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Federal advisory panel with reservations, recommends keeping Avandia on the Market

Federal advisers delivered a mixed verdict Wednesday on the diabetes drug Avandia,with a significant number of experts voting to recommend that it be pulled from the market because of safety concerns but a majority urging to keep it available, perhaps with tough new restrictions and new warnings.Avandia was once the world's most popular diabetes drugs but has become the focus of intense debate because of concerns that it increases the risk for heart attacks and strokes.

16 Jul 2010

Columbia scientists discover new way to alleviate chronic pain

Columbia scientists working to combat injury-related depression, substance abuse and suicide due to unremitting, persistent pain may have discovered a new way of treating that pain: a powerful analgesic dubbed N60 that leads to neither tolerance nor addiction.

16 Jul 2010

Judge says FTC likely overstepped authority in sharing drugmaker pay-for-delay info

A judge Wednesday criticized the Federal Trade Commission for the "strong possibility" that it "overstepped its bounds and shared confidential information" in a pay-for-delay case between the government and a generic drug company, Reuters reports.

16 Jul 2010

Arsenic nanoparticle to combat aggressive type of breast cancer prevalent in young women

You can teach an old drug new chemotherapy tricks. Northwestern University researchers took a drug therapy proven for blood cancers but ineffective against solid tumors, packaged it with nanotechnology and got it to combat an aggressive type of breast cancer prevalent in young women, particularly young African-American women.

16 Jul 2010

i26 hyperimmune egg balances improper immune inflammatory response

Our immune systems are in a constant battle with foreign invaders to keep our bodies healthy. Outside forces like pollution, poor nutrition and new strains of disease keep our immune systems at an overly boosted or inflamed state, which affects energy levels, body and emotional health and overall quality of life. Through inflammatory immune cells, our bodies fight to defend us from this onslaught. Too few of these cells can result in illness, while too many could lead to a high immune response, resulting in heightened inflammation and collateral damage to the body's once-healthy tissues.

16 Jul 2010

ACTOS offers safety profile regarding risk of CV events in people with type 2 diabetes: Takeda

The U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee held a joint meeting primarily focused on reviewing the cardiovascular safety of rosiglitazone, as presented by the FDA and GlaxoSmithKline. Following this two day discussion, Takeda Pharmaceuticals North America, Inc. ("Takeda") underscores its position that ACTOS (pioglitazone HCl) offers an established safety profile regarding the risk of CV events in people living with type 2 diabetes.

16 Jul 2010

Glaxo announces a $2.3 billion in legal liability charges

British pharmaceutical giant GlaxoSmithKline, announced this Thursday that its second-quarter charges related to legal cases involving the two drugs Avandia (diabetes drug) and Paxil (drug for anxiety and depression) would run up to $2.36 billion. Avandia’s use and its potential risk of causing heart problems were being debated this week by an advisory panel to the US Food & Drugs Administration (FDA).

16 Jul 2010

$235 million announced for expansion of biotech sector at CSL

A $235 million expansion of Australia's largest biotech facility in Melbourne is planned and this is expected to create hundreds of jobs. CSL biopharmaceutical research complex in Broadmeadows, in the north of Melbourne will be receiving this financial aid from both the State as well as Federal government over a five year investment plan. This will create an estimated 320 temporary construction jobs and later 333 new highly-skilled medical research openings by 2018.

15 Jul 2010

Access announces agreement to develop oral formulation of proprietary injectable drugs

Access Pharmaceuticals, Inc., announced today that it has entered into a pre-licensing feasibility agreement with a leading biotechnology company to develop an oral formulation of its currently-marketed, proprietary injectable drugs. Access will utilize its proprietary Cobalamin Oral Drug Delivery Technology to develop oral formulations of the drug for pre-clinical testing.

15 Jul 2010

NovaBay Pharmaceuticals issued Notice of Allowance for broad portfolio of anti-infective compounds

NovaBay Pharmaceuticals, Inc. announced today that it has received a Notice of Allowance from the United States Patent and Trademark Office on a patent application for a broad portfolio of anti-infective compounds, including NVC-612. The patent will broaden protection for NovaBay's first-in-class Aganocide family of compounds, which are designed to fight infections without causing drug resistance.

15 Jul 2010

First Edition: July 15, 2010

Headlines topping today's news include reports about the White House release of new coverage rules for certain screening tests and other types of preventive care, and calls from the GOP for hearings on Berwick's recess appointment to run Medicare and Medicaid top today's news.

