Insomnia News and Research

Latest Insomnia News and Research

Somaxon Pharmaceuticals to meet FDA to discuss the NDA for Silenor for insomnia treatment

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today stated that it is scheduled to meet with the U.S. Food and Drug Administration (FDA) on January 20, 2010 to discuss the New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia.

18 Dec 2009

HealthInsight and HealthMedia join to deliver Internet-based Digital Coaching solutions

HealthInsight, provider of the only value-based health care administration platform, today announced a partnership with HealthMedia, Inc., a Johnson & Johnson company, to deliver Internet-based Digital Coaching™ solutions focused on lifestyle and behavioral change.

16 Dec 2009

NovaDel receives Issue Notification from USPTO for oral spray

NovaDel Pharma Inc., today announced that it received an Issue Notification from the United States Patent and Trademark Office (USPTO) for a new U.S. Patent, No. 7632517, entitled “Buccal, Polar and Non-polar Spray Containing Zolpidem,” which covers a method of treating insomnia by administering zolpidem to humans utilizing NovaDel’s oral spray technology.

16 Dec 2009

Jazz Pharmaceuticals announces submission of JZP-6 NDA for treatment of fibromyalgia

Jazz Pharmaceuticals, Inc. announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for JZP-6 (sodium oxybate oral solution) for the treatment of fibromyalgia.

15 Dec 2009

Study explores comorbidity of medical complaints and insomnia symptoms in school-aged children

A study in the Dec. 15 issue of the Journal of Clinical Sleep Medicine indicates that significant associations exist between parent-reported insomnia symptoms and medical complaints of gastrointestinal regurgitation and headaches in young school-aged children.

15 Dec 2009

Alexza Pharmaceuticals submits its NDA for Staccato loxapine to FDA

Alexza Pharmaceuticals, Inc. today announced that it has submitted its New Drug Application (NDA) for Staccato® loxapine (AZ-004) to the US Food and Drug Administration (FDA).

15 Dec 2009

Fulvestrant 500 mg reduces risk of disease progression in women with metastatic breast cancer

AstraZeneca (NYSE: AZN) today announced that data from a Phase III study of postmenopausal women with hormone receptor-positive advanced breast cancer presented at the San Antonio Breast Cancer Symposium (Abstract 25) showed treatment with fulvestrant (FASLODEX) 500 mg reduced the risk of disease progression (assessed as time to progression (TTP)) by 20%

11 Dec 2009

Schizophrenia: Once-monthly INVEGA SUSTENNA not inferior to bi-weekly RISPERDAL CONSTA

Treatment with once-monthly INVEGA® SUSTENNA(TM) is not inferior to treatment with bi-weekly RISPERDAL® CONSTA®, according to new data from a comparative study of both treatments in patients with schizophrenia. Results of the 13-week clinical trial were released this week.

10 Dec 2009

Eli Lilly provides financial guidance for 2010

At its annual meeting today with the investment community, Eli Lilly and Company highlighted how its innovation-based strategy will enable it to better serve patients and compete effectively in a challenging health care environment. The company also detailed the progress being made in its labs and across its five new business units on an expanding pipeline of innovative molecules and marketed medicines, and provided investors with the company's financial guidance for 2010.

10 Dec 2009

VERTICAL Phase II trial results for NHL released

The Takeda Oncology Company today reported data from a clinical trial evaluating a VELCADE based combination for patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL).

9 Dec 2009

Data evaluating combination therapy with REVLIMID and rituximab in patients with NHL presented

Celgene International Sàrl announced that investigational data evaluating combination therapy with REVLIMID (lenalidomide) and rituximab in patients with indolent non-Hodgkin’s lymphoma (NHL) were presented during the 51st American Society of Hematology’s annual meeting in New Orleans, LA.

9 Dec 2009

Clinical trial results of VELCADE based combinations for MM to be presented at the ASH meeting

Millennium: The Takeda Oncology Company today reported the presentation of results from a double randomized Phase III clinical trial of VELCADE based combinations for the treatment of patients with previously untreated multiple myeloma (MM). The VELCADE based combinations evaluated in the study demonstrated two-year overall survival rates ranging between 81 and 88 percent.

