Pharmaceutical Technology Editors

AstraZeneca Names Pascal Soriot CEO; The Merck Group Agrees to Acquire Biochrom; and More.

FDA Extends Pfizer's Action Date for Tofacitinib NDA; United Drug to Acquire Bilcare GCS; and More.

Bristol-Myers Squibb Completes Acquisition of Amylin; Quintiles Acquires Expression Analysis; and More.

Regulatory Roundup: ISPE issues ozone sanitization guidance and EMA amends incident management plan

Boehringer, Servier, Xoma Form Biomanufacturing Agreement; Teva Canada Completes Sale of Mirabel (Quebec) Facility to Halo Pharmaceutical; and More.

A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers.

FDA Issues Complete Response Letter to Luitpold Pharmaceuticals for Injectafer NDA; Novasep Invests to Expand API Manufacturing Capabilities; and More.

A roundup of developments in corporate social responsibility (CSR) and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

FDA announces FY 2013 user fee rates and EMA furthers relationship with Japan.

Amicus Therapeutics, GSK Expand Fabry Pact; US District Court Rules in Favor of Pfizer, Northwestern University in Lyrica Patent Case; and More.

A roundup of industry regulatory news.

Bristol-Myers Squibb Begins Tender Offer to Acquire Amylin Pharmaceuticals; FDA Approves Gilead's Truvada for Reducing the Risk of Acquiring HIV; and More.

The author discusses the regulatory requirements for electronic records contained in Title 21 CFR Part 211 and how they overlap with the requirements set forth in Title 21 CFR Part 11.

FDA promotes supply chain pilot program. EMA opens pharmacovigilance legistation up for public consultation. USP Calls for Somatropin Cell-Based Bioidentity Method.

Amgen Completes Acquisition of KAI Pharmaceuticals; Renaissance Acquisition Holdings Acquires DPT Laboratories; and More.

GSK Extends Deadline for Tender Offer to Acquire Human Genome Services; Sartorius Opens New Filter, Aseptic-Bag Production Facility in Puerto Rico; and More.

Bend Research, Catalent Enter into Oral Controlled-Release Technologies Pact; Quintiles Expands in China; and More.

US District Court for NJ Rules Against Merck & Co. in Nasonex Patent Infringement Case; FDA Issues Complete Response Letter to Pfizer for Tafamidis Meglumine NDA; and More.

Basilea, Stiefel Enter into Hand-Eczema Pact; Sandoz Recalls Generic Oral Contraceptive Drug; and More.

Updated European guideline provides more detail on quality issues surrounding biosimilar medicines.

Catalent Expands Fill–Finish Capabilities; Siegfried Acquires Alliance Medical Products; and More.

In July 2012, new pharmacovigilance legislation will come into effect across the EU as a result of changes adopted in 2010, specifically EU Regulation No. 1235 and Directive 84.

A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

Astra Zeneca, GlaxoSmithKline Enter into Antibiotics Pact; Takeda to Acquire Multilab; and More.

GSK Agrees to Acquire Cellzome; Patheon Restructures; and More.

The US Pharmacopeia has issued a third round of improvements to its blood thinner standard.

GSK Agrees to Acquire Cellzome; Patheon Restructures; and More.

Coherus BioSciences, Daiichi Sankyo Form Biosimilar Pact; Sandoz Agrees to Acquire Fougera Pharmaceuticals; and More.

AstraZeneca's CEO David Brennan To Retire; PRA, Amgen Reach New Biosimilar Agreement; and More.

A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations