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Moffitt Cancer Center initiates PV-10 Phase 1 study in melanoma

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, reports that the Moffitt Cancer Center has initiated a Phase 1 study to investigate potential immune biomarkers in both tumor tissue and peripheral blood after intralesional PV-10 injection of melanoma tumors.

9 Jan 2013

CTI initiates enrollment in pacritinib Phase 3 trial for myelofibrosis

Cell Therapeutics, Inc. (CTI) today announced that the Company has initiated clinical trial sites and began enrolling patients in a Phase 3 clinical trial, known as PERSIST-1 or PAC325, for pacritinib, CTI's investigational JAK2 inhibitor, which is being evaluated for the treatment of patients with myelofibrosis.

9 Jan 2013

Lilly, Boehringer Ingelheim announce top-line results from empagliflozin Phase III trials on T2D

Boehringer Ingelheim and Eli Lilly and Company today announced top-line results for four completed Phase III clinical trials for empagliflozin, an investigational sodium glucose co-transporter-2 (SGLT2) inhibitor being studied for treatment of patients with Type 2 Diabetes (T2D).

9 Jan 2013

Combination of pazopanib and paclitaxel shows promise in slowing anaplastic thyroid cancer

A combination of the drugs pazopanib and paclitaxel shows promise in slowing anaplastic thyroid cancer (ATC), according to a Mayo Clinic-led study published in the journal Science Translational Medicine.

9 Jan 2013

Oramed files IND with FDA to begin ORMD-0801 Phase 2 trial for type 2 diabetes

Oramed Pharmaceuticals Inc., a developer of oral drug delivery systems, announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin a Phase 2 clinical trial of its orally ingested insulin candidate, ORMD-0801.

9 Jan 2013

Sublingual immunotherapy can effectively treat peanut allergy

Peanuts are one of the most common triggers of severe food-induced allergic reactions, which can be fatal, and the prevalence of peanut allergy is increasing. However, there is currently no clinical treatment available for peanut allergy other than strict dietary elimination and, in cases of accidental ingestion, injections of epinephrine.

9 Jan 2013

Orexigen reports progress with FDA on faster path to Contrave NDA resubmission

Orexigen Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced progress with the United States Food and Drug Administration (FDA) on a faster path to resubmission of the Contrave (naltrexone SR / bupropion SR) New Drug Application (NDA).

9 Jan 2013

Esperion reports positive results from ETC-1002 Phase 2 clinical trial on type 2 diabetes

Esperion Therapeutics, the leading developer of small molecule therapies for the treatment of cardiometabolic disorders, today announced positive results of a recently completed Phase 2 clinical trial of ETC-1002 in patients with type 2 diabetes with LDL-C lowering of up to 43% compared to placebo.

8 Jan 2013

Spectrum Pharmaceuticals reveals positive RenaZorb Phase 1 clinical trial results

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced positive, statistically significant data from the Company's Phase 1 clinical trial evaluating the safety and tolerability of RenaZorb (also referred to as SPI-014) in healthy volunteers.

8 Jan 2013

Real life experience of defibrillators lives up to clinical trial expectations

There is no significant difference in survival between clinical trial patients who receive an implantable cardioverter and clinical registry patients who receive a primary prevention ICD, researchers suggest.

7 Jan 2013

Edison Pharmaceuticals to commence EPI-743 phase 2B Friedreich's ataxia study

Edison Pharmaceuticals today announced the initiation of a phase 2B study entitled, "Safety and Efficacy Study of EPI-743 on Visual Function in Patients with Friedreich's Ataxia."

7 Jan 2013

Inovio, MVI collaborate to advance malaria vaccine development and new delivery technologies

The PATH Malaria Vaccine Initiative (MVI) and Inovio Pharmaceuticals, Inc. today announced a follow-on collaboration to advance malaria vaccine development and new vaccination delivery technologies.

7 Jan 2013

Rhythm commences RM-493 Phase 2 trial in obesity

Rhythm announced today the initiation of a Phase 2 clinical trial with RM-493, the company's novel melanocortin 4 receptor (MC4R) agonist, for the treatment of obesity.

7 Jan 2013

Celtaxsys commences CTX-4430 Phase 1 study to treat pulmonary inflammation

Celtaxsys, Inc., a private biopharmaceutical company developing a new class of drugs to treat chronic inflammatory disorders, today announced the initiation of a first-in-human Phase 1 clinical study of CTX-4430, which blocks the pro-inflammatory enzyme Leukotriene A4 Hydrolase (LTA4H).

3 Jan 2013

Kareus announces start of KU-046 Phase I study in Alzheimer's

Kareus Therapeutics SA, the private biotechnology company focused on the development of novel therapeutics for the unmet treatment of age-related and chronic diseases, today announces the start of a Phase I clinical study following the Investigational New Drug (IND) approval from the US Food and Drug Administration for the development of KU-046, a first-in-class disease modifying new chemical entity discovered for the treatment of Alzheimer's disease using Kareus' proprietary bioenergetics and KARLECT platforms.

3 Jan 2013

TFP5 molecule restores memory in mice with Alzheimer's

A new ray of hope has broken through the clouded outcomes associated with Alzheimer's disease. A new research report published in January 2013 print issue of the FASEB Journal by scientists from the National Institutes of Health shows that when a molecule called TFP5 is injected into mice with disease that is the equivalent of human Alzheimer's, symptoms are reversed and memory is restored-without obvious toxic side effects.

3 Jan 2013

Salix receives FDA approval for crofelemer to treat HIV-associated diarrhea

On New Year's Eve of 2012, the US Food and Drug Administration (FDA) announced its approval of crofelemer (Fulyzaq, Salix Pharmaceuticals, Ltd., Raleigh, North Carolina) — marking the second time a botanical, and the first time an orally administered botanical, has received drug approval from the Administration.

3 Jan 2013

Bristol-Myers Squibb, Pfizer receive FDA approval for ELIQUIS to reduce risk of stroke and SE

Bristol-Myers Squibb Company and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) approved ELIQUIS (apixaban) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

2 Jan 2013

Study highlights value of defibrillators in typical medical settings

Patients who received an implantable heart defibrillator in everyday practice had survival benefits on par with those who received the same devices in carefully controlled clinical trials, according to a new study that highlights the value of defibrillators in typical medical settings.

1 Jan 2013

Few hepatitis C patients receive complete treatment

Less than 10% of patients with hepatitis C receive the treatment they need to achieve a sustained virologic response, results from a systematic review show.

31 Dec 2012