Welcome to the latest edition of the Life Sciences Voice Top Five Newsletter, your source for the top developments in the life sciences industry! This week we take a look at FDA delaying Eisai & Biogen’s submission plans for its Alzheimer’s drug, Abbvie’s acquisition of Cereval Therapeutics, FDA & CDC’s investigation into counterfeit botox injections, and other top news!
Eisai and Biogen’s Plans for Leqembi Delayed by FDA
Eisai and Biogen face setbacks in their plans to bring their Alzheimer’s disease drug, Leqembi, to patients as promised with the FDA demanding additional data for its subcutaneous version. The FDA’s request for more immunogenicity analyses delays the companies’ original plan of starting a rolling submission in March, potentially pushing the filing to the latter half of the year. The shift to a subcutaneous version mainly aims to alleviate logistical burdens.
MaaT Pharma’s Pooled Fecal Treatment Shows Promise for Acute Graft-versus-Host Disease
MaaT Pharma announces promising results for its pooled fecal treatment medicine for acute graft-versus-host disease (aGvHD), with data showing improved survival rates among extensively pretreated patients. The company aims to market the treatment within two years based on data collected from its ongoing trials. The treatment, MaaT013, demonstrates efficacy in patients refractory to steroids or other medications, positioning it as a potential third-line therapy option.
AbbVie’s Acquisition of Cerevel Therapeutics Spotlighted by Successful Phase 3 Study on Tavapadon
AbbVie’s acquisition of Cerevel Therapeutics gains attention with the success of tavapadon, a dopamine D1/D5 receptor partial agonist, in a phase 3 study for Parkinson’s disease. Tavapadon shows promise in reducing dyskinesia and improving motor function in patients with motor fluctuations. This success marks a significant step in AbbVie’s strategic investment in Cerevel, positioning tavapadon as a potential new option in Parkinson’s disease treatment.
Neumora Therapeutics’ Schizophrenia Treatment Faces FDA Halt Due to Safety Concerns
Neumora Therapeutics faces FDA halt of its phase 1 trial for NMRA-266, a treatment for schizophrenia, following preclinical investigations revealing convulsions in rabbits. While no participants in the trial exhibited convulsions, the company is collaborating with the FDA to address any safety concerns. Despite setbacks, Neumora continues to progress with its portfolio, including its lead asset navacaprant for major depressive disorder.
FDA and CDC Investigate Counterfeit Botox Causing Adverse Reactions
The FDA and CDC launched an investigation into counterfeit Botox injections causing adverse reactions in multiple states, including symptoms such as blurred vision and difficulty swallowing. Authorities warn of the dangers of counterfeit Botox, emphasizing the risk of botulism, a rare but potentially life-threatening condition. This investigation highlights the ongoing issue of unlicensed cosmetic procedures and the need for stricter regulation in the industry.
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