health: Lincoln Tribune

الثلاثاء، 31 يناير 2012

Lincoln Tribune

U.S. FDA approves new skin cancer medicine
Norway sentences 3 for terrorist plot against Danish newspaper
Small plane’s propeller kills pilot at San Diego-area airport
Sweden halts all deportations to Syria due to violence
UN experts begin evaluating effects of Fukushima nuclear disaster

U.S. FDA approves new skin cancer medicine

Posted: 31 Jan 2012 02:09 AM PST

WASHINGTON, D.C. (BNO NEWS) -- The United States Food and Drug Administration (FDA) on Monday announced the approval of a drug to treat one of most common types of skin cancer.

The FDA approved Erivedge (vismodegib), reviewed under the agency's priority review program and ahead of the March 8 prescription user fee goal date, to treat adult patients with basal cell carcinoma, the most common type of skin cancer.

The drug, however, is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic).

Basal cell carcinoma is generally a slow growing and painless form of skin cancer that starts in the top layer of the skin (epidermis). The cancer develops on areas of skin that are regularly exposed to sunlight or other ultraviolet radiation.

Erivedge is the first FDA-approved drug for metastatic basal cell carcinoma and was reviewed under the FDA's priority review program that provides for an expedited six-month review of drugs that may offer major advances in treatment.

"Our understanding of molecular pathways involved in cancer, such as the Hedgehog pathway, has enabled the development of targeted drugs for specific diseases," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.

"This approach is becoming more common and will potentially allow cancer drugs to be developed more quickly. This is important for patients who will have access to more effective therapies with potentially fewer side effects," Pazdur added.

The safety and effectiveness of Erivedge was evaluated in a single, multi-center clinical study in 96 patients with locally advanced or metastatic basal cell carcinoma. The clinical study's primary endpoint was objective response rate (ORR) or the percentage of patients who experienced complete and partial shrinkage or disappearance of the cancerous lesions after treatment.

Of the patients with metastatic disease receiving Erivedge, 30 percent experienced a partial response and 43 percent of patients with locally advanced disease experienced a complete or partial response, the FDA said.

Erivedge, which is a pill taken once a day, works by inhibiting the Hedgehog pathway, a pathway that is active in most basal cell cancers and only a few normal tissues, such as hair follicles.

The most common side effects observed in patients treated with Erivedge were muscle spasms, hair loss, weight loss, nausea, diarrhea, fatigue, distorted sense of taste, decreased appetite, constipation, vomiting, and loss of taste function in the tongue.

The FDA said Erivedge is being approved with a boxed warning alerting patients and health care professionals of the potential risk of death or severe birth effects to a fetus. Also, pregnancy status must be verified prior to the start of Erivedge treatment. Male and female patients should be warned about these risks and the need for birth control, the FDA cautioned.

Norway sentences 3 for terrorist plot against Danish newspaper

Posted: 31 Jan 2012 02:01 AM PST

OSLO, NORWAY (BNO NEWS) -- A Norwegian court on Monday convicted and sentenced three people for their roles in a terrorist plot to attack a Danish newspaper which caricatured the Prophet Muhammad, officials said.

40-year-old Mikael Davud, 38-year-old Iraqi-Kurd Shawan Sadek Saeed Bujak and 33-year-old Uzbek David Jakobsen were all sentenced for their roles in a terror plot against the Danish newspaper Jyllands-Posten and murder the newspaper's cartoonist, Kurt Westergaard.

Controversy began after the Jyllands-Posten newspaper published several cartoons in 2005 depicting Mohammed, one of the most important Muslim religious figures. One of the most controversial publications was one drawn up by Westergaard and showed Mohammed wearing a bomb-like turban.

The publications caused widespread protests, including from Muslims in Denmark and elsewhere in the world. Despite public apologies, the Danish newspaper has maintained its stand on freedom of speech and its right to publish the cartoons.

Following the arrest of the three individuals in February 2008, the Jyllands-Posten again published the cartoons to show its commitment to freedom of speech.

In addition to the terrorist plot in Denmark, the three individuals were also allegedly linked to al-Qaeda and plans to attack both U.S. and British targets in 2009. The men have denied those charges.

