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ESC concerned over interpretation of JUPITER sub-analysis trial results about HDL cholesterol

The European Society of Cardiology (ESC) is concerned that interpretations of a paper about cholesterol, published in the Lancet, could act to deter ongoing research efforts into developing new therapeutic strategies to increase high density lipoprotein (HDL) cholesterol. Caution, the ESC experts advise, should be displayed in the interpretation of the results.

26 Jul 2010

Teva comments on FDA's approval of generic Lovenox injection

Teva Pharmaceutical Industries Ltd. commented today on the U.S. Food and Drug Administration's response to a citizen petition questioning the approval criteria for a generic Lovenox (enoxaparin sodium) injection and its subsequent approval of another generic filer's Abbreviated New Drug Application.

26 Jul 2010

FDA approves Aricept 23 mg tablet for Alzheimer's disease

Eisai Inc. and Pfizer Inc announced today that the U.S. Food and Drug Administration (FDA) approved a new once-daily, higher-dose Aricept 23 mg tablet for the treatment of moderate-to-severe Alzheimer's disease (AD). Aricept 23 mg tablet offers another dosing option for patients with moderate-to-severe AD, for whom few treatments are available

26 Jul 2010

Einstein scientists awarded $4.1M to test microbicide Carraguard against HPV

The National Cancer Institute has awarded Albert Einstein College of Medicine of Yeshiva University $4.1 million to test the microbicide Carraguard- against the human papillomavirus, which causes cervical cancer. The research will evaluate the efficacy of Carraguard- - a clear gel made from the seaweed derivative carrageenan - in preventing new HPV infections in women.

26 Jul 2010

First patient enrolled in Phase 3 SyNAPSe study of BHR-100 for TBI

BHR Pharma, LLC announced today that the first patient has been enrolled in its SyNAPSe study, a global, Phase 3, pivotal trial to evaluate the safety and effectiveness of its intravenous progesterone infusion product (BHR-100) as a neuroprotective agent for treating severe (Glasgow Coma Scale scores of 4-8) traumatic brain injury patients.

23 Jul 2010

Tarsa Therapeutics completes patient enrollment in Phase III ORACAL trial of oral calcitonin

Unigene Laboratories, Inc. today noted that Tarsa Therapeutics has completed patient enrollment in the Phase III ORACAL trial of Tarsa's oral calcitonin product for the treatment of postmenopausal osteoporosis. Unigene licensed the product to Tarsa and owns 26% of the company.

23 Jul 2010

NPS completes patient randomization in GATTEX Phase 3 study for PN dependent short bowel syndrome

NPS Pharmaceuticals, a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today announced the completion of patient randomization in its Phase 3 registration study of GATTEX® (teduglutide). The double-blind, placebo-controlled safety and efficacy study, which is known as STEPS, is being conducted in patients with parenteral nutrition (PN) dependent short bowel syndrome (SBS) and is now fully randomized with 86 patients.

23 Jul 2010

Human Genome Sciences second-quarter revenues increase to $38.8 million

Human Genome Sciences, Inc. today announced financial results for the quarter ended June 30, 2010, and provided highlights of recent key developments.

23 Jul 2010

Tarsa completes enrollment in Phase III ORACAL trial for postmenopausal osteoporosis

Tarsa Therapeutics, Inc. today announced progress in the ORACAL trial of its oral calcitonin product for the treatment of postmenopausal osteoporosis. The company has completed patient enrollment in this multinational, randomized, double-blind, placebo-controlled Phase III trial designed to enroll approximately 550 patients. In addition, Tarsa announced that the independent Data Monitoring Committee (DMC) for the ORACAL trial has completed two separate safety reviews of patient data and recommended that the trial proceed as planned.

22 Jul 2010

Repros granted IRB approval to commence low dose Proellex study

Repros Therapeutics Inc. today announced it has received IRB approval to commence the low dose Proellex® study. The contract for clinical services was previously awarded to ICON. The new low dose study is designed to explore both safety and signals of efficacy in an escalating dose fashion. The study will test 5 different doses of Proellex (1, 3, 6, 9 and 12 mg) with 1 mg being the first dose tested. In previous studies a 12.5 mg dose was well tolerated and yielded statistically significant efficacy signals for both uterine fibroids and endometriosis.

22 Jul 2010

Somaxon's Silenor Phase 3 clinical data accepted for publication in Sleep, Sleep Medicine journals

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today announced that detailed results from two Phase 3 clinical trials of the company's product Silenor® (doxepin) have been accepted for publication in peer-reviewed scientific journals.

22 Jul 2010

Amylin reports $164.4M total revenue for quarter ended June 30, 2010

Amylin Pharmaceuticals, Inc. today reported financial results for the quarter ended June 30, 2010. The Company reported total revenue of $164.4 million for the quarter ended June 30, 2010, which includes net product sales of $162.5 million. Net loss, excluding a restructuring charge of $3.4 million, was $40.8 million, or $0.28 per share.

