Drug Development

Articles

Industry has changed, but its basic tenets have not. INTERPHEX's RJ Palermo discusses a 7-step process to keep pharma moving forward.

Critical Challenges Require Core Values

Brief pharmaceutical news items for March 2009.

Pharma Capsules

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Contract manufacturers of APIs and intermediates report gains, but express caution.

API Outsourcing is Mixed

Contract manufacturers deploy a business model using operations in the US and Western Europe with facilities in Asia.

Narrowing the Geographic Divide in API Sourcing

Also, GPC Biotech AG and Agennix to merge; BASi appoints COO of scientific services; more...

Company and People Notes: Genentech Tells Shareholders to Reject Roche's Tender Offer; Cryoport Appoints President and CEO; More...

The United States Trade Representative (USTR) is seeking documentation from chemical companies to identify possible non-tariff trade barriers, created by the European Union's Registration, Evaluation, Authorization and restriction of Chemicals (REACH) regulation, which would be inconsistent with the EU international trade obligations under World Trade Organization (WTO) rules, according to an informational release by the Synthetic Organic Chemical Manufacturers Association (SOCMA).

USTR To Evaluate Trade Implications of REACH

After two years of hearings, more than 5000 pages of expert testimonies, and 939 medical articles, a special federal court ruled that there was little, if any, evidence to support the claim that substances in the measles, mumps, and rubella vaccine (including the use of thimerosal) had led to the autism of three children.

Court Rules No Link Between MMR Vaccine and Autism

Also, Sandoz received approval for its third biosimilar from the EU, WuXi PharmaTech's CFO Benson Tsang to leave at month's end; more...

Company and People Notes: KV Pharmaceutical Restructures; Otsuka America Appoints Mark Altmeyer President and CEO; More...

The US Food and Drug Administration sent letters to manufacturers of certain opioid drug products, indicating that these drugs will be required to have a Risk Evaluation and Mitigation Strategy (REMS).

FDA Seeks to Establish REMS for Opioid Drugs

The US Food and Drug Administration issued its first approval for a biological product produced by genetically engineered animals.

Ingredients