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Exposure to common fire retardant may cause developmental malformations, behavioral changes and death

A new study by Baylor University environmental health researchers found that zebra fish exposed to several different technical mixtures of polybrominated diphenyl ethers (PBDEs) - a common fire retardant - during early development can cause developmental malformations, changes in behavior and death.

25 May 2011

Cardioxyl's CXL-1020 preclinical data against heart failure presented at ACC meeting

Cardioxyl Pharmaceuticals, Inc. announced today that it is presenting two abstracts from studies of its lead clinical candidate, CXL-1020, at the American College of Cardiology's 60th Annual Scientific Session & Expo in New Orleans, Louisiana.

5 Apr 2011

FDA approves change to prescribing information for Gilead Sciences' Letairis

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration has approved a change to the prescribing information for Letairis (ambrisentan 5 mg and 10 mg tablets), the company's once-daily treatment to improve exercise ability and delay clinical worsening in pulmonary arterial hypertension (PAH, WHO Group 1) patients with predominantly WHO Functional Class II-III symptoms.

5 Mar 2011

Positive results from Medtronic CoreValve System study for treatment of aortic valve disease

Medtronic, Inc. today issued a statement on results from an independent study published online in the journal Circulation, which confirmed both early and sustained clinical benefits for patients receiving the Medtronic CoreValve® System for the treatment of aortic valve disease.

19 Feb 2011

Patient need to share medication side effects with health care team: Retired family doctor

"I had a wonderful gentleman patient who had resistant blood pressure," recalls Vicki Koenig, M.D., a retired family doctor in Exmore, VA. "When he came for a blood pressure check on the latest new med and it was great, I was ecstatic. Then he said, 'But I notice my urine's a little dark.' His was one of the first cases of fatal liver complications from this medication."

5 Feb 2011

Phase III study shows tapentadol ER relieves chronic pain associated with DPN

New research has been published indicating that patients suffering from a painful complication of diabetes may experience a significant improvement in their pain as measured by a pain intensity scale when using an investigational pain medication.

29 Jan 2011

SPRYCEL receives FDA approval for treating adult patients with Ph+ CML in chronic phase

After receiving a priority review, Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved SPRYCEL (dasatinib) 100 mg once daily for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.

29 Oct 2010

Researchers investigate impact of fungal toxin on birth defects

A Creighton University School of Medicine researcher has been awarded a $2.7 million grant by the National Institutes of Health (NIH) to investigate a possible link between the ingestion of tortillas and corn-based food products contaminated with a fungal toxin and increased risk for birth defects.

26 Oct 2010

FDA approves Gamunex-C for primary immunodeficiency treatment

Talecris Biotherapeutics announced today that the U.S. Food and Drug Administration (FDA) approved Gamunex-C (Immune Globulin Injection [Human], 10% Caprylate/Chromatography Purified) for subcutaneous administration in the treatment of primary immunodeficiency (PI).

15 Oct 2010

J&JPRD receives FDA Complete Response Letter for tapentadol ER tablets NDA

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for tapentadol extended release tablets.

4 Oct 2010

PGIC analysis indicates tapentadol ER tablets provide significant improvement in pain intensity

Phase 3 safety and efficacy data comparing tapentadol extended release (ER) tablets, an investigational pain medication, to placebo in patients with moderate to severe chronic low back pain have been published online by Expert Opinion on Pharmacotherapy. In addition, this study compared oxycodone controlled-release (CR) to placebo as an active control.

28 Sep 2010

Tapentadol ER improves average intensity of chronic osteoarthritis knee pain: Study

Phase 3 safety and efficacy data comparing tapentadol extended release (ER) tablets, an investigational pain medication, to placebo in patients with moderate to severe chronic osteoarthritis knee pain have been published by Clinical Drug Investigation.

31 Aug 2010

Dose-defining Phase IIa trial of CXL-1020 initiated for treating patients with ADHF

Cardioxyl Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing therapeutic agents for the treatment of cardiovascular disease, today announced that it has initiated a dose-defining Phase IIa trial of its lead drug candidate, CXL-1020, for the treatment of patients with acute decompensated heart failure.

26 Aug 2010

Cardioxyl Pharmaceuticals achieves positive results in first clinical study of CXL-1020 for ADHF

Cardioxyl Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing novel therapeutic agents for the treatment of cardiovascular disease, today announced that it has achieved positive safety and tolerability results in the first clinical study of its lead drug candidate, CXL-1020, for the treatment of patients with acute decompensated heart failure. Each year in the United States, more than one million patients are hospitalized with acute heart failure.

2 Aug 2010

Phase 3 study: Tapentadol ER lowers incidence of gastrointestinal adverse events

A Phase 3 open-label study, recently published online by Pain Practice, has compared tapentadol extended release tablets, an investigational pain medication, to an existing prescription pain medication, oxycodone controlled release tablets.

20 Jul 2010

FDA accepts to review sNDA for SPRYCEL for treating adult patients with CML

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration has accepted for filing and review the supplemental New Drug Application for SPRYCEL (dasatinib) for the treatment of adult patients with newly diagnosed chronic myeloid leukemia in chronic phase.

12 Jul 2010

Pfizer to discontinue commercial availability of Mylotarg for AML in U.S.

Pfizer Inc. announced today that based on discussions with the U.S. Food and Drug Administration (FDA), it will be discontinuing commercial availability of Mylotarg® (gemtuzumab ozogamicin for Injection) (used for the treatment of relapsed acute myeloid leukemia (AML)) in the United States and that it will be voluntarily withdrawing the new drug application (NDA) for Mylotarg effective October 15, 2010.

22 Jun 2010

St. Jude Medical commences enrollment in LAPTOP-HF study

St. Jude Medical, Inc., a global medical device company, today announced the first enrollment in its LAPTOP-HF (Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy) study. The goal of the LAPTOP-HF study is to demonstrate that the new investigational left atrial pressure (LAP) management system safely and effectively improves outcomes in patients with heart failure (HF).

17 Jun 2010

Phase II study results of riociguat for CTEPH and PAH published online

Bayer HealthCare Pharmaceuticals, Inc. today announced that the study "Riociguat for chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension: a phase II study" was published online this week by the European Respiratory Journal. Results of this study to assess the safety, tolerability and the feasibility of individual dose titration of riociguat were previously presented at the 2009 International Conference of the American Thoracic Society.

11 Jun 2010

Four-year follow-up results from SPRYCEL Phase 3 study in CML-CP presented at ASCO

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced four-year follow-up results from a Phase 3 randomized, open-label, dose-optimization study of SPRYCEL® (dasatinib) in chronic-phase chronic myeloid leukemia (CML-CP) patients resistant or intolerant to Gleevec®* (imatinib mesylate). At four years, for all patients administered SPRYCEL 100 mg once daily, overall survival was 82% (95% CI: 76%-88%) and progression-free survival was 66% (95% CI: 57%-74%).

9 Jun 2010