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UCB propels Vimpat monotherapy along Keppra path, but can it beat Keppra?

 
• By Pial Ganguli

UCB has reported positive Phase III data that shows that its anti-epileptic drug, lacosamide (Vimpat) performs better when used as monotherapy than when used an adjunct. This data, the company said, will be included as part of a supplemental new drug application (sNDA) submission to the US FDA in the second half of this year.

UCB has reported positive Phase III data that shows that its anti-epileptic drug, lacosamide (Vimpat) performs better when used as monotherapy than when used an adjunct. This data, the company said, will be included as part of a supplemental new drug application (sNDA) submission to the US FDA in the second half of this year.

The data means that UCB may be able pursue a similarly deep incremental market penetration with Vimpat as with an...

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Atai Gives Up On Recognify’s Schizophrenia Drug After Phase IIb Miss

 
• By Joseph Haas

Set to merge with Beckley Psytech, Atai will focus on psychedelic candidates for treatment-resistant depression while Recognify will analyze Phase IIb data for possible next steps.

Roche Unveils Alzheimer’s Phase III Plan And Preclinical Study

 
• By Andrew McConaghie

The trontinemab Phase III study is due to get underway this year, with Roche confident its brainshuttle technology will help it surpass approved rivals.

Gilead’s Yeytuo, Lilly’s Kisunla Headline CHMP Positive Opinions

 
• By Alaric DeArment

Yeytuo will have remaining challenges to PrEP to overcome, while Kisunla’s label reflects dosing titration data from a Phase IIIb study to mitigate ARIA-E.

Alkermes To Advance Alixorexton After Positive Phase II Narcolepsy Results

 
• By Alaric DeArment

The biotech company is planning for Phase III based on positive topline results from Vibrance-1 in narcolepsy type 1 and remains optimistic about type 2 disease.

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Bristol Myers Shifts Five Drugs To Bain-Partnered Immunology Venture

 
• By Manas Mishra

Bristol Myers and Bain will form a new company focused on five immunology drugs that Cantor Fitzgerald analysts say have been off investors’ radar.

Atai Gives Up On Recognify’s Schizophrenia Drug After Phase IIb Miss

 
• By Joseph Haas

Set to merge with Beckley Psytech, Atai will focus on psychedelic candidates for treatment-resistant depression while Recognify will analyze Phase IIb data for possible next steps.

Celcuity Preps For Potentially Huge Market After Phase III Gedatolisib Win

 
• By Alaric DeArment

The biotech announced positive results in the PIK3CA wild-type population in second-line HR+/HER2- breast cancer for its PAM inhibitor.