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Merck's MK-4305 improves overall sleep efficiency in primary insomnia patients

Clinical results from a Phase IIb study showed that MK-4305, Merck's investigational dual orexin receptor antagonist, was significantly more effective than placebo (p<0.005) in improving overall sleep efficiency at night one and at the end of week four in patients with primary insomnia. MK-4305 was generally well-tolerated in the study. Orexins are neuropeptides (chemical messengers) that are released by specialized neurons in the hypothalamus region of the brain and are believed to be an important regulator of the brain's sleep-wake process.

9 Jun 2010

Helix BioPharma reports Phase II clinical results of Topical Interferon Alpha-2b for ano-genital warts

Helix BioPharma Corp. today announced results from the Phase II clinical trial assessing the efficacy and safety of Topical Interferon Alpha-2b cream for the treatment of ano-genital warts (AGW).

9 Jun 2010

Lubiprostone phase 3 clinical trial in Japan for chronic idiopathic constipation meets primary endpoint

Sucampo Pharmaceuticals, Inc. and Abbott today announced that a pivotal phase 3 clinical trial of lubiprostone for chronic idiopathic constipation (CIC) in Japanese patients met its primary endpoint with statistical significance and demonstrated a safety profile consistent with previously reported clinical lubiprostone data.

9 Jun 2010

Aerovance reports top-line results from Aerovant Phase 2b clinical trial for eosinophilic asthma

Aerovance Inc. today announced top-line results from its Phase 2b clinical trial that show the inhaled dry powder formulation of Aerovant (pitrakinra inhalation powder) is effective in a pre-defined subset of patients with eosinophilic asthma.

8 Jun 2010

Phase 2 study results of Qnexa in patients with OSA presented at SLEEP 2010

VIVUS, Inc. today announced that data from a previously reported phase 2 study evaluating the safety and efficacy of the investigational drug Qnexa for the treatment of obstructive sleep apnea were presented at SLEEP 2010, the 24th Annual Meeting of the Associated Professional Sleep Societies.

8 Jun 2010

Columbia completes enrollment in PROCHIEVE 8% Phase III study to reduce preterm birth in short cervix women

Columbia Laboratories, Inc. today announced it completed enrollment in the PREGNANT (PROCHIEVE Extending GestatioN A New Therapy) Study last week. This randomized, double-blind, placebo controlled Phase III clinical study is evaluating the safety and efficacy of PROCHIEVE® 8% (progesterone gel) to reduce the risk of preterm birth in women with a cervical length between 1.0 and 2.0 centimeters as measured by transvaginal ultrasound at mid-pregnancy.

8 Jun 2010

TG-MV-006 study: Microplasmin shows promise for treatment of VMA, MH

A Phase III trial of a drug used for the treatment of vitreomacular adhesion and macular hole revealed key findings for patients diagnosed with these severe conditions which can lead to significant vision impairment.

8 Jun 2010

GTx presents quality of life results from Ostarine Phase IIb study in cancer cachexia patients at ASCO 2010

GTx, Inc. today presented additional results from the Ostarine™ Phase IIb study demonstrating an improvement in quality of life (fatigue and anorexia) in cancer patients with muscle wasting (cancer cachexia) who demonstrated improvement in functional performance as measured by stair climb. Ostarine (GTx-024) is GTx's lead selective androgen receptor modulator (SARM) which the company is developing for the treatment of cancer cachexia.

8 Jun 2010

Vandetanib extends Progression Free Survival in ZETA phase III study for advanced medullary thyroid cancer

Results from ZETA, a phase III study in patients with advanced medullary thyroid cancer (MTC), showed that treatment with the investigational drug vandetanib significantly extended Progression Free Survival (PFS), the primary endpoint of the study, by demonstrating a 54% reduction in the rate of progression compared to placebo.

8 Jun 2010

Can-Fite BioPharma opens CF101 IND for psoriasis with US FDA

Can-Fite BioPharma Ltd, a biotechnology company traded on the Tel Aviv Stock Exchange, announced today that it has opened Investigational New Drug application (IND) with the United States Food and Drug Administration (US FDA). The IND is for Can-Fite's lead compound, CF101, for the treatment of patients with psoriasis. This is the third US IND for CF101, and the fourth for Can-Fite.

8 Jun 2010

Erlotinib can reduce lung cancer death by 26% : Study

Three times as many women with advanced lung cancer were alive and had no progression of their cancer 12 months after taking the drug erlotinib (also known as Tarceva) compared to those who did not receive the drug according to new data being presented at the ASCO1 conference today (Monday).

8 Jun 2010

XCell-Center GmbH announces approval of clinical trial in patients with chronic spinal cord injury

XCell-Center GmbH, Europe's leading provider of adult autologous stem cell therapy, announced approval of the first placebo controlled double blind clinical trial in patients with chronic spinal cord injury.

7 Jun 2010

EDEMA4 study results of KALBITOR for treatment of acute attacks of HAE published

Dyax Corp. announced today the publication of results from its second Phase 3, placebo-controlled trial, known as EDEMA4, evaluating KALBITOR (ecallantide) for the treatment of acute attacks of hereditary angioedema. The results, published in the June 2010 issue of the Annals of Allergy, Asthma, and Immunology, indicate that KALBITOR is effective in ameliorating HAE attacks, resolving associated symptoms and preventing attack progression.

