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Biogen decision could mark a big shift for big pharma

Beyond the immediate impact for Biogen, the US regulator's decision could have repercussions for the broader pharma sector
Biogen decision could mark a big shift for big pharma

 

  • Biogen has filed findings for its Alzheimer's clinical trial with the FDA
  • A landmark case for US regulators and their first major test under the Biden administration

The successful results reported by US pharma group Biogen (US: BIIB) in the clinical study of its Alzheimer’s drug aducanumab have been compared to “firing a shotgun at a barn door and then drawing a target around the bullet holes.”

It’s not a completely unfair criticism. Scientists working on the clinical trial initially concluded that it had been unsuccessful in slowing the progression of Alzheimer’s Disease - the leading cause of dementia - before retracting their early comments after finding that patients who had been given a higher dosage showed good signs of progress. A subsequent trial found that aducanumab has the potential to slow the underlying disease pathology and cognitive decline in patients with mild symptoms. 

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