H. Lundbeck A/S
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143 articles about H. Lundbeck A/S
Otsuka and Lundbeck Announce FDA Acceptance and Priority Review of sNDA for Brexpiprazole for the Treatment of Agitation Associated With Alzheimer’s Dementia
Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announce the U.S. Food and Drug Administration has determined that the supplementary New Drug Application for brexpiprazole for the use in the treatment of agitation associated with Alzheimer’s dementia is sufficiently complete to permit a substantive review.
The FDA has a broad range of activities in the drug and medical device space. Here’s a look at the agency’s work this week.
Otsuka and Lundbeck Announce U.S. FDA Acceptance of New Drug Application for Aripiprazole 2-month, Ready-to-Use, Long-acting Injectable to Treat Schizophrenia and Bipolar I Disorder in Adults
Otsuka America Pharmaceutical, Inc., (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the U.S. Food and Drug Administration (FDA) acceptance of their New Drug Application (NDA) for aripiprazole 2-month, ready-to-use, long-acting injectable, a medication administered for the treatment of schizophrenia in adults and for maintenance monotherapy treatment of bipolar I disorder in adults.
Otsuka Pharmaceutical and Lundbeck present positive results showing reduced agitation in patients with Alzheimer’s dementia treated with brexpiprazole at the 2022 Alzheimer's Association International Conference
Results from a Phase 3 clinical study for treatment of agitation in patients with Alzheimer’s dementia showed that patients treated with brexpiprazole had a statistically significantly greater reduction in agitation compared to placebo Agitation is a very prevalent clinical manifestation in Alzheimer’s dementia and one of the most complex and stressful aspects of care in patients affected by the disease.
CORRECTING and REPLACING Otsuka Pharmaceutical and Lundbeck Announce Positive Results Showing Reduced Agitation in Patients with Alzheimer’s Dementia Treated with Brexpiprazole
Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announce positive results of the Phase 3 clinical trial of brexpiprazole in the treatment of agitation in patients with Alzheimer's dementia.
Otsuka Pharmaceutical and Lundbeck Announce Positive Results Showing Reduced Agitation in Patients with Alzheimer’s Dementia Treated with Brexpiprazole
Results from a Phase 3 clinical study for treatment of agitation in patients with Alzheimer’s dementia showed that patients treated with brexpiprazole had a statistically significantly greater reduction in agitation compared to placebo.
Since its $63 billion acquisition of Allergan in 2019, AbbVie has become one of the leading companies developing therapies for migraine.
Otsuka and Lundbeck Announce Decision to Continue Phase III Clinical Trial Evaluating Brexpiprazole for Treatment of Agitation in Patients With Alzheimer's-type Dementia
Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announce the decision to continue the recruitment of patients in the phase III clinical trial of brexpiprazole in the treatment of agitation in patients with dementia of the Alzheimer's type.
Positive headline results from the Vyepti (eptinezumab-jjmr) RELIEF study
Initiating VYEPTI™ (eptinezumab-jjmr) migraine prevention during a migraine attack demonstrated positive results in the RELIEF study
Patient Groups Rank Lundbeck #1 in Corporate Reputation for 5th Straight Year
Annual survey finds Lundbeck US is first among leading pharmaceutical companies in the eyes of patient-group partners
H. Lundbeck A/S is making a statement with its newly approved treatment for migraine, the first intravenous medication approved for the preventative treatment of migraine.
The public’s perception of the drug industry can be confusing. Recent studies take a hard look at the industry from different perspectives.
Lundbeck announced the acquisition aimed at eptinezumab, Alder’s investigational monoclonal antibody (mAb) for migraine prevention targeting the calcitonin gene-related peptide that has been submitted to the U.S. Food and Drug Administration for potential approval.
With a $250 million cash down payment, Denmark’s H. Lundbeck A/S snapped up San Diego-based Abide Therapeutics to gain a novel discovery platform and a U.S.-based research hub.
Enamine Extends Multi-Year Drug Discovery Collaboration with Lundbeck
Enamine Ltd. and H. Lundbeck A/S announced the expansion of their research collaboration.
Denmark’s H. Lundbeck and Japan’s Otsuka Pharmaceutical announced that their brexpiprazole failed to meet its primary endpoint in two Phase III clinical trials to treat manic episodes in patients with bipolar I disorder.
Lundbeck Named 2018 Chicago Tribune Top Workplace
Company committed to improving the lives of people affected by brain disorders earns spot on Top Workplace list and is recognized for unique culture
Lundbeck Schizophrenia Drug Fails to Differentiate Itself from Conventional Therapies, Stocks Plunge
10/26/2018Shares of H. Lundbeck A/S plunged more than 25 percent after the company announced Thursday that its Phase III treatment for treatment-resistant schizophrenia failed to differentiate itself against conventional therapies.
As the U.S. Food and Drug Administration begins to take aim at updating its 40-year-old draft guidance on drugs that treat major depressive disorder (MDD), three drugmakers with key business in that space are raising some concerns.
It’s been a big year so far for activity in the U.S. biopharma market—record IPOs and plenty of big acquisitions. But things may be heating up in Europe as well.