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Takeda, Lundbeck announce FDA acceptance of vortioxetine NDA submission

Takeda Global Research & Development Center, Inc., (Takeda) and H. Lundbeck A/S (Lundbeck) jointly announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing their submission of a New Drug Application (NDA) for vortioxetine for the treatment of major depressive disorder (MDD) in adult patients.

13 Dec 2012

Unigene announces results from oral PTH Phase 2 study on osteoporosis

Unigene Laboratories, Inc., a leader in the design, delivery, manufacture and development of peptide-based therapeutics, today announced that the results of its successful Phase 2 clinical trial evaluating an experimental oral parathyroid hormone (PTH) analog for the treatment of osteoporosis in postmenopausal women has been published online by Bone, the Official Journal of the International Bone and Mineral Society.

13 Dec 2012

Industry sponsored clinical trials present a more favourable picture of reported findings

Studies reporting the results of industry sponsored clinical trials present a more favourable picture of the effects of drugs and medical devices than those reporting on non-industry sponsored trials, according to a new Cochrane systematic review. The researchers call for a rethink of the way that industry bias is handled in medical guidelines and reviews.

12 Dec 2012

Acetazolamide plus autoCPAP may reduce insomnia and control sleep apnea at high altitudes

For individuals with obstructive sleep apnea traveling to higher altitudes (which may exacerbate symptoms), use of a combination therapy resulted in improvement in symptoms including reduced insomnia and better control of sleep apnea, according to a preliminary study published in the December 12 issue of JAMA.

12 Dec 2012

Tiotropium benefits patients with chronic obstructive pulmonary disease

In order to widen the narrowed airways in patients with chronic obstructive pulmonary disease (COPD), tiotropium bromide (tiotropium in brief) is one of the drugs available that can be prescribed for inhalation. The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined whether tiotropium offers a perceptible advantage to patients compared to a dummy medication (placebo) and to other COPD drugs.

12 Dec 2012

Naltrexone may help avoid weight gain among women smokers

A medication being tested to help smokers kick the habit also may help avoid the weight gain that is common after quitting but only in women, according to a study published in the December issue of Biological Psychiatry. This is the first medication shown to reduce weight gain for up to one year in women smokers who quit.

11 Dec 2012

AMAG presents new data from two ferumoxytol phase III trials on IDA at ASH annual meeting

AMAG Pharmaceuticals, Inc. today announced that new data from two pivotal phase III clinical trials were presented at the American Society of Hematology's (ASH) annual meeting in Atlanta, Georgia.

11 Dec 2012

Almirall, Forest Laboratories' Tudorza Pressair now available in the U.S. pharmacies

Forest Laboratories, Inc. and Almirall, S.A. announced today that Tudorza Pressair (aclidinium bromide inhalation powder) 400mcg is now available in pharmacies throughout the United States.

11 Dec 2012

Metformin therapy improves BMI and fasting glucose levels in obese children

Metformin therapy has a beneficial treatment effect over placebo in improving body mass index (BMI) and fasting glucose levels in obese children, according to a recent study accepted for publication in The Endocrine Society's Journal of Clinical Endocrinology & Metabolism (JCEM). The study showed reduction in BMI was sustained for six months.

11 Dec 2012

Oxytocin administration to fathers increases parental engagement with their infants

A large body of research has focused on the ability of oxytocin to facilitate social bonding in both marital and parenting relationships in human females. A new laboratory study, led by Dr. Ruth Feldman from Bar-Ilan University in Israel and published in the current issue of Biological Psychiatry, has found that oxytocin administration to fathers increases their parental engagement, with parallel effects observed in their infants.

11 Dec 2012

Celgene announces results from REVLIMID plus VIDAZA phase II study on AML

Celgene International Sàrl today announced that results from a study evaluating the combination of REVLIMID (lenalidomide) plus VIDAZA (azacitidine) in patients 60 years or older with untreated acute myeloid leukemia (AML) were presented at the American Society of Hematology annual meeting in Atlanta, GA.

11 Dec 2012

Infinity announces new data from IPI-145 Phase 1 trial on advanced hematologic malignancies

Infinity Pharmaceuticals, Inc. today announced new data from its ongoing Phase 1, open-label, dose-escalation trial of IPI-145, the company's potent, oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in patients with advanced hematologic malignancies.

