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Virostatics' VS411 Phase 2a trial results against HIV presented at 18th CROI

An analysis of immune markers measured in a sub-study of ViroStatics' proof-of-concept Phase 2a trial showed that VS411 was able to reduce immune activation while producing a median 1.5 log10 reduction in viral load.

2 Mar 2011

Court case question: Who holds the patent — drug company or research institution

The invention of an AIDS test is a big deal, and it takes a lot of time, smarts and money to develop a good one. So there's a lot at stake in the legal tussle between Stanford University and the pharmaceutical giant Roche, with oral arguments opening Monday before the U.S. Supreme Court.

2 Mar 2011

EMD Serono receives FDA CRL on Cladribine Tablets NDA for relapsing-remitting multiple sclerosis

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, announced today that it received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) on the new drug application (NDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for relapsing-remitting multiple sclerosis (MS).

2 Mar 2011

Neuralstem announces initiation of NSI-189 Phase Ia trial for major depressive disorder

Neuralstem, Inc. announced that the first subject was dosed yesterday in a Phase Ia trial to evaluate the safety of its drug, NSI-189, which is being developed for the treatment of major depressive disorder and other psychiatric indications. NSI-189 is the lead compound in Neuralstem's neurogenerative small molecule drug platform. This phase of the trial is in healthy volunteers and seeks to determine the maximum tolerated single dose.

2 Mar 2011

Physician administered preventive dental program reduces tooth decay treatment among young children

A preventive dental program targeting preschoolers under age 4 administered by physicians instead of dentists effectively reduces the need for tooth decay-related treatment among young children, a University of North Carolina at Chapel Hill study shows.

2 Mar 2011

Scientists at retrovirus conference present findings on microbicide gel, Truvada, male circumcision, ART care by nurses

At the annual Conference on Retroviruses and Opportunistic Infections (CROI) in Boston on Monday, researchers "suggested the potential" of a gel containing the antiretroviral drug tenofovir to reduce the risk of anal HIV transmission, TIME's "Healthland" blog reports.

2 Mar 2011

Good oral health habits begin even before the first baby teeth appear

For many parents, thoughts of their children's dental health often comes long after the first baby teeth appear. Yet a lifetime of good oral health habits begins even with toothless infants, says Dr. Louis Amendola, D.D.S., Chief Dental Director at Western Dental Services, Inc.

2 Mar 2011

OneWorld Health receives FDA clearance for iOWH032 phase 1 trials to treat secretory diarrhea

The Institute for OneWorld Health (iOWH) announced a major milestone in the fight against cholera. The Food and Drug Administration (FDA) granted iOWH permission to begin phase 1 trials for iOWH032, a drug to treat secretory diarrhea. This is the first submission of an Investigational New Drug application for a completely new chemical entity by a non-profit of this size to receive such rapid FDA clearance, and it could be the first synthetic drug of its kind for diarrheal diseases.

2 Mar 2011

FDA approves Forest Labs' Daliresp to treat COPD

Forest Laboratories, Inc. announced today that Daliresp was approved by the U.S. Food and Drug Administration as a treatment to reduce the risk of chronic obstructive pulmonary disease exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

1 Mar 2011

Tenofovir gel more effective than oral tablet for HIV treatment: Study

In the first study to make head-to-head comparisons between tenofovir gel and oral tenofovir - two promising approaches for preventing HIV in women - researchers found that daily use of the vaginal gel achieved a more than 100-times higher concentration of active drug in vaginal tissue than did the oral tablet, while, compared to the gel, the tablet used daily was associated with a 20-times higher active drug concentration in blood.

1 Mar 2011

Anti-AIDS gel shows promise

Dr. Ian McGowan, a professor of medicine at the University of Pittsburgh who is leading a second-phase study of the gel said, “These are early results, but [they] help set the stage for current and future trials of rectal microbicides and the development of a rectal-specific formulation of tenofovir gel.” Researchers have focused on the use of microbicides such as tenofovir, as a preventive treatment to be used in vaginal sex. However, scientists think unprotected anal sex is much more risky.

1 Mar 2011

Excella achieves SafeBridge Potent Compound Safety Certification

SAFEBRIDGE® CONSULTANTS, INC., headquartered in Mountain View, California, has announced that Excella GmbH in Feucht, Germany has met the criteria established under the SafeBridge program for "Potent Compound Safety Certification" and has been deemed competent and proficient in the safe handling of potent active pharmaceutical ingredients ("APIs") and potent drug products.

1 Mar 2011

Daiichi Sankyo enters merger agreement to acquire Plexxikon

Plexxikon Inc. today announced it has entered into a merger agreement with Daiichi Sankyo Company, Limited, a Japan-based global pharmaceutical company.