22 Jul 2010

NovaBay reports positive results from NVC-422 Phase 2a proof-of-concept clinical trial for impetigo

NovaBay Pharmaceuticals, Inc. today announced that its lead product candidate was safe and efficacious against the highly contagious skin infection impetigo in a Phase 2a proof-of-concept clinical trial. This dose-ranging study showed that the drug cleared impetigo infections, including those in the trial caused by a drug-resistant strain of bacteria called methicillin-resistant Staphylococcus aureus or MRSA. Impetigo afflicts approximately 1 million people, primarily infants and children, in the United States annually.

21 Jul 2010

AIDS 2010: Study finds microbicide containing HIV drug lowers infection risk in women by 39%

A microbicide gel containing Gilead's HIV drug tenofovir used by women before and after sex has been shown to reduce their risk of HIV infection by nearly 40%, according to a study unveiled at the International AIDS Conference-AIDS 2010, Reuters reports

21 Jul 2010

UDCA fails to improve overall histology in NASH patients: Study

A study conducted by researchers at Johann Wolfgang Goethe University in Frankfurt, Germany found that high doses of ursodeoxycholic acid, suggested by some studies to have a beneficial effect on nonalcoholic steatohepatitis, does not improve overall histology in these patients. Full findings of this study are published in the August issue of Hepatology, a journal of the American Association for the Study of Liver Diseases.

21 Jul 2010

Major turning point in antiepileptic drug testing, development

New York University researchers revealed that data from previously completed withdrawal to monotherapy studies for antiepileptic drugs provide a valid control for future studies, obviating the need for placebo/pseudo-placebo trials to demonstrate the efficacy of these drugs as monotherapy. Results of this study are now available online in Epilepsia, a journal published by Wiley-Blackwell on behalf of the International League Against Epilepsy.

21 Jul 2010

Ingestion of probiotic supplements prevents eczema: Study

Mothers who drank milk with a probiotic supplement during and after pregnancy were able to cut the incidence of eczema in their children by almost half,a new study published in the British Journal of Dermatology has shown.

21 Jul 2010

Arcion reports top-line results from ARC-4558 Phase 2b clinical trial for painful diabetic neuropathy

Arcion Therapeutics, a venture backed clinical stage biotechnology company developing topical therapies for chronic pain, today announced top-line results from a successful Phase 2b double-blind, randomized, placebo-controlled clinical trial of its lead topical pain candidate, ARC-4558, in adult patients with painful diabetic neuropathy (PDN). Arcion recently held an End of Phase 2 meeting with the United States Food and Drug Administration (FDA) and the ARC-4558 program is now poised to enter Phase 3 studies.

20 Jul 2010

KAI Pharmaceuticals completes enrollment in Phase 1 study of KAI-4169 for SHPT

KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, today announced the Company has completed enrollment in a Phase 1 study of KAI-4169, a novel pharmaceutical agent for the treatment of secondary hyperparathyroidism, which is a frequent complication of end stage renal disease.

20 Jul 2010

Tenofovir gel reduces HIV by 39% in women: CAPRISA 004 study

Researchers who conducted a study testing a vaginal microbicide with an antiretroviral (ARV) drug called tenofovir found its use before and after sex was significantly more protective against HIV infection than a placebo gel among women at high risk of HIV. Results of the study, known as CAPRISA 004, are to be reported at the International AIDS Conference (AIDS 2010) in Vienna and published online by the journal Science.

20 Jul 2010

Placebo News and Research

ESC concerned over interpretation of JUPITER sub-analysis trial results about HDL cholesterol

Teva comments on FDA's approval of generic Lovenox injection

FDA approves Aricept 23 mg tablet for Alzheimer's disease

Einstein scientists awarded $4.1M to test microbicide Carraguard against HPV

First patient enrolled in Phase 3 SyNAPSe study of BHR-100 for TBI

Tarsa Therapeutics completes patient enrollment in Phase III ORACAL trial of oral calcitonin

NPS completes patient randomization in GATTEX Phase 3 study for PN dependent short bowel syndrome

Human Genome Sciences second-quarter revenues increase to $38.8 million

Tarsa completes enrollment in Phase III ORACAL trial for postmenopausal osteoporosis

Repros granted IRB approval to commence low dose Proellex study

Somaxon's Silenor Phase 3 clinical data accepted for publication in Sleep, Sleep Medicine journals

Amylin reports $164.4M total revenue for quarter ended June 30, 2010

NovaBay reports positive results from NVC-422 Phase 2a proof-of-concept clinical trial for impetigo

AIDS 2010: Study finds microbicide containing HIV drug lowers infection risk in women by 39%

UDCA fails to improve overall histology in NASH patients: Study

Major turning point in antiepileptic drug testing, development

Ingestion of probiotic supplements prevents eczema: Study

Arcion reports top-line results from ARC-4558 Phase 2b clinical trial for painful diabetic neuropathy

KAI Pharmaceuticals completes enrollment in Phase 1 study of KAI-4169 for SHPT

Tenofovir gel reduces HIV by 39% in women: CAPRISA 004 study

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