FDA delays Biogen's ALS drug review by three months, decision to now come next April-Endpoints News

[anonymous]

Loses gonna lose.


FDA delays Biogen's ALS drug review by three months, decision to now come next April – Endpoints News


FDA delays Biogen's ALS drug review by three months, decision to now come next April


Attempting to push forward an ALS drug despite a failed Phase III study, Biogen saw its FDA review date delayed Monday.

The big biotech announced that the agency pushed back its decision deadline by three months to April 25, 2023 for tofersen, an antisense drug designed to treat a genetic subset of ALS. Biogen had previously received priority review for the application, which will fall under the accelerated approval pathway.

In a press release, Biogen said the FDA had requested additional information, but it’s not clear what they sought. A Biogen spokesperson told Endpoints News, “We aren’t able to provide further detail on our regulatory interactions, but information requests are a standard part of the FDA review process.”

 

[anonymous]

Losers gonna lose.

 

[anonymous]

Maybe Biogen products work in the metaverse. It will move from biomarkers to ridiculous digital twin models. Please ensure that the digital twins are DEI rated though.

 

[anonymous]

I was in your clinal trial for this drug. I stayed in the trial for 2 years until the risk outweighed the benefits and they booted me. I have a feeling I know what side effects the FDA is seeking but I won’t disclose it here. I will tell you that EVERY TIME the side effect showed up it was accompanied by a 104 degree temp for me and a hospitalization.

I also found out that it was named Toferson after some guy named Todd Ferguson at Biogen. He named it after himself. He isn’t narcissistic, is he ?

 

[Turd Ferguson]

Not Todd, Turd. Turd Ferguson.

 

[anonymous]

Loses gonna lose.


FDA delays Biogen's ALS drug review by three months, decision to now come next April – Endpoints News


FDA delays Biogen's ALS drug review by three months, decision to now come next April


Attempting to push forward an ALS drug despite a failed Phase III study, Biogen saw its FDA review date delayed Monday.

The big biotech announced that the agency pushed back its decision deadline by three months to April 25, 2023 for tofersen, an antisense drug designed to treat a genetic subset of ALS. Biogen had previously received priority review for the application, which will fall under the accelerated approval pathway.

In a press release, Biogen said the FDA had requested additional information, but it’s not clear what they sought. A Biogen spokesperson told Endpoints News, “We aren’t able to provide further detail on our regulatory interactions, but information requests are a standard part of the FDA review process.”

Biogen has nothing in the pipeline that has good data. They’re hoping that market need drives approval, as opposed to the drug actually working. This place is pathetic.

 

[anonymous]

I was in your clinal trial for this drug. I stayed in the trial for 2 years until the risk outweighed the benefits and they booted me. I have a feeling I know what side effects the FDA is seeking but I won’t disclose it here. I will tell you that EVERY TIME the side effect showed up it was accompanied by a 104 degree temp for me and a hospitalization.

I also found out that it was named Toferson after some guy named Todd Ferguson at Biogen. He named it after himself. He isn’t narcissistic, is he ?

I will also tell you that the drug worked great for me while I could tolerate it. I really hope it gets approved and it helps slow the disease down for those that need it.