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FDA grants Albireo's A4250 orphan-drug designation for treatment of PFIC and PBC

Albireo AB, a biopharmaceutical company specializing in gastroenterology, today announced that A4250 (an inhibitor of the ileal bile acid transporter, IBAT/ASBT) has been granted orphan-drug designation by the U.S Food and Drug Administration for the treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) and Primary Biliary Cirrhosis (PBC).

8 Nov 2012

BioCryst completes planned interim analysis of peramivir Phase 3 trial for serious influenza

BioCryst Pharmaceuticals, Inc. announced completion of the planned interim analysis of the peramivir Phase 3 trial in patients admitted to the hospital with serious influenza. The difference between peramivir and control groups for the primary endpoint was small and the recalculated sample size was greater than the predefined futility boundary of 320 subjects. Based on this information, the independent data monitoring committee (DMC) recommended that the study be terminated for futility.

8 Nov 2012

Stapled Peptide oncology drug candidate exhibits robust efficacy in xenograft cancer models

Aileron Therapeutics, Inc. and its collaborator Roche today announced new results of a preclinical study of its Stapled Peptide oncology drug candidate ATSP-7041, which exhibited robust efficacy in MDM2 and MDMX xenograft cancer models.

8 Nov 2012

Duration of ibuprofen use may reduce risk of bladder cancer in northern New England patients

Dartmouth researchers have found that duration of ibuprofen use was associated with a reduced risk of bladder cancer in patients in northern New England, which has a high mortality rate of this disease. In a 2012 collaborative project with the National Cancer Institute, Margaret Karagas, PhD, co-director, Cancer Epidemiology & Chemoprevention program at Norris Cotton Cancer Center, and Professor of Community and Family Medicine at the Geisel School of Medicine at Dartmouth, and Richard Waddell, D.Sc, Research Assistant Professor of Medicine at the Geisel School of Medicine, looked for connections between ibuprofen use and bladder cancer.

7 Nov 2012

Teva announces additional data from QNASL Phase III program on seasonal allergic rhinitis

Teva Pharmaceutical Industries Ltd. announced today that additional data from the Phase III clinical program for QNASL- (beclomethasone dipropionate) Nasal Aerosol will be presented at the 2012 Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Anaheim, CA on November 8-13, 2012.

7 Nov 2012

Arisaph’s ARI-3037MO well tolerated in healthy male and female volunteers

Arisaph Pharmaceuticals, Inc. announced today during an oral presentation at the American Heart Association (AHA) meeting in Los Angeles, CA that its niacin analog, ARI-3037MO, was extremely well tolerated in a single-ascending dose (SAD) and a multiple-ascending dose (MAD) trial in healthy male and female volunteers.

7 Nov 2012

Synta announces interim results from docetaxel Phase 2b/3 trial on NSCLC

Synta Pharmaceuticals Corp. announced today that interim results from the Phase 2b/3 GALAXY trial will be presented at the Chemotherapy Foundation Symposium in New York City on Friday, November 9 during the 11:45 a.m. session on new agents for lung cancer. Presenting this data at the conference will be Dr. Suresh Ramalingham, Professor, Hematology & Medical Oncology, and Director, Translational Thoracic Malignancies Program, of the Winship Cancer Institute of Emory University.

7 Nov 2012

People more likely to take heart medicines in combo pill

People are much more likely to take heart medicines if they're combined in one pill, according to a late-breaking clinical trial presented at the American Heart Association's Scientific Sessions 2012.

7 Nov 2012

Treatment with AMG 145 reduces LDL cholesterol

Amgen today announced that results from the LAPLACE-TIMI 57 and MENDEL Phase 2 studies evaluating AMG 145 in hypercholesterolemic patients with or without statins, respectively, showed that treatment with AMG 145 resulted in a statistically significant reduction in low-density lipoprotein (LDL) cholesterol.

7 Nov 2012

Positive results from Santarus and Pharming’s RUCONEST Phase III trial on HAE

Santarus, Inc. and Pharming Group NV today announced that their pivotal Phase III clinical study to evaluate the safety and efficacy of the investigational drug RUCONEST (recombinant human C1 esterase inhibitor) 50 U/kg for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE) met the primary endpoint of time to beginning of symptom relief.

