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Chest: January news briefs

New research suggests that subcutaneous omalizumab is safe and effective an add-on treatment to corticosteroids for moderate to severe asthma in children and adults. Researchers from Uruguay, Argentina, and Chile performed a meta-analysis on eight trials where 1,883 patients received omalizumab and 1,546 received a placebo.

4 Jan 2011

Repros receives IRB approval for Androxal Phase IIb study in secondary hypogonadism

Repros Therapeutics Inc. today reported it has received Institutional Review Board (IRB) approval to commence the Phase IIb study of Androxal® in men with secondary hypogonadism. The Company has submitted the protocol for FDA comment and plans to begin enrolling subjects in January. Depending on the rate of subject enrollment, Repros hopes to have the study completed before the end of 2011.

3 Jan 2011

FDA authorizes Juventas' JVS-100 Phase II clinical trial for critical limb ischemia

Juventas Therapeutics, a clinical-stage regenerative medicine company developing novel therapies for cardiovascular disease, announces that the U.S. Food and Drug Administration (FDA) authorized commencement of a Phase II clinical trial evaluating the efficacy and safety of its lead product, JVS-100, for the treatment of critical limb ischemia (CLI).

3 Jan 2011

FDA approves 200 mg formulation of INTELENCE for HIV-1

The U.S. Food and Drug Administration (FDA) approved a label update to include a 200 mg formulation of INTELENCE® (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adults with resistance to an NNRTI and other antiretroviral (ARV) agents.

3 Jan 2011

Celera seeks FDA premarketing approval for KIF6 Genotyping Assay

Celera Corporation today announced that it has submitted a Premarket Approval Application (PMA) to the U.S. Food and Drug Administration (FDA) for its KIF6 Genotyping Assay, a new molecular In Vitro diagnostic (IVD) test designed to detect a marker for risk of coronary heart disease (CHD) independent of traditional risk factors and aid clinical evaluation when statin treatment is being considered.

3 Jan 2011

Top-line results of TIGER-2 Phase 3 clinical trial for CF treatment

Inspire Pharmaceuticals, Inc. announced today the top-line results from its second Phase 3 clinical trial, TIGER-2, with denufosol tetrasodium for the treatment of cystic fibrosis.

3 Jan 2011

New guideline provides evidence-based recommendation for children undergoing tonsillectomy

A multidisciplinary clinical practice guideline, "Tonsillectomy in Children" will be published in the January issue of Otolaryngology-Head and Neck Surgery.

3 Jan 2011

Immunitor reports positive safety imm01 clinical trial against tuberculosis

Immune Network Ltd., advises that Immunitor has published data from the first half of the 120-patient imm01 clinical trial of its V5 immunomodulator product against tuberculosis, including difficult-to-treat forms of the disease.

30 Dec 2010

Dosing initiated in combination Phase I study of palifosfamide with etoposide and cisplatin/carboplatin in SCLC

ZIOPHARM Oncology, Inc., announced today that the first patient has been dosed in a Phase I, single arm, dose escalation study at the Indiana University Cancer Center of intravenous (IV) palifosfamide (ZIO-201) in combination with etoposide (VP-16) and cisplatin/carboplatin (platinum) in the treatment of small cell lung cancer (SCLC) and other cancers.

29 Dec 2010

Positive results from OMS201 Phase 1/2 trial in patients undergoing urologic procedures

Omeros Corporation, a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system, today announced results from the Phase 1/2 clinical trial of OMS201, the Company's urological PharmacoSurgery™ product candidate.

29 Dec 2010

Santarus, Pharming submit RHUCIN BLA to FDA for treatment of HAE attacks

Specialty biopharmaceutical company Santarus, Inc. and biotech company Pharming Group NV today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to obtain marketing approval for RHUCIN® (recombinant human C1 inhibitor) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE).

29 Dec 2010

Patients unresponsive to anti-anemia drug have higher risk of cardiovascular disease, death

Patients with diabetes, kidney disease and anemia who don't respond to treatment with an anti-anemia drug have a higher risk of cardiovascular disease or death, researchers at UT Southwestern Medical Center have found.

28 Dec 2010

Intellect obtains pharmacokinetic data from OX1 Phase 1b trial for Alzheimer's disease

Intellect Neurosciences, Inc., a biopharmaceutical company with an internal preclinical and clinical-stage pipeline and multiple licenses with major pharmaceutical companies covering products in late-stage clinical trials, announced that it has obtained a draft pharmacokinetic report from its completed Phase 1b trial for its lead Alzheimer's candidate, OX1. The Company previously reported on the safety aspects of the trial, which demonstrated that OX1 is safe and well tolerated at all dose levels tested.

