FDAnews Drug Daily Bulletin

In observance of the Memorial Day holiday, FDAnews Drug Daily Bulletin will not be published Monday, May 27. The next issue will be published Tuesday, May 28.

Drugmakers need to shift from phased, single-drug clinical trials toward a new paradigm of collaborative assessments of multiple drugs based on biomarkers, CDER Director Janet Woodcock said Tuesday, using the ongoing breast cancer trial I-Spy 2 as an illustrative example.

Congressional carping that the FDA is taking too long to decide if hydrocodone combination products should be further restricted is well-intentioned but dismisses the fine line between enforcement and ensuring pain medications are available to those who need them, experts say.

The FDA May 10 denied Endo Pharmaceuticals’ citizen petition requesting the agency acknowledge that its noncrush-resistant version of its opioid painkiller Opana ER was withdrawn from the market for safety reasons, a move that would have blocked generic versions of the drug.

Finland’s National Institute for Health and Welfare claimed that GlaxoSmithKline’s H1N1 shot may lead to narcolepsy in adults as well as children.

In the PhillyPharma column, David Sell rakes Actavis over the coals for its purchase of Ireland-based Warner Chilcott.

Increasing statistics on abuse of benzodiazepines has caused Australia’s Therapeutic Drugs Administration to consider a decision to reschedule valium and Xanax.

The U.S. government has made a deal with GlaxoSmithKline for $200 million to develop antidotes to drug-resistant bacteria and drugs that could be used as weapons.

Japanese pharma company Daiichi Sankyo is claiming that India’s Ranbaxy Laboratories omitted critical drug safety information while Daiichi was in the process of buying a stake in Ranbaxy.

India’s government has issued new API guidelines in an effort to boost pharma exports to the EU via better harmonization of the country’s GMP requirements.