Outsourcing

Legislative decisions to increase Medicare's formulary may lead to a fight over drug approvals.

CMC service providers are doing well, but clinical and preclinical CROs are doing even better.

Despite its flaws, a recent release fills a need for books about pharmaceutical project management.

The author outlines the opportunities and challenges for manufacturers aiming to enter the BRIC-country markets.

To meet the demands of early-stage development, contract research organizations can evaluate various dosage-form options. The author examines various methods of capsule filling, including binary blends.

J. Scott Tarrant, executive vice-president of Xceleron, explains the role of microdosing in drug development. He describes how microdose data can be used to predict pharmacological dose absorption, distribution, metabolism, and excretion/pharmacokinetic outcomes using accelerator mass spectrometry.

Gonghua Pan, associate director and head of the parallel medicinal chemistry sourcing operations at Pfizer, explains the evolution of the company's approach to outsourcing research and development from a line-or function-centric approach to an integrated sourcing model. This analysis includes the role that contract research organizations in Asia play in the company's outsourcing actvities.

A sponsor company must investigate the manufacturing automation and systems, laboratory automation and systems, information-technology infrastructure, and business applications of each potential contract manufacturing organization.

Survey results indicate a healthy market, but increasing competition.

Outsourcing strategies of large pharma companies are changing. The CEO of Patheon talks about his company's plan to meet customers' changing needs.

As pharma companies outsource new types of projects, contractors are trying to meet new needs.

The high-profile case of contaminated heparin from a Chinese supplier has intensified the debate on the effectiveness of FDA's process for inspecting foreign drug-manufacturing facilities. The article examines proposed legislative and regulatory reforms and actions taken by the agency to improve drug-import safety.

Also, Cobra Biomanufacturing to extend collaboration and form joint venture with ViroMed, Epix Pharmaceuticals CEO resigns, more...

Senator Sherrod Brown sent a letter to Richard T. Clark, president and chief executive officer of Merck (Whitehouse Station, NJ), to ask for information about the company's reliance on global outsourcing for the manufacture of pharmaceutical ingredients and finished products.

Also, Niro changes its name to GEA Process Engineering; Frances K. Heller joins Exelixis as executive vice-president of business development, more...

Also, Roche to end HIV/AIDS research program, WuXi PharmaTech makes appointments, more...

A pharmaceutical company's information-technology infrastructure could facilitate the appraisal of the performance of contract manufacturing organizations.

Also, Catalent Pharma Solutions to collaborate with One World Design and Manufacturing Group, Bioheart appoints Howard J. Leonhardt as CEO, more...

The European Pharmacopoeia Commission adopted revised monographs for heparin calcium and heparin sodium to strengthen the level of testing required for quality control.

Global manufacturing excellence will be a game changer for CMOs that can achieve it.

Also, Covance and WuXi PharmaTech to form contract research joint venture in China, Covidien makes appointments to its Pharmaceutical Products and Imaging Solutions businesses, more...

Forums, blogs, and more can spark innovation.

With no economic relief in sight, industry, like all of us, is grappling with high-and new-costs.

Providing the right information upfront may ease new requirements to assess solvent levels.

Recent reports discuss the future of pharma's emerging markets.

Despite high ambitions for its pharmaceutical and biotech sectors, South Korea still faces a number of hurdles against competing internationally.

How can any company be sure that the standards that suppliers might claim to operate, and might be able to demonstrate from time to time, are actually being practised all the time?

Also, Stiefel Laboratories will acquire Barrier Therapeutics, Danube Pharmaceuticals appoints Brian Levy COO, more...

Also, Patheon to expand Puerto Rico facility, Creabilis Therapeutics appoints Tony Wilson CEO, more...

Senator Sherrod Brown (D-Ohio), member of the Senate Health, Education and Labor Pensions (HELP) Committee, is requesting additional information from the US Food and Drug Administration and the pharmaceutical industry, concerning the regulation and practice of outsourcing.