Asenapine News and Research RSS Feed - Asenapine News and Research

Asenapine is a new drug under development for the treatment of schizophrenia and acute mania associated with bipolar disorder.
Forest Laboratories third quarter net sales increase 24.9% to $846.8 million

Forest Laboratories third quarter net sales increase 24.9% to $846.8 million

Forest Laboratories, Inc., a leading, fully integrated, specialty pharmaceutical company largely focused on the United States market, announced that reported diluted earnings per share equaled $0.07 in the third quarter of fiscal 2014, compared to a reported loss per share of ($0.58) in the third quarter of fiscal 2013. The third quarter of fiscal 2014 included a $45 million charge ($28.2 million net of tax) related to Project Rejuvenate. [More]
Forest Laboratories to acquire exclusive rights in the U.S. for Saphris sublingual tablets

Forest Laboratories to acquire exclusive rights in the U.S. for Saphris sublingual tablets

Forest Laboratories Holdings Limited, a wholly owned subsidiary of Forest Laboratories, Inc. today announced that the company is acquiring exclusive rights in the United States for Saphris (asenapine) sublingual tablets, a treatment for adult patients with schizophrenia or acute bipolar mania, from Merck Sharp & Dohme B.V., a wholly owned subsidiary of Merck & Co., Inc. [More]
Assurex Health announces release of new psychiatric pharmacogenomic test panel

Assurex Health announces release of new psychiatric pharmacogenomic test panel

Assurex Health today announced the release of GeneSight Psychotropic 2.0, its lead psychiatric pharmacogenomic test panel. This latest GeneSight Psychotropic version has been updated to include four additional medications that now cover a total of 36 of the most commonly prescribed psychotropic medications in the US. [More]
New report finds little evidence to support off-label use of atypical antipsychotics

New report finds little evidence to support off-label use of atypical antipsychotics

There is little evidence to support the use of atypical antipsychotic drugs for some treatments other than their officially approved purposes, even though many clinicians continue to commonly prescribe these drugs for so-called "off label" uses, according to a new report from the U.S. Department of Health and Human Services' (HHS) Agency for Healthcare Research and Quality. [More]
Benefits and harms vary among atypical antipsychotics for off-label use

Benefits and harms vary among atypical antipsychotics for off-label use

A review of previous studies suggests that even though atypical antipsychotic medications are commonly used for off-label conditions such as behavioral symptoms of dementia, anxiety, and obsessive-compulsive disorder, these medications are effective for only a few off-label conditions, and that the benefits and harms of these medications for these uses vary, according to an article in the September 28 issue of JAMA. [More]
Merck reports $342 million net income for 2010 third quarter

Merck reports $342 million net income for 2010 third quarter

Merck & Co., Inc. today announced financial results for the third quarter of 2010. The company reported non-GAAP (generally accepted accounting principles) earnings per share (EPS) for the third quarter of $0.85, which excludes purchase accounting adjustments, restructuring costs, merger-related expenses and a $950 million legal reserve. [More]
Lundbeck, Merck announce commercialization agreement for SYCREST sublingual tablets

Lundbeck, Merck announce commercialization agreement for SYCREST sublingual tablets

H. Lundbeck A/S (Lundbeck) and Merck, known outside the United States and Canada as MSD, today announced a commercialization agreement for SYCREST (asenapine) sublingual tablets (5 mg, 10 mg). Under the terms of the agreement, Lundbeck will pay an undisclosed fee as well as product supply payments in exchange for exclusive commercial rights to SYCREST in all markets outside the United States, China and Japan. Lundbeck expects to launch SYCREST in the European Union (EU), where it is already approved, at the beginning of 2011. [More]
European Commission approves MSD's MAA for SYCREST in manic episodes associated with bipolar I disorder

European Commission approves MSD's MAA for SYCREST in manic episodes associated with bipolar I disorder

MSD announced today that the European Commission has approved the Marketing Authorization Application (MAA) for SYCREST® (asenapine) sublingual tablets for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. Today's decision was based on recommendations from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The Commission Decision applies to all 27 European Member States. [More]
Merck reports strong bottom-line performance in second quarter

