FDAnews Drug Daily Bulletin

The FDA has informed Gilead Sciences it needs at least three more months to weigh its Truvada sNDA for HIV prevention, AIDS advocates say.

The overall number of adverse drug events in China in 2011 remained level with 2010, but reporting by individual municipalities increased, according to the State Food and Drug Administration’s (SFDA) 2011 annual report on adverse drug reaction (ADR) monitoring.

Pharma companies seeking approval for drugs along with companion diagnostics could see more streamlined FDA decisions as the agency moves toward a stricter preapproval path for the diagnostic portion of companion products.

Alarmed by an “imminent threat of future injury,” the D.C. Circuit on Friday revived a proposed class action accusing the District of Columbia of systematically denying Medicaid coverage of prescription drugs without providing written explanation required by federal and local laws.

Denmark’s Novo Nordisk said on Monday a study had confirmed its diabetes drug Victoza provided greater reductions in blood sugar levels than rival drug Byetta from Amylin.

A proposed trial of an old antiretroviral drug, stavudine, which is no longer recommended due to its side-effects, has raised concern among AIDS activists who argue that its low cost is not enough reason to consider using it.

Forest Laboratories announced revised FY 2013 earnings guidance.

Sanofi’s Lantus insulin reduced blood-sugar levels to a greater degree than Merck’s Januvia in people with Type 2 diabetes in a clinical trial.

The Indian Pharmaceutical Alliance says the export earnings of the manufacturers will be hit if the government continues with the cost-based pricing mechanism under the proposed drug policy.