7 Jun 2010

Positive results from VIVUS' Phase 3 study of avanafil for ED in men with diabetes

VIVUS, Inc. today announced positive results from the phase 3 REVIVE-Diabetes (TA-302) study, evaluating the safety and efficacy of the investigational drug avanafil for the treatment of erectile dysfunction (ED) in men with type 1 and type 2 diabetes. The REVIVE-Diabetes study met all three primary endpoints across the two doses studied by demonstrating statistically significant improvement in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the International Index of Erectile Function (IIEF) score.

7 Jun 2010

Celera applies CE mark to real-time PCR test for detection of variant in KIF6 gene

Celera Corporation today announced that it has signed a Declaration of Conformity and applied the CE mark to a real-time PCR (polymerase chain reaction) test for detection of a variant in the KIF6 gene, allowing the test to be marketed in the European Union and other geographic areas that recognize the CE Mark.

7 Jun 2010

Adeona completes 50% enrollment in Part 2 CopperProof-2 study of oral zinc cysteine for Alzheimer's Disease

Adeona Pharmaceuticals, Inc. announced the completion of 50% enrollment in Part 2 of its clinical study, A Prospective, Randomized, Double Blind Trial of a Novel Oral Zinc Cysteine Preparation in Alzheimer's Disease (CopperProof-2).

7 Jun 2010

GSK submits BENLYSTA MAA for systemic lupus erythematosus

Human Genome Sciences, Inc. today announced that GlaxoSmithKline (GSK) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for approval to market BENLYSTA® (belimumab) for the treatment of systemic lupus erythematosus (SLE).

7 Jun 2010

Sanofi-aventis reports new 1-year data from teriflunomide Phase II study for relapsing multiple sclerosis

Sanofi-aventis reported today new one-year data from a Phase II study with teriflunomide, a novel oral disease modifier being investigated for the treatment of relapsing multiple sclerosis (RMS). Study results demonstrated an improvement in outcomes, with a consistent safety profile with the data from a previous Phase II monotherapy study, in patients treated with interferon beta (IFN-[BETA]) - a standard therapy in RMS - and receiving teriflunomide 7mg or 14mg, compared with patients treated with IFN-[BETA] and receiving oral placebo.

7 Jun 2010

AMG 386 demonstrates antitumor activity in Phase 2 trial involving patients with recurrent ovarian cancer

Amgen today announced that AMG 386, combined with paclitaxel, demonstrated antitumor activity in a randomized Phase 2 trial involving 161 patients with recurrent ovarian cancer. The results are being presented for the first time in an oral presentation at the 2010 American Society of Clinical Oncology Annual Meeting.

7 Jun 2010

Bevacizumab extends progression-free survival in women with advanced ovarian cancer

Newly reported results from a major clinical trial show that adding bevacizumab (Avastin) to standard frontline chemotherapy for women with advanced ovarian cancer and then continuing a maintenance dose of the drug afterwards significantly extends progression-free survival. Women receiving the new treatment regimen saw no worsening of their disease for 14.1 months, compared to 10.3 months for women receiving standard therapy.

7 Jun 2010

Placebo News and Research

Merck's MK-4305 improves overall sleep efficiency in primary insomnia patients

Helix BioPharma reports Phase II clinical results of Topical Interferon Alpha-2b for ano-genital warts

Lubiprostone phase 3 clinical trial in Japan for chronic idiopathic constipation meets primary endpoint

Aerovance reports top-line results from Aerovant Phase 2b clinical trial for eosinophilic asthma

Phase 2 study results of Qnexa in patients with OSA presented at SLEEP 2010

Columbia completes enrollment in PROCHIEVE 8% Phase III study to reduce preterm birth in short cervix women

TG-MV-006 study: Microplasmin shows promise for treatment of VMA, MH

GTx presents quality of life results from Ostarine Phase IIb study in cancer cachexia patients at ASCO 2010

Vandetanib extends Progression Free Survival in ZETA phase III study for advanced medullary thyroid cancer

Can-Fite BioPharma opens CF101 IND for psoriasis with US FDA

Erlotinib can reduce lung cancer death by 26% : Study

XCell-Center GmbH announces approval of clinical trial in patients with chronic spinal cord injury

EDEMA4 study results of KALBITOR for treatment of acute attacks of HAE published

Positive results from VIVUS' Phase 3 study of avanafil for ED in men with diabetes

Celera applies CE mark to real-time PCR test for detection of variant in KIF6 gene

Adeona completes 50% enrollment in Part 2 CopperProof-2 study of oral zinc cysteine for Alzheimer's Disease

GSK submits BENLYSTA MAA for systemic lupus erythematosus

Sanofi-aventis reports new 1-year data from teriflunomide Phase II study for relapsing multiple sclerosis

AMG 386 demonstrates antitumor activity in Phase 2 trial involving patients with recurrent ovarian cancer

Bevacizumab extends progression-free survival in women with advanced ovarian cancer

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