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Eli Lilly's Cymbalta receives FDA approval

The U.S. Food and Drug Administration (FDA) has approved Cymbalta® (duloxetine HCl) for the maintenance treatment of generalized anxiety disorder (GAD) in adults, announced Eli Lilly and Company (NYSE: LLY).

30 Nov 2009

Spectrum Pharmaceuticals completes enrollment in apaziquone Phase 3 trial

Spectrum Pharmaceuticals today announced that one of the two Phase 3 pivotal clinical trials of apaziquone has achieved its enrollment target, having enrolled approximately 800 patients with non-invasive bladder cancer. The second Phase 3 clinical trial of apaziquone is expected to complete enrollment by the end of the year.

30 Nov 2009

Study on placebo effect

A short time ago, Swedish scientists published a paper suggesting the existence of a genetic disposition to respond to placebo, thus giving rise to debate in the media about a possible "placebo gene." In the current issue of Deutsches Ärzteblatt International (Dtsch Arztebl Int 2009; 106[46]: 751-5), Matthias Breidert and Karl Hofbauer summarize the most recent data about placebos.

28 Nov 2009

European Commission approves MICARDIS medication for CV protection

MICARDIS® is the first treatment in its class to be approved for this indication. The EMEA approval is the second major milestone for MICARDIS® in cardiovascular protection. It follows the approval by the US FDA for the reduction of the risk of myocardial infarction (heart attack), stroke, or death from cardiovascular (CV) causes in patients 55 years of age or older at high risk of developing major CV events who are unable to take ACE inhibitors.

27 Nov 2009

Merck to commence MK-6913 phase IIa efficacy trial for treatment of hot flashes/hot flushes

The Swedish biotech company Karo Bio today announced that Merck & Co., Inc., through an affiliate, plans to enter a clinical phase IIa trial with the collaboration's lead investigational drug candidate, MK-6913, identified as part of their joint research collaboration. No milestone payment to Karo Bio is associated with the initiation of phase II clinical development.

26 Nov 2009

Tibotec Therapeutics' INTELENCE granted FDA traditional approval

The FDA granted traditional approval for INTELENCE® (etravirine) tablets, a non-nucleoside reverse transcriptase inhibitor (NNRTI). INTELENCE is the only NNRTI specifically indicated for use in treatment-experienced adults who are experiencing virologic failure with HIV-1 strains resistant to an NNRTI and other antiretroviral (ARV) agents.

25 Nov 2009

Additional data on lubiprostone presented at the GASTRO 2009 UEGF/WCOG meeting

Sucampo Pharma Europe, Ltd., and Sucampo Pharma Americas, Inc., subsidiaries of Sucampo Pharmaceuticals, Inc., today presented additional clinical data for lubiprostone (Amitiza®) at GASTRO 2009 UEGF/WCOG, the joint meeting of the United European Gastroenterology Federation (UEGF), the World Gastroenterology Organisation (WGO), the World Organisation of Digestive Endoscopy (OMED) and the British Society of Gastroenterology (BSG), in London.

25 Nov 2009

FDA approves Berinert for treating HAE in adults and adolescents

Berinert®, a human C1 esterase inhibitor (C1-INH) for treating acute episodes of facial or abdominal hereditary angioedema (HAE) in adults and adolescents has obtained approval from the US Food and Drug Administration (FDA).

25 Nov 2009

Positive Phase II/III clinical data from ChemoCentryx' PROTECT-1 Traficet-EN trial

ChemoCentryx, Inc., announced today that Phase II/III clinical data from the Company's PROTECT-1 (the Prospective Randomized Oral Therapy Evaluation in Crohn's disease Trial) of Traficet-EN(TM) (CCX282-B) in patients with moderate-to-severe Crohn's disease demonstrated clinical efficacy with a favorable safety and tolerability profile. The

25 Nov 2009

Worldwide collaboration leads to treatment for rare skin disorder

Researchers at Huntsman Cancer Institute, in collaboration with a worldwide group of physicians and scientists, have discovered a remarkable treatment for a rare, yet debilitating, skin condition.

