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Euthymics Bioscience completes $24 million Series A financing

Euthymics Bioscience, Inc., a clinical-stage company developing next-generation antidepressants, today announced the completion of a Series A financing -- led by Novartis Venture Funds and Venture Investors - for a total investment commitment of $24 million in milestone-conditioned tranches. Hambrecht & Quist Capital Management, LLC, GBS Venture Partners and the State of Wisconsin Investment Board also participated in the financing.

22 Jul 2010

Predator-released chemicals function as warning signals for egg-laying mosquitoes

A scientific breakthrough might assist in the fight against mosquitoes. New research carried out at the University of Haifa in collaboration with researchers from other universities has chemically identified, for the first time, compounds released by mosquitoes' natural aquatic predators that function as warning signals for egg laying mosquitoes. Introducing these natural chemicals into mosquito breeding sites will cause the mosquitoes to sense risk of predation to their progeny and avoid laying their eggs there.

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

Elan total revenue increases 10% to $579.4 million for first half of 2010

Elan Corporation, plc today reported its second quarter and first half 2010 financial results.

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

Onyx begins Phase 3 trial of carfilzomib in combination with lenalidomide, dexamethasone for relapsed myeloma

Onyx Pharmaceuticals, Inc. today announced that the company has begun enrollment in the ASPIRE trial, a Phase 3 international clinical trial evaluating carfilzomib in combination with lenalidomide (Revlimid®) and low dose dexamethasone in patients with relapsed multiple myeloma. The company has an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) and received Scientific Advice from the European Medicines Agency (EMA) on the design and planned analysis of the ASPIRE trial.

22 Jul 2010

Flat global funding for HIV prevention research could have serious consequences: Report

Following significant advances in vaccine and microbicide research, including results presented today of 39% efficacy in the CAPRISA 004 microbicide gel trial among women in South Africa, a new report released today warns that flat funding for HIV prevention research may limit researchers' ability to quickly move promising approaches forward.

22 Jul 2010

ASP EVOTECH Endoscope Cleaner and Reprocessor technology superior to manual cleaning: Study

Advanced Sterilization Products (ASP) announced today newly published data showing the ASP EVOTECH® Endoscope Cleaner and Reprocessor (ECR) provides an automated approach superior to the manual cleaning required when using traditional AERs. Published in the July issue of Biomed Central, the combination clinical-use and simulated-use study was led by Michelle Alfa, Ph.D., FCCM, Medical Director, Microbiology Discipline Diagnostic Services of Manitoba (DSM) St. Boniface General Hospital Site.

22 Jul 2010

Avastin – breast cancer drug, fails to pass the FDA advisory panel vote on efficacy

According to a Food and Drug Administration (FDA) advisory committee’s (The Oncology Drugs Advisory Committee, or ODAC) recommendation this Tuesday, the marketing approval of the popular breast cancer drug, Avastin or Bevacizumab should be withdrawn.

21 Jul 2010

Shionogi-ViiV Healthcare to advance '572 inhibitor into Phase III clinical trials

Shionogi-ViiV Healthcare LLC today announced that it will be progressing its once-daily, unboosted investigational integrase inhibitor, S/GSK1349572 ('572) into Phase III clinical trials. '572 will be the only once-daily, unboosted integrase inhibitor in Phase III clinical development.

21 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

Concentric Medical announces treatment of first stroke patient with Merci Retriever

Concentric Medical, Inc., the global leader in devices for clot removal in acute ischemic stroke patients, today announced the treatment of the first patient in Japan with the Merci Retriever. The Merci Retriever is a catheter-based medical device that stroke centers use to remove blood clots from the brains of patients suffering an acute ischemic stroke.

21 Jul 2010

Health Canada grants Osiris Priority Review for Prochymal NDS

Osiris Therapeutics, Inc. announced today that the Biologics and Genetic Therapies Directorate of Health Canada has completed its initial evaluation and accepted for full review the company's New Drug Submission (NDS) of Prochymal (remestemcel-L), an adult stem cell therapy for the treatment of graft vs. host disease (GvHD). Based on a separate review of summary clinical data, Health Canada has notified Osiris that the application has been granted Priority Review, shortening the examination period from 300 to 180 days.

21 Jul 2010

WHO, UNAIDS and PSI call for scale up of male circumcision in Eastern, Southern Africa

The U.S. Global AIDS Coordinator Ambassador Eric Goosby and the World Health Organization's Director of HIV, TB, and Malaria, Africa Regional Office, Dr. David Okello, joined PSI (Population Services International) today in calling for greater efforts to rapidly and efficiently scale up male circumcision service delivery in Eastern and Southern Africa.

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

Gilead Sciences second-quarter total revenues increase 17% to $1.93 billion

Gilead Sciences, Inc. announced today its results of operations for the quarter ended June 30, 2010. Total revenues for the second quarter of 2010 were $1.93 billion, up 17 percent compared to total revenues of $1.65 billion for the second quarter of 2009. Net income for the second quarter of 2010 was $712.1 million, or $0.79 per diluted share, compared to net income for the second quarter of 2009 of $571.4 million, or $0.61 per diluted share.

21 Jul 2010

FDA accepts MannKind's resubmission of AFREZZA NDA, sets PDUFA action date

MannKind Corporation today announced that it has submitted, and the U.S. Food and Drug Administration has accepted, MannKind's resubmission of its New Drug Application for AFREZZA™ (insulin human [rDNA origin]) and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding Prescription Drug User Fee Act action date of December 29, 2010.

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

Archer Biosciences initiates third drug-escalation cohort in TPI-287 trial for metastatic melanoma

Archer Biosciences, Inc. announced that the trial of its novel, proprietary drug TPI-287 (an abeotaxane) for the treatment of metastatic melanoma has initiated a third drug-escalation cohort. The primary objective of this study is to determine the safety, tolerability and maximum tolerated dose (MTD) of TPI-287 in combination with temozolomide (TMZ) in adult patients with metastatic melanoma.

20 Jul 2010

Biogen Idec second-quarter revenues increase 11% to $1.2 billion

Biogen Idec Inc., a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today announced its second quarter 2010 results.

20 Jul 2010

Efficacy News and Research

Euthymics Bioscience completes $24 million Series A financing

Predator-released chemicals function as warning signals for egg-laying mosquitoes

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

Elan total revenue increases 10% to $579.4 million for first half of 2010

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

Onyx begins Phase 3 trial of carfilzomib in combination with lenalidomide, dexamethasone for relapsed myeloma

Flat global funding for HIV prevention research could have serious consequences: Report

ASP EVOTECH Endoscope Cleaner and Reprocessor technology superior to manual cleaning: Study

Avastin – breast cancer drug, fails to pass the FDA advisory panel vote on efficacy

Shionogi-ViiV Healthcare to advance '572 inhibitor into Phase III clinical trials

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

Concentric Medical announces treatment of first stroke patient with Merci Retriever

Health Canada grants Osiris Priority Review for Prochymal NDS

WHO, UNAIDS and PSI call for scale up of male circumcision in Eastern, Southern Africa

Major turning point in antiepileptic drug testing, development

Gilead Sciences second-quarter total revenues increase 17% to $1.93 billion

FDA accepts MannKind's resubmission of AFREZZA NDA, sets PDUFA action date

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

Archer Biosciences initiates third drug-escalation cohort in TPI-287 trial for metastatic melanoma

Biogen Idec second-quarter revenues increase 11% to $1.2 billion

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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