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Lipid Therapeutics to proceed with US LT-02 Phase III trial for mild-moderate ulcerative colitis

Lipid Therapeutics announces today that it has successfully filed its first US IND for its lead product LT-02 and is now in a position to proceed with a planned Phase III trial in the US in mild-moderate ulcerative colitis patients. The LT-02 IND was subject to the FDA's customary 30 day review period.

11 Apr 2013

OncoMed highlights progress of anti-cancer biologics at AACR annual meeting

OncoMed Pharmaceuticals, Inc., a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today summarized new data highlighting the progress of OncoMed's pipeline of anti-cancer biologics presented this week in an oral presentation and five posters at the Annual Meeting of the American Association of Cancer Research in Washington, DC.

11 Apr 2013

$Pharmacyclics presents positive results of ibrutinib Phase II trial in untreated, relapsed and refractory CLL patients$

Pharmacyclics presents positive results of ibrutinib Phase II trial in untreated, relapsed and refractory CLL patients

Pharmacyclics, Inc. today announced results from a Phase II trial of the investigational oral agent ibrutinib which demonstrated rapid and sustained disease control as a monotherapy in untreated, relapsed and refractory chronic lymphocytic leukemia (CLL) patients, irrespective of characteristics that predict poor outcomes to chemoimmunotherapy.

11 Apr 2013

New data on Merck’s VICTRELIS for chronic HCV to be presented at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced today that two analyses of VICTRELIS (boceprevir) and data from Phase II studies of two of Merck's investigational medicines for chronic hepatitis C virus (HCV) genotype 1, MK-5172 and vaniprevir (MK-7009), will be presented at the 2013 International Liver Congress (EASL) Annual Meeting.

11 Apr 2013

FDA accepts Merck's NDA for NOXAFIL tablets

Merck, known as MSD outside the United States and Canada, today announced that its New Drug Application for an investigational, tablet formulation of the company's antifungal agent, NOXAFIL (posaconazole), has been accepted for review by the U.S. Food and Drug Administration.

11 Apr 2013

Pfizer's breast cancer compound wins FDA's Breakthrough Therapy designation

Pfizer Inc. announced today its investigational compound palbociclib (PD-0332991), an oral and selective inhibitor of cyclin dependent kinases (CDK) 4 and 6, has received Breakthrough Therapy designation by the United States Food and Drug Administration for the potential treatment of patients with breast cancer.

From Pfizer, Inc. 11 Apr 2013

Study: Circumcision does not increase risk of herpes in infants

Jewish leaders this week pointed to a recent independent study by Penn Medicine at the University of Pennsylvania that found little evidence to support the claim that a circumcision practice known as Metzitzah B'Peh (MBP) leads to an increased likelihood of herpes in infants.

10 Apr 2013

Phase I results show Rogosertib is well tolerated in patients with advanced solid tumors

Results of a phase 1 clinical trial reported at the American Association for Cancer Research (AACR) annual conference show that orally administered Rigosertib is well tolerated in patients with advanced solid tumors.

10 Apr 2013

CYP1B1 protein prevents head and neck cancers, say researchers

Head and neck cancers typically begin in squamous cells that line moist surfaces inside the mouth, nose and throat. Squamous cell carcinoma of the head and neck (HNSCC) is the sixth most common type of cancer in the United States, and it is sometimes preceded by the appearance of changes inside the oral cavity called precancerous lesions.

10 Apr 2013

Boehringer Ingelheim's STARTVerso 1 Phase 3 hepatitis C data to be presented at EASL Congress

Boehringer Ingelheim today announced that data from its pivotal STARTVerso 1 Phase 3 hepatitis C clinical trial have been accepted for oral presentation as a late-breaker at the International Liver Congress 2013: 48th Annual Meeting of the European Association for the Study of the Liver, taking place from April 24-28 in Amsterdam, The Netherlands.

10 Apr 2013

Onconova reports positive results from rigosertib Phase 1 trial in patients with advanced solid tumors

Onconova Therapeutics, Inc., a development-stage pharmaceutical company focused on discovering and developing novel small molecule drug products to treat cancer, today announced that tolerability and favorable anti-tumor activity data from a Phase 1 trial evaluating oral rigosertib, a dual pathway inhibitor, in patients with advanced solid tumors including refractory metastatic head and neck cancer were presented today at the American Association for Cancer Research Annual Meeting.

10 Apr 2013

Researchers present data on ARQ 092 at 2013 AACR Annual Meeting

Researchers presented data today on ARQ 092, an AKT inhibitor in Phase 1 clinical development by ArQule, Inc. at the AACR Annual Meeting held in Washington, D.C., April 6-10, showing that this novel, oral agent inhibits the AKT pathway and has a manageable safety profile in an ongoing Phase 1 clinical trial.