15 Jul 2010

Plexxikon announces promising preclinical data of PLX3397

Plexxikon Inc. today announced promising preclinical data from in vivo Alzheimer's Disease studies demonstrating a dramatic reduction in activated microglia in the brains of very old (22 months) 3xTG-AD mice, a triple transgenic model for Alzheimer's Disease. This reduction of activated microglia led to significantly improved learning in the treated group.

15 Jul 2010

New drug launches for HCV in the Philippines to increase market earned revenues to $4.5 billion by 2017

Efforts to raise disease awareness in the Philippines have increased the number of cases and patient pool available for hepatitis C treatment. Screening and detection efforts by the Red Cross as well as growing awareness in the Philippines have been largely responsible for the rise in the number of diagnosed cases. These campaigns have encouraged people, mostly from the urban areas, to opt for physical examinations that enable the detection of hepatitis C.

15 Jul 2010

Research addresses challenges for future HIV vaccine

On the eve of the world's biggest AIDS conference this month in Austria, a new research review shows many people wouldn't get inoculated against HIV even if a vaccine was developed.

15 Jul 2010

First 1M doses of smallpox vaccine for immune-compromised populations delivered

Delivery to the Strategic National Stockpile of the first 1 million doses of the nation's first smallpox vaccine for certain immune-compromised populations is now complete, the result of a Project BioShield contract.

15 Jul 2010

American Heart Association comments on FDA advisory committee's rosiglitazone recommendations

After two days of hearings, an advisory committee to the U.S. Food and Drug Administration (FDA) recommended that the FDA allow the type 2 diabetes drug rosiglitazone (brand name, Avandia), to stay on the market, but with most committee members suggesting that the label be revised to include increased warnings. Rosiglitazone is one in a class of drugs called thiazolidinediones (TZDs), used to treat type 2 diabetes.

15 Jul 2010

Aduro BioTech announces issuance of two important patents

Aduro BioTech, a clinical-stage immunotherapy company, announced today the issuance of two important patents, the formation of a distinguished scientific advisory board, the addition of key members to its Board of Directors, and the reporting of preliminary top line long-term survival data from a Phase 1 clinical trial with 2 year follow-up.

15 Jul 2010

Cervical cancer vaccine could reduce number of cases from 3,000 to less than 700 every year

The cervical cancer vaccine could prevent even more cases of the disease in England than previously thought, UK scientists have found.

15 Jul 2010

Pre-clinical study results of EVP-0015962 presented at AAICAD 2010

EnVivo Pharmaceuticals today announced at the Alzheimer's Association 2010 International Conference on Alzheimer's Disease results from its proprietary gamma-secretase modulator pre-clinical study. In a transgenic mouse model, EnVivo's EVP-0015962 reduced amyloid plaque buildup which is believed to be a cause of Alzheimer's disease, reversed behavioral deficits and reduced brain inflammation associated with Alzheimer's disease.

15 Jul 2010

Variations in quality of illegal Class B drug mephedrone could risk safety of users

Pharmaceutical scientists have discovered that the recently reclassified drug mephedrone varies in quality so much that users could be at risk of overdosing. Six samples were tested in the University of Sunderland's labs by Dr John Lough and his team, and although impurities levels were low, three samples revealed various particle size and crystalline form, which means that the drug is more likely to vary in its affect and safety on the user.

15 Jul 2010

Pharmaceutical News

Federal advisory panel with reservations, recommends keeping Avandia on the Market

Columbia scientists discover new way to alleviate chronic pain

Judge says FTC likely overstepped authority in sharing drugmaker pay-for-delay info

Arsenic nanoparticle to combat aggressive type of breast cancer prevalent in young women

i26 hyperimmune egg balances improper immune inflammatory response

ACTOS offers safety profile regarding risk of CV events in people with type 2 diabetes: Takeda

Glaxo announces a $2.3 billion in legal liability charges

$235 million announced for expansion of biotech sector at CSL

Access announces agreement to develop oral formulation of proprietary injectable drugs

NovaBay Pharmaceuticals issued Notice of Allowance for broad portfolio of anti-infective compounds

First Edition: July 15, 2010

Plexxikon announces promising preclinical data of PLX3397

New drug launches for HCV in the Philippines to increase market earned revenues to $4.5 billion by 2017

Research addresses challenges for future HIV vaccine

First 1M doses of smallpox vaccine for immune-compromised populations delivered

American Heart Association comments on FDA advisory committee's rosiglitazone recommendations

Aduro BioTech announces issuance of two important patents

Cervical cancer vaccine could reduce number of cases from 3,000 to less than 700 every year

Pre-clinical study results of EVP-0015962 presented at AAICAD 2010

Variations in quality of illegal Class B drug mephedrone could risk safety of users

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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