FDAnews Drug Daily Bulletin

A new study shows the U.S. outpaces Europe in approving new cancer drugs, but that lead could be in jeopardy under the fifth authorization of the Prescription Drug User Fee Act.

With the final FDA user fee legislation lacking language to support a national track-and-trace system for pharmaceuticals, Congress must now act fast to preempt California’s epedigree law, slated to go into effect in 2015, said Sen. Michael Bennet (D-Colo.).

Beginning this month, drugmakers and competent authorities must report all adverse drug reactions — not just serious ones — to the EU’s centralized EudraVigilance database.

A federal judge shot down the latest attempt by AstraZeneca Pharmaceuticals to block Food and Drug Administration approval of the generic versions of its antipsychotic drug Seroquel (quetiapine).

A.P. Pharma announced that the PTO has allowed three new patents covering the company’s lead product candidate, APF530, which is being developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting.

When 70-year-old Bill Price signed on in 2006 to become one of the early testers of the Alzheimer’s drug bapineuzumab, he held high hopes the injections would stop the disease that was starting to claim his memory.

South Africa’s Adcock Ingram has acquired the pharmaceutical brands of privately held Cosme Farma Laboratories for $86 million.

Specialty pharmaceutical company Merus Labs said Wednesday it acquired from Novartis Pharma the Canadian and European rights to Emselex, a treatment for overactive bladder.

Pernix Therapeutics, a specialty pharmaceutical company, has announced the availability of Omeclamox-Pak to treat Helicobacter pylori (H. pylori) infection and duodenal ulcer disease to eradicate H. pylori in adult patients.