Postmarket research
After the FDA flagged patient deaths linked to Amgen’s rare disease drug Tavneos and called for its voluntary removal, the pharma recruited an independent data analysis from Duke researchers to help build the case for the drug’s continued market approval.
Update: Reversal after 20 deaths allows new Japan patients to take Amgen’s rare disease drug Tavneos
Kissei Pharmaceutical is reversing a recommendation related to Amgen-shared Tavneos that it made just a few days ago, now saying the rare disease drug can be given to new patients.
The selloff in Eli Lilly’s shares was “overdone,” according to RBC Capital Markets, which noted that the overall safety profile of Foundayo remains favorable.
The FDA has renewed calls for Amgen’s Tavneos to be pulled from the market, saying it has discovered new evidence that study personnel doctored the results of the drug’s pivotal study in order to make it look effective.
The FDA is asking Eli Lilly to submit cardiovascular and liver safety data from an ongoing Phase 3 trial of Foundayo by July.
GSK discontinued Wellcovorin in 1999, but the FDA in September last year asked the pharma to refile an application, pointing to its potential to treat cerebral folate deficiency with “autistic features.”
Long-term data presented at the Alzheimer’s Association International Conference show Leqembi can help patients stay in the earlier stages of Alzheimer’s disease as compared to the condition’s natural progression.
After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, noting the need to maintain a good working relationship with the regulator.
Roche’s asthma drug Xolair appears to be safer and more effective than oral immunotherapy at treating adults and children with one or more food allergies.
The drugs’ active ingredient, glatiramer acetate, has been linked to more than 80 cases of anaphylaxis worldwide since December 1996 and six patient deaths.
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