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Tibotec submits NDA for TMC278 anti-HIV compound to FDA

Tibotec Pharmaceuticals today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TMC278 (rilpivirine), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), being studied for once-daily use with other antiretroviral agents in treatment-naive HIV-1-infected adults. If approved, TMC278 will be the third anti-HIV compound to be introduced by Tibotec Pharmaceuticals.

26 Jul 2010

Experimental treatment for sickle cell disease enters Phase 3 clinical trials

An experimental treatment for sickle cell disease developed at the Los Angeles Biomedical Research Institute has entered Phase 3 clinical trials, David I. Meyer, PhD, LA BioMed president and CEO announced today.

26 Jul 2010

Control of cell migration gene can reduce spread of oral cancer cells: Study

The spread of cancer cells in the tongue may be reduced if a gene that regulates cancer cell migration can be controlled, according to new research at the University of Illinois at Chicago.

26 Jul 2010

Tarsa Therapeutics completes patient enrollment in Phase III ORACAL trial of oral calcitonin

Unigene Laboratories, Inc. today noted that Tarsa Therapeutics has completed patient enrollment in the Phase III ORACAL trial of Tarsa's oral calcitonin product for the treatment of postmenopausal osteoporosis. Unigene licensed the product to Tarsa and owns 26% of the company.

23 Jul 2010

Preclinical data of new acamprosate prodrug to be presented at International Fragile X Conference

XenoPort, Inc. announced today that it has discovered a novel prodrug that has the potential to improve significantly the blood concentration of acamprosate compared with the currently approved formulation of acamprosate. Preclinical data on this new product candidate will be presented tomorrow at the National Fragile X Foundation's 12th International Fragile X Conference in Detroit, Michigan.

23 Jul 2010

Update on Phase III Study of oral calcitonin for treatment of osteoarthritis

Emisphere Technologies, Inc. today announced that Novartis Pharma AG and its license partner Nordic Bioscience a/s have reported the following in connection with their Phase III Study 2302 in osteoarthritis assessing the safety and efficacy of oral calcitonin in the treatment of osteoarthritis of the knee.

23 Jul 2010

Novartis, Nordic Bioscience to continue oral calcitonin Phase III study in osteoarthritis patients

Unigene Laboratories, Inc. announced today that Novartis and its license partner Nordic Bioscience have decided to continue the companies' two-year, Phase III Study 2302 assessing safety and efficacy of oral calcitonin in patients with osteoarthritis of the knee. Novartis has a worldwide license to produce recombinant calcitonin under Unigene's patented SecraPep® E. coli manufacturing technology.

23 Jul 2010

Chronic facial pain may be symptom of temporomandibular joint disorder

Do you suffer from chronic facial pain, including constant pain in or around your ears, sore jaw, ringing in your ears, clicking or popping sounds when you open or close your mouth or chronic headaches and neck pain? Do you often feel like your jaw is stuck open or closed? Do you feel as though you have a limited opening of your mouth?

23 Jul 2010

Cytrx’s tamibarotene achieves molecular complete remission in advanced acute promyelocytic leukemia

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced that a 44-year-old female patient with advanced acute promyelocytic leukemia (APL) achieved molecular complete remission with no evidence of disease in the blood cells and/or bone marrow following treatment with CytRx's oncology drug candidate tamibarotene.

23 Jul 2010

hBD-3 biomarker helps early stage detection of oral cancer

Detecting oral cancer in its earliest stages can save the lives of the nearly 40,500 people diagnosed annually. But early detection has been difficult. Case Western Reserve University School of Dental Medicine researchers discovered a biomarker, called human beta defensin-3 (hBD-3), which may serve as an early warning. The defensin is present in all oral cancers and associated with the early stages of oral cancer.

23 Jul 2010

Tarsa completes enrollment in Phase III ORACAL trial for postmenopausal osteoporosis

Tarsa Therapeutics, Inc. today announced progress in the ORACAL trial of its oral calcitonin product for the treatment of postmenopausal osteoporosis. The company has completed patient enrollment in this multinational, randomized, double-blind, placebo-controlled Phase III trial designed to enroll approximately 550 patients. In addition, Tarsa announced that the independent Data Monitoring Committee (DMC) for the ORACAL trial has completed two separate safety reviews of patient data and recommended that the trial proceed as planned.

22 Jul 2010

3M second-quarter global sales increase 17.7% to $6.7 billion

3M today reported record second-quarter earnings of $1.54 per share on sales of $6.7 billion. Sales and per-share earnings increased 17.7 percent and 37.5 percent, respectively, versus the second quarter of 2009. Excluding special items recorded in the second quarter of 2009, earnings per share rose 28.3 percent.

