FDAnews Drug Daily Bulletin

The FDA’s fiscal 2013 budget could be reduced by $318 million if Congress fails to agree to a deficit reduction plan by Dec. 31.

Axara Pharmaceuticals has not justified deviations from process control procedures that resulted in drug products gone astray and equipment cleaning confusion, according to an FDA Form 483.

Despite pressure from senators at a roundtable on the implementation of the Physician Payments Sunshine Act, a representative from the Centers for Medicare & Medicaid Services (CMS) simply said the agency hopes the rule will be released soon and that manufacturers’ data collection will begin in 2013.

GlaxoSmithKline said it has submitted a regulatory application in the European Union seeking approval of an additional indication for Synflorix, a paediatric pneumococcal vaccine, for the active immunization against pneumonia caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 5 years of age.

Jennerex presented Phase II clinical data of JX-594 delivered first intravenously and subsequently through intra-tumoral route demonstrating safety as well as disease control and tumor responses in patients with hepatocellular carcinoma.

A Finnish pharmaceutical company illegally supplied medicines to the country’s skiing team but too long ago for it to be prosecuted, regulators have concluded.

In a new development which on first glance resembles a storyline plucked from the pages of Harry Potter, researchers at the U.S. Department of Energy’s Argonne National Laboratory, Illinois, have adopted a system of levitation in order to more effectively develop pharmaceuticals - no magic wand required.

Glenmark Pharmaceuticals, a research-driven, integrated pharmaceutical company, has begun Phase II study for GBR 500, an antagonist of the VLA2 (alpha2-beta1) integrin, for ulcerative colitis.

Takeda Pharmaceutical is rapidly expanding its business in emerging countries, such as Russia, Brazil and China, as part of its global growth strategy.