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Gates annual letter addresses importance of innovation for global health, agriculture

In his second annual letter, Bill Gates reflects on the Bill & Melinda Gates Foundation's work and the importance innovation will play in overcoming some of the world's greatest challenges, including in global health and agriculture, the Associated Press reports. "Gates says the foundation currently is backing 30 areas of innovation including online learning, teacher improvement, malaria vaccine development, HIV prevention, and genetically modified seeds," according to the news service (Gordon Blankinship, 1/25).

27 Jan 2010

FDA approves the NDA of Roxane Laboratories' Morphine Sulfate Oral Solution CII

Roxane Laboratories, Inc. announced today the New Drug Application (NDA) approval of Morphine Sulfate Oral Solution CII, 100mg/5mL (20mg/mL) 30mL and 120mL bottles as of January 25th, 2010 by the Food and Drug Administration.

27 Jan 2010

Majority of inuit preschoolers live in food-insufficient households

Seventy percent of Inuit preschoolers in Nunavut, Canada's largest territory, live in households where there isn't enough food, a situation with implications for children's academic and psychosocial development, found an article in CMAJ (Canadian Medical Association Journal) (pre-embargo link only) http://www.cmaj.ca/embargo/cmaj091297.pdf.

27 Jan 2010

Sumavel DosePro and Levadex to earn up to $400M by 2018

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that Zogenix/Astellas Pharma/Desitin Pharmaceuticals' needle-free Sumavel DosePro, which launched earlier this month in the United States, and MAP Pharmaceuticals' orally-inhaled Levadex will earn approximately $400 million in combined sales by 2018 in the migraine drug market.

27 Jan 2010

Sinobiopharma's solid dosage Perindopril production facility receives Chinese SFDA approval

Sinobiopharma, Inc. is pleased to announce that its production facility for solid dosage Perindopril has passed the required Chinese State Food and Drug Administration (SFDA) inspection and is now approved for production and marketing.

27 Jan 2010

EpiCept's NP-1 for treatment of PHN receives FDA orphan drug designation

EpiCept Corporation announced today that EpiCeptTM NP-1 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of post-herpetic neuralgia (PHN). NP-1 is a prescription topical analgesic cream designed to provide long-term relief from the pain of peripheral neuropathies.

27 Jan 2010

Eating green leafy vegetables could reverse the effects of aflatoxin poisoning

Not only are the vitamins and minerals good for you, but eating greens could also save your life, according to a recent study led by the National Nuclear Security Administration's Lawrence Livermore National Laboratory scientists.

27 Jan 2010

Donors agree to 10-Year Haitian rebuilding effort amid concerns; no firm financial commitments

At a meeting in Montreal, Canada, on Monday, international donors noted concerns, but agreed to a 10-year reconstruction plan to rebuild Haiti, the New York Times reports. "Given Haiti's long history of mismanagement of funds, international donors were hesitant to write a blank check. And foreign governments had concerns as well about the government's ability to direct a large reconstruction project after most government buildings were flattened or severely damaged in the Jan. 12 quake," the newspaper writes (Lacey/Thompson, 1/25).

27 Jan 2010

FDA approves oral pain relief solution for opioid-tolerant patients

The U.S. Food and Drug Administration today approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients. This medicine will be available in 100 milligrams per 5 mL or 20 milligrams per 1 mL.

27 Jan 2010

AIDS Healthcare Foundation bans Merck's sales representatives for unwarranted pricing of Isentress

AIDS Healthcare Foundation, the largest global AIDS organization which operates free AIDS treatment clinics in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe, including 18 healthcare centers in California, Florida, and Washington, DC, has banned pharmaceutical sales representatives from Merck and Co. Pharmaceuticals, from calling on AHF’s medical providers and staff in its US healthcare centers.

27 Jan 2010

Medtronic' Melody Transcatheter Pulmonary Valve receives FDA approval under HDE

In a significant development for congenital heart disease patients, Medtronic, Inc. (NYSE: MDT), announced today that its Melody® Transcatheter Pulmonary Valve has received U.S. Food and Drug Administration (FDA) approval under a Humanitarian Device Exemption (HDE).

27 Jan 2010

Osiris Therapeutics completes enrollment in Prochymal MSC therapy Phase II trial for type 1 diabetes

Osiris Therapeutics, Inc. today announced that it has achieved a $750,000 milestone payment from the Juvenile Diabetes Research Foundation (JDRF) for completing enrollment in a Phase II clinical trial evaluating Prochymal, an adult mesenchymal stem cell (MSC) therapy, as a treatment for patients recently diagnosed with type 1 diabetes. The milestone is the fourth in a series of payments resulting from JDRF’s partnership with Osiris for the development of a therapy for type 1 diabetes.

27 Jan 2010

AAN guideline finds diazepam drug is effective for treating children with cerebral palsy

A new guideline from the American Academy of Neurology and the Child Neurology Society finds botulinum toxin type A to be an effective treatment for spasticity, muscle tightness that interferes with movement, in children and adolescents with cerebral palsy, but poses some risk.

