The QMN Weekly Bulletin

Cardinal Health received a warning letter after an FDA inspection revealed several quality-system violations related to some of its needle-disposal containers.

The FDA is looking for companies to participate in a quality-by-design (QbD) pilot program intended to help the agency develop guidance on biotechnology submissions.

In the wake of recent drug quality incidents such as the heparin contamination, the FDA is seriously considering how drug ingredient supply chains need to be audited, according to staff from the Center for Drug Evaluation and Research’s Office of Compliance.

Merck will spend an additional $300 million to expand its vaccine manufacturing complex ..., according to the company.

Zimmer Holdings plans to expand its northcentral Indiana operations, creating nearly 100 jobs over the next three years, its fourth expansion since 2004.

Minister of National Development and Economy Gordon Bajnai announced at a press conference in Budapest that Hungarian drug company Richter had received an unspecified amount of government support to build a new HUF 15bn (EUR 65.76m) biotechnology R&D and manufacturing plant in Debrecen (E Hungary).

Public sector pharma companies may soon get a shot in the arm to revive themselves. The government is planning to exempt PSUs such as Indian Drug and Pharmaceuticals (IDPL), Bengal Chemicals and Hindustan Antibiotics (HAL) from the price control blanket for two to three years.

GeoVax Labs … together with Vivalis … announced the signing of a letter of intent for joint collaboration and commercial license on the use of Vivalis’ EBx technology, to manufacture the MVA component of the GeoVax HIV-1 vaccine.

Roche Holding, which makes a version of a stamina-building drug illegally used by some athletes, said it didn’t plant a molecule in the substance to help identify it in doping tests, spokeswoman Martina Rupp said.