The US Food and Drug Administration recently published guidance for the characterization and qualification of cell substrates, viral seeds, and other biological materials used to manufacture viral vaccines for human use.

A UK consortium completed pilot runs of a pharmaceutical-safety program that uses electronic tracking and authentication to ensure the safety of drugs in the supply chain.

FDA Published The International Conference on Harmonization S9 Guideline; ISPE Released A New Good Practice Guide On Manufacturing Execution Systems.

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.

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

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

Contract manufacturers report improving business conditions, but will they continue?

Analysis of the opportunities and challenges in the biosimilars market.

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.

Pharmaceutical companies and their suppliers share approaches in risk mitigation in sourcing and ways to optimize the outsourced relationship.

Last year, a member of the PTE editorial team attended the 2nd Annual Lyophilisation Conference in London (UK).

The University of California, San Francisco (CA, USA; UCSF) has signed an agreement with Genentech with the aim of discovering and developing drug candidates for neurodegenerative diseases.

A significant increase in the recruitment of contract staff is expected during the next 12 months in the UK biotechnology sector, according to a survey conducted by SRG, which provides personnel to various science-based sectors.

A significant increase in the recruitment of contract staff is expected during the next 12 months in the UK biotechnology sector, according to a survey conducted by SRG.

FDA issues data on drug-induced liver injuries and serious skin reactions; IPEC Federation Week starts in France.

Eli Lilly, Merck Sharp & Dohme, and Pfizer form the Asian Cancer Research Group, a nonprofit aimed at accelerating research and improving treatment for patients affected with the most commonly diagnosed cancers in Asia.

Arnesto Segredo of Miami, Florida, was sentenced to 70 months in prison for conspiring to divert prescription drugs.

Merck To Eliminate 15,000 jobs; Tauzin Stepping Down At PhRMA; And More.

RUSNANO, a corporation established by the Russian government to foster the development of nanotechnology, launched a project last week to manufacture targeted-delivery nanodrugs to treat malignant neoplasms.

The Society for Chemical Manufacturers and Affiliates offered its support for a Senate proposal to extend to 2015 current chemical-security standards, the Chemical Facility Anti-Terrorism Standards, which are set to expire this year.

Abbott Completes Acquisition Of Solvay; Merck Names President of Consumer Healthcare; And More.

The European Medicines Agency and the Swiss Agency for Therapeutic Products, Swissmedic, have agreed to exchange information about the authorization and safety of H1N1 pandemic medicines.