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FDA guides Apricus Bio on RayVa's approvability for Raynaud's syndrome secondary to scleroderma

Apricus Biosciences, backed by a revenue-generating CRO business and seeking to leverage its multi-route NexACT® drug delivery technology and internal pipeline through out-licensing partnerships, announced today that the U.S. Food and Drug Administration (FDA) has provided guidance on the clinical requirements for assessing the approvability of RayVa for the treatment of Raynaud's syndrome secondary to scleroderma.

22 Sep 2010

Aeras and Crucell commence Phase II study of TB vaccine candidate in infants

Dutch biopharmaceutical company Crucell N.V. and the Aeras Global TB Vaccine Foundation today announced the start of a Phase II clinical trial in infants of the jointly developed tuberculosis (TB) vaccine candidate, AERAS-402/Crucell Ad35.

22 Sep 2010

Novartis' SOM230 reduces cortisol levels in Cushing's disease patients

Novartis Pharmaceuticals Corporation announced today that the results of a Phase III study of SOM230 (pasireotide) showed a reduction in cortisol levels in patients with Cushing's disease, a condition in which a benign (non-cancerous) pituitary tumor causes the adrenal glands to produce excess cortisol and can be fatal. Results will be presented at the 14th Congress of the European Neuroendocrine Association (ENEA).

22 Sep 2010

ChemoCentryx presents CCX140 clinical data at EASD

ChemoCentryx, Inc., today announced that it reported positive preclinical and Phase I study results at the European Association for the Study of Diabetes (EASD). CCX140, a novel, orally bioavailable small molecule antagonist of the chemokine receptor CCR2, improved metabolic function while significantly reducing inflammatory macrophages found in adipose tissue in an animal model, and was well tolerated in Phase I clinical trials.

21 Sep 2010

NIDA awards 5-year, $3.7M research grant for development of drug to treat cocaine addiction

The University of Maryland School of Pharmacy has received a prestigious $3.7 million grant to develop a drug to treat cocaine addiction based on an active ingredient found in some Chinese prescription medicines.

21 Sep 2010

VIVUS announces QNEXA study results for obesity treatment

VIVUS, Inc. today announced positive top-line results from a two-year study of QNEXA(phentermine/topiramate) Controlled Release Capsules, an investigational therapy for treatment of obesity, a condition that affects approximately one-third of adult Americans.

21 Sep 2010

Cytheris commences enrollment in CYT107 recombinant human Interleukin-7 clinical trial for HIV

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced that it has begun enrolling patients in INSPIRE 3, a Phase II clinical program evaluating the effect of repeated cycles of the company's investigative immune-modulator, recombinant human Interleukin-7 (CYT107), in the treatment of chronically HIV-1 infected patients classified as Immunological Non-Responders (INR) after at least 24 months of highly active anti-retroviral therapy (HAART).

21 Sep 2010

ImmunoGen commences clinical testing with SAR566658 anticancer compound

ImmunoGen, Inc., a biotechnology company that develops targeted antibody-based anticancer products, today announced the start of clinical testing with SAR566658. Eight compounds are now in the clinic through ImmunoGen's product programs and those of its partners, consistent with Company expectations of as many as 12 such compounds being in the clinic by late 2011 and marked, sustained pipeline growth thereafter.

21 Sep 2010

Annals of Internal Medicine publishes GRACE study data on HIV therapy

Data from the GRACE study will be published in the September 21st issue of the Annals of Internal Medicine. GRACE is the largest-ever study of treatment experienced adult women with HIV-1 to examine gender differences in response to HIV therapy. Sponsored by Tibotec Therapeutics Clinical Affairs, a division of Centocor Ortho Biotech Services, LLC, the GRACE study enrolled 67 percent women, demonstrating that it is possible to recruit large numbers of women into U.S.-based HIV treatment studies.

21 Sep 2010

ProtAffin presents impressive efficacy data for PA401 in COPD

ProtAffin AG, a biotechnology company developing a novel class of biopharmaceutical products that act by targeting cell-surface glycan structures, today presents compelling preclinical data in chronic obstructive pulmonary disease (COPD) for its lead product PA401 at the European Respiratory Society Congress in Barcelona, Spain. This conference is the largest gathering of scientists and clinicians in the respiratory community in the world. The Oral Presentation will be made in the session "Pre-clinical models of airways disease".

21 Sep 2010

Inovio Pharmaceuticals completes enrollment for PENNVAX-B vaccine Phase I clinical study

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today the Phase I clinical study assessing Inovio's PENNVAX-B DNA vaccine delivered using its proprietary electroporation technology in a preventive setting has fully completed the enrollment of 48 healthy volunteers. The multi-center study is being conducted by Inovio's clinical collaborator, the HIV Vaccine Trials Network (HVTN), at several clinical sites under a protocol designated HVTN-080.

