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Novartis receives FDA approval for expanded use of Promacta for younger children with rare blood disorder

Novartis announced today that the US Food and Drug Administration has approved an expanded use for Promacta to include children 1 year of age and older with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

26 Aug 2015

New studies evaluate viral suppression rate of HIV-infected pregnant women at delivery

Pregnancy could be a turning point for HIV-infected women, when they have the opportunity to manage their infection, prevent transmission to their new baby and enter a long-term pattern of maintenance of HIV care after giving birth--but most HIV-infected women aren't getting that chance.

26 Aug 2015

Epinephrine delay decreases survival for children with in-hospital, nonshockable cardiac arrest

Among children with in-hospital cardiac arrest with an initial nonshockable heart rhythm who received epinephrine (adrenaline), delay in administration of epinephrine was associated with a decreased chance of 24-hour survival and survival to hospital discharge, according to a study in the August 25 issue of JAMA.

26 Aug 2015

Omega-3 supplements fail to slow cognitive decline in older persons, NIH clinical study shows

While some research suggests that a diet high in omega-3 fatty acids can protect brain health, a large clinical trial by researchers at the National Institutes of Health found that omega-3 supplements did not slow cognitive decline in older persons. With 4,000 patients followed over a five-year period, the study is one of the largest and longest of its kind.

26 Aug 2015

AirXpanders' pivotal XPAND trial meets primary endpoint in patients who have undergone mastectomy

AirXpanders Inc., a medical device company focused on the design, manufacture, sale and distribution of the AeroForm Tissue Expander, is pleased to report that its pivotal XPAND trial has met its primary endpoint in patients who have undergone a mastectomy.

26 Aug 2015

FDA, EMA accept filing applications for Boehringer Ingelheim's afatinib to treat patients with advanced SCC of the lung

Boehringer Ingelheim today announced that both the U.S. Food and Drug Administration and the European Medicines Agency have accepted filing applications for afatinib for the treatment of patients with advanced squamous cell carcinoma (SCC) of the lung progressing after treatment with first-line chemotherapy.

26 Aug 2015

Clementia expands enrollment to include children with FOP in ongoing Phase 2 clinical trial

Clementia Pharmaceuticals, Inc. today announced the initiation of enrollment of children as young as 6 years old in the company's ongoing Phase 2 study of palovarotene for the treatment of fibrodysplasia ossificans progressiva (FOP).

26 Aug 2015

Tocagen's Toca 511 & Toca FC receives FDA orphan drug designation for treatment of glioblastoma

Tocagen Inc., a clinical-stage immuno-oncology company, today announced that the U.S. Food and Drug Administration has granted orphan drug designation to the company's lead immuno-oncology product candidate, Toca 511 & Toca FC, for the treatment of glioblastoma.

26 Aug 2015

Study shows significant link between macular pigment levels in the eye and cognitive function

Ongoing European Research Council-funded research at Waterford Institute of Technology's Macular Pigment Research Group is investigating the potential link between cognitive function and levels of a vital eye pigment linked to diet. The study suggests that measuring macular pigment offers potential as a biomarker of cognitive health

25 Aug 2015

Dr. Sharma receives research award from ASCO to continue study on triple-negative breast cancer

Dr. Sharma was awarded the 2015 Advanced Clinical Research Award in Breast Cancer from the American Society of Clinical Oncology to continue her research on triple-negative breast cancer.

25 Aug 2015

High dietary iron intake suppresses hormone that regulates appetite

Here's one more reason to cut down on the amount of red meat you eat. Using an animal model, researchers at Wake Forest Baptist Medical Center have found that dietary iron intake, equivalent to heavy red meat consumption, suppresses leptin, a hormone that regulates appetite.

25 Aug 2015

SI-BONE announces publication of results from INSITE and SIFI studies

SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System, a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced the publication of one-year results from two separate prospective multicenter clinical trials as well as the publication of a systematic review of 18 MIS SI joint fusion studies.

24 Aug 2015

Esperance, MD Anderson form strategic alliance to accelerate development of anti-cancer candidate EP-100

Esperance Pharmaceuticals Inc. today announced that it has entered into a strategic alliance agreement with MD Anderson Cancer Center to accelerate the clinical development of its lead anti-cancer candidate EP-100 for the treatment of ovarian cancer and to collaborate on preclinical studies of EP-100 as a treatment for breast cancer.

