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Nearly 70,000 people signed a petition online asking Biogen to provide an experimental amyotrophic lateral sclerosis (ALS) drug to a patient, but the pharmaceutical company decided not to provide treatment.
On Tuesday (March 23), the patient’s husband said in an interview with the WCNC News Channel of the National Broadcasting Corporation: “His wife was in the weeks after the enrollment of the Phase 3 clinical trial of Bojian’s experimental drug.
The core reason for Biogen's refusal of this patient to use the drug is for more patients to use it in the future.
In other words, if Biogen provides the drug to patients who are not involved in clinical research, the research conducted on subjects randomized to receive placebo treatment is unfair.
Biogen Research and Development Director Al Sandrock (Al Sandrock), MD, wrote in a piece of information about the trial treatment published on his company website: The company will only provide early Opportunity to use tofersen.
Sandlock pointed out: "When considering a wider range of treatment options, we cannot ignore the patients in the current study, and they cannot continue to use the placebo while providing tofersen to people outside of our study.
Currently, tofersen is conducting a phase 3 clinical study, a controlled study of 178 patients with ALS and SOD1 gene mutations.
Bojian expects the results of this clinical study to be announced later this year.
Stockman Morriello said in a statement issued on Wednesday: "I fully agree that all those who participated in the clinical trial deserve deep gratitude, because they all know the risks of receiving placebo treatment, and Unknown adverse events that may occur when receiving experimental drug treatment.
ALS is a difficult area of treatment.
Since then, the company has "reorganized" the treatment of ALS, shifting the focus from drugs with specific mechanisms (such as anti-inflammatory drugs) to drugs that target gene mutations (such as tofersen).
Although 90% of ALS cases are considered "non-genetic", Bojian believes that these patients have underlying genetic factors.
