Drug Development

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

Bayer and its subsidiary Icon Genetics (Halle, Germany) have developed a production process to produce therapeutic proteins from tobacco plants.

Bayer Advances Protein Production from Tobacco Plants

Also, Patheon to expand Puerto Rico facility, Creabilis Therapeutics appoints Tony Wilson CEO, more...

Company and People Notes: SAFC Biosciences to Collaborate With Celltrion, USP Names K.V. Surendra Nath VP of USP-India, More...

Effective July 1, 2008, the Office of Generic Drugs (OGD) will require abbreviated new drug applications (ANDAs) to include data that demonstrate the manufacturer's control of residual solvents.

OGD Requires Residual-Solvent Data in ANDAs

Senator Sherrod Brown (D-Ohio), member of the Senate Health, Education and Labor Pensions (HELP) Committee, is requesting additional information from the US Food and Drug Administration and the pharmaceutical industry, concerning the regulation and practice of outsourcing.

Senator Probes into Pharmaceutical Outsourcing Practices

The European Chemicals Agency (ECHA), the European Union regulatory body overseeing the implementation of the REACH (Registration, Evaluation, and Restriction of Chemicals) regulation, began full operations on June 1.

European Chemicals Agency Begins REACH Implementation

In an assessment report about medicinal products containing heparin, the European Medicines Agency (EMEA)'s Committee for Medicinal Products for Human Use (CHMP) said it could not draw firm conclusions about the level of risk associated with unfractionated heparins (UFH) contaminated with oversulfated chondroitin sulfate (OSCS). Nevertheless, CHMP recommended that contaminated lots be withdrawn completely.

EMEA Report Assesses Contaminated-Heparin Risk

Also, Shire voluntarily recalls ADHD patch Daytrana

Company and People Notes: Daiichi Sankyo to Acquire a Controlling Stake in Ranbaxy, Amgen Appoints Anna S. Richo Senior Vice-President of Worldwide Compliance, More...

Also, Pall plans expansion in South America, Anthony Clarke joins Alexza Pharmaceuticals, more...

Company and People Notes: BMS to Acquire Kosan, L. Patrick Gage Resigns from PDL, More...

The global and US biotechnology industries performed well in 2007 as each recorded higher revenues and inched toward aggregate profitability.

Global and US Biotech Markets Show Strength

As part of a larger effort to address drug counterfeiting, the European Commission is seeking to tighten manufacturing and related supply-chain requirements for active pharmaceutical ingredients.

Ingredients