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FDA approves Tris Pharma's first-time generic of Methylphenidate Hydrochloride Oral Solution

Tris Pharma, a specialty pharmaceutical company that develops innovative drug delivery technologies, announced that the US Food and Drug Administration (FDA) has approved a first-time generic of Methylphenidate Hydrochloride Oral Solution equivalent to brand name Methylin® Oral Solution marketed by Shionogi Pharmaceuticals, Inc.

28 Jul 2010

ViroPharma second-quarter net sales increase 33% to $109.0 million

ViroPharma Incorporated reported today its financial results for the second quarter ended June 30, 2010.

28 Jul 2010

Vitro Diagnostics, Mokshagundam Biotechnologies enter contract to develop stem cell-derived food

Vitro Diagnostics, Inc., dba Vitro Biopharma, announced that it has entered into a contract with Mokshagundam Biotechnologies, a private research organization established to develop alternative meat sources, to develop cell culture medium for use in exploration of alternative food sources derived from stem cells.

28 Jul 2010

Therapists introduce new parenting skills to end child maltreatment

Mothers who live in poverty and who have abused their children can stop if they are taught parenting skills and given emotional support. A new study has found that mothers in families in which there is a history of child abuse and neglect were able to reduce how much they cursed at, yelled at, slapped, spanked, hit or rejected their children after a series of home visits from therapists who taught them parenting skills.

28 Jul 2010

NEI, FDA to sponsor Glaucoma Endpoints conference

The National Eye Institute and the Food and Drug Administration are sponsoring a Glaucoma Endpoints conference on September 24, 2010, to develop definitions and standards for describing structural changes in the glaucomatous optic nerve and functional changes in vision, as criteria for approval of new glaucoma therapeutics in clinical trials. The one-day meeting will take place at the Natcher Center, National Institutes of Health in Bethesda, Md.

28 Jul 2010

New funding made available to tackle common cause of food poisoning in the UK

Up to £2 Million is being made available today to tackle the most common cause of food poisoning in the UK - Campylobacter. Three of the UK's main public funders of food safety research have come together to invite research proposals to find out more about the organism and how best to control it. To provide safe and nutritious food for a growing world population it is important to reduce the incidence of food poisoning. Campylobacter species are responsible for more than 300,000 cases of food poisoning a year in England and Wales.

28 Jul 2010

Medtronic reports FDA Panel's affirmative votes on AMPLIFY rhBMP-2 Matrix for posterolateral spine fusion

The U.S. Food and Drug Administration (FDA) Orthopaedic and Rehabilitation Devices Panel today voted 9 for and 4 against (1 abstention) on safety and 10 for and 3 against (1 abstention) on effectiveness, that data including results from a large, prospective randomized clinical trial demonstrated the safety and effectiveness of AMPLIFY™ rhBMP-2 Matrix for fusions of the lower spine in patients with degenerative disc disease.

28 Jul 2010

PhRMA asks FDA to be more straightforward on safeguards it wants to fight drug risks

The pharmaceutical industry trade group PhRMA said Monday that the Food and Drug Administration should do a better job of explaining additional safeguards it mandates against certain drugs when it issues warnings, Reuters reports.

28 Jul 2010

FDA accepts for filing Cladribine Tablets NDA for MS

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Cladribine Tablets as a therapy for relapsing forms of multiple sclerosis (MS).

28 Jul 2010

GSK awards NCCN $4 million grant for study of ofatumumab and pazopanib

The National Comprehensive Cancer Network has been awarded two individual $2 million grants from GlaxoSmithKline to support clinical studies of ofatumumab (Arzerra®, GlaxoSmithKline) in the treatment of hematologic malignancies and pazopanib (Votrient®, GlaxoSmithKline) in the treatment of solid tumors.

28 Jul 2010

Mediomics receives additional $460,000 in STTR Phase II grant for PINCER protein assay development

Mediomics, LLC has received an additional $460,000 in a renewal of its 2nd year STTR Phase II grant (R42GM079891) from the National Institute of General Medical Sciences. Since 2007, Mediomics has received over one million dollars of STTR funding to develop its quick and sensitive homogenous PINCER™ protein assay. The major goal of the second year project is to further increase the sensitivity of the biosensor.

28 Jul 2010

U.S. Marshals seize FastSize Extender devices and FastSize EQM Erectile Quality Monitor devices

At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized $346,954.43 worth of FastSize Extender devices and FastSize EQM™ Erectile Quality Monitor devices, as well as component parts used in the manufacture of the FastSize Extender. The FastSize Extender and the FastSize EQM™ Erectile Quality Monitor are manufactured and distributed by FastSize, LLC of Aliso Viejo, Calif.

