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A day after Pfizer closed its hotly contested Metsera deal, Lundbeck has made an unsolicited offer to steal Avadel Pharmaceuticals away from Alkermes.

Lundbeck had tried to scoop the narcolepsy drug maker out from under Alkeremes with $2.4 billion, but Avadel has elected to go with its original suitor.

These 27 markets, comprising countries across Asia, Europe and South America, together contributed some 12% of Lundbeck’s earnings in 2024.

Otsuka and Lundbeck’s data are insufficient to establish significant efficacy of Rexulti plus sertraline in PTSD, according to the FDA’s outside experts.

FDA reviewers flag “discordant results” in a briefing document published ahead of Friday’s advisory committee meeting for the partners’ application for the antipsychotic in post-traumatic stress disorder.

Lundbeck US, the US subsidiaries of H. Lundbeck A/S, announced 11 data presentations at the 66th Annual Scientific Meeting of the American Headache Society taking place in San Diego, Calif., June 13-16, 2024.

Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) today presented results from the Phase II (Trial 061) and Phase III trials (Trial 071 and 072) evaluating the safety and efficacy of brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD).

Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has determined that the supplemental New Drug Application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) is sufficiently complete to permit a substantive review. The FDA has assigned the application for a Prescription Drug User Fee Act (PDUFA) target action date of February 8, 2025.

Otsuka and Lundbeck Present New Data Analyses on the Efficacy of REXULTI ® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer’s Disease.