FDA Approves Arnuity Ellipta (fluticasone furoate) for the Treatment of Asthma

In continuation of my update on Ellipta (fluticasone furoate)

GlaxoSmithKline plc  announced that the Food and Drug Administration has approved Arnuity Ellipta (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. Arnuity is not indicated for relief of acute bronchospasm

FDA Approves Arnuity Ellipta (fluticasone furoate) for the Treatment of Asthma

FDA Approves Triumeq for the Treatment of HIV-1 Infection

ViiV Healthcare announced today that the U.S. Food and Drug Administration (FDA) has approved Triumeq (abacavir 600mg (below-Ist), dolutegravir (below -IInd) 50mg and lamivudine (below IIIrd respectively) 300mg) tablets for the treatment of HIV-1 infection.  Triumeq is ViiV Healthcare’s first dolutegravir-based fixed-dose combination, offering many people living with HIV the option of a single-pill regimen that combines the integrase strand transfer inhibitor (INSTI) dolutegravir, with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine.

FDA Approves Triumeq for the Treatment of HIV-1 Infection

FDA Approves Movantik (naloxegol) for Opioid-Induced Constipation

In continuation with my update on Movantik(naloxegol)

The U.S. Food and Drug Administration today approved Movantik(naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.

FDA Approves Movantik (naloxegol) for Opioid-Induced Constipation

Pfizer Announces Submission of Palbociclib New Drug Application to the FDA

Pfizer Inc. today announced it has completed the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for palbociclib. This NDA requests FDA approval of palbociclib, in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease. The submission is based on the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients.

Pfizer Announces Submission of Palbociclib New Drug Application to the FDA

Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. This designation was based on interim data from the PALOMA-1 trial.

FDA Grants Amgen Priority Review Designation For Ivabradine For The Treatment Of Chronic Heart Failure

Amgen announced the U.S. Food and Drug Administration (FDA) has granted priority review designation for ivabradine for the treatment of chronic heart failure (HF). Ivabradine is an oral drug that inhibits the I_f current ("funny" current) in the sinoatrial node, the body's cardiac pacemaker.  Ivabradine works to slow the heart rate without negative effects on myocardial contractility or ventricular repolarization.  Heart failure is a common condition that affects approximately 26 million worldwide, including approximately 5.1 million people in the U.S. 

FDA Grants Amgen Priority Review Designation For Ivabradine For The Treatment Of Chronic Heart Failure

FDA Approves Eliquis (apixaban) for the Treatment of Deep Vein Thrombosis and Pulmonary Embolism

In continuation of my update on Apixaban (BMS-562247-01, tradename Eliquis)

Bristol-Myers Squibb Company and Pfizer Inc.  announced the U.S. Food and Drug Administration (FDA) has approved a Supplemental New Drug Application (sNDA) for Eliquis for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. Combined, DVT and PE are known as VTE. It is estimated that every year, approximately 900,000 Americans are affected by DVT and PE.

FDA Approves Eliquis (apixaban) for the Treatment of Deep Vein Thrombosis and Pulmonary Embolism

Actavis Announces FDA Acceptance for Filing of NDA for Eluxadoline

Actavis plc (NYSE: ACT) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Actavis' New Drug Application (NDA) for eluxadoline, an investigational drug for the treatment of diarrhea and abdominal pain in men and women with diarrhea predominant Irritable Bowel Syndrome (IBS-D). Actavis' NDA for eluxadoline has been granted priority review status by the FDA.

Actavis Announces FDA Acceptance for Filing of NDA for Eluxadoline

FDA Advisory Committee Votes 14-1 in Favor of Saxenda (liraglutide) for Obesity

In continuation of my update on Lirglutide

Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the Food and Drug Administration (FDA) has completed its meeting regarding the New Drug Application (NDA) for Saxenda, the intended brand name for liraglutide 3 mg, a once-daily human GLP-1 analogue for the treatment of obesity.

FDA Advisory Committee Votes 14-1 in Favor of Saxenda (liraglutide) for Obesity

New class of compounds protect brain cells from traumatic brain injury

A new class of compounds has now been shown to protect brain cells from the type of damage caused by blast-mediated traumatic brain injury (TBI). Mice that were treated with these compounds 24-36 hours after experiencing TBI from a blast injury were protected from the harmful effects of TBI, including problems with learning, memory, and movement.

Traumatic brain injury caused by blast injury has emerged as a common health problem among U.S. servicemen and women, with an estimated 10 to 20 percent of the more than 2 million U.S. soldiers deployed in Iraq or Afghanistan having experienced TBI. The condition is associated with many neurological complications, including cognitive and motor decline, as well as acquisition of psychiatric symptoms like anxiety and depression, and brain tissue abnormalities that resemble Alzheimer's disease.

"The lack of neuroprotective treatments for traumatic brain injury is a serious problem in our society," says Andrew Pieper, M.D., Ph.D., senior study author and associate professor of psychiatry, neurology, and radiation oncology at the University of Iowa Carver College of Medicine. "Everyone involved in this work is motivated to find a way to offer hope for patients, which today include both military personnel and civilians, by establishing a basis for a new treatment to combat the deleterious neuropsychiatric outcomes after blast injury."

It is known that TBI, as well as certain neurodegenerative diseases, damages axons - the tendril-like fibers that sprout from brains cells (neurons) and form the connections called synapses. In TBI, axon damage is followed by death of the neuron. The new study, published Sept. 11 in the journal Cell Reports, shows that a group of compounds, called the P7C3 series, blocks axon damage and preserves normal brain function following TBI.

Pieper led the team of scientists that discovered the P7C3 compound several years ago at UT Southwestern Medical Center. Subsequent studies showed that the root compound and its active analogs protect newborn neurons from cell death and also protect mature neurons in animal models of neurodegenerative diseases, including Parkinson's disease and amyotrophic lateral sclerosis (ALS).

The researchers have also previously shown efficacy of P7C3 molecules in brain injury due to concussion, and plan to investigate whether these compound might be applicable in stroke as well, given that there appear to be common factors mediating neuronal cell death in these conditions.
Ref : http://www.cell.com/cell/abstract/S0092-8674(10)00672-0

New class of compounds protect brain cells from traumatic brain injury

Prana's PBT2 receives FDA Orphan Drug designation for treatment of Huntington disease

Prana's PBT2 receives FDA Orphan Drug designation for treatment of Huntington disease