific Partnership trade pact appear to have made some headway on the thorny issue of data exclusivity for biologics with Australia and other countries opposed to the U.S.'s 12-year standard now willing to consider 8 years,  Nikkei Asian Review  reports.