Drug Development

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

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.

First Protein Produced by Transgenic Animals Approved

Congressman John D. Dingell (D-MI) introduced HR 759, known as the Food and Drug Globalization Act of 2009, which would amend the Food, Drug, and Cosmetic Act to address food, drug, and device safety, including registration of producers of drugs and applicable fees, documentation for admissibility of drug imports, country of origin labeling, and the inspection of producers of drugs and active pharmaceutical ingredients (API).

Congress Introduces FDA Globalization Act of 2009

Also, PPD to acquire AbC.R.O.; Bilcare Global Clinical Supplies named Tony Moult general manager of Bilcare GCS Europe; more...

Company and People Notes: King Announces Restructuring; SCOLR Pharma Appoints President and CEO; More...

Also, recalls for two KV Pharmaceutical subsidiaries; Human Genome Sciences delivers anthrax drug to US Strategic National Stockpile; Akorn president and CEO leaves the company; more...

Company and People Notes: AstraZeneca Announces More Job Cuts; Deirdre Connelly Leaves Eli Lilly for GSK; More...

The Federal Trade Commission has filed a complaint in federal district court challenging agreements in which Solvay Pharmaceuticals (Marietta, GA) paid generic drug makers Watson Pharmaceuticals (Corona, CA) and Par Pharmaceutical Companies (Woodcliff Lake, NJ) to delay generic competition to Solvay's branded testosterone-replacement drug "AndroGel," a prescription pharmaceutical with annual sales of more than $400 million, according to an FTC press release.

FTC Files Complaint Against Generic Drug Makers

Cambrex CEO Steve Klosk looks to higher valued-added segments such as high-potency actives, controlled substances, and drug-delivery technologies to drive growth.

Ingredients