FDAnews Drug Daily Bulletin

Counterproductive cross-border repackaging requirements in the EU are holding back a group of drug distributors from approving a drugmaker-backed supply chain security plan to scan all treatments at the point of dispensing.

A number of drugmakers in China are being ordered to power down production lines and hand over their licenses for producing capsule-based drugs after a crackdown on chromium contamination by the country’s regulatory agency.

The FDA has outlined provisional trial designs, study endpoints and efficacy analyses that can be used for testing and assessing new irritable bowel syndrome (IBS) drugs until a well-defined and reliable patient-reported outcome (PRO) tool — the ideal efficacy assessment instrument — can be developed.

Vicodin and other hydrocodone-combination painkillers may face tighter U.S. oversight following repeated reports of misuse and addiction that have been cited by the Drug Enforcement Administration.

Patients who want an injectable form of Roche Holding AG’s bone-strengthening drug Boniva may not be able to get it in the next few weeks because the company did not accurately forecast demand, federal officials said.

The Austrian company AFFiRiS A.G. of Vienna said this week it has begun the first-ever clinical trials of a vaccine to treat Parkinson’s disease.

The U.S. Food and Drug Administration has approved Horizant, a drug developed and marketed by GlaxoSmithKline and XenoPort for the management of postherpetic neuralgia, a nerve disease that sometimes follows shingles.

Versartis announced today that its manuscript “A Novel Long-Acting Human Growth Hormone Fusion Protein (VRS-317): Enhanced In Vivo Potency and Half-Life” was published in the online edition of The Journal of Pharmaceutical Sciences.

Nektar Therapeutics said that regulators are giving fast track status to an experimental pain drug the company is developing.