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Shire announces Phase IIIb study results of Daytrana

Shire plc, the global specialty biopharmaceutical company, today announced findings at a major medical meeting from a Phase IIIb study of the tolerability and effectiveness of Daytrana® (methylphenidate transdermal system) in adolescents aged 13 to 17 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).

31 Oct 2009

Schering-Plough receives FDA complete response letter regarding PEGINTRON

Schering-Plough Corp. announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter to the company's supplemental Biologics License Application regarding PEGINTRON® (pegylated interferon alfa-2b) for the adjuvant treatment of patients with stage III malignant melanoma after complete lymphadenectomy.

31 Oct 2009

Shire announces new pharmacokinetic data of ADHD medication

Shire plc, the global specialty biopharmaceutical company, announced new data about the pharmacokinetics of its Attention-Deficit/Hyperactivity Disorder (ADHD) medication, Vyvanse- (lisdexamfetamine dimesylate) Capsules CII, which showed that Vyvanse provided similar concentrations of its active medication in the blood when administered either intranasally or when administered orally.

23 Oct 2009

Millennium commences Vc-R-CHOP Phase II trial for diffuse large B-cell lymphoma

Millennium: The Takeda Oncology Company today announced the initiation of a Phase II clinical trial examining rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) with or without VELCADE® (bortezomib) for Injection for patients with a common type of lymphoma. The study will examine previously untreated patients with a genomically defined subtype of lymphoma called non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma.

22 Oct 2009

Schering-Plough to present data on boceprevir at the AASLD 2009 Annual Meeting

Schering-Plough announced that data on boceprevir, an investigational hepatitis C virus (HCV) protease inhibitor, will be reported in an oral presentation at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting in Boston, Oct. 30-Nov. 3.

19 Oct 2009

Soligenix commences enrollment in its Phase 3 Orbec clinical trial for acute GI GVHD

Soligenix, Inc., formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today that it has initiated enrollment in its confirmatory Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating orBec(®) for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD).

15 Oct 2009

VitalProteinRx nutritional supplement for chronic kidney disease affected patients

VitalRemedyMD, a physician-established company, offers scientifically formulated integrative nutritional supplements designed to improve the quality of traditional healthcare. "We are proud that VitalProteinRx is now an integral part of Fresenius' armamentarium in helping patients with chronic kidney disease," stated Dr. Seth Baum, Founder of VitalRemedyMD.

13 Oct 2009

Schering-Plough receives FDA recommendation approval for PEGINTRON

Schering-Plough Corp. announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval by a vote of six to four for PEGINTRON® (pegylated interferon alfa-2b) in the adjuvant treatment of patients with Stage III malignant melanoma.

6 Oct 2009

2009 Mini-Psych School Program dispels myths surrounding mental illness

The Mental Illness Awareness Week is coming up, from October 4 to 10. On this occasion, Joseph Rochford, Ph.D., Director of the Academic Affairs at the Douglas Mental Health University Institute, presents his top ten list of myths about mental illness.

29 Sep 2009

Bayer's regorafenib showed 50% stabilization rate in RCC patients

Bayer today announced results from a Phase II trial of regorafenib (BAY 73-4506), a potent oral multi-kinase inhibitor, which demonstrated that treatment with regorafenib resulted in a 31 percent partial response rate and 50 percent stabilization rate in patients with metastatic renal cell carcinoma (RCC).

22 Sep 2009

Study reveals that patients with NSCLC who received maintenance therapy with ALIMTA showed survival benefit

Data published today in The Lancet showed a survival benefit in nonsquamous patients with advanced non-small cell lung cancer (NSCLC) who received maintenance therapy with ALIMTA(R) (pemetrexed for injection) plus best supportive care as compared to placebo plus best supportive care.

21 Sep 2009

Pfizer Oncology to present early-stage research of investigational agents for cancer treatment

Pfizer Oncology will present data from across its portfolio, including results from long-term follow-up of Aromasin® (exemestane tablets) in a study of early breast cancer, updated study results from a Phase 3 study of Sutent® (sunitinib malate) in pancreatic neuroendocrine tumors (NET), and early-stage research of investigational agents PF-02341066 and figitumumab (CP-751,871) in patients with non-small cell lung cancer (NSCLC).

19 Sep 2009

Millennium's sNDA for VELCADE granted priority review by the FDA

Millennium: The Takeda Oncology Company today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the Company’s supplemental new drug application (sNDA) for VELCADE. The sNDA contains long-term overall survival (OS) data from the landmark VISTA trial examining the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

19 Sep 2009

Merck update on the status of telcagepant clinical development programs

Merck & Co., Inc. today updated the status of the clinical development programs for telcagepant (MK-0974) and MK-3207, the Company's investigational oral calcitonin gene-related peptide (CGRP) receptor antagonists for the intermittent treatment of acute migraine.

11 Sep 2009

FDA approves Supplemental New Drug Application for DOXIL

Centocor Ortho Biotech Products, L.P. today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its Supplemental New Drug Application (sNDA) for DOXIL (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of women with locally advanced and metastatic breast cancer.

10 Sep 2009

Millennium's sNDA to be reviewed by the FDA

The Takeda Oncology Company today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s supplemental new drug application (sNDA) based on long- term overall survival (OS) data from the landmark VISTA1 trial examining the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

3 Sep 2009

FDA: Randomized clinical trial necessary to better interpret Clolar’s efficacy and safety in adult AML

Genzyme Corporation (Nasdaq: GENZ) announced today that the FDA’s Oncologic Drugs Advisory Committee voted 9 to 3 that a randomized, controlled trial is needed to support the currently proposed label expansion for Clolar® (clofarabine) in adult myeloid leukemia (AML). The committee found that the single-arm clinical study results submitted to support the label expansion showed Clolar was an active agent in acute AML patients, but concluded that a randomized clinical trial should be necessary to better interpret Clolar’s efficacy and safety in the proposed patient population.

2 Sep 2009

Genzyme’s supplemental NDA for treating adult AML with Clolar to be discussed by the FDA

Genzyme Corporation (Nasdaq: GENZ) announced today that its supplemental New Drug Application for Clolar® (clofarabine) will be discussed Tuesday, September 1 at a public meeting of the FDA’s Oncologic Drugs Advisory Committee in Silver Spring, Maryland. The panel is expected to consider the clinical trial results Genzyme submitted to support the approval and labeling of Clolar to treat older adult patients with acute myeloid leukemia (AML), the most common type of acute leukemia in adults.

29 Aug 2009

Insight Psychological Centers to open a living facility for women coping with eating disorders

On September 1, the founders of Insight Psychological Centers will open Millennium Place, a cozy urban living facility for women coping with eating disorders. Millennium Place, LLC is the first transitional housing program in Chicago developed specifically for women with anorexia, bulimia and binge eating disorders.

28 Aug 2009

New website launched by Eating Disorder Hope to provide a comprehensive resource on eating disorders

Millions of Americans suffer from eating disorders and many don't know where to turn to for help. Jacquelyn Ekern, a licensed counselor and founder of Eating Disorder Hope, launched the site, www.eatingdisorderhope.com, to provide a comprehensive resource for support, referrals and education about eating disorders.

26 Aug 2009