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U.S. watching EMA’s adaptive licensing pilot

The industry is closely watching the European Medicines Agency’s (EMA) experiment in adaptive licensing, which challenges the way new medicines are evaluated and approved—since a successful outcome could play an important role in moving the approach forward in the U.S. and other regions.

Ice Bucket Challenge a boon for ALS research

It was like nothing medical-research fundraising had ever seen.

Three men with amyotrophic lateral sclerosis, also known as ALS or Lou Gehrig’s disease, decided to videotape themselves dumping buckets of ice water on their own heads, the way coaches get buckets of ice and Gatorade dumped on their heads after a victory. And while standing there wringing wet, these three men—all very young, all of whom had been heavily involved in sports before their diagnoses—challenged three other friends and family members to do the same, saying if they didn’t take the challenge, they’d have to send a check to an organization benefitting ALS—a progressive neurodegenerative disease that has no cure, has no effective treatments and leads to paralysis and death two to five years after diagnosis.

Also in this issue:

• Clearing up the confusion: SDV v. SDR
• The guessing game in clinical trial design—patient behavior
• Regulatory Update
• Month in Review
• FDA Actions
• Study Lead Opportunities
• New Drugs in the Pipeline