Outsourcing

The GDP committee of IPEC–Europe is trying to seal one more broken link in the supply chain. This article contains bonus online-exclusive material.

Technology can solve enterprise-level problems.

The CRO market is experiencing two-tiered growth: firstly from pharmaceutical companies seeking to lower fixed costs by outsourcing clinical research to CROs; and secondly, from biotechnology and specialty pharmaceutical companies that lack the infrastructure to conduct trials.

A Pharmaceutical Technology survey examines capacity expansions, outsourcing practices, innovation levels, and the role of quality by design in sterile manufacturing and aseptic processing.

As the pharma industry desperately seeks to cut costs and streamline production, a new breed of CMO is growing in Europe. Find out how today's CMO is capitalizing on pharma's plant closures and divestments.

Also, Roche's Avastin trial does not meet endpoint; Innate Pharma names regulatory VP; more...

Senators Chuck Grassley (R-IA) and Ted Kennedy (D-MA) introduced legislation last Thursday that would give the US Food and Drug Administration more resources to inspect domestic and foreign plants that manufacture drugs and medical devices.

Also: Sanofi-aventis acquires BiPar Sciences; FDA issues Warning Letter to Chinese heparin manufacturer; Halo Pharmaceutical appoints chief scientific officer; more...

Also, Sanofi-aventis acquires Medley and Laboratorios Kendrick; Eli Lilly's Cook to retire from board; more...

Also, Genzyme and Bayer HealthCare form agreement; FDA releases draft guidances; TransMolecular appointed Robert Radie president and CEO

Although industry is tightening its belt, contract manufacturers across Europe are actually making out quite well by taking on additional projects and new roles.

Also, SOCMA changes name; two FDA approvals; Biogen Idec names chief operating officer; more...

Brief pharmaceutical news items for April 2009.

FDA is poised to gain authority and resources to ensure the quality of food and drugs.

Obama's cost-containment and science-innovation initiatives need to overlap.

The financial and economic downturn is likey to have long-term implications for outsourcing.

The role of automation suppliers is transforming to meet the pharma industry's demand for change.

Despite the market downturn, private equity investors are lining up for pharmaceutical services.

Despite the market downturn and financial meltdown, private equity investors are lining up for pharmaceutical services businesses.

Also, Hospira to reduce workforce; WuXi AppTech makes senior appointments; more...

The US Pharmacopeial Convention (USP) and the National Institute for the Control of Pharmaceutical Biological Products (NICPBP), China's agency for overseeing the quality of large- and small-molecule drugs, signed a memorandum of understanding (MOU) to bolster the quality of medicines in China and in the countries that buy Chinese drug products, including the United States.

Also, Genzyme receives warning letter; Mesa Laboratories appoints John J. Sullivan CEO and a member of the board of directors; more...

Also, Penn Pharma to expand; stem cell research funding ban lifted; Bristol-Myers Squibb made senior appointments; more...

Weakening fundamentals in 2008 and projected for 2009 dampen the outlook for pharmaceutical chemical outsourcing, but near-term growth and investments levels in R&D and capital spending remain fairly robust.

Gilles Cottier, SAFC's new president, plans to continue a growth strategy that emphasizes value-added technologies positions, growth in Asia, and customization in its supply-chain solutions.

In a press release dated Feb. 25, 2009, the US Food and Drug Administration charged that Ranbaxy Laboratories's (Gurgaon, Haryana, India) Paonta Sahib facility falsified data and test results in approved and pending drug applications.

Also, Schering-Plough's vaccine unit, Nobilon, formed an agreement with the World Health Organization; Ore Pharmaceuticals named president and CEO; more...

Industry has changed, but its basic tenets have not. INTERPHEX's RJ Palermo discusses a 7-step process to keep pharma moving forward.

When the business environment returns to "normal," our industry may appear quite different.

Small- and large-molecule drugmakers debate whether they can replicate other industries' success with just-in-time manufacturing.