Michelle Hoffman

A Conversation with Otonomy

After years of promomting QbD concepts, FDA's ready to take action on nonconformers.

Individuals and companies at the top seem to have no problem short-circuiting their success.

View the corporate lineages of pharma's top companies.

As the pharmaceutical supply chain expands, sponsor companies need to weigh all their options.

A Pharmaceutical Technology report looks at trends in biopharmaceutical manufacturing. This article contains bonus online-exclusive material.

Is it good policy to pay for bad behavior?

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

Manufacturers of therapeutic monoclonal antibodies consider new paradigms in purification technologies.

Obama's cost-containment and science-innovation initiatives need to overlap.

Scientists studying epilepsy have traditionally focused on the comings and goings of ions through molecular channels in nerve cells, and many current antiseizure therapies seek to modulate that dynamic.

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

The incoming administration has renewed hope for stem cells, but less adequate copycats may follow.

China's quality approach to domestic versus exported products seems to be a lose-lose situation.

Pharma companies could benefit from the lessons learned in this fall's financial crisis.

Molecules called "chaperones" facilitate correct protein folding.

Can previous trends of Democratic and Republican administrations predict industry's future?

Are hypersanitation trends a result of scaremongering or a lack of faith in medicine?

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

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.

Drugmakers seeking to block the activity of a protein may have a new strategy at their disposal.

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

Creating a kinder, gentler manufacturing process that doesn't kill the product is the goal of process developers doing large-scale cell culture for cell therapy.

The good, the bad, and the ugly about direct-to-consumer advertising.

Scientists are uncovering signaling systems that operate via cannabinoid messenger molecules.

Scientists are giving up on a preventive vaccine for AIDS, but there are lessons to be learned.

The FDA itself issues a cry for help. Is anybody listening?

Antibodies are highly specific molecules that can be tailored to recognize almost any stretch of peptide that nature can conjure: a feature that has been exploited for years now to produce therapeutic antibodies.

New research and ideas for March 2008