Food News and Research

RSS

Experts examine corporate websites dedicated to 100 best-selling prescription drugs

Dartmouth Linguistics Professor Lewis Glinert and Jon Schommer, the associate head of the Department of Pharmaceutical Care and Health Systems at the University of Minnesota, have examined the corporate websites dedicated to the 100 best-selling prescription drugs. They found a startling lack of consistency in an industry where advertising standards are regulated by the Food and Drug Administration.

1 Jul 2010

Endo responds to FDA Complete Response letter for FORTESTA NDA

Endo Pharmaceuticals has submitted a complete response to the U.S. Food and Drug Administration (FDA) following the company's receipt of a Complete Response letter in October 2009 related to the New Drug Application (NDA) submission for FORTESTA™ (testosterone) 2% gel. The company's Class 2 resubmission is the next step in its intention to offer FORTESTA as a treatment option in the United States for men diagnosed with low testosterone (Low T), also known as hypogonadism. The FDA's review period for Class 2 resubmissions typically is six months.

1 Jul 2010

Eisai to commercialize lorcaserin for obesity and weight management in U.S.

Arena Pharmaceuticals, Inc. today announced that Eisai Inc. will market lorcaserin for obesity and weight management in the United States following U.S. Food and Drug Administration (FDA) approval under the terms of a marketing and supply agreement between Arena Pharmaceuticals GmbH, a wholly owned subsidiary of Arena Pharmaceuticals, Inc., and Eisai. Lorcaserin, which Arena discovered and has developed for weight management, is intended for obese patients as well as overweight patients who have at least one weight-related co-morbid condition.

1 Jul 2010

Eisai signs agreement with Arena Pharmaceuticals GmbH to commercialize lorcaserin

Eisai Inc., the U.S. pharmaceutical operation of Tokyo-based Eisai Co., Ltd., announced today that it has entered into an agreement with Arena Pharmaceuticals GmbH, a wholly owned subsidiary of Arena Pharmaceuticals, Inc., for exclusive U.S. rights to commercialize lorcaserin, a drug candidate for potential use in the treatment of obesity, including weight loss, for patients who are obese (Body Mass Index or BMI ≥ 30) or overweight (BMI ≥ 27) with at least one weight-related co-morbid condition.

1 Jul 2010

Researchers report no increased rate of heart attack in patients taking rosiglitazone

The diabetes drug rosiglitazone has been under intense scrutiny since a 2007 study in the New England Journal of Medicine looked at more than 40 clinical trials and linked the drug's use with increased risk of heart attack and death from heart disease.

1 Jul 2010

Study examines long-term effect of TBI on women's reproductive health

After a brain injury, women often ask how the injury will affect their fertility, pregnancy and postpartum health. Now a new study provides some much-needed answers. Published in the June issue of the Journal of Women's Health, the study is the most comprehensive investigation to date of women's health issues after traumatic brain injury.

1 Jul 2010

Biospherics acquires worldwide patent rights to Dtagatose from UKRF

Spherix Incorporated, an innovator in biotechnology for therapy in diabetes, metabolic syndrome, and atherosclerosis; and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced that its wholly-owned subsidiary, Biospherics Incorporated, has signed a license agreement with the University of Kentucky Research Foundation (UKRF).

1 Jul 2010

Eisai reports preliminary results from Dacogen for Injection Phase III study in AML

Eisai Inc. announced today preliminary results from a randomized Phase III clinical trial of Dacogen® (decitabine) for Injection versus either a low-dose chemotherapy agent or supportive care in elderly patients with acute myeloid leukemia (AML), a life-threatening cancer of the blood that generally occurs in older adults.

1 Jul 2010

pSivida's licensee submits NDA to FDA for Iluvien

pSivida Corp., a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, today announced that its licensee, Alimera Sciences has submitted a New Drug Application to the U.S. Food and Drug Administration for Iluvien for Diabetic Macular Edema.

1 Jul 2010

Bisphenol A (BPA) containing baby bottles to be phased out

Federal Parliamentary Secretary for Health Mark Butler has announced that following public concern and a safety review ordered by US health regulators, the phase out will begin from today. He also revealed that according to Food Standards Australia New Zealand intake levels are very low and do not pose a risk to babies' health.

1 Jul 2010

Biomerix receives FDA 510(k) Clearance to market Ventral Hernia Repair Mesh

Biomerix Corporation announced today that it has received U.S. Food and Drug Administration 510(k) Clearance to market its Biomerix Ventral Hernia Repair Mesh, the latest addition to its innovative portfolio of soft tissue repair devices. The Biomerix Ventral Hernia Repair Mesh, with two distinctly different sides, is the first and only device featuring the Biomerix Biomaterial on one side, designed to promote tissue ingrowth, and a resorbable protective film on the other side, designed to minimize tissue attachment to the device in case of direct contact with the viscera.

