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Data from Novavax's Pivotal 2009 A/H1N1 VLP pandemic influenza vaccine study presented at WHO meeting

Novavax, Inc. today presented to the world's leading pandemic influenza vaccine experts a summary of the recent preliminary safety and immunogenicity data from its Pivotal 2009 A/H1N1 VLP pandemic influenza vaccine study in Mexico.

19 Feb 2010

BioSante Pharmaceuticals' LibiGel clinical update to be presented at 2010 ISSWSH annual meeting

BioSante Pharmaceuticals, Inc., will present a LibiGel clinical update at the 2010 Annual Meeting of the International Society for the Study of Women’s Sexual Health (ISSWSH), being held from February 18-20, 2010 in St. Petersburg, Florida.

19 Feb 2010

Incyte announces 2009 financial results and key fourth-quarter accomplishments

Incyte Corporation today reported fourth quarter and full year 2009 financial results, provided an update on key fourth quarter accomplishments and 2010 objectives, and announced its 2010 financial guidance.

18 Feb 2010

Phase 2 study results: VEGF Trap-Eye improves vision in patients with DME

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare AG announced that VEGF Trap-Eye showed positive results in a Phase 2 study in patients with diabetic macular edema (DME).

18 Feb 2010

PK/PD data demonstrates clear relationship between TBR-652 plasma concentrations and antiviral activity

Pharmacokinetic/pharmacodynamic (PK/PD) data for TBR-652, which is being developed by Tobira Therapeutics for the treatment of HIV infection, show a strong relationship between drug exposure and viral suppression with this next-generation CCR5 receptor antagonist. These data were presented here today at the 17th Conference on Retroviruses and Opportunistic Infections (CROI).

18 Feb 2010

Aprea's AML treatment receives EMEA recommendation for orphan drug status

The European Medicines Agency (EMEA) recommends orphan drug status for Aprea's treatment of acute myeloid leukemia (AML). The treatment is currently undergoing a Phase I clinical study and a final decision from the European Commission regarding status is expected in a few weeks. Aprea is part of the Karolinska Development portfolio.

18 Feb 2010

Gilead Sciences’ “Quad” regimen for HIV exhibits antiretroviral activity comparable to Atripla

Gilead Sciences, Inc. announced Phase II clinical trial results today showing that its investigational fixed-dose single-tablet “Quad” regimen of elvitegravir, GS 9350 (cobicistat) and Truvada® (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection exhibited antiretroviral activity comparable to that of Atripla® (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg).

18 Feb 2010

Phase III data reveals potential of Merck’s GARDASIL in preventing HPV and HPV-related cancers

Merck & Co., Inc. announced today that in new Phase III data, GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] was 77.5 percent (95 percent CI: 39.6, 93.3) efficacious against anal intraepithelial neoplasia (AIN) associated with human papillomavirus (HPV) types 6, 11, 16 and 18 in 16-to-26 year-old men who have sex with men. The data were presented at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) conference in Monte Carlo, Monaco.

18 Feb 2010

Phase 3b ODIN study of once-daily PREZISTA in HIV-1 adults presented at CROI 2010

In a new study of treatment-experienced HIV-1-infected adults with no PREZISTA® (darunavir) resistance-associated mutations (RAMs), 72 percent of patients in the PREZISTA/ritonavir (r) (800/100 mg) once-daily arm achieved undetectable viral loads (<50 copies/mL) compared with 71 percent of patients in the PREZISTA/r (600/100 mg) twice-daily arm. The study met its primary objective of non-inferiority. These data from the Phase 3b ODIN study were presented today at CROI 2010, the 17th Conference on Retroviruses and Opportunistic Infections, in San Francisco.

18 Feb 2010

Roche completes enrollment in RG7128 Phase 2b PROPEL study

Pharmasset, Inc. announced today the complete enrollment by Roche of the 12 week RG7128 Phase 2b study (PROPEL) of approximately 400 treatment-naive patients with hepatitis C virus (HCV) genotypes 1 and 4. The study remains blinded to Roche and Pharmasset.

17 Feb 2010

Tioga Pharmaceuticals to utilize $18M equity funding for Phase 3 clinical trial of asimadoline

Tioga Pharmaceuticals, Inc. today announced the closing of an $18 million equity financing. Current investors Forward Ventures, New Leaf Venture Partners and BB Biotech Ventures were joined by new investor Genesys Capital Partners.

17 Feb 2010

FDA clears Otonomy's IND for clinical trial of OTO-104 in Meniere's disease patients

Otonomy, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of OTO-104 in patients with Meniere's disease, a debilitating disorder of the inner ear affecting balance and hearing.

