Newsletter - April 7, 2022
Is FDA Ready to Make Another Sarepta- and Biogen-Like Decision?
In July 2016, FDA approved Sarepta’s DMD drug, and in June 2021, it approved Biogen’s Aduhelm for Alzheimer’s disease, both times going against the vote of its Advisory Committees. Now FDA is being lobbied again by patient groups to approve Amylyx’s AMX0035 for ALS despite a no-vote from the Advisory Committee...Read More
Does FDA Have a Double-Standard for Review for China-Only Data?
In February, FDA pushed hard against a cancer drug arguing that data from the China-only clinical trials was not acceptable for US approval. But does it imply an FDA policy or a one-time decision? Another cancer drug, this time for a rare cancer common in Asian population, with a similar China-only clinical trial may answer...Read More
Is FDA Ready to Make Another Sarepta- and Biogen-Like Decision?
In July 2016, FDA approved Sarepta’s DMD drug, and in June 2021, it approved Biogen’s Aduhelm for Alzheimer’s disease, both times going against the vote of its Advisory Committees. Now FDA is being lobbied again by patient groups to approve Amylyx’s AMX0035 for ALS despite a no-vote from the Advisory Committee...Read More
Does FDA Have a Double-Standard for Review for China-Only Data?
In February, FDA pushed hard against a cancer drug arguing that data from the China-only clinical trials was not acceptable for US approval. But does it imply an FDA policy or a one-time decision? Another cancer drug, this time for a rare cancer common in Asian population, with a similar China-only clinical trial may answer...Read More