7 Nov 2012

Results from liraglutide and exenatide head-to-head comparison trial on type 2 diabetes

A direct, head-to-head comparison of two of the newer treatments available for type 2 diabetes yielded mixed results.

7 Nov 2012

Lexicon announces data from LX4211 Phase 2b trial on type 2 diabetes

Lexicon Pharmaceuticals, Inc. announced that data from the Phase 2b clinical trial of LX4211 are being presented today as a Clinical Sciences Special Report in the Emerging Therapeutics for Diabetes and Dyslipidemia section of the American Heart Association (AHA) Scientific Sessions Conference held in Los Angeles, California.

7 Nov 2012

SCYNEXIS announces results from SCY-635 Phase 2a study on HCV

SCYNEXIS, Inc. today announced that the results of a Phase 2a study of lead candidate SCY-635 for the treatment of the hepatitis C virus (HCV) will be the subject of an oral presentation at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place from November 9-13 in Boston, Massachusetts.

7 Nov 2012

AMG 145 can reduce LDL cholesterol levels by up to 66% after 12 weeks

For many people with high cholesterol, statins serve as the first line of treatment. However, some patients are unable to effectively reduce their low-density lipoprotein cholesterol (LDL cholesterol) or "bad cholesterol" levels with statins, the most commonly used medication to treat high cholesterol, due to their bodies' inability to tolerate or sufficiently respond to the medicine.

7 Nov 2012

Positive results from POZEN's PA32540 Phase 3 trials presented at AHA Scientific Sessions 2012

POZEN Inc., a pharmaceutical company committed to transforming medicine that transforms lives, presented positive results from two pivotal Phase 3 clinical trials of the investigational product, PA32540, at The American Heart Association (AHA) Scientific Sessions 2012, as Poster #12057: Treatment Continuation and Cardiovascular Safety of Antiplatelet Therapy with PA32540, A Tablet with Enteric-Coated Aspirin and Immediate-Release Omeprazole: Results of Two 6-Month, Phase 3 Studies.

6 Nov 2012

$Cryopraxis/CellPraxis initiates recruitment in ReACT Phase III trial for refractory angina$

Drug Trial News

FDA grants Albireo's A4250 orphan-drug designation for treatment of PFIC and PBC

BioCryst completes planned interim analysis of peramivir Phase 3 trial for serious influenza

Stapled Peptide oncology drug candidate exhibits robust efficacy in xenograft cancer models

Duration of ibuprofen use may reduce risk of bladder cancer in northern New England patients

Teva announces additional data from QNASL Phase III program on seasonal allergic rhinitis

Arisaph’s ARI-3037MO well tolerated in healthy male and female volunteers

Synta announces interim results from docetaxel Phase 2b/3 trial on NSCLC

People more likely to take heart medicines in combo pill

Treatment with AMG 145 reduces LDL cholesterol

Positive results from Santarus and Pharming’s RUCONEST Phase III trial on HAE

Results from liraglutide and exenatide head-to-head comparison trial on type 2 diabetes

Lexicon announces data from LX4211 Phase 2b trial on type 2 diabetes

SCYNEXIS announces results from SCY-635 Phase 2a study on HCV

AMG 145 can reduce LDL cholesterol levels by up to 66% after 12 weeks

Positive results from POZEN's PA32540 Phase 3 trials presented at AHA Scientific Sessions 2012

Cryopraxis/CellPraxis initiates recruitment in ReACT Phase III trial for refractory angina

Sabin initiates Part II of Na-GST-1 vaccine Phase I hookworm trial

Probiotic formulation can reduce cholesterol esters

Celldex to present results from CDX-301 Phase 1 study in healthy volunteers

Intravenous infusion of HDL cholesterol could reduce risk of subsequent heart attack

Flow chemistry, AI, and NMR: A next-gen approach to scalable API production

Digital pathology and the PathoVerse: A conversation with Dr. Singh

Bioprocess Efficiency with Cell Density Monitoring

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