FDA announced the availability of the guidance “Q11 Development and Manufacture of Drug Substances†in the Nov. 20, 2011 edition of the Federal Register.

Thermo Fisher Scientific has officially opened its new manufacturing facility in Suzhou, China. The $20-million plant will manufacture life-sciences consumables and equipment as well as establish local production capabilities to meet increasing demand in China and other regions in Asia Pacific.

USP announces new drug naming policy and FDA releases two guidance documents.

House Democrats have requested the Government Accountability Office (GAO) to conduct an inquiry into factors leading to an increased reliance on compounded products.

The launch of a global cross-pharmaceutical Investigator Databank follows the formation of TransCelerate BioPharma, another industry collaboration to address challenges in drug development.

Neptune Provides Update on Incident at its Production Plant; Tekmira and Alnylam Restructure Relationship and Settle All Litigation; and More.

The Italian Medicines Agency lifted a temporary hold on the use of Novartis seasonal influenza vaccines in Italy after affirming the vaccines' safety and efficacy.

The European Fine Chemicals Group has proposed that mandatory inspections be introduced for all global API manufacturers wishing to supply the European Union market.

FDA provides information on its Enhanced Communication Team created in response to PDUFA V.

Merck & Co. Resolves Vioxx Lawsuit; Takeda Agrees to Acquire Envoy Therapeutics; and More.

Pharmaceutical companies and public health officials gather at the IFPMA Assembly to urge for greater innovation and private and public partnerships to address global health concerns.

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

The European Commission has issued final approval for Europe's first gene therapy-a treatment for a rare genetic disorder that currently has no other treatment options.

Watson Pharmaceuticals has completed its EUR 4.25 billion ($5.4 billion) acquisition of the Actavis Group. The combination creates the world's third largest generic-drug pharmaceutical company, with anticipated pro forma combined 2012 revenues in excess of $8 billion, according to Watson.

FDA pushes back goals due to Hurricane Sandy and EMA announces changes to variation regulations.

Boehringer Ingelheim has agreed to pay $95 million to settle allegations that it improperly promoted four of its drugs.

USP revises labeling requirements for Heparin.

A Q&A with Yves de Montcheuil, vice-president of marketing at Talend, a provider of open-source integration software.

Consider critical process parameters and strategies to optimize the manufacturing process.

Even when all is well at the facility, one must expect the worst while braving the elements.

Key talks from the recent PDA/FDA regulatory conference highlight room for improvement.

The government of Turkey is drawing up a program in coordination with the pharmaceutical industry to create ways to make the country a regional production center for pharmaceuticals serving Europe, Central Asia, and the Middle East.

A disciplined approach to changing behavior can achieve change agility.

Overt and covert packaging technologies evolve to authenticate drugs and fight counterfeits.

Global tactics that incorporate online technologies and social media are reshaping disease response.

Novartis to Construct New Biotechnology Facility in Singapore; Patheon to Acquire Banner Pharmacaps; and More.

Patheon will acquire softgel-specialist company Banner Pharmacaps, based in North Carolina in the US, for $255 million

Novartis is investing more than half a billion US dollars in the construction of a new state-of-the-art biotechnology production site in Singapore for the manufacturing of drugs based on cell culture technology.