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FDA clears Aradigm IND for Pulmaquin Phase 3 clinical trial in non-cystic fibrosis BE

Aradigm Corporation today announced that the Company's Investigational New Drug Application (IND) to conduct a pivotal Phase 3 clinical trial of Pulmaquin (dual release ciprofloxacin for inhalation) in non-cystic fibrosis bronchiectasis (BE) has been cleared by the U.S. Food and Drug Administration.

12 Mar 2012

Top-line results from Inviragen's INV21 Phase 1 trial on HFMD

Inviragen today reported top-line results of a placebo-controlled, randomized Phase 1 trial of INV21, the Company's highly purified virus particle vaccine against Hand, Foot and Mouth Disease (HFMD) caused by enterovirus 71.

12 Mar 2012

Estrogen-only form of menopausal hormone therapy may protect against breast cancer

Rowan T. Chlebowski, M.D., Ph.D., an LA BioMed investigator whose research activities have focused on breast cancer therapy and prevention, and chronic diseases impacting women's health, is co-author of a study that indicates that women who use the estrogen-only form of menopausal hormone therapy appear less likely to develop breast cancer in the longer term, according to new research which was recently published The Lancet Oncology.

12 Mar 2012

FDA denies AstraZeneca Citizen Petitions on SEROQUEL labeling

AstraZeneca today announced that on March 7, 2012, the Food and Drug Administration denied Citizen Petitions requesting that the FDA withhold finally approving any generic quetiapine product with labeling that omits certain hyperglycemia warning language that the FDA required AstraZeneca to include in the labeling for SEROQUEL (quetiapine fumarate) tablets and SEROQUEL XR (quetiapine fumarate) extended-release tablets.

12 Mar 2012

Enrollment complete in Palatin's bremelanotide Phase 2B trial for FSD

Palatin Technologies, Inc. today announced it has completed enrollment in its Phase 2B clinical trial evaluating the efficacy and safety of bremelanotide for treatment of female sexual dysfunction.

9 Mar 2012

MEDVAMC initiates Aeterna Zentaris' AEZS-130 Phase 2A trial in cancer cachexia

Aeterna Zentaris Inc. today announced that the Michael E. DeBakey Veterans Affairs Medical Center, in Houston, Texas, has initiated a Phase 2A trial assessing the safety and efficacy of repeated doses of the Company's ghrelin agonist, AEZS-130 (macimorelin), in patients with cancer cachexia.

9 Mar 2012

FDA approves Teva's ProAir HFA with dose counter for asthma, COPD and EIB

Teva Respiratory announced today that the U.S. Food and Drug Administration (FDA) has approved ProAir HFA with a dose counter for use in patients 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

8 Mar 2012

Estrogen only HRT in some postmenopausal women could lower breast cancer risk: Study

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8 Mar 2012

Heart rate lowering drug may reduce “implicit” racial prejudices: Study

It was found that volunteers given the beta-blocker, used to treat chest pains and lower heart rates, scored lower on a standard psychological test of “implicit” racist attitudes. They appeared to be less racially prejudiced at a subconscious level than another group treated with a “dummy” placebo pill.

8 Mar 2012

Positive phase II trial results from Circassia's ragweed allergy therapy

Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced that its ragweed allergy therapy has achieved positive results in a key phase II clinical trial.

8 Mar 2012

Preliminary results of Partners PrEP Study show promise, investigators report at CROI

"Investigators gave more details about the positive results of the Partners PrEP Study Tuesday at the 19th Conference on Retroviruses and Opportunistic Infections in Seattle," the Center for Global Health Policy's "Science Speaks" blog reports.

8 Mar 2012

Study highlights challenges of adherence in successful deployment of PrEP interventions

"Data presented from the FEM-PrEP trial by Dr. Lut Van Damme Tuesday at the 19th Conference on Retroviruses and Opportunistic Infections in Seattle highlighted the challenge that adherence plays in successfully deploying effective Pre-Exposure Prophylaxis (PrEP) interventions," HIV Medicine Association Executive Director Andrea Weddle writes in this guest post in the Center for Global Health Policy's "Science Speaks" blog.

