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FDA grants priority review to Pharmacyclics drug

August 29, 2013 7:54 am | by The Associated Press | News | Comments

Pharmacyclics is getting a priority review of its blood cancer treatment by federal regulators. A priority review shortens a drug evaluation by the U.S. Food and Drug Administration from 10 months to six. The acceptance of the application triggers a $75 million milestone payment to Pharmacyclics from Johnson & Johnson's Janssen unit.

Onyx, Bayer expect new Nexavar decision by Dec. 25

August 27, 2013 11:17 am | by The Associated Press | News | Comments

Onyx Pharmaceuticals and Bayer said Tuesday that regulators will conduct a faster review of their pill Nexavar as a treatment for thyroid cancer. The U.S. Food and Drug Administration (FDA) is reviewing Nexavar as a treatment for locally advanced or metastatic thyroid cancer that doesn't respond to treatment with radioactive iodine. The companies said the FDA expects to complete its review by Dec. 25. to.

Dropout rates for oncology Phase I trials remain under 10%

August 26, 2013 8:12 am | by The Associated Press | News | Comments

The overall dropout rate for oncology Phase I trials is very low at only 8%, a study by Cutting Edge Information found. However dropout rates tend to rise as the number of required visits increases. The study discovered that the average number of patients enrolled for these trials across all therapeutic areas is 47.2.

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FDA proposes rules for safer imported foods

July 26, 2013 5:14 pm | by MARY CLARE JALONICK - Associated Press - Associated Press | News | Comments

Chances are that about 15% of the food you eat—more if your diet includes lots of fruits, vegetables and cheese—comes from abroad, and the government is taking steps now to make it safer. New rules proposed Friday by the U.S. Food and Drug Administration would make U.S. food importers responsible for ensuring that their foreign suppliers are handling and processing food safely.

Activists warn trade pact will keep out generics

July 3, 2013 4:42 am | by EILEEN NG - Associated Press - Associated Press | News | Comments

A free trade pact being negotiated by the U.S. and 11 Asia-Pacific nations will impose aggressive intellectual property rules that will restrict access to affordable medicines in developing nations, health activists warned Wednesday. The 12 countries will start an 18th round of talks in Malaysia on July 15 and hope to complete negotiations by October.

Biopharma Software Solution

June 27, 2013 2:04 pm | Product Releases | Comments

Dassault Systèmes, a maker of solutions for 3-D design and product lifecycle management, has launched a new industry solution experience for pharmaceutical and biotech companies, called “Licensed to Cure for BioPharma.” Based on Dassault Systèmes’ 3DEXPERIENCE platform, the new solution helps biotech and pharmaceutical companies manage product and process complexity by smoothing drug variation, enabling easier and faster expansion into new markets, and managing increasing regulatory requirements.

Policy issues plague hydropower as wind power backup

June 25, 2013 11:25 am | News | Comments

Theoretically, hydropower can step in when wind turbines go still, but barriers to this non-polluting resource serving as a backup are largely policy- and regulation-based, according to Penn State Univ. researchers. The U.S. Dept. of Energy recently examined the feasibility of producing 20% of U.S. electricity from wind by 2030. 

U.S. court says human genes cannot be patented

June 13, 2013 11:53 am | by JESSE J. HOLLAND - Associated Press Writer - Associated Press | News | Comments

The U.S. Supreme Court ruled Thursday that companies cannot patent parts of naturally-occurring human genes, a decision with the potential to profoundly affect the emerging and lucrative medical and biotechnology industries. The high court's unanimous judgment reverses three decades of patent awards by government officials.

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Agilent announces compliance with RoHS directive

June 10, 2013 4:25 pm | News | Comments

Agilent Technologies Inc. announced that the majority of its electronic test and measurement products are now designed for compliance with the European Union’s restrictions on the use of certain hazardous substances in electrical and electronic equipment. Commonly referred to as RoHS, the European directive bans the sale of equipment containing more than the agreed level of lead, mercury, cadmium and other substances.

U.N. chemicals summit expected to adopt new controls

April 27, 2013 1:42 pm | by JOHN HEILPRIN - Associated Press - Associated Press | News | Comments

At the start of a major conference to regulate chemical and hazardous waste safety, top officials voiced optimism Saturday that delegates will approve new international controls on several industrial compounds and agree to clamp down on some cross-border pollution.

A Close Eye on Nanotechnology

April 24, 2013 12:30 pm | by Lindsay Hock | Articles | Comments

Nanotechnology typically describes any material, device, or technology where feature sizes are smaller than 100 nanometers in dimension. However, this new and uncharted direction in research provides a large spark for new product and drug delivery development. To achieve these discoveries, scientists must rely on specialized instruments and materials to drive their experiments and analysis.

IAEA: Japan nuke cleanup may take more than 40 yrs

April 22, 2013 11:59 am | by Mari Yamaguchi, Associated Press | News | Comments

A U.N. nuclear watchdog team said Japan may need longer than the projected 40 years to decommission its tsunami-crippled nuclear plant and urged its operator to improve plant stability. Damage at the Fukushima Dai-ichi plant is so complex that it is "impossible" to predict how long the cleanup may last.