28 Dec 2010

Proellex vaginal delivery exhibits four times activity of oral dose in animal study

Repros Therapeutics Inc. today announced it has completed two animal model studies of the use of Proellex® in a vaginally administered formulation that demonstrated effects on progesterone sensitive tissues equivalent to the highest oral dose formerly in development by the Company.

28 Dec 2010

Vicus initiates VT-122 Phase 2 trial in advanced liver cancer, systemic inflammation and cachexia

Vicus Therapeutics, LLC, today announced the initiation of a Phase 2 trial evaluating VT-122, a novel investigational combination of etodolac and propranolol, and Nexavar® (sorafenib) tablets, as a potential new treatment option for patients with advanced liver cancer (hepatocellular carcinoma), systemic inflammation and cachexia.

28 Dec 2010

Placebos work

According to a new study people who knowingly take a dummy pill or placebo may benefit from it. These pills are usually made from sugar or other inert non-harmful materials. Usually when used in clinical trials patients are unaware whether they are taking the tested drug or a placebo to ensure the medical benefits of a potential new drug are assessed rigorously. However this new study published in the science journal PLoS ONE, found placebos may work even when patients are aware that they are taking them.

27 Dec 2010

Janssen files abiraterone acetate NDS with Health Canada for metastatic, advanced prostate cancer

Janssen Inc. has filed a New Drug Submission (NDS) to Health Canada for the investigational drug abiraterone acetate administered with prednisone for the treatment of metastatic, advanced prostate cancer in patients who have received prior chemotherapy containing a taxane. Submissions for abiraterone acetate have also been filed with health authorities in the United States and Europe.

23 Dec 2010

Medicago completes first part of H5N1 vaccine Phase II trial

Medicago, a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles, today announced that the last dose of vaccine has been administered completing the first part of the Company's Phase II human clinical trial with its H5N1 Avian Influenza vaccine.

23 Dec 2010

Enrollment begins in Phase 2 trial of RegeneRx’s RGN-259 in dry eye associated with graft vs. host disease

RegeneRx Biopharmaceuticals, Inc. announced today that the first patient has been screened and is being enrolled in a Phase 2 clinical trial testing the Company's drug candidate RGN-259 in patients with dry eye associated with graft vs. host disease. The double-blind, placebo-controlled, investigator-sponsored trial is expected to enroll a total of 20 patients over the next several months, with data reported later in 2011. RGN-259 is a sterile, preservative-free topical eye drop formulation of the novel therapeutic peptide Thymosin beta 4, or Tβ4.

23 Dec 2010

Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) for the expanded use of BYETTA® (exenatide) injection as an add-on therapy to basal insulin, with or without metformin and/or a thiazolidinedione (TZD) in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control.

23 Dec 2010

Placebo News and Research

Chest: January news briefs

Repros receives IRB approval for Androxal Phase IIb study in secondary hypogonadism

FDA authorizes Juventas' JVS-100 Phase II clinical trial for critical limb ischemia

FDA approves 200 mg formulation of INTELENCE for HIV-1

Celera seeks FDA premarketing approval for KIF6 Genotyping Assay

Top-line results of TIGER-2 Phase 3 clinical trial for CF treatment

New guideline provides evidence-based recommendation for children undergoing tonsillectomy

Immunitor reports positive safety imm01 clinical trial against tuberculosis

Dosing initiated in combination Phase I study of palifosfamide with etoposide and cisplatin/carboplatin in SCLC

Positive results from OMS201 Phase 1/2 trial in patients undergoing urologic procedures

Santarus, Pharming submit RHUCIN BLA to FDA for treatment of HAE attacks

Patients unresponsive to anti-anemia drug have higher risk of cardiovascular disease, death

Intellect obtains pharmacokinetic data from OX1 Phase 1b trial for Alzheimer's disease

Proellex vaginal delivery exhibits four times activity of oral dose in animal study

Vicus initiates VT-122 Phase 2 trial in advanced liver cancer, systemic inflammation and cachexia

Placebos work

Janssen files abiraterone acetate NDS with Health Canada for metastatic, advanced prostate cancer

Medicago completes first part of H5N1 vaccine Phase II trial

Enrollment begins in Phase 2 trial of RegeneRx’s RGN-259 in dry eye associated with graft vs. host disease

Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

Advancing Neuroscience Research Through Collaboration and Patient-Centered Innovation

The impact of vibration on microscopy

How Omics Technologies Are Transforming Biological Research and Drug Discovery

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