8 Mar 2012

Metformin drug appears to prevent growth of atherosclerosis in patients with HIV

Treatment with the common diabetes drug metformin appears to prevent progression of coronary atherosclerosis in patients infected with HIV.

8 Mar 2012

New clinical trial: Pycnogenol improves signs and symptoms of menopause

Half the population experiences menopause, and for those women, it is a condition they will experience for approximately one third of their lifetime. Alternative or natural remedies are an easy, effective way to improve signs and symptoms linked to the menopausal transition, without side effects.

7 Mar 2012

Physicians study human stem cell use as possible treatment for ischemic stroke

Physicians at the Methodist Neurological Institute are studying the use of human stem cells as a possible treatment for acute ischemic stroke, a leading cause of death and disability. Each year, stroke affects more than 15 million people around the world.

7 Mar 2012

Timely treatment with Berinert provides faster symptom relief for HAE patients

CSL Behring announced today that treatment with Berinert, C1 Esterase Inhibitor (Human) within six hours of the onset of an acute hereditary angioedema (HAE) attack provides faster symptom relief than later treatment, according to data presented at the 2012 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

7 Mar 2012

Shire to commence two Vyvanse and Concerta Phase 4 comparison trials for ADHD

As part of its continued commitment to ADHD research, Shire plc, the global specialty biopharmaceutical company, today announced it is initiating two Phase 4 clinical trials to compare Vyvanse (lisdexamfetamine dimesylate) Capsules, (CII) to Concerta (methylphenidate HCl) Extended-Release Tablets.

7 Mar 2012

AcelRx initiates ARX-01 Phase 3 study for treatment of post-operative pain

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, reported dosing of the first patient in a Phase 3 study for ARX-01, the Sufentanil NanoTab PCA System, its novel sublingual patient-controlled analgesia system.

6 Mar 2012

Merck announces results from AIT Phase III clinical study for ragweed allergy

Merck, known as MSD outside the United States and Canada, today announced the results from a Phase III clinical study of its investigational allergy immunotherapy tablet (AIT) for ragweed pollen.

6 Mar 2012

Santarus fourth quarter total revenues increase 65% to $42.6M

Santarus, Inc. (NASDAQ: SNTS) today reported financial and operating results for the three and 12 month periods ended December 31, 2011.

5 Mar 2012

Placebo News and Research

FDA clears Aradigm IND for Pulmaquin Phase 3 clinical trial in non-cystic fibrosis BE

Top-line results from Inviragen's INV21 Phase 1 trial on HFMD

Estrogen-only form of menopausal hormone therapy may protect against breast cancer

FDA denies AstraZeneca Citizen Petitions on SEROQUEL labeling

Enrollment complete in Palatin's bremelanotide Phase 2B trial for FSD

MEDVAMC initiates Aeterna Zentaris' AEZS-130 Phase 2A trial in cancer cachexia

FDA approves Teva's ProAir HFA with dose counter for asthma, COPD and EIB

Estrogen only HRT in some postmenopausal women could lower breast cancer risk: Study

Heart rate lowering drug may reduce “implicit” racial prejudices: Study

Positive phase II trial results from Circassia's ragweed allergy therapy

Preliminary results of Partners PrEP Study show promise, investigators report at CROI

Study highlights challenges of adherence in successful deployment of PrEP interventions

Metformin drug appears to prevent growth of atherosclerosis in patients with HIV

New clinical trial: Pycnogenol improves signs and symptoms of menopause

Physicians study human stem cell use as possible treatment for ischemic stroke

Timely treatment with Berinert provides faster symptom relief for HAE patients

Shire to commence two Vyvanse and Concerta Phase 4 comparison trials for ADHD

AcelRx initiates ARX-01 Phase 3 study for treatment of post-operative pain

Merck announces results from AIT Phase III clinical study for ragweed allergy

Santarus fourth quarter total revenues increase 65% to $42.6M

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