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Positive preclinical results from Inovio's novel DNA vaccine targeting HIV Clade C virus

Inovio Pharmaceuticals, a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today the publication of a scientific paper highlighting positive preclinical results from Inovio's novel DNA vaccine targeting HIV Clade C viruses in the journal Vaccine.

10 Jan 2011

FDA, EMA accept boceprevir for expedited review

Merck, known as MSD outside the United States and Canada, announced today that regulatory applications for boceprevir, Merck's investigational oral hepatitis C virus (HCV) protease inhibitor, were submitted in 2010 and have been accepted for expedited review in both the U.S. and the European Union.

10 Jan 2011

Positive PK study results from ECLIPSE trial against cardiovascular disease

Omthera Pharmaceuticals, a privately-held emerging specialty pharmaceuticals company, today announced data from its ECLIPSE trial, designed to evaluate the bioavailability of Epanova™, the Company's lead compound for the treatment of very high triglycerides, in comparison to Lovaza®, the leading prescription Omega 3.

10 Jan 2011

Positive results form INX-189 Phase 1b trial against hepatitis C virus

Inhibitex, today reported positive preliminary interim safety and antiviral data from the first two monotherapy cohorts of its ongoing Phase 1b clinical trial of INX-189, an oral NS5b nucleotide inhibitor being developed to treat chronic infections caused by hepatitis C virus.

10 Jan 2011

AFQ056 drug improves symptoms in Fragile X patients: Study

The first drug to treat the underlying disorder instead of the symptoms of Fragile X, the most common cause of inherited intellectual disability, shows some promise according to a new study published in the January issue of Science Translational Medicine.

9 Jan 2011

MedImmune announces in-licensing agreement with Amgen for IL-1 pathway targeting novel monoclonal antibody

MedImmune today announced an in-licensing agreement with Amgen for a novel monoclonal antibody targeting the IL-1 pathway. The antibody, AMG 108, a fully human monoclonal antibody to the IL-1 receptor, has been studied in multiple phase 1 and phase 2 clinical trials and will now be explored by MedImmune for its potential against certain inflammatory diseases.

7 Jan 2011

Synergy's plecanatide Phase II/III trial to begin in second quarter 2011

Synergy Pharmaceuticals, Inc., a developer of new drugs to treat gastrointestinal (GI) disorders and diseases, today announced that the next clinical trial of plecanatide to treat chronic idiopathic constipation patients, planned to begin in the second quarter of 2011, has been designed as a Phase II/III trial.

7 Jan 2011

Iroko reports positive results from Phase I clinical study of nanotechnology based unique formulation of naproxen

Iroko Pharmaceuticals, LLC today reported the results of the Phase I clinical study of its unique formulation of naproxen, a widely used pain medication, using proprietary, patent protected nanotechnology.

7 Jan 2011

Chimerix initiates enrollment in CMX001 clinical study for life-threatening conditions caused by dsDNA viruses

Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, today announced that patient enrollment has begun in a multicenter, open-label clinical study of CMX001 (the CMX001-350 study) for the treatment of life-threatening or serious conditions caused by double-stranded DNA (dsDNA) viruses.

7 Jan 2011

Sucampo, Takeda initiate dosing in third lubiprostone phase 3 trial for opioid-induced bowel dysfunction

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc. today announced the dosing of the first patient in the third phase 3 clinical trial of lubiprostone for the treatment of opioid-induced bowel dysfunction (OBD) in subjects with chronic, non-cancer pain, excluding those taking methadone. The primary endpoint is an overall responder rate based on the change from baseline in the reported frequency of spontaneous bowel movements (SBMs).

7 Jan 2011

BIND Biosciences commences BIND-014 Phase 1 clinical trial in cancer

BIND Biosciences announced today that it has initiated a Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetic profile of BIND-014 in cancer patients. BIND-014, the first product candidate to enter clinical evaluation from BIND's broad proprietary Medicinal Nanoengineering platform, is a targeted polymeric nanoparticle containing the cytotoxic agent, docetaxel.

7 Jan 2011

Pharmasset reports positive data from PSI-7977 and PSI-938 HCV clinical programs

Pharmasset, Inc., announced today positive data from interim analyses of two of its clinical programs: the HCV genotype 2 or 3 (GT2/3) arm of the PSI-7977 Phase 2b trial and the 14 day PSI-938 monotherapy cohort of the dual nucleotide study.

