Biogen Inc (NASDAQ:BIIB) shares traded higher Thursday morning before pulling back. Reports indicate that the FDA's process for approving Biogen's Alzheimer's drug Aduhelm was filled with "irregularities."

The committee also criticized Biogen for setting "an unjustifiably high price" on its Aduhelm drug despite knowing the elevated prices would be a challenge for patients in need. The company reportedly planned to use aggressive marketing tactics to push back against uproar over high prices. 

The congressional report indicates that the FDA needs to make changes to ensure that its process for reviewing Alzheimer's candidates doesn't create doubts about the honesty and fairness of the review process. 

Biogen discovers, develops and delivers innovative therapies for people living with serious neurological diseases.

Check This Out: Biogen's 2nd Alzheimer's Antibody, BeiGene's Cancer Drug Label Expansion, Adcom Test For Regeneron And More: January PDUFA Catalysts For Biotech Investors

BIIB Price Action: Biogen has a 52-week high of $311.88 and a 52-week low of $187.16.

Biogen shares are up 0.7% at $275.97 Thursday afternoon, according to Benzinga Pro.

Photo: Michal Jarmoluk from Pixabay.