10 Apr 2013

BIND Therapeutics presents positive Phase 1 clinical study results for BIND-014 at AACR meeting

BIND Therapeutics, a clinical-stage biopharmaceutical company developing a new class of highly selective targeted and programmable therapeutics called AccurinsTM, announced today that positive Phase 1 clinical data for BIND-014, the company's lead drug candidate, were presented today in an oral presentation at the American Association for Cancer Research 2013 Annual Meeting.

10 Apr 2013

Cuts to NIH 'inconsistent' with university interest in global health research

"As the debate over federal budget allocations and cuts continues, the National Institutes of Health, a leading funder for both domestic and global health research, could experience a whopping $1 billion budget cut," Karen Siegel and colleagues from Emory University write in the Health Affairs Blog.

9 Apr 2013

Clinical data of two Transgene products to be presented at EASL Conference

Transgene SA, a biopharmaceutical company that develops targeted immunotherapy products to treat major unmet medical needs in cancer and infectious diseases, today announced that favourable pre-clinical and clinical data on two Transgene products - TG1050 and TG4040 to treat chronic hepatitis B and chronic hepatitis C, respectively - will be presented in oral presentations at this year's European Association for the Study of the Liver Conference (Amsterdam, Netherlands, April 24-28, 2013).

9 Apr 2013

Argentina's ANMAT approves AUBAGIO for patients with relapsing multiple sclerosis

Genzyme, a Sanofi company, announced today Argentina's National Administration of Drugs, Food and Medical Technology has approved once-daily, oral AUBAGIO 14 mg as a new treatment indicated for patients with relapsing forms of multiple sclerosis.

9 Apr 2013

Gilead Sciences submits sofosbuvir NDA to FDA for treatment of chronic HCV infection

Gilead Sciences today announced that the company has submitted a New Drug Application to the U.S. Food and Drug Administration for approval of sofosbuvir, a once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus infection.

9 Apr 2013

New drug combination shows anti-cancer activity in patients with solid tumors and germline mutation

A novel combination of two drugs has shown anti-cancer activity in patients who had incurable solid tumors and carried a germline mutation in their BRCA genes, Dana-Farber Cancer Institute researchers are reporting at the American Association for Cancer Research annual meeting in Washington, April 6-10.

8 Apr 2013

Antibody-guided drug shows promising activity in ovarian cancer patients with platinum drug-resistant disease

A new antibody-guided drug has shown promising activity in a phase I trial involving ovarian cancer patients with platinum drug-resistant disease, researchers from Dana-Farber Cancer Institute will report today at the annual meeting of the American Association for Cancer Research.

8 Apr 2013

Blood test reveals more gene mutations in cancer than traditional tumor biopsy

A new blood test revealed more of the gene mutations that sustain certain digestive-tract tumors than did a DNA analysis of a traditional tumor biopsy, Dana-Farber Cancer Institute investigators will report at a special symposium of the American Association for Cancer Research annual meeting in Washington, April 6-10.

8 Apr 2013

Oral News and Research

Lipid Therapeutics to proceed with US LT-02 Phase III trial for mild-moderate ulcerative colitis

OncoMed highlights progress of anti-cancer biologics at AACR annual meeting

Pharmacyclics presents positive results of ibrutinib Phase II trial in untreated, relapsed and refractory CLL patients

New data on Merck’s VICTRELIS for chronic HCV to be presented at EASL annual meeting

FDA accepts Merck's NDA for NOXAFIL tablets

Pfizer's breast cancer compound wins FDA's Breakthrough Therapy designation

Study: Circumcision does not increase risk of herpes in infants

Phase I results show Rogosertib is well tolerated in patients with advanced solid tumors

CYP1B1 protein prevents head and neck cancers, say researchers

Boehringer Ingelheim's STARTVerso 1 Phase 3 hepatitis C data to be presented at EASL Congress

Onconova reports positive results from rigosertib Phase 1 trial in patients with advanced solid tumors

Researchers present data on ARQ 092 at 2013 AACR Annual Meeting

BIND Therapeutics presents positive Phase 1 clinical study results for BIND-014 at AACR meeting

Cuts to NIH 'inconsistent' with university interest in global health research

Clinical data of two Transgene products to be presented at EASL Conference

Argentina's ANMAT approves AUBAGIO for patients with relapsing multiple sclerosis

Gilead Sciences submits sofosbuvir NDA to FDA for treatment of chronic HCV infection

New drug combination shows anti-cancer activity in patients with solid tumors and germline mutation

Antibody-guided drug shows promising activity in ovarian cancer patients with platinum drug-resistant disease

Blood test reveals more gene mutations in cancer than traditional tumor biopsy

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