8 Dec 2009

Study data of REVLIMID-dexamethasone combination therapy for high-risk smoldering multiple myeloma

Celgene International Sàrl announced that data evaluating combination therapy REVLIMID (lenalidomide) and dexamethasone in patients with high-risk smoldering multiple myeloma were presented during the American Society of Hematology’s annual meeting in New Orleans, LA. The landmark study demonstrated REVLIMID and dexamethasone prolonged time to progression, including complete responses, with manageable toxicity.

8 Dec 2009

Study results comparing REVLIMID regimen to stem cell transplant in multiple myeloma patients

Celgene International Sàrl announced clinical data from an investigational study of patients with multiple myeloma who were younger than 65 years old and received either REVLIMID (lenalidomide), melphalan and prednisone (MPR) or melphalan plus autologous stem cell transplant (MEL200) following an induction treatment of REVLIMID plus low-dose dexamethasone (Rd) were presented during the 51st American Society of Hematology’s annual meeting in New Orleans, LA.

8 Dec 2009

Amgen announces results from first Phase 1/2 study of Nplate

Amgen Inc. today announced results from its first Phase 1/2 study evaluating the safety and efficacy of Nplate® (romiplostim) in children with chronic immune thrombocytopenic purpura (ITP).

8 Dec 2009

CAM314 randomized Phase 3 clinical trial results released

Genzyme Corporation announced data from its CAM314 randomized Phase 3 clinical trial comparing Campath (alemtuzumab) in combination with Fludara (fludarabine phosphate) (FluCAM) to Fludara alone in patients with relapsed and refractory chronic lymphocytic leukemia (CLL) demonstrated that the FluCAM regimen significantly reduced the risk of disease progression or death compared to single-agent Fludara.

8 Dec 2009

FDA provides a Complete Response Letter for Somaxon Pharmaceuticals' Silenor NDA

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today announced that the company has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia.

7 Dec 2009

VELCADE based regimens are cost-effective for payers and patients, finds study

Millennium: The Takeda Oncology Company today announced that two studies presented at the 51st American Society of Hematology (ASH) Annual Meeting found that VELCADE based regimens are more cost-effective for payers and reduced out-of-pocket costs for patients than other commonly used multiple myeloma treatments.

7 Dec 2009

Amgen announces results from three studies on the safety and efficacy of Nplate

Amgen Inc. today announced results from three studies on the safety and efficacy of Nplate® (romiplostim) in adult patients with myelodysplastic syndromes (MDS).

7 Dec 2009

Watson Laboratories files an ANDA for generic version of Rozerem

Watson Pharmaceuticals, Inc., a leading global specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc.-Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its 8mg ramelteon tablets prior to the expiration of a patent owned by Takeda Pharmaceutical Company Limited.

4 Dec 2009

Insomnia News and Research

Latest Insomnia News and Research

Somaxon Pharmaceuticals to meet FDA to discuss the NDA for Silenor for insomnia treatment

HealthInsight and HealthMedia join to deliver Internet-based Digital Coaching solutions

NovaDel receives Issue Notification from USPTO for oral spray

Jazz Pharmaceuticals announces submission of JZP-6 NDA for treatment of fibromyalgia

Study explores comorbidity of medical complaints and insomnia symptoms in school-aged children

Alexza Pharmaceuticals submits its NDA for Staccato loxapine to FDA

Fulvestrant 500 mg reduces risk of disease progression in women with metastatic breast cancer

Schizophrenia: Once-monthly INVEGA SUSTENNA not inferior to bi-weekly RISPERDAL CONSTA

Eli Lilly provides financial guidance for 2010

VERTICAL Phase II trial results for NHL released

Data evaluating combination therapy with REVLIMID and rituximab in patients with NHL presented

Clinical trial results of VELCADE based combinations for MM to be presented at the ASH meeting

Study data of REVLIMID-dexamethasone combination therapy for high-risk smoldering multiple myeloma

Study results comparing REVLIMID regimen to stem cell transplant in multiple myeloma patients

Amgen announces results from first Phase 1/2 study of Nplate

CAM314 randomized Phase 3 clinical trial results released

FDA provides a Complete Response Letter for Somaxon Pharmaceuticals' Silenor NDA

VELCADE based regimens are cost-effective for payers and patients, finds study

Amgen announces results from three studies on the safety and efficacy of Nplate

Watson Laboratories files an ANDA for generic version of Rozerem

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

Insomnia News and Research

Latest Insomnia News and Research

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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