21 Sep 2010

Multinational study demonstrates positive effects of laquinimod in patients with RRMS

Teva Pharmaceutical Industries Ltd. and Active Biotech today announced results from a 36-week active extension study evaluating two doses of laquinimod, an investigational, once-daily oral immunomodulator, for the treatment of relapsing remitting multiple sclerosis.

21 Sep 2010

Lixisenatide experimental diabetes drug shows potential in trial

Researchers at the R&D section of drug maker Sanofi Aventis have confirmed this Monday that a study of its experimental diabetes drug showed better blood sugar control than placebo.

21 Sep 2010

Dengue fever vaccine in the pipeline

Australians researchers are moving towards producing the first ever vaccine for dengue fever, the potentially life-threatening infection spread by mosquitoes in the tropics. At present late stage clinical trials are underway for a vaccine that would protect against all four known strains of the disease. Participants are now being recruited in Perth, Adelaide and Brisbane.

20 Sep 2010

Seven abstracts on Lantheus' PET imaging candidates to be presented at ASNC2010

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, today announced that seven abstracts related to two of the company's cardiac Positron Emission Tomography (PET) imaging candidates will be presented at ASNC2010, the 15th Annual Scientific Session of the American Society of Nuclear Cardiology, being held September 23-26, 2010 in Philadelphia.

20 Sep 2010

Celldex commences CDX-011 Phase 2b trial in advanced breast cancer patients expressing GPNMB

Celldex Therapeutics, Inc. today announced that the first patient has been treated in a randomized Phase 2b study of the Company's CDX-011 (glembatumumab vedotin) antibody drug conjugate in glycoprotein NMB (GPNMB) expressing advanced, refractory breast cancer patients. CDX-011 targets the protein GPNMB, which is over expressed in a variety of cancers including breast cancer, melanoma, and brain tumors.

20 Sep 2010

Micromet initiates MT103 phase 2 trial in adult ALL patients

Micromet, Inc. today announced the initiation of a phase 2 trial of the Company's lead product candidate blinatumomab (MT103) in adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL). Blinatumomab is the first of a new class of agents called BiTE antibodies, designed to harness the body's T cells to kill cancer cells.

20 Sep 2010

Dapagliflozin added to glimepiride therapy reduces HbA1c in adult type 2 diabetes patients

Bristol-Myers Squibb Company and AstraZeneca today announced results from a randomized, double blind Phase 3 clinical study, which demonstrated that the addition of the investigational drug dapagliflozin to existing glimepiride (sulphonylurea) therapy produced significant reductions in glycosylated hemoglobin levels (HbA1c) in adult patients with type 2 diabetes compared to glimepiride alone.

20 Sep 2010

Sanofi-aventis releases Lantus(R) study results for type 2 diabetes

Sanofi-aventis announced today results of two studies presented at the European Association for the Study of Diabetes (EASD) 46th Annual Meeting in Stockholm, Sweden.

20 Sep 2010

Phase III trial results of lixisenatide for type 2 diabetes presented at 46th EASD

Sanofi-aventis announced today the first Phase III results of the GetGoal clinical trial program assessing the efficacy and safety of lixisenatide, a once-daily GLP-1 receptor agonist, as monotherapy in patients with type 2 diabetes. These results were presented at the European Association for the Study of Diabetes (EASD) 46th Annual Meeting in Stockholm, Sweden.

20 Sep 2010

Drug Trial News

FDA guides Apricus Bio on RayVa's approvability for Raynaud's syndrome secondary to scleroderma

Aeras and Crucell commence Phase II study of TB vaccine candidate in infants

Novartis' SOM230 reduces cortisol levels in Cushing's disease patients

ChemoCentryx presents CCX140 clinical data at EASD

NIDA awards 5-year, $3.7M research grant for development of drug to treat cocaine addiction

VIVUS announces QNEXA study results for obesity treatment

Cytheris commences enrollment in CYT107 recombinant human Interleukin-7 clinical trial for HIV

ImmunoGen commences clinical testing with SAR566658 anticancer compound

Annals of Internal Medicine publishes GRACE study data on HIV therapy

ProtAffin presents impressive efficacy data for PA401 in COPD

Inovio Pharmaceuticals completes enrollment for PENNVAX-B vaccine Phase I clinical study

Multinational study demonstrates positive effects of laquinimod in patients with RRMS

Lixisenatide experimental diabetes drug shows potential in trial

Dengue fever vaccine in the pipeline

Seven abstracts on Lantheus' PET imaging candidates to be presented at ASNC2010

Celldex commences CDX-011 Phase 2b trial in advanced breast cancer patients expressing GPNMB

Micromet initiates MT103 phase 2 trial in adult ALL patients

Dapagliflozin added to glimepiride therapy reduces HbA1c in adult type 2 diabetes patients

Sanofi-aventis releases Lantus(R) study results for type 2 diabetes

Phase III trial results of lixisenatide for type 2 diabetes presented at 46th EASD

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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