25 Nov 2009

Reboxetine drug does not alleviate depression, says new study

There is no scientific proof that people suffering from depression can benefit from taking reboxetine. However, clinical trials do provide proof of benefit of bupropion XL and mirtazapine: both agents can alleviate symptoms. This is the conclusion of the final report of the Institute for Quality and Efficiency in Health Care (IQWiG) published on 24 November 2009.

24 Nov 2009

Ohr Pharmaceutical to develop OHR/AVR118 for cachexia treatment

Ohr Pharmaceutical Inc. is developing OHR/AVR118 for treatment of cachexia based on technology acquired earlier this year from Advanced Viral Research Corp. OHR/AVR118 has shown excellent therapeutic efficacy and safety in human clinical trials in over 100 patients with applications for cachexia in Cancer and AIDS patients, as well as Rheumatoid Arthritis.

24 Nov 2009

Fourth-quarter and full year fiscal 2009 results announced by AVANIR Pharmaceuticals

AVANIR Pharmaceuticals, Inc. today reported unaudited financial results for the three and twelve months ended September 30, 2009.

24 Nov 2009

Cardiovascular risks associated with taking Vioxx could have been identified earlier, say researchers

Evidence of cardiovascular risks associated with taking Vioxx, the popular, nonsteroidal anti-inflammatory drug (rofecoxib), could have been identified nearly four years before its manufacturer, Merck & Co. Inc., voluntarily pulled the drug from the market.

24 Nov 2009

New data indicates early association between anti-inflammatory medication and cardiovascular risk

Clinical trial data indicated an association between the anti-inflammatory medication rofecoxib and cardiovascular risk as early as December 2000, before the product was taken off the market in September 2004, according to a report in the November 23 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

24 Nov 2009

Lysteda tablets to treat menorrhagia approved by the FDA

The U.S. Food and Drug Administration today approved Lysteda tablets (tranexamic acid), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot.

24 Nov 2009

Proteon Therapeutics commences PRT-201 Phase 1/2 clinical study in hemodialysis patients

Proteon Therapeutics, Inc., has initiated a Phase 1/2 human clinical study of its lead product, PRT-201, in end-stage renal disease (ESRD) patients undergoing surgery for arteriovenous graft (AVG) creation. The AVG study represents Proteon's second human clinical study in hemodialysis patients, previously announcing the initiation of a Phase 1/2 study of PRT-201 in ESRD patients undergoing surgery for arteriovenous fistula (AVF) creation earlier this year.

23 Nov 2009

Caldolor Injection effective in treating fever in hospitalized burn patients

Cumberland Pharmaceuticals Inc. today announced positive new top-line results from a study evaluating the safety and efficacy of Caldolor (ibuprofen) Injection in treating fever in hospitalized burn patients.

23 Nov 2009

Acucela to present data on its ACU-4429 visual cycle modulator for dry AMD

Acucela, a clinical-stage biotechnology company focused on developing new treatments for blinding eye diseases, announced today that data for the company’s novel visual cycle modulator, ACU-4429, a potential oral treatment for dry age-related macular degeneration (dry AMD), will be featured at the 8th International Symposium on Ocular Pharmacology and Therapeutics (ISOPT) being held in Rome, Italy from December 3 to 6, 2009.

23 Nov 2009

Phase IIb/III clinical trial results of CINQUIL for pediatric EoE announced

Ception Therapeutics, Inc., a privately held biopharmaceutical company, and Cephalon, Inc. today announced results from a Phase IIb/III clinical trial for CINQUIL(TM) (reslizumab) as a treatment for pediatric eosinophilic esophagitis (EoE). The study was designed to evaluate improvement in the co-primary endpoints of changes in esophageal eosinophil levels and clinical symptoms.

23 Nov 2009