7 Jan 2011

Plexxikon, Genentech enter PLX4032 co-promotion agreement

Plexxikon, Inc., announced today that it has signed an agreement with Genentech to co-promote PLX4032 (RG7204) in the United States. PLX4032, an oral, novel kinase inhibitor that targets the oncogenic BRAF mutation, is being tested in late-stage clinical trials for the treatment of metastatic melanoma.

7 Jan 2011

ANAVEX 2-73 named 2010's 'most promising trial drug' by Alzheimer's Weekly

Anavex Life Sciences Corp. announced today that ANAVEX 2-73 has been named 2010's "most promising trial drug" by the editorial staff at Alzheimer's Weekly. The publication selected the ANAVEX 2-73 trial from a field of over 100 trials that treat dementias such as Alzheimer's and following the review of more than 10,000 articles.

7 Jan 2011

Positive results from LifeCycle Pharma's LCP-Tacro comparative trial in de novo liver transplant patients

LifeCycle Pharma A/S has announced positive top-line results from a Phase 2 clinical trial involving 58 patients comparing LCP-Tacro™ tablets administered once-daily versus Prograf® (tacrolimus) capsules (Astellas Pharma) administered twice-daily in de novo liver transplant patients for one year.

7 Jan 2011

Athersys completes patient enrollment in MultiStem Phase I study for leukemia

Athersys, Inc. today announced that it has completed patient enrollment of the single dose arm of a clinical study involving administration of MultiStem to patients being treated for leukemia or other blood born cancers.

7 Jan 2011

Nippon Kayaku begins apaziquone Phase 1 bladder cancer study in Japan

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the first patient has been dosed in Japan in a Nippon Kayaku sponsored Phase 1 study of apaziquone in bladder cancer.

7 Jan 2011

Esperion Therapeutics commences ETC-1002 Phase 2 clinical study for cardio-metabolic diseases

Esperion Therapeutics, a privately held biotechnology company working to discover, develop and commercialize treatments for cardiovascular and metabolic diseases, today announced that it has initiated a Phase 2 clinical study for ETC-1002, the company's lead product candidate.

7 Jan 2011

Positive topline results from RDEA594 Phase 2b study in patients with gout, allopurinol

Ardea Biosciences, Inc. announced positive, preliminary, top-line results from its Phase 2b study of RDEA594 in combination with the current standard of care for the treatment of gout, allopurinol.

7 Jan 2011

CeNeRx commences TriRima Phase II trial for treatment resistant depression

CeNeRx BioPharma, today reported that it has initiated a Phase II trial of its new formulation of TriRima, the company's novel antidepressant in development as monotherapy for treatment resistant depression.

7 Jan 2011

Drug Trial News

Positive preclinical results from Inovio's novel DNA vaccine targeting HIV Clade C virus

FDA, EMA accept boceprevir for expedited review

Positive PK study results from ECLIPSE trial against cardiovascular disease

Positive results form INX-189 Phase 1b trial against hepatitis C virus

AFQ056 drug improves symptoms in Fragile X patients: Study

MedImmune announces in-licensing agreement with Amgen for IL-1 pathway targeting novel monoclonal antibody

Synergy's plecanatide Phase II/III trial to begin in second quarter 2011

Iroko reports positive results from Phase I clinical study of nanotechnology based unique formulation of naproxen

Chimerix initiates enrollment in CMX001 clinical study for life-threatening conditions caused by dsDNA viruses

Sucampo, Takeda initiate dosing in third lubiprostone phase 3 trial for opioid-induced bowel dysfunction

BIND Biosciences commences BIND-014 Phase 1 clinical trial in cancer

Pharmasset reports positive data from PSI-7977 and PSI-938 HCV clinical programs

Plexxikon, Genentech enter PLX4032 co-promotion agreement

ANAVEX 2-73 named 2010's 'most promising trial drug' by Alzheimer's Weekly

Positive results from LifeCycle Pharma's LCP-Tacro comparative trial in de novo liver transplant patients

Athersys completes patient enrollment in MultiStem Phase I study for leukemia

Nippon Kayaku begins apaziquone Phase 1 bladder cancer study in Japan

Esperion Therapeutics commences ETC-1002 Phase 2 clinical study for cardio-metabolic diseases

Positive topline results from RDEA594 Phase 2b study in patients with gout, allopurinol

CeNeRx commences TriRima Phase II trial for treatment resistant depression

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