FDAnews Drug Daily Bulletin

A new business coalition backed by PhRMA and the Biotechnology Industry Organization is calling on the Obama administration to pressure India to end trade practices it says discriminate against foreign pharmaceutical companies and discourage U.S. drug exports.

Language on traceability requirements in the EU’s 2007 regulation on innovative “advanced therapies” is overly broad and should be clarified in forthcoming guidance, pharma giant Pfizer says.

The FDA has finalized changes to orphan drug regulations, clarifying confusion around orphan drug designation and the terms that have hung up sponsors of rare-disease treatments.

Just months after the Indian Supreme Court blocked the evergreening of Novartis’ Gleevec, Ugandan health experts argue against stringent intellectual property protections in the Trade Related Aspects of Intellectual Property Rights.

In several Phase III clinical trials, a melatonin receptor agonist has proven that it can reset the body’s natural circadian rhythms, thus helping blind people sleep better.

An antibiotic called planosporicin has reproduced itself at the John Innes Center.

A U.S. appeals court has decided that Novo Nordisk’s patent on Prandin — a diabetes drug used in combination with metformin — is invalid, thus allowing generic manufacturers to begin making lower-cost copies of the drug.

Israeli pharmaceutical company Teva has declared its intention to stop filing for patents in its home country, preferring instead to take advantage of tax breaks in Switzerland.

Yet another country is projecting an increase in pharmaceutical prices.