17 Feb 2010

Marcadia Biotech commences Phase 1 clinical trial of MAR701 for type 2 diabetes

Marcadia Biotech Inc. today announced that it has initiated a Phase 1 clinical trial of MAR701, a novel dual agonist of the incretin hormone receptors for glucagon-like peptide-1 (GLP-1) and gastric inhibitory peptide (GIP). Marcadia plans to initially develop this compound as a treatment for type 2 diabetes with once-weekly dosing. The Phase 1 trial will evaluate MAR701 in healthy volunteers at escalating dose levels.

17 Feb 2010

Fourth-quarter and full-year 2009 results announced by Celsion

Celsion Corporation, a leading oncology drug development company, today announced financial results for the fourth quarter and year ended December 31, 2009. Management also highlighted the progress made in clinical trials of ThermoDox®, Celsion's heat activated liposomal encapsulation of doxorubicin, including the Company's pivotal Phase III trial for the treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer, and recurrent chest wall breast cancer.

17 Feb 2010

Phase III study: GARDASIL prevents 77.5% of pre-cursor lesions to anal cancer

In a new phase III study, GARDASIL(R) (Quadrivalent Human Papillomavirus (Types 6, 11, 16 and 18) Recombinant Vaccine) prevented 77.5 per cent of anal intraepithelial neoplasia (AIN) associated with human papillomavirus (HPV) types 6, 11, 16 and 18 in 16-to-26 year-old men who have sex with men.

17 Feb 2010

Phase II clinical trial result of abiraterone drug shows promise for advanced prostate cancer

New results from a phase II clinical trial of the prostate cancer drug abiraterone suggest that it may help men with advanced disease who have tried standard treatments.

17 Feb 2010

ITS secures £8.65M Series-A equity funding round extension to fund synthetic flu vaccine study

Immune Targeting Systems (ITS) Limited (“ITS”), one of the leading developers of synthetic vaccines for mutating viruses, today announced it had secured a Series-A equity funding round extension for £8.65m which brings the total Series A financing to £13.15m. The company’s key investors HealthCap (Sweden), London Technology Fund (UK), Novartis Venture Fund (US & Basel) and Truffle Capital (France) are all participating. The round will be kept open until mid-2010 for new potential investors to invest.

17 Feb 2010

Generx clinical development opportunities: bioRASI to assist Cardium

Cardium Therapeutics today announced that it has entered into an agreement with bioRASI, an international contract research organization, to assist Cardium in the evaluation of Generx clinical development opportunities within major newly-industrializing markets in Eastern Europe, Asia and Latin America, for patients with chronic coronary artery disease who are either not optimal candidates for or do not have access to costly angioplasty/stenting or cardiac bypass surgery procedures.

17 Feb 2010

Cancer Research UK, immatics Biotechnologies sign collaboration agreement to trial IMA950 vaccine for GMB

CANCER RESEARCH UK and Cancer Research Technology - the charity's development and commercialisation arm - have reached a collaboration agreement with immatics Biotechnologies to trial their new treatment vaccine, IMA950, for glioblastoma multiforme (GMB), one of the most common forms of brain cancer.

16 Feb 2010

Positive topline data from Alkermes' phase 1 clinical study of ALKS 37 announced

Alkermes, Inc. today announced positive topline data from a phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the effects of opioid agonists on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC).

16 Feb 2010

Drug Trial News

Data from Novavax's Pivotal 2009 A/H1N1 VLP pandemic influenza vaccine study presented at WHO meeting

BioSante Pharmaceuticals' LibiGel clinical update to be presented at 2010 ISSWSH annual meeting

Incyte announces 2009 financial results and key fourth-quarter accomplishments

Phase 2 study results: VEGF Trap-Eye improves vision in patients with DME

PK/PD data demonstrates clear relationship between TBR-652 plasma concentrations and antiviral activity

Aprea's AML treatment receives EMEA recommendation for orphan drug status

Gilead Sciences’ “Quad” regimen for HIV exhibits antiretroviral activity comparable to Atripla

Phase III data reveals potential of Merck’s GARDASIL in preventing HPV and HPV-related cancers

Phase 3b ODIN study of once-daily PREZISTA in HIV-1 adults presented at CROI 2010

Roche completes enrollment in RG7128 Phase 2b PROPEL study

Tioga Pharmaceuticals to utilize $18M equity funding for Phase 3 clinical trial of asimadoline

FDA clears Otonomy's IND for clinical trial of OTO-104 in Meniere's disease patients

Marcadia Biotech commences Phase 1 clinical trial of MAR701 for type 2 diabetes

Fourth-quarter and full-year 2009 results announced by Celsion

Phase III study: GARDASIL prevents 77.5% of pre-cursor lesions to anal cancer

Phase II clinical trial result of abiraterone drug shows promise for advanced prostate cancer

ITS secures £8.65M Series-A equity funding round extension to fund synthetic flu vaccine study

Generx clinical development opportunities: bioRASI to assist Cardium

Cancer Research UK, immatics Biotechnologies sign collaboration agreement to trial IMA950 vaccine for GMB

Positive topline data from Alkermes' phase 1 clinical study of ALKS 37 announced

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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