Hawaii land board approves Thirty Meter Telescope

April 15, 2013 8:39 am | by Audrey McAvoy, Associated Press | News | Comments

A plan by California and Canadian universities to build the world's largest telescope at the summit of Hawaii's Mauna Kea volcano won approval from the state Board of Land and Natural Resources on Friday, clearing the way for a land lease negotiation. The telescope, with its proposed 30-m long segmented primary mirror, should help scientists see some 13 billion light years away.

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Court: Can human genes be patented?

April 15, 2013 3:38 am | by JESSE J. HOLLAND - Associated Press - Associated Press | News | Comments

DNA may be the building block of life, but can something taken from it also be the building block of a multimillion-dollar medical monopoly? The Supreme Court grapples Monday with the question of whether human genes can be patented. Its ultimate answer could reshape U.S. medical research, the fight against diseases like breast and ovarian cancer and the multibillion-dollar medical and biotechnology business.

FDA approves first-of-its-kind diabetes drug from J&J

March 29, 2013 3:38 pm | by The Associated Press | News | Comments

The Food and Drug Administration on Friday approved a first-of-its-kind diabetes drug from Johnson & Johnson that uses a new method to lower blood sugar—flushing it out in patients' urine. The agency cleared J&J's Invokana tablets for adults with Type 2 diabetes, which affects an estimated 26 million Americans. The once-a-day medication works by blocking the kidneys from reabsorbing sugar, which occurs at higher levels in patients with diabetes than in healthy patients.

High court weighs drug companies' generics policy

March 25, 2013 3:14 am | by JESSE J. HOLLAND - Associated Press - Associated Press | News | Comments

Federal regulators are pressing the Supreme Court to stop big pharmaceutical corporations from paying generic drug competitors to delay releasing their cheaper versions of brand-name drugs. They argue these deals deny American consumers, usually for years, steep price declines that can top 90%.

EU fines Microsoft $733M for breaking browser pact

March 7, 2013 9:18 am | by Toby Sterling, Associated Press | News | Comments

The European Union has fined Microsoft €561 million ($733 million) for breaking a pledge to offer personal computer users a choice of Internet browsers when they install the company's flagship Windows operating system. The penalty imposed by the EU's executive arm, the Commission, is a first for Brussels: no company has ever failed to keep its end of a bargain with EU authorities before.

DOE plays major role in FDA-approved retinal prosthesis

February 20, 2013 8:02 am | News | Comments

The U.S. Department of Energy announced that its support for a decade of revolutionary research has contributed to the creation of the first-ever retinal prosthesis, or bionic eye, to be approved in the United States by the U.S. Food and Drug Administration for blind individuals with end-stage retinitis pigmentosa. The artificial retina, dubbed the Argus II Retinal Prosthesis System, a previous R&D 100 winner, can partially restore the sight of blind individuals after surgical implantation.

U.N. agency moves to kill aircraft battery exemption

February 12, 2013 11:08 am | by JOAN LOWY - Associated Press - Associated Press | News | Comments

A U.N. agency that sets global aviation safety standards is moving to prevent aircraft batteries like the one that caught fire on a Boeing 787 last month from being shipped as cargo on passenger planes, people familiar with the effort said.

U.S. warns of new fake batch of cancer drug Avastin

February 6, 2013 12:25 pm | by The Associated Press | News | Comments

The Food and Drug Administration is warning U.S. doctors about another counterfeit version of the cancer drug Avastin, the third case involving the best-selling Roche drug in the past year. The FDA said in an online post Tuesday that at least one batch of the drug distributed by a New York company does not contain the active ingredient in real Avastin, which is used to treat cancers of the colon, lung, kidney, and brain.

Treaty aimed at reducing mercury emissions signed

January 19, 2013 4:35 am | by The Associated Press | News | Comments

U.N. officials say more than 130 nations have adopted the first legally binding international treaty aimed at reducing mercury emissions. The U.N. Environment Program says the treaty was adopted Saturday morning, after all-night negotiations that capped a week of talks.

Judge backs NASA lab in work discrimination case

November 5, 2012 10:32 am | News | Comments

A California judge has tentatively ruled in favor of NASA's Jet Propulsion Laboratory in a wrongful termination lawsuit brought by a former computer specialist who alleged he was singled out in part because of his belief in intelligent design.

Article: New technology being stymied by copyright law

September 17, 2012 5:08 am | News | Comments

From Napster to iTunes to Pandora, the methods by which the public can obtain and share music have rapidly progressed. Future groundbreaking innovations may need to wait, though, as the next generation of technology is being stymied by the very copyright laws that seek to protect the industry, says Rutgers-Camden University professor Michael Carrier in a new article for a law journal..

EPA releases nanomaterial case study regarding nanoscale silver

August 6, 2012 6:05 am | News | Comments

The U.S. Environmental Protection Agency has completed and published a comprehensive environmental assessment (CEA) framework study of engineered nanoscale silver, specifically with regard to its behavior in disinfectant sprays. Though not a formal assessment, many factors such as product life cycle, environmental transport and fate, exposure-dose in receptors, and potential impacts in these receptors are covered in the report.

Gas drilling research suffers from lack of funding

August 2, 2012 10:28 am | by Kevin Begos, Associated Press | News | Comments

Is gas drilling ruining the air, polluting water and making people sick? The evidence is sketchy and inconclusive, but a lack of serious funding is delaying efforts to resolve those pressing questions and creating a vacuum that could lead to a crush of lawsuits, some experts say.

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