27 Jan 2010

FDA approves Victoza to treat type 2 diabetes in some adults

The U.S. Food and Drug Administration today approved Victoza (liraglutide), a once-daily injection to treat type 2 diabetes in some adults.

27 Jan 2010

Ecolab and AvidBiotics to develop new technology to reduce E. coli in red meat products

Ecolab Inc. has entered into an agreement with AvidBiotics Corp. under which they will jointly work to develop a new technology that could significantly reduce the presence of the pathogen E. coli O157:H7 in red meat products.

27 Jan 2010

Twenty nations meet in Montreal to discuss Haiti recovery; Haitian officials increase Port-Au-Prince death toll estimate

Officials from 20 countries are meeting in Montreal, Canada, Monday "to discuss long-term reconstruction and arrangements for a donor conference to be held in March," the U.N. said, Bloomberg reports (Gaouette/Craze, 1/25). "U.S. Secretary of State Hillary Clinton, Canadian Prime Minister Stephen Harper, French Foreign Minister Bernard Kouchner and others will examine eventual debt forgiveness and" a strategy for rebuilding Haiti at the one-day gathering, according to Reuters (Palmer, 1/25).

27 Jan 2010

Phadia's ImmunoCAP Rapid System receives FDA marketing clearance

Phadia, the world leader in allergy blood testing diagnostics, today announced that the United States Food and Drug Administration (FDA) has cleared the ImmunoCAP® Rapid Reader II, a part of the ImmunoCAP Rapid System, used to aid in the diagnosis of allergy in the physician’s office.

27 Jan 2010

FDA approves Novo Nordisk's Victoza for type 2 diabetes

Novo Nordisk, a global healthcare company, announced today the U.S. Food and Drug Administration (FDA) approved the new drug application for Victoza® (liraglutide [rDNA origin] injection), the first once-daily human glucagon-like peptide-1 (GLP-1) analog for the treatment of type 2 diabetes. Victoza is indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

27 Jan 2010

ZIOPHARM receives Notice of Allowance for palifosfamide from U.S. patent office

ZIOPHARM Oncology, Inc. announced today that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for Application Serial No. 11/257,766 entitled “Salts of Isophosphoramide mustard and analogs thereof as anti-tumor agents” with claims directed to compounds, pharmaceutical compositions, and lyophilisates. These claims cover the Company’s proprietary palifosfamide composition (ZIO-201 or ZymafosTM). The Company has recently reported positive randomized Phase II sarcoma interim data for intravenous palifosfamide at the Annual Meeting of the Connective Tissue Oncology Society (CTOS) on November 6, 2009 and expects, following U.S. Food and Drug Administration (FDA) review, to initiate a registration trial the first half of 2010.

27 Jan 2010

FDA approves first heart valve conduit that can delay need for open-heart surgery

The U.S. Food and Drug Administration today approved the Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System, the first heart valve to be implanted through a catheter, or tube, in a leg vein and guided up to the heart. This new approach to the treatment of adults and children with previously implanted, poorly functioning pulmonary valve conduits can delay the need for open-heart surgery.

27 Jan 2010

Food News and Research

Gates annual letter addresses importance of innovation for global health, agriculture

FDA approves the NDA of Roxane Laboratories' Morphine Sulfate Oral Solution CII

Majority of inuit preschoolers live in food-insufficient households

Sumavel DosePro and Levadex to earn up to $400M by 2018

Sinobiopharma's solid dosage Perindopril production facility receives Chinese SFDA approval

EpiCept's NP-1 for treatment of PHN receives FDA orphan drug designation

Eating green leafy vegetables could reverse the effects of aflatoxin poisoning

Donors agree to 10-Year Haitian rebuilding effort amid concerns; no firm financial commitments

FDA approves oral pain relief solution for opioid-tolerant patients

AIDS Healthcare Foundation bans Merck's sales representatives for unwarranted pricing of Isentress

Medtronic' Melody Transcatheter Pulmonary Valve receives FDA approval under HDE

Osiris Therapeutics completes enrollment in Prochymal MSC therapy Phase II trial for type 1 diabetes

AAN guideline finds diazepam drug is effective for treating children with cerebral palsy

FDA approves Victoza to treat type 2 diabetes in some adults

Ecolab and AvidBiotics to develop new technology to reduce E. coli in red meat products

Twenty nations meet in Montreal to discuss Haiti recovery; Haitian officials increase Port-Au-Prince death toll estimate

Phadia's ImmunoCAP Rapid System receives FDA marketing clearance

FDA approves Novo Nordisk's Victoza for type 2 diabetes

ZIOPHARM receives Notice of Allowance for palifosfamide from U.S. patent office

FDA approves first heart valve conduit that can delay need for open-heart surgery

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

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