11 Dec 2012

FDA expands approved use of Janssen Biotech’s Zytiga to treat men with mCRPC

The U.S. Food and Drug Administration today expanded the approved use of Zytiga (abiraterone acetate) to treat men with late-stage (metastatic) castration-resistant prostate cancer prior to receiving chemotherapy.

10 Dec 2012

Janssen receives FDA approval for ZYTIGA to treat metastatic castration-resistant prostate cancer

Janssen announced today that the U.S. Food and Drug Administration (FDA) has approved a broader indication for the oral, once-daily medication ZYTIGA (abiraterone acetate).

10 Dec 2012

Contrast agent ‘not recommended’ in premature neonates

Premature neonates who are given oral Gastrografin immediately after birth do not pass meconium more quickly than others, study findings suggest.

10 Dec 2012

Ipsen, Active Biotech complete enrollment in tasquinimod Phase III trial for prostate cancer

Active Biotech and Ipsen today announced that the Phase III clinical trial for tasquinimod, a novel compound for the treatment of prostate cancer, is successfully enrolled with over 1,200 randomized patients as planned in the clinical protocol.

10 Dec 2012

New survival results from Genentech’s Perjeta Phase III combination study on HER2-positive mBC

Genentech, a member of the Roche Group, today announced updated survival results from the Phase III CLEOPATRA study, which showed that the combination of Perjeta (pertuzumab), Herceptin (trastuzumab) and docetaxel chemotherapy significantly extended the lives (overall survival) of people with previously untreated HER2-positive metastatic breast cancer (mBC), compared to Herceptin, chemotherapy and placebo.

10 Dec 2012

Iroko’s submicron indomethacin Phase 3 study on post-surgical acute pain meets primary endpoint

Iroko Pharmaceuticals, LLC today announced that the Phase 3 study evaluating the company's investigational, lower dose submicron indomethacin in post-surgical acute pain met its primary endpoint of demonstrating significant pain relief compared with placebo.

10 Dec 2012

Sanofi Pasteur’s IMOJEV vaccine against Japanese encephalitis is now available in Australia

Sanofi Pasteur, the vaccines division of Sanofi, announced today that IMOJEV vaccine against Japanese encephalitis (JE) is now available in Australia.

10 Dec 2012

Anti-seizure drug benefits women with severe morning sickness

Good news may be on the horizon for Kate Middleton, Duchess of Cambridge, and other women stricken with severe nausea and vomiting during pregnancy, thanks to the work of a University at Buffalo professor who is conducting research on a drug that is showing success treating pregnant women with this condition.

8 Dec 2012

Placebo News and Research

Takeda, Lundbeck announce FDA acceptance of vortioxetine NDA submission

Unigene announces results from oral PTH Phase 2 study on osteoporosis

Industry sponsored clinical trials present a more favourable picture of reported findings

Acetazolamide plus autoCPAP may reduce insomnia and control sleep apnea at high altitudes

Tiotropium benefits patients with chronic obstructive pulmonary disease

Naltrexone may help avoid weight gain among women smokers

AMAG presents new data from two ferumoxytol phase III trials on IDA at ASH annual meeting

Almirall, Forest Laboratories' Tudorza Pressair now available in the U.S. pharmacies

Metformin therapy improves BMI and fasting glucose levels in obese children

Oxytocin administration to fathers increases parental engagement with their infants

Celgene announces results from REVLIMID plus VIDAZA phase II study on AML

Infinity announces new data from IPI-145 Phase 1 trial on advanced hematologic malignancies

FDA expands approved use of Janssen Biotech’s Zytiga to treat men with mCRPC

Janssen receives FDA approval for ZYTIGA to treat metastatic castration-resistant prostate cancer

Contrast agent ‘not recommended’ in premature neonates

Ipsen, Active Biotech complete enrollment in tasquinimod Phase III trial for prostate cancer

New survival results from Genentech’s Perjeta Phase III combination study on HER2-positive mBC

Iroko’s submicron indomethacin Phase 3 study on post-surgical acute pain meets primary endpoint

Sanofi Pasteur’s IMOJEV vaccine against Japanese encephalitis is now available in Australia

Anti-seizure drug benefits women with severe morning sickness

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