Drug Development

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

Short-term problems in software or hardware lead to long-term manufacturing troubles.

The importance of liposomes as an effective drug delivery system is well accepted in the pharmaceutical industry, but their handling remains a challenge.

In 2005, a small delegation (myself included) of the European Fine Chemicals Group (EFCG) met with the deputy head of the cabinet of Commissioner Kyprianou (the then Commissioner responsible for health and consumer protection). Our mission was simple - we were there to raise a red flag.

Today, approximately 1.5 million counterfeit medicine packs enter the legal supply chain each year - in other words, one pack in every 20000 is counterfeit.

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...

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

Covance talks about the risks, challenges, and tests required to develop a pandemic vaccine.

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

The president of BIO proposes the ingredients needed for industry growth.

Process steps, GMP documents, a purification vessel, and validation seem to disappear.

The authors describe the importance of a rapid and an abbreviated screening strategy by initial solvent screening in 20-mL scintillation vials.

The Japanese government is eager to jumpstart its generic-drug market, but changes must come first.

The authors investigate whether the addition of an antioxidant could be used to stabilize the solvent ethyl lactate by preventing the formation of peroxides

The GDP committee of IPEC–Europe is trying to seal one more broken link in the supply chain. This article contains bonus online-exclusive material.

Brief pharmaceutical news items for May 2009.

The organizations' presidents discuss market exclusivity, approval processes, and pending legislation.

Technology can solve enterprise-level problems.

With a new head of the FDA expected to be announced imminently, the pharmaceutical industry waits to witness the changes that will inevitably accompany the new appointment. These changes could, however, also impact the rest of the world's pharmaceutical markets.

Based on formulation simplicity and blinding capability, hard gelatin capsules are preferrable compared with other oral solid dosage forms, including tablets, in the early clinical phases of drug development.

Orally disintegrating tablets offer numerous advantages compared with traditional tablets and capsules, and can be an effective solution for developing line extensions of currently marketed therapies.

The author reviews the draft guidance on process validation, its QbD applications, and its potential impact on sterile manufacturing operations.

Also, Roche's Avastin trial does not meet endpoint; Innate Pharma names regulatory VP; more...

Also: Sanofi-aventis acquires BiPar Sciences; FDA issues Warning Letter to Chinese heparin manufacturer; Halo Pharmaceutical appoints chief scientific officer; more...