28 Feb 2011

UCSF collaborates with Zcube to develop new ways to deliver drugs

A pill filled with microscopic, drug-laden adhesive squares is at the center of an agreement between UCSF and Zcube srl, the research corporate venture arm of Italian pharmaceutical leader Zambon Co., SpA, to license UCSF-developed microtechnology and support early research into new ways to deliver oral medications directly to a targeted site in the body.

28 Feb 2011

ACT Biotech files SPA with FDA for telatinib combination Phase 3 trial for stomach cancer

ACT Biotech, Inc., a biopharmaceutical company focused on the development of highly targeted, oral therapeutics for the treatment of cancer, announced today that it has filed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) related to a randomized Phase 3 trial of telatinib in combination with chemotherapy for the first-line treatment of patients with advanced stomach cancer.

28 Feb 2011

Tenofovir gel may help reduce risk of HIV from anal sex

A gel developed to protect against HIV during vaginal sex produced a strong antiviral effect when used in the rectum, according to an early-phase study presented today at the 18th Conference on Retroviruses and Opportunistic Infections (CROI). The results, based on rectal tissue biopsies sampled from HIV-negative men and women who used the product daily for one week, provide the first-ever evidence that tenofovir gel could help reduce the risk of HIV from anal sex, even though the vaginal gel formulation may not be optimal for rectal use.

28 Feb 2011

Astra Tech enters global strategic alliance with 3Shape

Astra Tech, a market leader and innovator in the field of implant dentistry and CAD/CAM abutments, announces a global strategic alliance with 3Shape A/S, the Danish-based provider of 3D scanners and CAD/CAM software solutions.

28 Feb 2011

Positive results from Trius torezolid Phase 1 lung study

Trius Therapeutics, Inc. today announced results from its Phase 1 clinical trial to evaluate the ability of torezolid to penetrate into the lung for potential use to treat lung infections. In this study a 200 mg dose of torezolid phosphate was administered orally once-daily for three days to healthy adult volunteers. The trial achieved its primary goal of establishing the steady-state plasma pharmacokinetics and distribution of active drug into epithelial lining fluid (ELF).

28 Feb 2011

Immunitor to present latest results from imm01 trial in tuberculosis patients at African conference

Immune Network Ltd. advises that Immunitor will present latest results from its imm01 clinical trial in tuberculosis patients in Abuja, Nigeria at the 18th Union TB and Lung Diseases Conference of the African Region, 2nd to 5th March, 2011.

28 Feb 2011

Final data from 4SC vidofludimus ENTRANCE Phase IIa trial against IBD presented at ECCO IBD Conference

4SC AG, a drug discovery and development company focused on autoimmune and cancer indications, announces the final data from the ENTRANCE Phase IIa trial in inflammatory bowel disease with vidofludimus, an oral inhibitor of interleukin-17 release and DHODH, including the secondary endpoints comprising the analysis of CDAI and CAI disease scores, change of prednisolone intake and threshold doses, safety, pharmacokinetics and biomarkers.

28 Feb 2011

Oral News and Research

Virostatics' VS411 Phase 2a trial results against HIV presented at 18th CROI

Court case question: Who holds the patent — drug company or research institution

EMD Serono receives FDA CRL on Cladribine Tablets NDA for relapsing-remitting multiple sclerosis

Neuralstem announces initiation of NSI-189 Phase Ia trial for major depressive disorder

Physician administered preventive dental program reduces tooth decay treatment among young children

Scientists at retrovirus conference present findings on microbicide gel, Truvada, male circumcision, ART care by nurses

Good oral health habits begin even before the first baby teeth appear

OneWorld Health receives FDA clearance for iOWH032 phase 1 trials to treat secretory diarrhea

FDA approves Forest Labs' Daliresp to treat COPD

Tenofovir gel more effective than oral tablet for HIV treatment: Study

Anti-AIDS gel shows promise

Excella achieves SafeBridge Potent Compound Safety Certification

Daiichi Sankyo enters merger agreement to acquire Plexxikon

UCSF collaborates with Zcube to develop new ways to deliver drugs

ACT Biotech files SPA with FDA for telatinib combination Phase 3 trial for stomach cancer

Tenofovir gel may help reduce risk of HIV from anal sex

Astra Tech enters global strategic alliance with 3Shape

Positive results from Trius torezolid Phase 1 lung study

Immunitor to present latest results from imm01 trial in tuberculosis patients at African conference

Final data from 4SC vidofludimus ENTRANCE Phase IIa trial against IBD presented at ECCO IBD Conference

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