FDAnews Drug Daily Bulletin

UCB plans to submit marketing applications for Cimzia in psoriatic arthritis and axial spondyloarthritis (AxSpA), including ankylosing spondylitis, to the FDA and EU by the end of the year. 

U.S. manufacturers looking to import their drugs to Latin America are finding that the greatest challenges are capacity-related, as more narrow-bodied aircraft are now flying south, an expert says.

In an effort to increase transparency, Health Canada says it will begin publishing administrative information on clinical trials that have received a No Objection Letter pursuant to a clinical trial application.

The Federal Circuit Bar Association urged the Federal Circuit to rehear a patent infringement dispute involving Smith & Nephew Inc. and West Forrest University Health Sciences, saying the court should clarify its role in reviewing obviousness and nonobviousness determinations in patent cases tried before juries.

Watson Pharmaceuticals has sold its Rugby OTC pharmaceutical Product Trademark and Assets to The Harvard Drug Group for nearly $117 million.

Anchen Pharmaceuticals received final approval from the FDA for its abbreviated new drug application for tretinoin capsules, 10 mg.

GlaxoSmithKline’s ViiV Healthcare agreed to buy the rights to HIV treatments the unit has developed with Shionogi, giving the Japanese drugmaker a 10 percent stake in ViiV as the companies prepare to seek approval of the most advanced medicine from the collaboration.

Needham-based immunotherapy company Celldex Therapeutics announced positive results from a Phase I study involving its solid tumor cancer vaccine, CDX-1401, in combination with two other drugs.

A publicly financed $3 billion effort to spur innovative cancer research, reduce cancer rates and speed up the commercialization of new treatments has floundered amid controversy after the mass resignation of nearly three dozen scientists, including two Nobel laureates, from review committees.