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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

Cerenis, Novasep awarded French Government funding for development of CER-001 HDL mimetic

Cerenis Therapeutics SA (Cerenis), a biopharmaceutical company developing novel high-density lipoprotein (HDL) therapies to treat cardiovascular and other metabolic diseases, and Groupe Novasep (Novasep), a leading supplier of manufacturing solutions to the life sciences industries, announce today that they have received French Government funding through OSEO to finance the development of CER-001, a Cerenis HDL mimetic.

26 Jul 2010

L2FU reports 100% recovery of recent study's lost clinical trial patients

Recovering unnecessarily lost patient information is now a viable reality. Lost to follow up rates in clinical research trials can range from 20- 60%. As a result, patients who drop from a clinical trial and 'go missing' can impart a major set-back in pharmaceutical research. Failure to contact patients and obtain final closure data, or bring them back into the clinical trial (if the protocol allows) results in study delays, increased patient recruitment costs, compromised study data, and in some cases an insufficient amount of information to prove the safety and efficacy of a drug.

26 Jul 2010

Teva comments on FDA's approval of generic Lovenox injection

Teva Pharmaceutical Industries Ltd. commented today on the U.S. Food and Drug Administration's response to a citizen petition questioning the approval criteria for a generic Lovenox (enoxaparin sodium) injection and its subsequent approval of another generic filer's Abbreviated New Drug Application.

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

AIDS 2010: Obama, Clinton vow U.S. support to global fight against HIV/AIDS

During the closing ceremonies of the International AIDS Conference-AIDS 2010, President Barack Obama "on Friday pledged to redouble efforts to fight HIV and AIDS through his Global Health Initiative, despite dealing with economic hard times in the wake of a global recession," Reuters reports. According to the news service, "Obama and his Secretary of State Hillary Clinton said their focus was on a broad, sustainable and effective approach to the global epidemic" (Kelland, 7/23).

26 Jul 2010

Einstein scientists awarded $4.1M to test microbicide Carraguard against HPV

The National Cancer Institute has awarded Albert Einstein College of Medicine of Yeshiva University $4.1 million to test the microbicide Carraguard- against the human papillomavirus, which causes cervical cancer. The research will evaluate the efficacy of Carraguard- - a clear gel made from the seaweed derivative carrageenan - in preventing new HPV infections in women.

26 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

Boehringer Ingelheim's VERxVE study of nevirapine meets primary endpoint

New data were presented today at the 18th International AIDS Conference from the VERxVE study that show an investigational, once-daily extended-release (400 mg QD) formulation of nevirapine was non-inferior to twice-daily immediate release Viramune® (nevirapine) tablets (200 mg BID), both in combination with Truvada® (tenofovir and emtricitabine) tablets in treatment-naive HIV-1 infected patients through 48 weeks.

23 Jul 2010

NPS completes patient randomization in GATTEX Phase 3 study for PN dependent short bowel syndrome

NPS Pharmaceuticals, a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today announced the completion of patient randomization in its Phase 3 registration study of GATTEX® (teduglutide). The double-blind, placebo-controlled safety and efficacy study, which is known as STEPS, is being conducted in patients with parenteral nutrition (PN) dependent short bowel syndrome (SBS) and is now fully randomized with 86 patients.

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

Independent DSMB recommends Inhibitex to complete FV-100 Phase II clinical trial for shingles

Inhibitex, Inc. today announced that the independent data safety monitoring board (DSMB) responsible for reviewing safety data from the Company's ongoing Phase II clinical trial of FV-100 met, as scheduled, after the Company had provided it with complete 30-day follow-up safety data on the third quartile (75%) of the patients that the Company plans to enroll in the trial. Based upon its review, the DSMB recommended that the trial continue to completion without modification.

23 Jul 2010

Human Genome Sciences second-quarter revenues increase to $38.8 million

Human Genome Sciences, Inc. today announced financial results for the quarter ended June 30, 2010, and provided highlights of recent key developments.

23 Jul 2010

Tibotec reports Phase 3 trial results of TMC278 vs. EFV in treatment-naive HIV-1-infected adults

Tibotec Pharmaceuticals announced today results from two pivotal Phase 3, double-blind, randomized clinical trials comparing the efficacy, safety and tolerability of its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine) versus efavirenz (EFV), each administered once daily with a nucleoside/nucleotide background regimen in treatment-naive, HIV-1-infected adults.

22 Jul 2010

Bristol-Myers Squibb second-quarter net sales increase 2% to $4.8 billion

Bristol-Myers Squibb Company today reported results for the second quarter of 2010 which featured data on key marketed and investigational compounds in its oncology, diabetes and cardiovascular franchises, and growth in sales and EPS. The company also confirmed guidance for 2010 and minimum guidance for non-GAAP EPS in 2013.

22 Jul 2010

Baxter second-quarter global sales increase 2% to $3.2 billion

Baxter International Inc. today announced its financial results for the second quarter of 2010, reporting earnings in line with the company's previously issued guidance of $0.90 to $0.93 per diluted share.

From Baxter International Inc. 22 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

Repros granted IRB approval to commence low dose Proellex study

Repros Therapeutics Inc. today announced it has received IRB approval to commence the low dose Proellex® study. The contract for clinical services was previously awarded to ICON. The new low dose study is designed to explore both safety and signals of efficacy in an escalating dose fashion. The study will test 5 different doses of Proellex (1, 3, 6, 9 and 12 mg) with 1 mg being the first dose tested. In previous studies a 12.5 mg dose was well tolerated and yielded statistically significant efficacy signals for both uterine fibroids and endometriosis.

22 Jul 2010

Efficacy News and Research

Tibotec submits NDA for TMC278 anti-HIV compound to FDA

Cerenis, Novasep awarded French Government funding for development of CER-001 HDL mimetic

L2FU reports 100% recovery of recent study's lost clinical trial patients

Teva comments on FDA's approval of generic Lovenox injection

Experimental treatment for sickle cell disease enters Phase 3 clinical trials

AIDS 2010: Obama, Clinton vow U.S. support to global fight against HIV/AIDS

Einstein scientists awarded $4.1M to test microbicide Carraguard against HPV

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

Boehringer Ingelheim's VERxVE study of nevirapine meets primary endpoint

NPS completes patient randomization in GATTEX Phase 3 study for PN dependent short bowel syndrome

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

Independent DSMB recommends Inhibitex to complete FV-100 Phase II clinical trial for shingles

Human Genome Sciences second-quarter revenues increase to $38.8 million

Tibotec reports Phase 3 trial results of TMC278 vs. EFV in treatment-naive HIV-1-infected adults

Bristol-Myers Squibb second-quarter net sales increase 2% to $4.8 billion

Baxter second-quarter global sales increase 2% to $3.2 billion

Tarsa completes enrollment in Phase III ORACAL trial for postmenopausal osteoporosis

Repros granted IRB approval to commence low dose Proellex study

Event guide: 4th Extra-Hepatic Lipid-Based Nanoparticles Delivery Summit eBook

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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