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Pivotal Phase 3 IMPACT study results of PROVENGE published in New England Journal of Medicine

Dendreon Corporation announced today the publication of data from the pivotal Phase 3 IMPACT study in the New England Journal of Medicine, showing that PROVENGE (sipuleucel-T) demonstrated a statistically significant improvement in overall survival compared to control in men with asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer. The manuscript is published in the July 29, 2010 issue of the journal.

29 Jul 2010

Teva Respiratory reports positive results from BDP HFA Nasal Aerosol Phase III trial in seasonal allergic rhinitis

Teva Respiratory today announced positive results from a Phase III trial evaluating the efficacy and safety of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) Nasal Aerosol in the treatment of seasonal allergic rhinitis (SAR). The study met all efficacy endpoints, demonstrating a statistically significant benefit as compared to placebo. Furthermore, the safety profile of BDP HFA Nasal Aerosol was similar to placebo.

29 Jul 2010

FDA approves Cuvposa Oral Solution for chronic severe drooling in children

The U.S. Food and Drug Administration today approved Cuvposa (glycopyrrolate) Oral Solution to treat chronic severe drooling caused by neurologic disorders in children ages 3 years to 16 years.

29 Jul 2010

AMAG attributes increased second-quarter revenues of $18.8 million to Feraheme

AMAG Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today reported unaudited consolidated financial results for the second quarter and six months ended June 30, 2010. For the second quarter, AMAG reported total revenue of $18.8 million, including $16.0 million of Feraheme® (ferumoxytol) Injection for intravenous (IV) use net product revenues.

29 Jul 2010

Limerick to announce new results from LIM-0705 human trials at 23rd Transplantation Society congress

Limerick BioPharma, Inc., a developer of innovative therapies that help cells pump out unwanted or toxic substances, will announce new results from human trials of its lead compound, LIM-0705, at the 23rd International Congress of the Transplantation Society in Vancouver, Canada, in an oral presentation on August 19, 2010.

29 Jul 2010

Pharmasset announces data from PSI-352938 single ascending dose study

Pharmasset, Inc. announced today that safety and pharmacokinetic data from the PSI-352938 single ascending dose study support progression to a multiple ascending dose trial with PSI-938, which has initiated dosing. PSI-938 is a guanine nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus infection.

28 Jul 2010

New study on treating CP with HBOT is making waves in India, U.S.

A new study on treating Cerebral Palsy with Hyperbaric Oxygen Therapy is making waves in India and the U.S. The largest sample of children studied to assess neuro-developmental improvements focuses on a combination of standard rehabilitation therapies, such as Occupational, Physical, Speech Therapies and HBOT.

28 Jul 2010

FDA accepts for filing Cladribine Tablets NDA for MS

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Cladribine Tablets as a therapy for relapsing forms of multiple sclerosis (MS).

28 Jul 2010

Regeneron second-quarter total revenues increase to $115.9 million

Regeneron Pharmaceuticals, Inc. announced financial and operating results for the second quarter of 2010. The Company reported a net loss of $25.5 million, or $0.31 per share (basic and diluted), for the second quarter of 2010 compared with a net loss of $14.9 million, or $0.19 per share (basic and diluted), for the second quarter of 2009.

28 Jul 2010

Antares Pharma reports positive results from Anturol Gel Phase 3 study in overactive bladder patients

Antares Pharma, Inc. announced today positive results from its Phase 3 study of Anturol Gel in patients with overactive bladder. The study met its primary endpoint of a statistically significant reduction in urinary incontinence episodes for both doses studied.

28 Jul 2010

Antigenics announces positive results of AG-707 genital herpes vaccine

Antigenics announced positive results with AG-707, an investigational therapeutic vaccine being developed to treat herpes simplex virus-2,the virus that causes genital herpes, in infected patients. Developed by Antigenics, the vaccine triggers a cellular immune response, stimulating both CD4+ and CD8+ T cells.

28 Jul 2010

Omeros initiates enrollment in OMS302 Phase 2b clinical trial in patients undergoing cataract surgery

Omeros Corporation, a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system, today announced that it has enrolled the first patient in its Phase 2b clinical trial evaluating OMS302 in patients undergoing cataract surgery.

27 Jul 2010

Idenix second-quarter total revenues decrease to $1.3 million

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today reported unaudited financial results for the second quarter and six months ended June 30, 2010. At June 30, 2010, Idenix's cash and cash equivalents totaled $51.0 million.

27 Jul 2010

Seaside Therapeutics reports positive data from STX209 Phase 2 study in fragile X syndrome

Seaside Therapeutics, Inc. announced today data from the largest randomized, placebo-controlled study conducted to date in individuals with fragile X syndrome. In a Phase 2 study of STX209, clinically meaningful improvements on global and specific neurobehavioral outcomes were observed in the general study population. The improvements were statistically significant in pediatric patients with more severe impairments in sociability -- a core symptom of fragile X syndrome.

26 Jul 2010

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

Placebo News and Research

Pivotal Phase 3 IMPACT study results of PROVENGE published in New England Journal of Medicine

Teva Respiratory reports positive results from BDP HFA Nasal Aerosol Phase III trial in seasonal allergic rhinitis

FDA approves Cuvposa Oral Solution for chronic severe drooling in children

AMAG attributes increased second-quarter revenues of $18.8 million to Feraheme

Limerick to announce new results from LIM-0705 human trials at 23rd Transplantation Society congress

Pharmasset announces data from PSI-352938 single ascending dose study

New study on treating CP with HBOT is making waves in India, U.S.

FDA accepts for filing Cladribine Tablets NDA for MS

Regeneron second-quarter total revenues increase to $115.9 million

Antares Pharma reports positive results from Anturol Gel Phase 3 study in overactive bladder patients

Antigenics announces positive results of AG-707 genital herpes vaccine

Omeros initiates enrollment in OMS302 Phase 2b clinical trial in patients undergoing cataract surgery

Idenix second-quarter total revenues decrease to $1.3 million

Seaside Therapeutics reports positive data from STX209 Phase 2 study in fragile X syndrome

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

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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