Drug Development

Articles

Eli Lilly Ends Semagacestat Program; Selecta Appoints CEO; And More.

Week of Aug. 16, 2010: Company and People Notes: Eli Lilly Ends Semagacestat Program; Selecta Appoints CEO; And More.

Making highly potent active pharmaceutical ingredients (HPAPIs) can be costly because the process often requires equipment specialized to achieve containment and extra attention to safety concerns. Pharmaceutical professionals may wonder whether disposable components, which have reduced the cost of some operations, might be appropriate in the manufacture of HPAPIs.

Are Disposable Components Powerful Enough to Manufacture Highly Potent Drugs?

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Sen. Michael Bennet (D-CO) introduced a bill earlier this month, the Drug Safety and Accountability Act of 2010, which is designed to improve regulatory oversight of drug-manufacturing facilities and improve related quality standards and monitoring.

Senate Introduces New Bill on Drug-Manufacturing Quality Standards

Penwest and Endo to Merge; Watson Makes Senior Appointments; And More.

Week of Aug. 9, 2010: Company and People Notes: Penwest and Endo to Merge; Watson Makes Senior Appointments; And More.

In a draft guidance published this week, the US Food and Drug Administration recommended that makers of transdermal and transmucosal drug-delivery systems use "an appropriate scientific approach" during product design, development, and manufacturing to minimize the amount of residual drug substance present at the end of the products' labeled use periods.

FDA Recommends Reducing Residual Drug in Transdermal Delivery Systems

FDA Approves Flu Vaccines; Caraco Names COO; And More.

Week of August 2, 2010: Company and People Notes: FDA Approves Flu Vaccines; Caraco Names COO; And More.

Legislative efforts to modernize provisions in the Toxic Substances Control Act of 1976 (TSCA), which involve chemical safety and reporting requirements is drawing criticism from the chemical industry.

SOCMA Raises Concern over TSCA Reform

Michelle Hoffman, editorial director of Pharmaceutical Technology.

Industry's focus on cost cutting has led to a dangerous gap in training and knowledge.

An Ounce of Prevention

Jane Wan is a freelance writer based in Singapore.

Manufacturers and regulators on both sides of the ocean move to ensure the safety of heparin and other globally distributed drug products.

Report from Asia

Chemocatalytic and biocatalytic approaches in asymmetric synthesis help provide a pathway for producing single-enantiomer drugs.

Ingredients