28 Jul 2010

FDA clears IL's new point-of-care total bilirubin assay

Instrumentation Laboratory (IL) today announced that it has received clearance from the US Food and Drug Administration (FDA) to market the first-ever, rapid point-of-care, lab-quality blood test for measuring total bilirubin (tBili) in newborns.

28 Jul 2010

AirStrip Remote Patient Monitoring solution receives FDA marketing clearance

AirStrip Technologies, a pioneer in mobile medical software applications, today announced that it has received U.S. Food and Drug Administration (FDA) clearance to market the AirStrip Remote Patient Monitoring solution (RPM), including AirStrip RPM CRITICAL CARE and AirStrip RPM CARDIOLOGY.

28 Jul 2010

GE Healthcare completes new $15 million medical technology manufacturing facility in Cardiff, Wales

Life sciences giant GE Healthcare has opened a $15 million medical technology manufacturing facility in Cardiff, Wales. The new facility is based at the 30-acre Maynard Centre, where the company already employs over 400 people.

28 Jul 2010

InterMune second-quarter total revenue decreases to $5.9 million

InterMune, Inc. today announced results from operations for the second quarter and six months ended June 30, 2010. InterMune also highlighted its recent clinical development and business activities, and provided forward-looking financial guidance for 2010.

28 Jul 2010

FDA approves addition of 10 sites to WorldHeart's Levacor VAD BTT clinical study

World Heart Corporation, a developer of mechanical circulatory systems, announced today that the United States Food and Drug Administration (FDA) has approved the addition of ten sites to the Levacor ventricular assist device (VAD) Bridge-to-Transplant (BTT) clinical study. WorldHeart's pivotal BTT study is now approved to enroll patients at 20 sites in the U.S.

28 Jul 2010

Scientists develop novel chemotherapeutic method for anticancer drug delivery

Combining nature and Greek mythology, researchers at the Technion-Israel Institute of Technology have developed a tiny "Trojan Horse" system for delivering cancer-fighting drugs. With this system, the drugs are delivered only once they are inside the cancerous cells, so there is no damage to the healthy cells in the surrounding area.

28 Jul 2010

WWHI participates in joint meeting to explore barriers to wireless communications, health care solutions

The West Wireless Health Institute today announced its participation in the first joint meeting hosted by the Federal Communications Commission and Food & Drug Administration to explore the potential barriers that may slow the convergence of wireless communications and health care solutions.

27 Jul 2010

Momenta Pharmaceuticals provides update on generic Lovenox ANDA litigation

Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex drugs, today provided an update regarding a lawsuit that Sanofi-Aventis U.S. LLC filed in the United States District Court for the District of Columbia against the U.S. Food and Drug Administration (FDA), Margaret A. Hamburg, Commissioner of Food and Drugs, and Kathleen Sebelius, Secretary of Health and Human Services.

27 Jul 2010

Food News and Research

FDA approves Tris Pharma's first-time generic of Methylphenidate Hydrochloride Oral Solution

ViroPharma second-quarter net sales increase 33% to $109.0 million

Vitro Diagnostics, Mokshagundam Biotechnologies enter contract to develop stem cell-derived food

Therapists introduce new parenting skills to end child maltreatment

NEI, FDA to sponsor Glaucoma Endpoints conference

New funding made available to tackle common cause of food poisoning in the UK

Medtronic reports FDA Panel's affirmative votes on AMPLIFY rhBMP-2 Matrix for posterolateral spine fusion

PhRMA asks FDA to be more straightforward on safeguards it wants to fight drug risks

FDA accepts for filing Cladribine Tablets NDA for MS

GSK awards NCCN $4 million grant for study of ofatumumab and pazopanib

Mediomics receives additional $460,000 in STTR Phase II grant for PINCER protein assay development

U.S. Marshals seize FastSize Extender devices and FastSize EQM Erectile Quality Monitor devices

FDA clears IL's new point-of-care total bilirubin assay

AirStrip Remote Patient Monitoring solution receives FDA marketing clearance

GE Healthcare completes new $15 million medical technology manufacturing facility in Cardiff, Wales

InterMune second-quarter total revenue decreases to $5.9 million

FDA approves addition of 10 sites to WorldHeart's Levacor VAD BTT clinical study

Scientists develop novel chemotherapeutic method for anticancer drug delivery

WWHI participates in joint meeting to explore barriers to wireless communications, health care solutions

Momenta Pharmaceuticals provides update on generic Lovenox ANDA litigation

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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