Outsourcing

Brief pharmaceutical news items for March 2009.

Contract manufacturers of APIs and intermediates report gains, but express caution.

Contract manufacturers deploy a business model using operations in the US and Western Europe with facilities in Asia.

With the economy down and multinational firms capitalizing on patents in developing countries, India's R&D sector still has a long way to grow.

After a year of increased attention on the pharmaceutical supply chain in Asia, what will be the region?s short? and long?term role?

Michiel Ultee talks about the challenges involved in transferring technology to a CMO and why communication is so important.

The productivity of the pharma industry has been declining for several years. Could biotechnology reinvigorate drug development?

Also, GPC Biotech AG and Agennix to merge; BASi appoints COO of scientific services; more...

Also, Sandoz received approval for its third biosimilar from the EU, WuXi PharmaTech's CFO Benson Tsang to leave at month's end; more...

Congressman John D. Dingell (D-MI) introduced HR 759, known as the Food and Drug Globalization Act of 2009, which would amend the Food, Drug, and Cosmetic Act to address food, drug, and device safety, including registration of producers of drugs and applicable fees, documentation for admissibility of drug imports, country of origin labeling, and the inspection of producers of drugs and active pharmaceutical ingredients (API).

Also, PPD to acquire AbC.R.O.; Bilcare Global Clinical Supplies named Tony Moult general manager of Bilcare GCS Europe; more...

GS1 UK, an independent organization that develops supply-chain standards, successfully completed the Pharma Traceability Pilot program and demonstrated the viability of a complete track-and-trace system for pharmaceutical products in a live, international supply-chain environment.

Also, recalls for two KV Pharmaceutical subsidiaries; Human Genome Sciences delivers anthrax drug to US Strategic National Stockpile; Akorn president and CEO leaves the company; more...

Cambrex CEO Steve Klosk looks to higher valued-added segments such as high-potency actives, controlled substances, and drug-delivery technologies to drive growth.

Several contract manufacturers announced capacity and service expansions at InformEx, the exhibition of custom and batch manufacturers, held in San Francisco, last week.

The financial crisis could lead to consolidation in the contract services industry.

Brief pharmaceutical news items for February 2009.

Dire circumstances are driving major drug companies to seek out CRO partners. This article contains bonus online-exclusive material.

A recent reader poll focused on predictions for the industry's future.

The Romanian pharmacetuical market has grown significantly in recent years, but with stagnation on the horizon, a path forward is needed.

FDA's role should not be overlooked as it has been in years past.

The European dose CMO sector appears to be very vibrant, probably more so than the market in the US.

Also, UCB will divest certain business in emerging markets to GSK; the KineMatik Group named Michael G. Jarjour president and CEO; more...

Also, Elan explores strategic alternatives; NanoGuardian appoints John D. Glover to lead its Security Advisory Board; more...

The US Food and Drug Administration issued its Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories.

An integrated information technology environment can help pharmaceutical companies find new processes and approaches to improve manufacturing efficiency, productivity, and quality.

Also, Bristol-Myers Squibb forms collaboration with ZymoGenetics, Hana Biosciences appoints VP of regulatory affairs, more...

Also, Novozymes Biologicals settles pollution case with the US Department of Justice; EntreMed restructures management team; more...

Outsourcing sterile manufacturing involves an integrated approach in product life-cycle management.

Although its domestic market is on the rise, Pakistan's market conditions have not proved welcoming enough to keep foreign investors.