Merck reports strong bottom-line performance in second quarter

Merck & Co., Inc. today announced financial results for the second quarter of 2010. The company reported non-GAAP (generally accepted accounting principles) earnings per share (EPS) for the second quarter of $0.86, which excludes purchase accounting adjustments, merger-related expenses, restructuring costs and the gain on AstraZeneca's asset option exercise. Second-quarter GAAP EPS was $0.24. [More]
CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets

CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets

Merck announced that the Committee for Medicinal Products for Human Use adopted a positive opinion on the pending Marketing Authorization Application for SYCREST (asenapine) sublingual tablets. The CHMP has recommended that the European Commission grant a marketing authorization for SYCREST for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. The CHMP did not support an indication for the treatment of schizophrenia. [More]
Merck hosts R&D and Business Briefing

Merck hosts R&D and Business Briefing

Merck & Co., Inc. today hosted its first R&D and Business Briefing since the completion of the Merck and Schering-Plough merger. The event included a comprehensive review of the company's late-stage pipeline, as well as the company's commercial strategy and progress made in the integration of Merck's worldwide operations. [More]
Merck announces updated late-stage pipeline following its recent merger with Schering-Plough

Merck announces updated late-stage pipeline following its recent merger with Schering-Plough

Merck & Co., Inc. today announced its updated, newly integrated, late-stage pipeline following its recent merger with Schering-Plough. The new pipeline features a broad and diversified portfolio of investigational medicines and vaccines, including more than 20 candidates in Phase III or under regulatory review, and more than 20 candidates in Phase II of development. [More]
Merck announces global sales of $27.4 billion for full-year 2009

Merck announces global sales of $27.4 billion for full-year 2009

Merck & Co., Inc. today announced financial results for the fourth quarter and the full year of 2009 which include the results of legacy Schering-Plough operations from the close of the merger on Nov. 3, 2009 through Dec. 31, 2009. [More]
Schering-Plough's Phase III study of Grass Allergy Immunotherapy meets primary endpoint

Schering-Plough's Phase III study of Grass Allergy Immunotherapy meets primary endpoint

Schering-Plough Corporation today announced that its investigational sublingual Grass (Phleum Pratense) Allergy Immunotherapy Tablet (AIT) has met the primary endpoint in a Phase III study of adult subjects in the U.S. with a history of grass pollen induced rhinoconjunctivitis with or without asthma. The investigational Grass AIT treatment is designed to work by inducing a protective immune response against grass pollen allergy and providing sustained prevention of allergy symptoms, treating both the symptoms and the underlying cause of the disease. [More]
Schering-Plough announces 2009 third quarter financial results

Schering-Plough announces 2009 third quarter financial results

Schering-Plough Corporation (NYSE: SGP) today reported financial results for the 2009 third quarter. [More]
Final results of SAPHRIS clinical study released

Final results of SAPHRIS clinical study released

Schering-Plough Corporation today reported final results of a SAPHRIS(R) (asenapine) long-term schizophrenia relapse prevention clinical study. [More]
Schering-Plough announces European filing of Sycrest (asenapine) for schizophrenia and bipolar I disorder

Schering-Plough announces European filing of Sycrest (asenapine) for schizophrenia and bipolar I disorder

Schering-Plough Corporation has announced that the European Medicines Agency (EMEA) has validated (accepted for review) the company's Marketing Authorization Application (MAA) for Sycrest (asenapine) sublingual tablets for the treatment of schizophrenia and manic episodes associated with bipolar I disorder. The application will follow the Centralized Procedure. [More]

Schering-Plough submits response to FDA for SAPHRIS (asenapine) in the acute treatment of schizophrenia and bipolar I disorder

Schering-Plough Corporation has announced that it has responded to the U.S. Food and Drug Administration (FDA) complete response letter for SAPHRIS (asenapine) sublingual tablets, which was received in January 2009. [More]

FDA issues complete response letter for SAPHRIS (asenapine) sublingual tablets in acute treatment of schizophrenia and bipolar disorder

Schering-Plough Corporation has announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for SAPHRIS (asenapine) sublingual tablets in the acute treatment of schizophrenia in adults and in the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy. [More]
FDA accepts Schering-Plough's new drug application for Asenapine

FDA accepts Schering-Plough's new drug application for Asenapine

Schering-Plough Corporation has announced that the U.S. Food and Drug Administration (FDA) recently accepted the filing for review of the New Drug Application (NDA) for asenapine, a fast-dissolving, sublingual tablet. [More]