The QMN Weekly Bulletin

Two high-ranking members of Congress have sent letters to Cordis, a Johnson & Johnson (J&J) subsidiary, as well as the FDA, investigating the agency’s handling of a warning letter related to the company’s Cypher stents.

Discovery Labs is anticipating approval for its preventative respiratory distress syndrome (RDS) drug Surfaxin in the spring of 2008 as it resolves manufacturing issues that have long- delayed approval of the product, the company announced last month.

Early last month, Rep. John Dingell (D-Mich.) introduced draft legislation that would establish a user fee on imported drug shipments to fund more inspectors at the U.S. border and in FDA laboratories.

Pharma company Draxis Health is building a new Montreal plant and hiring up to 100 people after the company’s contract manufacturing division expanded its existing relationship with Johnson & Johnson, one of the world's biggest consumer products companies.

Foster Wheeler announced that its Singapore subsidiary Foster Wheeler Eastern Private Limited, part of its Global Engineering and Construction Group, has been awarded an engineering, procurement, construction management and commissioning services contract by GlaxoSmithKline Biologicals for a new biotechnology production facility in Singapore.

Medical device manufacturers, economic engine for the Glens Falls area, see difficulties filling jobs.

China’s food and drug safety watchdog, the State Food and Drug Administration, announced that it has finalized the targets of its national reform campaign for the pharmaceutical industry.

China’s drug watchdog and the Ministry of Health (MOH) have suspended the production and sale of methotrexate and cytarabin hydrochloride, two drugs often used to treat acute leukemia and rheumatoid arthritis, made by Shanghai Hualian Pharmaceutical Co., Ltd.

Shire voluntarily withdrew a limited number its Daytrana patches for attention deficit hyperactivity disorder because of reported difficulties removing the release liner off the patches.