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FDA grants final approval for Hi-Tech Pharmacal's ANDA for levofloxacin ophthalmic solution

Hi-Tech Pharmacal Co., Inc., a specialty pharmaceuticals company, announced today that the US Food and Drug Administration granted final approval for the Company's Abbreviated New Drug Application for levofloxacin ophthalmic solution, 0.5% the generic for Vistakon's Quixin ophthalmic solution, which had sales of $2 million for the 12 months ended December 2010 according to IMS sales data.

10 Feb 2011

Gilead resubmits NDA for single-tablet regimen of Truvada/TMC278

Gilead Sciences, Inc. announced today that it has refiled a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the single-tablet regimen of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults.

10 Feb 2011

Zogenix completes enrollment in ZX002 Phase 3 study in opioid-experienced adults with moderate to severe pain

Zogenix, Inc. announced today the completion of enrollment in its pivotal Phase 3 efficacy study (Study 801) of ZX002. ZX002 is a novel, oral, single-entity, controlled-release formulation of hydrocodone for the treatment of moderate to severe pain in patients requiring around-the-clock opioid therapy for an extended period of time.

10 Feb 2011

Mallinckrodt receives FDA approval for Fentanyl Transdermal System patch ANDA

Covidien, a leading global provider of healthcare products, today announced that Mallinckrodt Inc., a Covidien company, has received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for its Fentanyl Transdermal System (FTS) patch. Covidien is the largest supplier of controlled pain medications in the United States based on number of prescriptions.

10 Feb 2011

TMJ Medical receives FDA postmarket surveillance study order

TMJ Medical acknowledged Tuesday receiving a postmarket surveillance study order from the U.S. Food and Drug Administration. TMJ Medical is one of three medical device manufacturers approved to market temporomandibular joint (TMJ) implants in the United States. Each manufacturer received the same FDA order.

10 Feb 2011

EMA grants QLT positive opinions for Orphan Drug Designation of QLT091001 to treat inherited blindness

QLT Inc. today announced that QLT091001, an oral synthetic retinoid, has received positive opinions for two distinct Orphan Drug Designations by the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) for the treatment of the inherited retinal degenerative diseases, Leber Congenital Amaurosis (LCA) and Retinitis Pigmentosa (RP).

10 Feb 2011

Phospholipid membranes demonstrate ability to absorb lanthanum cations

University of Granada scientists and the Spanish Higher Institute for Scientific Research (CSIC) have made significant progress in understanding lipid membranes, which are extensively employed in the development of cosmetic and drug products, and which have potential application in the field of nanotechnology.

10 Feb 2011

FDLI's new Policy Forum takes close look on emerging health care liability issues

The ability of families to sue vaccine producers for faulty design could lead to a rise in litigation and force manufacturers to abandon the market, which, in turn, could cause disastrous public health consequences in the United States, assert Daniel J. Gage, Assistant Director and Alison R. Perencevich, Legislative Assistant, at the American Academy of Pediatrics' Department of Federal Affairs.

10 Feb 2011

Key advance in development of fast, simple test for detection of cholera

With cholera on the rampage in Haiti and almost 40 other countries, scientists are reporting the development of a key advance that could provide a fast, simple test to detect the toxin that causes the disease. The report appears in ACS' journal Bioconjugate Chemistry. Cholera affects more than 200,000 people annually, mainly in developing countries, and causes about 5,000 deaths. Many involve infants, children, and the elderly.

10 Feb 2011

Indiana University creates Institute for Personalized Medicine

Indiana University has announced a major commitment to research in one of health care's most promising fields with the creation of the Indiana Institute for Personalized Medicine.

10 Feb 2011

Idenix announces updates on HCV and HIV clinical development programs

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced updates to three clinical development programs.

10 Feb 2011

Brain reacts differently to fructose compared with another common sweetener, glucose

The dietary concerns of too much fructose is well documented. High-fructose corn syrup has become the sweetener most commonly added to processed foods. Many dietary experts believe this increase directly correlates to the nation's growing obesity epidemic. Now, new research at Oregon Health & Science University demonstrates that the brain - which serves as a master control for body weight - reacts differently to fructose compared with another common sweetener, glucose.

10 Feb 2011

Afinitor plus BSC doubles progression-free survival in patients with advanced pancreatic neuroendocrine tumors

The New England Journal of Medicine (NEJM) published a study today that shows Afinitor® (everolimus) tablets plus best supportive care (BSC) more than doubled progression-free survival (PFS), or time without tumor growth, versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (NET).

10 Feb 2011

CHI commends FDA's recognition of more efficient regulatory pathway for innovative medical devices

"CHI commends the FDA for its recognition of the need for a more efficient regulatory pathway for innovative medical devices that have the potential to improve lives," said CHI President and CEO David L. Gollaher, Ph.D. "It is essential that the FDA maintains focus on initiatives that strengthen the medical device review process, bringing greater clarity and consistency, while ensuring the U.S. maintains its competitive edge."

10 Feb 2011

Benson Group listed on 'Europe's 500' top growth companies

Europe's 500, the association of top European growth entrepreneurs met at the European Parliament in Brussels on February 3rd for the European Growth Summit 2011. An integral part of the event, the "Europe's 500" awards ceremony honoured the top-growth-companies in Europe, and released a list of the 200 fastest-growing, job-creating businesses.

10 Feb 2011

Breakfast important for teen mothers

Teen mothers who eat breakfast have healthier weights and snacking habits and may influence healthy eating habits among their children, says a recent study by obesity prevention expert Debra Haire-Joshu, PhD, professor at the Brown School at Washington University in St. Louis.

10 Feb 2011

Americans willing to pay more, but up to a limit, for safer food

Government regulators could more realistically assess the value of improving food safety if they considered the fact that consumers typically want to avoid getting sick - even if it means they have to pay a little extra for safer food, researchers say.

10 Feb 2011

Food News and Research

FDA grants final approval for Hi-Tech Pharmacal's ANDA for levofloxacin ophthalmic solution

Gilead resubmits NDA for single-tablet regimen of Truvada/TMC278

Zogenix completes enrollment in ZX002 Phase 3 study in opioid-experienced adults with moderate to severe pain

Mallinckrodt receives FDA approval for Fentanyl Transdermal System patch ANDA

TMJ Medical receives FDA postmarket surveillance study order

EMA grants QLT positive opinions for Orphan Drug Designation of QLT091001 to treat inherited blindness

Phospholipid membranes demonstrate ability to absorb lanthanum cations

FDLI's new Policy Forum takes close look on emerging health care liability issues

Key advance in development of fast, simple test for detection of cholera

Indiana University creates Institute for Personalized Medicine

Idenix announces updates on HCV and HIV clinical development programs

Brain reacts differently to fructose compared with another common sweetener, glucose

Afinitor plus BSC doubles progression-free survival in patients with advanced pancreatic neuroendocrine tumors

CHI commends FDA's recognition of more efficient regulatory pathway for innovative medical devices

Benson Group listed on 'Europe's 500' top growth companies

Breakfast important for teen mothers

Americans willing to pay more, but up to a limit, for safer food

Human-worm connection research provides insight into brain development, diseases

Meredith announces launch of Diabetic Living in Russia, Mexico and India

Tart cherries can help athletes reduce muscle damage more quickly

Enhancing confidence in chemical ionization spectrometry data eBook

A New Approach to Preventing Bladder Cancer Recurrence

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

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