1 Jul 2010

SuperGen encouraged by Eisai's intent to file Dacogen sNDA for new indication

SuperGen, Inc., a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, announced that Eisai Inc. today released information regarding a randomized Phase III clinical trial of Dacogen® (decitabine) for Injection in elderly patients with acute myeloid leukemia (AML). The comparator in this trial was low-dose cytarabine, a chemotherapy agent, or supportive care.

30 Jun 2010

Chelsea completes enrollment in Northera Phase III Study 301 for neurogenic orthostatic hypotension

Chelsea Therapeutics International, Ltd. has successfully reached its target enrollment of 150 patients in its Northera™ (Droxidopa) pivotal Phase III Study 301 for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH). Results from the trial are expected in September 2010 and the full registration program is on track to initiate a new drug application (NDA) in the first half of 2011.

30 Jun 2010

First Edition: June 30, 2010

Today's headlines highlight the results of a new tracking poll that indicate that the health reform law has gained popularity among Americans while implementation advances for overhaul initiatives such as high-risk pools and the early retiree reinsurance program.

30 Jun 2010

Raptor partners with Uni Pharma to commercialize Convivia in Taiwan

Raptor Pharmaceutical Corp., announced that it has entered into an exclusive agreement with Uni Pharma Co., Ltd. to commercialize Convivia™, Raptor's proprietary oral formulation of 4-methylpyrazole, in Taiwan.

30 Jun 2010

Celgene signs definitive merger agreement to acquire Abraxis BioScience

Celgene Corporation and Abraxis BioScience Inc. today jointly announced the signing of a definitive merger agreement in which Celgene has agreed to acquire Abraxis BioScience. Under the terms of the merger agreement, each share of Abraxis BioScience common stock will be converted into the right to receive an upfront payment of $58.00 in cash and 0.2617 shares of Celgene common stock.

30 Jun 2010

Federal agencies, state governments take action to educate, protect against serious risks of indoor tanning

As the scientific evidence mounts, more federal agencies and state governments are taking action to educate and protect Americans against the serious risks of indoor tanning. Recent and pending legislation in numerous states restricting access to indoor tanning, along with the federal 10 percent indoor tanning tax that goes into effect on July 1, are important steps in keeping Americans safe from overexposure to ultraviolet (UV) radiation and the potential for future skin cancers.

30 Jun 2010

Yayi International net sales decrease 25.0% to $7.0M for five months ended March 31, 2010

Yayi International Inc.,, the first mover and a leading producer and distributor of premium goat milk formula products for infants, toddlers, young children, and adults in the People's Republic of China, today announced its financial results for the transition period from November 1, 2009 to March 31, 2010.

30 Jun 2010

NORD urges FDA to reduce regulatory uncertainty in developing medicines for rare disorders

Noting that only about 200 of the nearly 7,000 diseases classified as rare currently have treatments, the National Organization for Rare Disorders (NORD) today called for a Food and Drug Administration (FDA) statement of policy on regulation of therapies for rare disorders.

30 Jun 2010

InNexus develops IXS312 small protein fragment as topical therapy for AMD, diabetic retinal dysplasia

InNexus Biotechnology Inc., a drug development company commercializing the next generation of antibodies based on its groundbreaking Dynamic Cross Linking (DXL™) technology, today announced that it has developed IXS312(VEGF), an antibody fragment with activity against the growth factor VEGF for planned use in ocular treatments.

30 Jun 2010

Food News and Research

Experts examine corporate websites dedicated to 100 best-selling prescription drugs

Endo responds to FDA Complete Response letter for FORTESTA NDA

Eisai to commercialize lorcaserin for obesity and weight management in U.S.

Eisai signs agreement with Arena Pharmaceuticals GmbH to commercialize lorcaserin

Researchers report no increased rate of heart attack in patients taking rosiglitazone

Study examines long-term effect of TBI on women's reproductive health

Biospherics acquires worldwide patent rights to Dtagatose from UKRF

Eisai reports preliminary results from Dacogen for Injection Phase III study in AML

pSivida's licensee submits NDA to FDA for Iluvien

Bisphenol A (BPA) containing baby bottles to be phased out

Biomerix receives FDA 510(k) Clearance to market Ventral Hernia Repair Mesh

SuperGen encouraged by Eisai's intent to file Dacogen sNDA for new indication

Chelsea completes enrollment in Northera Phase III Study 301 for neurogenic orthostatic hypotension

First Edition: June 30, 2010

Raptor partners with Uni Pharma to commercialize Convivia in Taiwan

Celgene signs definitive merger agreement to acquire Abraxis BioScience

Federal agencies, state governments take action to educate, protect against serious risks of indoor tanning

Yayi International net sales decrease 25.0% to $7.0M for five months ended March 31, 2010

NORD urges FDA to reduce regulatory uncertainty in developing medicines for rare disorders

InNexus develops IXS312 small protein fragment as topical therapy for AMD, diabetic retinal dysplasia

The future is bioengineered: Synthetic biology and global sustainability eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Latest News