Outsourcing

Representatives of SOCMA and IPEC explain new quality agreement templates and their use for meeting regulatory expectations and securing the pharmaceutical supply chain.

The authors describe recent market trends and indicate the likely future direction of the pharmaceutical and biopharmaceutical industries. This article is part of the 2010 Outsourcing Resources special issue.

As biopharmaceuticals will soon make up 50% of new drug approvals there has been a significant rise in interest in the field of biosimilars.

View standardized quality agreement templates from IPEC and SOCMA.

The author describes the importance of risk management and offers strategies for risk-management preparedness in supply chains.

With more hands in the manufacturing pot, a good contingency plan is crucial to success.

Leading CMOs share their experiences with regard to client expectations and performance indicators as well as strategies for adapting to the changing contract-manufacturing environment. This article is part of the 2010 Outsourcing Resources special issue.

Merck and Sinopharm Sign Agreement; Agilent Appoints CFO; And More.

In 2009, the European Commission (EC) Customs Union seized 11,462,533 medicines and medical products for suspected violations of intellectual property (IP), according to the Commission's annual report on EU Customs Enforcement of Intellectual Property Rights, which was published last week.

A new report from the International Data Corporation (IDC) shows that life-science companies are increasingly using third-party outsourcing firms to augment or replace their information technology services.

Pfizer Ends Second Tanezumab Clinical Program; Catalent VP Joins USP Panel; And More.

The Society of Chemical Manufacturers and Affiliates (SOCMA) expressed "strong concern" over legislation introduced in the US Senate earlier this month regarding chemical-site security.

Merck KGaA (Darmstadt, Germany), a global pharmaceutical and chemical company, completed its acquisition of Millipore (Billerica, MA), a life-science company, last Thursday for an aggregate purchase price of roughly EUR 5.2 billion ($6.7 billion).

With the right technology tools, the sponsor organization and the contract manufacturer can have self-service, on-demand, and scheduled access to all manufacturing, quality, and process-development data.

Xcelience and Penn Form Joint Venture; Almac Appoints QA Director; And More.

Last week, Senator Charles Grassley (R-IA) sent letters to 16 drugmakers, including Pfizer (New York), AstraZeneca (London), and Eli Lilly (Indianapolis), asking them about their current policies regarding whistleblowers?employees who file complaints under the False Claims Act (FCA).

Eli Lilly to Acquire Alnara Pharmaceuticals; Exelixis CEO Leaves for Biogen Idec; And More.

To continue innovating, the biopharmaceutical sector needs support from all levels.

Varley, director of commercial operations, discusses one-stop shops and timelines.

As generic divisions become the most-wanted acquisitions of Big Pharma, India's domestic industry may be thinning out.

Rising labor costs in China may result in increased competition for higher value services.

After a spate of industrial disasters, the public seeks greater oversight of corporations-so does FDA.

More information may be released to improve public understanding of regulatory policies.

Pfizer Suspends Tanezumab Program; Actavis Appoints CEO; And More.

Company and People Notes: Valeant and Biovail to Merge; GPhA Names Interim Director; And More.