22 Jul 2010

Merrimack, sanofi-aventis initiate dosing in MM-121 and exemestane combination Phase 2 breast cancer study

Merrimack Pharmaceuticals, Inc. and sanofi-aventis announced today that the first patient has received an initial dose in a Phase 2 randomized double blind clinical study combining MM-121 with exemestane (Aromasin®) in breast cancer patients.

22 Jul 2010

Smoking cessation effectively alter subgingival microbiome in patients on periodontal therapy: Study

Patients with chronic gum disease who quit smoking in addition to undergoing nonsurgical therapy not only demonstrated a lower abundance of harmful oral pathogens, but also an increase in health-associated bacteria. The researchers from The Ohio State University, Columbus Ohio, and Newcastle University, United Kingdom report their findings in the July 2010 issue of the Journal of Clinical Microbiology.

22 Jul 2010

Severe state budget shortfalls trigger Medicaid program cuts

As states face severe budget shortfalls, many have cut home-care services for the elderly or the disabled, programs that have been shown to save states money in the long run because they keep people out of nursing homes. Since the start of the recession, at least 25 states and the District of Columbia have curtailed programs that include meal deliveries, housekeeping aid and assistance for family caregivers, according to the Center on Budget and Policy Priorities, a research organization.

22 Jul 2010

Study marks significant milestone for microbicide research field, HIV prevention

Today we congratulate the Centre for the AIDS Programme of Research in South Africa and the people of South Africa on the positive findings from the CAPRISA 004 microbicide study, which marks a significant milestone both for the microbicide research field and HIV prevention as a whole.

22 Jul 2010

Flat global funding for HIV prevention research could have serious consequences: Report

Following significant advances in vaccine and microbicide research, including results presented today of 39% efficacy in the CAPRISA 004 microbicide gel trial among women in South Africa, a new report released today warns that flat funding for HIV prevention research may limit researchers' ability to quickly move promising approaches forward.

22 Jul 2010

DenteMax offers largest network approved for Medicare dental benefits

DenteMax, the nation's largest seamless dental PPO network, now also offers the largest seamless network approved for Medicare dental benefits. The new network provides access to more than 65,000 approved dentist access points and is built on the strong foundation of the commercial DenteMax network.

22 Jul 2010

Ampio Pharmaceuticals commences Optina Phase II clinical trial for diabetic macular edema

Ampio Pharmaceuticals, Inc. today announced the initiation of a Phase II clinical trial of Optina™ for the treatment of diabetic macular edema, an early stage of diabetic retinopathy. Diabetic macular edema is responsible for most vision loss in patients with diabetes mellitus.

22 Jul 2010

IQPC presents summit for better implementation of PAT & QbD initiatives

IQPC presents the 4th PAT Summit: Implementing PAT & QbD for Improved Quality and Cost Savings, taking place September 13 - 15 in Philadelphia. In today's marketplace manufacturers are challenged to improve quality while simultaneously reducing development and production cost.

From IQPC Ltd 22 Jul 2010

Oral News and Research

Tibotec submits NDA for TMC278 anti-HIV compound to FDA

Experimental treatment for sickle cell disease enters Phase 3 clinical trials

Control of cell migration gene can reduce spread of oral cancer cells: Study

Tarsa Therapeutics completes patient enrollment in Phase III ORACAL trial of oral calcitonin

Preclinical data of new acamprosate prodrug to be presented at International Fragile X Conference

Update on Phase III Study of oral calcitonin for treatment of osteoarthritis

Novartis, Nordic Bioscience to continue oral calcitonin Phase III study in osteoarthritis patients

Chronic facial pain may be symptom of temporomandibular joint disorder

Cytrx’s tamibarotene achieves molecular complete remission in advanced acute promyelocytic leukemia

hBD-3 biomarker helps early stage detection of oral cancer

Tarsa completes enrollment in Phase III ORACAL trial for postmenopausal osteoporosis

3M second-quarter global sales increase 17.7% to $6.7 billion

Merrimack, sanofi-aventis initiate dosing in MM-121 and exemestane combination Phase 2 breast cancer study

Smoking cessation effectively alter subgingival microbiome in patients on periodontal therapy: Study

Severe state budget shortfalls trigger Medicaid program cuts

Study marks significant milestone for microbicide research field, HIV prevention

Flat global funding for HIV prevention research could have serious consequences: Report

DenteMax offers largest network approved for Medicare dental benefits

Ampio Pharmaceuticals commences Optina Phase II clinical trial for diabetic macular edema

IQPC presents summit for better implementation of PAT & QbD initiatives

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How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

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