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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

Preclinical data for potent IDO pathway inhibitor presented at AACR 2013 annual meeting

NewLink Genetics Corporation, a biopharmaceutical company primarily focused on discovering, developing and commercializing immunotherapeutic products in oncology, announced today that the company presented preclinical data for NLG919, a potent IDO (indoleamine-(2,3)-dioxygenase) pathway inhibitor, at the American Association for Cancer Research 2013 annual meeting.

8 Apr 2013

FDA grants Breakthrough Therapy Designation for ibrutinib as monotherapy for CLL patients

Pharmacyclics, Inc. announced today that the U.S. Food and Drug Administration has granted an additional Breakthrough Therapy Designation for the investigational oral agent ibrutinib as monotherapy for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma patients with deletion of the short arm of chromosome 17 (deletion 17p).

8 Apr 2013

Lipocine announces favorable Phase I study results for LPCN 1111

Lipocine Inc., a biopharmaceutical company focused on developing innovative oral hormone therapies for men's and women's health, today announced favorable Phase I results for LPCN 1111.

8 Apr 2013

FDA grants priority review for Bayer HealthCare's riociguat for treatment of CTEPH

Bayer HealthCare announced today that the New Drug Application for its oral investigational compound riociguat has been accepted for filing and granted priority review by the U.S. Food and Drug Administration for the treatment of inoperable chronic thromboembolic pulmonary hypertension or with persistent or recurrent CTEPH after pulmonary endarterectomy and pulmonary arterial hypertension.

8 Apr 2013

A*STAR's professor receives Szent-Gy-rgyi prize for groundbreaking cancer pill

Professor Alex Matter, Chief Executive Officer of A*STAR's Experimental Therapeutics Centre (ETC), has been awarded the 8th Annual Szent-Gy-rgyi Prize for Progress in Cancer Research by the National Foundation for Cancer Research (NFCR) for his contributions to the development of the first drug specifically targeting a molecular lesion in cancer.

7 Apr 2013

Vitamin D improves muscle function, boosts energy levels

Vitamin D is vital for making our muscles work efficiently and boosting energy levels, new research from Newcastle University has shown.

7 Apr 2013

AstraZeneca reports fostamatinib Phase 3 study results for treatment of rheumatoid arthritis

AstraZeneca today announced top-line results of OSKIRA-1, a Phase 3 study to assess the efficacy and safety of fostamatinib, the first oral spleen tyrosine kinase inhibitor in development for rheumatoid arthritis.

6 Apr 2013

Arena Pharmaceuticals kicks off APD334 Phase 1 clinical trial for treatment of autoimmune diseases

Arena Pharmaceuticals, Inc. announced today the initiation of dosing in a Phase 1 clinical trial of APD334, a novel oral drug candidate that targets the sphingosine 1-phosphate subtype 1 (S1P1) receptor for the potential treatment of autoimmune diseases.

6 Apr 2013

Vertex to conduct two Phase 2 studies of VX-135 in combination with daclatasvir

Vertex Pharmaceuticals Incorporated today announced it has entered into a non-exclusive agreement with Bristol-Myers Squibb Company to conduct Phase 2 studies of once-daily all-oral treatment regimens containing Vertex's nucleotide analogue hepatitis C virus polymerase inhibitor VX-135 and Bristol-Myers Squibb's NS5A replication complex inhibitor daclatasvir for the treatment of hepatitis C.

6 Apr 2013

Non-invasive gut health testing breakthrough

Health and functional claims made for foods such as probiotics still need to prove their effectiveness ― an important part of the answer rests in our small intestines and their role in digestion, and immunity.

5 Apr 2013

Editorials discuss GPEI polio eradication plan

he Global Polio Eradication Initiative on Tuesday launched its Global Polio Eradication and Endgame Strategic Plan in Washington, D.C.

5 Apr 2013

Dental anesthesia appears to affect the development of wisdom tooth

Researchers from Tufts University School of Dental Medicine have discovered a statistical association between the injection of local dental anesthesia given to children ages two to six and evidence of missing lower wisdom teeth.

4 Apr 2013

Finding solutions to protect U.S. troops against invisible killers

A Saint Louis University researcher has received a contract worth up to $980,000 to see if two cancer medications have the potential of protecting U.S. troops from biological agents that could be unleashed during an attack.

4 Apr 2013

GPEI announces 'endgame' plan to eradicate polio by 2018

"A new global plan aims to end most cases of polio by late next year, and essentially eradicate the paralyzing disease by 2018 -- if authorities can raise the $5.5 billion needed to do the work, health officials said Tuesday," the Associated Press reports (Neergaard, 4/2).

4 Apr 2013

Tris Pharma gets FDA NDA approval for Karbinal ER Extended-release Oral Suspension

Tris Pharma, a specialty pharmaceutical company focused on developing innovative drug delivery technologies, today announced that the U.S. Food and Drug Administration has approved its New Drug Application for Karbinal ER (carbinoxamine maleate) Extended-release Oral Suspension 4mg/5ml, the first sustained-release histamine receptor blocking agent indicated for the treatment of seasonal and perennial allergic rhinitis in children ages 2 and up.

4 Apr 2013

Oral News and Research

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

Preclinical data for potent IDO pathway inhibitor presented at AACR 2013 annual meeting

FDA grants Breakthrough Therapy Designation for ibrutinib as monotherapy for CLL patients

Lipocine announces favorable Phase I study results for LPCN 1111

FDA grants priority review for Bayer HealthCare's riociguat for treatment of CTEPH

A*STAR's professor receives Szent-Gy-rgyi prize for groundbreaking cancer pill

Vitamin D improves muscle function, boosts energy levels

AstraZeneca reports fostamatinib Phase 3 study results for treatment of rheumatoid arthritis

Arena Pharmaceuticals kicks off APD334 Phase 1 clinical trial for treatment of autoimmune diseases

Vertex to conduct two Phase 2 studies of VX-135 in combination with daclatasvir

Non-invasive gut health testing breakthrough

Editorials discuss GPEI polio eradication plan

Dental anesthesia appears to affect the development of wisdom tooth

Finding solutions to protect U.S. troops against invisible killers

GPEI announces 'endgame' plan to eradicate polio by 2018

Tris Pharma gets FDA NDA approval for Karbinal ER Extended-release Oral Suspension

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