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U.S. approves first pre-surgical breast cancer drug

September 30, 2013 1:12 pm | by MATTHEW PERRONE - AP Health Writer - Associated Press | News | Comments

A biotech drug from Roche has become the first medicine approved to treat breast cancer before surgery, offering an earlier approach against one of the deadliest forms of the disease. The U.S. Food and Drug Administration (FDA) approved Perjeta for women with a form of early-stage breast cancer who face a high risk of having their cancer spread to other parts of the body.

Obama moves to limit power-plant carbon pollution

September 20, 2013 3:40 pm | by DINA CAPPIELLO - Associated Press - Associated Press | News | Comments

Linking global warming to public health, disease and extreme weather, the Obama administration pressed ahead Friday with tough requirements to limit carbon pollution from new power plants, despite protests from industry and Republicans that it would dim coal's future. The proposal, which would set the first national limits on heat-trapping pollution from future power plants, is intended to help reshape where Americans get electricity.

FDA panel backs drug for early-stage breast cancer

September 12, 2013 2:52 pm | by The Associated Press | News | Comments

Government cancer experts say a drug from Roche has shown effectiveness as a new option to treat breast cancer before tumor-removing surgery. The U.S. Food and Drug Administration panel voted 13-0, with one abstention, that the benefits of Perjeta as an initial treatment for breast cancer outweigh its risks.

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Web tool expands access to scientific, regulatory chemical information

September 9, 2013 12:54 pm | News | Comments

The U.S. Environmental Protection Agency (EPA) has launched a web-based tool, called ChemView, to significantly improve access to chemical specific regulatory information developed by EPA and data submitted under the Toxic Substances Control Act. The tool displays key health and safety data in an online format that allows comparison of chemicals by use and by health or environmental effects.

FDA approves Celgene drug for pancreatic cancer

September 6, 2013 7:07 pm | by The Associated Press | News | Comments

Federal regulators have approved Celgene Inc.'s drug Abraxane to treat late-stage pancreatic cancer. In experimental trials, the drug extended the lives of patients by a little less than two months more than those treated with the current standard drug.

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.

PayPal looks to conquer space (payments)

June 28, 2013 9:42 am | by Barbara Ortutay, AP Technology Writer | News | Comments

eBay Inc.'s payments business, PayPal, says it is launching an initiative called PayPal Galactic with the help of the nonprofit SETI Institute and the Space Tourism Society, an industry group focused on space travel. Its goal, PayPal says, is to work out how commerce will work in space. In addition to regulatory and technical issues, even the currency that is to be used is up for debate.

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.

NIH to retire most chimps from medical research

June 26, 2013 1:49 pm | by LAURAN NEERGAARD - AP Medical Writer - Associated Press | News | Comments

It's official: The National Institutes of Health plans to end most use of chimpanzees in government medical research, saying humans' closest relatives "deserve special respect." The NIH announced Wednesday that it will retire about 310 government-owned chimpanzees from research over the next few years, and keep only 50 others essentially on retainer.

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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.

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.

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.

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