Outsourcing

This week, the US Pharmacopeial Convention and the Vietnamese Pharmacopoeia Commission signed a memorandum of understanding that will help ensure the safety of Vietnamese medicines.

The regulators are doing it. But industry's fear of sharing information may leave them behind.

Is it good policy to pay for bad behavior?

High-potency manufacturing of active pharmaceutical ingredients is a growing and specialized capability.

During the past decade, big pharmaceutical companies have been making major efforts to restructure their manufacturing networks. In their haste to shed costs and assets, however, some may be adding risk to their product supply chains.

Also, Adimab forms deals with Merck and Roche; Manhattan Pharmaceuticals' CEO and president steps down; more...

Also, FDA debars clinical investigators; Jubilant Organosys forms deal with Endo Pharmaceuticals; AMRI makes changes to its India management team; more...

Also, TorreyPines Therapeutics to liquidate assets and dissolve company; EU's competition services to examine Pfizer/Wyeth merger; Akorn appoints Raj Rai interim CEO; more...

Kemwell (Bangalore, Karnataka, India) plans to build a new biopharmaceutical manufacturing plant in Bangalore, India, in a strategic collaboration with Boehringer Ingelheim (BI, Ingelheim, Germany), according to a Kemwell press release.

The US biotechnology industry reached aggregate profitability for the first time ever in 2008, representing the only bright spot in an otherwise dismal year for biotechnology financing and performance.

A major CRO ventures further into proprietary drug development.

Also, WACKER expands Iowa facility; EMEA releases a Q&A document for PIPs; Metrics consolidates quality operations; more...

Compliance features help patients follow medication regimens correctly.

Misleading the public about their investments-be it money or medicine-is unacceptable.

CROs and CMOs expand to gain a piece of the market for clinical trial materials.

Pharma companies that sell redundant facilities could endanger their supply chains.

It can take a lot of work to make sure nothing happens.

Despite its shrinking domestic economy, Ireland is determined not to let its pharmaceutical industry fade into the shadow of global recession.

Agency officials and manufacturers anticipate stricter enforcement of drug safety and quality.

Brief pharmaceutical news items for June 2009.

FDA leaders explain the purpose and plan for ICH's three quality guidelines.

Pharmaceutical Technology Europe interviews Andrew MacGarvey, President at Quanticate (MA, USA), a specialist biometrics company.

Also, Johnson & Johnson acquires Cougar Biotechnology; NIH launches program for rare and neglected diseases; PPD restructures leadership positions; more...

Also, Oxford BioTherapeutics forms drug development pact with GSK; Avila Therapeutics names CEO; more...

On May 7, 2009, as part of the President's fiscal year (FY) 2010 budget, the US Food and Drug Administration requested a budget of $3.2 billion, which is 19% more than the agency's current budget.

Also, Takeda to consolidate operations in Ireland; FDA to redesign website; Archemix names president and CEO; more...

Also, Oxford BioMedica forms collaboration with sanofi-aventis; FDA requires labeling changes for botulinum toxin producs; C. Richter King joins IAVI; more...

Best practices show the value of effective project management when outsourcing between a virtual pharmaceutical company and a contract manufacturing organization.

Strong growth in biopharmaceuticals bodes well for contract manufacturing, but the perils and the promises of pipelines remain.

A major CRO ventures further into proprietary drug development.