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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

FDA grants Biovest's BiovaxID vaccine Orphan Drug Designation for mantle cell lymphoma

Biovest International, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BiovaxID®, Biovest's personalized cancer vaccine, for a second lymphoma indication: mantle cell lymphoma. Mantle cell lymphoma is an aggressive and lethal B-cell blood cancer for which there is no current consensus standard-of-care.

26 Jul 2010

Orthovita's PMA supplement for new collagen processing facility receives FDA approval

Orthovita, Inc., an orthobiologics and biosurgery company, reported today that the U.S. Food and Drug Administration (FDA) approved Orthovita's PMA supplement for a new collagen processing facility in Malvern, Pennsylvania. Orthovita will use the new facility to process the highly purified form of collagen used in its VITAGEL™ Surgical Hemostat product. VITAGEL is a composite liquid hemostat used in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

26 Jul 2010

Onyx reports positive results from carfilzomib Phase 2b 003-A1 study in multiple myeloma

Onyx Pharmaceuticals, Inc. today announced positive top-line results from the Phase 2b 003-A1 study of single-agent carfilzomib, a selective, next generation proteasome inhibitor, in patients with relapsed and refractory multiple myeloma.

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

British adults support removal of tobacco displays in shops, ban on cigarette vending machines: Survey

Three quarters of British adults support the removal of shop displays of tobacco (73 per cent) and a complete ban on cigarette vending machines (77 per cent) according to a new survey commissioned by Cancer Research UK this weekend.

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

Seven practical tips to help parents encourage kids to eat well during, after school

According to the Centers for Disease Control, the prevalence of obesity among children aged 6 to 11 years increased from 6.5% in 1980 to 19.6% in 2008. This astronomical rise has led many advocates to focus their energies on improving nutritional conditions in schools, including reforming cafeteria lunches and eliminating junk food in vending machines. While the debate is being staged at the national level, with Michelle Obama's "Let's Move" initiative focusing a spotlight on the issue, there are steps that parents can take to maintain or improve their child's diet and nutrition while at school.

26 Jul 2010

FDA approves Aricept 23 mg tablet for Alzheimer's disease

Eisai Inc. and Pfizer Inc announced today that the U.S. Food and Drug Administration (FDA) approved a new once-daily, higher-dose Aricept 23 mg tablet for the treatment of moderate-to-severe Alzheimer's disease (AD). Aricept 23 mg tablet offers another dosing option for patients with moderate-to-severe AD, for whom few treatments are available

26 Jul 2010

FDA grants marketing approval of ANDA for enoxaparin sodium for injection

Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the U.S. Food and Drug Administration has granted marketing approval of the Abbreviated New Drug Application for enoxaparin sodium for injection filed by Sandoz. Developed under a collaboration agreement between Momenta and Sandoz, this product has been designated therapeutically equivalent to the reference-listed drug, Lovenox, which is marketed by Sanofi-Aventis.

26 Jul 2010

First patient enrolled in Phase 3 SyNAPSe study of BHR-100 for TBI

BHR Pharma, LLC announced today that the first patient has been enrolled in its SyNAPSe study, a global, Phase 3, pivotal trial to evaluate the safety and effectiveness of its intravenous progesterone infusion product (BHR-100) as a neuroprotective agent for treating severe (Glasgow Coma Scale scores of 4-8) traumatic brain injury patients.

23 Jul 2010

First generic version of Lovenox receives FDA approval for DVT

The U.S. Food and Drug Administration today approved the first generic version of Lovenox (enoxaparin sodium injection), an anti-coagulant drug used to prevent deep vein thrombosis, a potentially deadly blood clotting condition.

23 Jul 2010

China Sky One Medical receives SFDA approval for producing Ciclopirox Olamine Vaginal Suppositories

China Sky One Medical, Inc., a leading fully integrated pharmaceutical company in the People's Republic of China, today announced that the Company has obtained approval from the State Food and Drug Administration in China for the production of Ciclopirox Olamine Vaginal Suppositories.

23 Jul 2010

Expert to speak on challenges, issues in development, implementation of REMS

At two Food and Drug Administration meetings, Sidney H. Schnoll, MD, PhD, Vice President, Pharmaceutical Risk Management Services of PinneyAssociates, will discuss the need for predictability, feasibility and transparency to ensure that Risk Evaluation and Mitigation Strategies benefit patient safety and public health.

23 Jul 2010

MiMedx Group reports revenues of $322,000 for second-quarter 2010

MiMedx Group, Inc., an integrated developer, manufacturer and marketer of patent protected biomaterial-based products, announced today its results for the second quarter ended June 30, 2010.

23 Jul 2010

After-school snack of graham crackers may increase whole-grain intake in children: Study

An after-school snack of graham crackers might be one way to get children to eat more whole grains, a new study from the University of Minnesota shows. Federal nutrition guidelines recommend at least three servings a day of whole-grain foods, but previous studies have found that children typically only eat about one serving per day, largely because they don't like the taste or texture of whole-grain foods.

23 Jul 2010

Study identifies infection mechanism of disease-causing microbes

A study published in the July 23 issue of Cell identifies the mechanism used by several types of common, virulent microbes to infect plants and cause devastating blights. Microbes using this infection mechanism include fungi that are currently causing wheat rust epidemics in Africa and Asia, and a class of parasitic algae, called oomycetes, that resulted in the Irish potato blight of the 19th Century. These microbes remain an agricultural scourge today.

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

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

Food News and Research

Tibotec submits NDA for TMC278 anti-HIV compound to FDA

FDA grants Biovest's BiovaxID vaccine Orphan Drug Designation for mantle cell lymphoma

Orthovita's PMA supplement for new collagen processing facility receives FDA approval

Onyx reports positive results from carfilzomib Phase 2b 003-A1 study in multiple myeloma

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

Teva comments on FDA's approval of generic Lovenox injection

British adults support removal of tobacco displays in shops, ban on cigarette vending machines: Survey

Experimental treatment for sickle cell disease enters Phase 3 clinical trials

Seven practical tips to help parents encourage kids to eat well during, after school

FDA approves Aricept 23 mg tablet for Alzheimer's disease

FDA grants marketing approval of ANDA for enoxaparin sodium for injection

First patient enrolled in Phase 3 SyNAPSe study of BHR-100 for TBI

First generic version of Lovenox receives FDA approval for DVT

China Sky One Medical receives SFDA approval for producing Ciclopirox Olamine Vaginal Suppositories

Expert to speak on challenges, issues in development, implementation of REMS

MiMedx Group reports revenues of $322,000 for second-quarter 2010

After-school snack of graham crackers may increase whole-grain intake in children: Study

Study identifies infection mechanism of disease-causing microbes

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

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

Understanding cultivated meat and its global potential 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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