24 Aug 2015

Primary care physicians' starring role key to weight loss, find Johns Hopkins researchers

A review of survey data from more than 300 obese people who participated in a federally funded weight loss clinical trial found that although the overall weight loss rates were modest, those who rated their primary care doctor's support as particularly helpful lost about twice as many pounds as those who didn't.

24 Aug 2015

HPPI commences enrollment for Phase II(b) SCORING clinical trial for cancer treatment

HedgePath Pharmaceuticals, Inc., a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize innovative therapeutics for patients with cancer, announced today enrollment has commenced in its Phase II(b) SCORING (SUBA-Cap Objective Response in Gorlin's) clinical trial.

23 Aug 2015

Berg and University of Miami extend partnership to battle cardiac dysfunction, heart failure

Berg, a Boston-based biopharmaceutical company, and the University of Miami Leonard M. Miller School of Medicine are extending its collaboration to battle cardiac dysfunction and heart failure. According to the American Heart Association, cardiovascular disease is the leading global cause of death, accounting for 17.3 million deaths per year, a number that is expected to grow to more than 23.6 million by 2030.

23 Aug 2015

NW Bio's DCVax-L Phase III trial ongoing for treatment of patients with newly diagnosed GBM

Northwest Biotherapeutics, a U.S. biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, confirmed today that its Phase III trial of DCVax-L for newly diagnosed glioblastoma multiforme (GBM) is ongoing and the patients enrolled in the trial are continuing to be treated per the protocol.

23 Aug 2015

MTG Biotherapeutics' MTG-201 granted FDA Orphan Drug Designation for malignant mesothelioma treatment

MTG Biotherapeutics, an immuno-oncology company developing novel therapeutics for the treatment of cancer, today announced that the US Food and Drug Administration has granted Orphan Drug Designation for MTG-201, an advanced biologic therapy targeting Dickkopf-3 gene defects in various cancers, for the treatment of malignant mesothelioma.

23 Aug 2015

60P to commence Phase II clinical trial among dengue fever patients

60 Degrees Pharmaceuticals, a company focused on development of therapeutics for tropical diseases, and Singapore General Hospital announced today that the Hospital has received a grant from Singapore's National Medical Research Council to support a Phase II clinical trial among dengue fever patients.

20 Aug 2015

DelMar closes on $2.6 million registered direct placement

DelMar Pharmaceuticals, Inc., a biopharmaceutical company focused on developing and commercializing proven cancer therapies in new orphan drug indications, today announced the closing of a registered direct placement (Placement) with $2.6 million received from the offering.

20 Aug 2015

Clinical Trial News and Research

Novartis receives FDA approval for expanded use of Promacta for younger children with rare blood disorder

New studies evaluate viral suppression rate of HIV-infected pregnant women at delivery

Epinephrine delay decreases survival for children with in-hospital, nonshockable cardiac arrest

Omega-3 supplements fail to slow cognitive decline in older persons, NIH clinical study shows

AirXpanders' pivotal XPAND trial meets primary endpoint in patients who have undergone mastectomy

FDA, EMA accept filing applications for Boehringer Ingelheim's afatinib to treat patients with advanced SCC of the lung

Clementia expands enrollment to include children with FOP in ongoing Phase 2 clinical trial

Tocagen's Toca 511 & Toca FC receives FDA orphan drug designation for treatment of glioblastoma

Study shows significant link between macular pigment levels in the eye and cognitive function

Dr. Sharma receives research award from ASCO to continue study on triple-negative breast cancer

High dietary iron intake suppresses hormone that regulates appetite

SI-BONE announces publication of results from INSITE and SIFI studies

Esperance, MD Anderson form strategic alliance to accelerate development of anti-cancer candidate EP-100

Primary care physicians' starring role key to weight loss, find Johns Hopkins researchers

HPPI commences enrollment for Phase II(b) SCORING clinical trial for cancer treatment

Berg and University of Miami extend partnership to battle cardiac dysfunction, heart failure

NW Bio's DCVax-L Phase III trial ongoing for treatment of patients with newly diagnosed GBM

MTG Biotherapeutics' MTG-201 granted FDA Orphan Drug Designation for malignant mesothelioma treatment

60P to commence Phase II clinical trial among dengue fever patients

DelMar closes on $2.6 million registered direct placement

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