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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

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

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

Industry sponsored drug and device studies: an interview with Professor Lisa Bero

Our review included analyses of drug and device studies conducted in humans. The drugs or devices could be compared to placebo or sham treatments, or other effective treatments. The drugs and devices examined for this review are used for a wide variety of clinical conditions, including cardiovascular and psychiatric diseases.

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

ThromboGenics to launch JETREA in the U.S. on Jan. 14

ThromboGenics NV, an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, confirms its JETREA US launch date of Monday January 14th, 2013.

4 Jan 2013

Top-line results from Biogen Idec’s dexpramipexole Phase 3 trial on amyotrophic lateral sclerosis

Today Biogen Idec reported top-line results of EMPOWER, a Phase 3 trial investigating dexpramipexole in people with amyotrophic lateral sclerosis (ALS).

3 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

$Bayer, Onyx announce data from Nexavar Phase 3 trial on RAI-refractory differentiated thyroid cancer$

Bayer, Onyx announce data from Nexavar Phase 3 trial on RAI-refractory differentiated thyroid cancer

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced that a Phase 3 trial of Nexavar (sorafenib) tablets in patients with locally advanced or metastatic radioactive iodine-refractory (RAI) differentiated thyroid cancer has met its primary endpoint of a statistically significant improvement of progression-free survival.

3 Jan 2013

FDA grants accelerated approval to drug to treat MDR-TB

"The U.S. Food and Drug Administration on Monday approved Johnson & Johnson's drug to treat a form of resistant tuberculosis that is uncommon in the U.S. but growing globally," the Wall Street Journal reports.

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

Fibrinogen could bypass intraoperative transfusion needs

Giving fibrinogen as first-line treatment for intraoperative bleeding could reduce the need for blood transfusion, shows a small randomized controlled trial.

2 Jan 2013

Crofelemer receives FDA approval for treatment of HIV associated diarrhea

Glenmark Pharmaceuticals Limited announced today that the US Food and Drug Administration has provided Marketing approval to its partner in US, Salix Pharmaceuticals Limited, for Crofelemer 125 mg delayed-release tablets for the symptomatic relief of non-infectious diarrhea in patients with human immunodeficiency virus (HIV)/ acquired immune deficiency syndrome (AIDS) on anti-retroviral therapy (ART).

2 Jan 2013