Manufacturing

The US Food and Drug Administration and the European Medicines Agency are implementing a streamlined process to help regulators better identify and share information regarding orphan-drug and biologic products.

Merck KGaA has agreed to acquire Millipore for EUR 5.3 billion ($7.2 billion).

Last week, the US Food and Drug Administration and the National Institutes of Health unveiled plans to establish a Joint Leadership Council to address important public-health issues.

Astellas Pharma Makes Bid for OSI Pharmaceuticals; Ringo Retiring From Pfizer; And More.

Top pharmaceutical and biotech companies should expect a major slowdown in sales growth between 2008 and 2014, according to business analysts Datamonitor.

Strategic rather than tactical considerations are driving biopharmaceutical outsourcing.

Following its $68-billion acquisition of Wyeth, Pfizer is integrating its manufacturing and outsourcing activities (Podcast).

Editors' Picks of Pharmaceutical Science & Technology Innovations

CMOs' business model has all of the flaws of the captive model it is meant to replace.

Could President Obama's tax reform, which is targeted at reducing outsourcing, endanger India's contract-services industry?

Emerging markets remain an important element in the strategies of pharmaceutical companies and their suppliers.

Pre-Interphex 2010 Product Releases.

Current methods for establishing visible residue limits (VRLs) are not statistically justifiable. The author proposes a method for estimating VRLs based on logistic regression.

In Part I of this article, the authors describe the materials and methods used in developing a screening strategy to accelerate the preparation and characterization of spherical agglomerates by spherical crystallization.

To best carry out the vision of Hatch-Waxman, Congress must act now on biogenerics.

Brief pharmaceutical news items for March 2010.

Analysis of the opportunities and challenges in the biosimilars market.

FDA modernizes information systems, expands access to drug safety and use information.

From last-minute product inserts to putting out fires, close calls are a common occurrence.

It's time to maintain a thorough traceable excipient trail.

If both sides of the aisle don't agree on even mild healthcare reform soon, the bill could die out.

The vice-president addresses shifts in process and more.

Technological developments make it easier to manufacture sterile parenterals.

Visitors to INTERPHEX 2010 will find an abundance of packaging innovations. Plus: Check out our preliminary program for LIVE video interviews at the show.

The author reviews the benefits, challenges, and considerations to be made when selecting a gamma-irradiation sterilization method.

Although efforts have been made to improve solubility, many poorly soluble drugs still reach the market. Peter Nielsen discusses new developments in solubilisation technology, which could help those companies seeking to reinvigorate marketed products.

The authors describe an industrialized process for the manufacture of iPSC-derived human cardiomyocytes. This article is part of a special issue on Bioprocessing and Sterile Manufacturing.

Single-use technologies can help simplify equipment and facility design, thus bringing cost advantages. But how are these cost advantages realized and what criteria can be used to assess their impact? This article is part of a special issue on Bioprocessing and Sterile Manufacturing.

The second annual Pharmaceutical Technology Bioprocessing Survey offers a snapshot of the industry following 2009's megamergers.

The author examines the use and advantages of disposable technologies in the fill–finish of sterile pharmaceutical products and how these technologies can reduce costs and time in producing clinical-trial materials.