Davud was sentenced to seven years in prison while Bujak received a prison term of 3.5 years. Jakobsen, who assisted police in the investigation and was as a result cleared of terrorism charges, was handed down a four-month prison term.

Small plane’s propeller kills pilot at San Diego-area airport

Posted: 30 Jan 2012 05:52 PM PST

SAN DIEGO, CALIFORNIA (BNO NEWS) -- A private pilot was killed on Monday morning when he was struck in the face by the propeller of his small plane at a San Diego-area airport, federal officials said.

The gruesome accident happened at approximately 8:30 a.m. local time when the pilot, whose identity was not immediately released, got out of his single-engine Piper Cherokee aircraft in the ramp area at Gillespie Field in El Cajon, a city in San Diego County.

"The pilot [..] got out of the aircraft in the ramp area and was struck in the head by the moving propeller. He was taken to a hospital with critical injuries," said Ian Gregor, a spokesman for the Federal Aviation Administration (FAA). The victim died several hours later at Sharp Memorial Hospital.

According to FAA records, the 1974-built aircraft was registered to a man in Lakeside, California.

Both the FAA and the National Transportation Safety Board (NTSB) will investigate the cause of the accident. "NTSB is the lead investigative agency," Gregor said.

Sweden halts all deportations to Syria due to violence

Posted: 30 Jan 2012 05:10 PM PST

STOCKHOLM (BNO NEWS) -- The Swedish Migration Board on Monday decided to suspend all expulsions and deportations to Syria due to the rapidly deteriorating security situation in the country, officials said.

Syria has been gripped by violence since pro-democracy demonstrations spread across the country in March 2011, resulting in a fierce government crackdown which has left at least 5,400 people killed. According to the opposition Local Coordination Committees in Syria (LCC), up to 100 people were killed on Monday alone.

"Now the violence has worsened, meaning no decision on deportation or expulsion may be enforced," the agency said in a brief statement. It attributed the suspension to the rising number of civilian casualties and increasing signs that the situation has escalated to an armed conflict.

Last month, Mikael Ribbenvik, Head of the Division for Legal Control at the Migration Board, announced that Swedish authorities would be able to more easily grant protection to Syrian immigrants in Sweden. "We are following events in Syria on a day by day basis and are very concerned about the situation," he said at the time. "More and more Syrians are receiving protection in Sweden."

On Saturday, Arab League Secretary-General Nabil el-Araby decided to suspend its observer mission in Syria due to an escalation of violence. The 100 observers arrived in Syria late last month to verify whether the regime has taken measures to protect civilians, but many of the observers refused to leave their hotels in Damascus on Friday and Saturday amid reports of increasing violence.

UN experts begin evaluating effects of Fukushima nuclear disaster

Posted: 30 Jan 2012 02:10 PM PST

NEW YORK/VIENNA (BNO NEWS) -- The United Nations (UN) on Monday announced that a group of international experts is assessing the radiation damage caused by the accident at the Fukushima Daiichi nuclear power plant in Japan last year.

The group of sixty experts kicked off a week-long meeting in the Austrian capital of Vienna on Monday in order to identity critical gaps in the data which is available, where additional focus is required, and how to ensure the quality and reliability of what the assessment is based on.

"We are putting together a jigsaw puzzle, evaluating the exposures of the general public, of workers, and radiation effects, and looking for the missing pieces," said Wolfgang Weiss, Chair of the UN Scientific Committee on the Effects of Atomic Radiation (UNSCEAR).

The power plant was damaged in March 2011 when a massive 9.0-magnitude earthquake and resulting tsunami struck to eastern coast of Japan. The disaster knocked out water cooling systems at the plant, contaminating air, water, plants and animals with radioactive plumes dozens of kilometers (miles) from the site.

Data is being collected and evaluated from different sources, including Japan, the UN Food and Agriculture Organization (FAO), the World Meteorological Organization (WMO), the Preparatory Commission for the Comprehensive Nuclear-Test-Ban Treaty Organization, the World Health Organization (WHO) and the International Atomic Energy Agency (IAEA).

A preliminary report about the effects of the nuclear disaster, the worst since Chernobyl, will be released during UNSCEAR's annual meeting which is to be held from May 21 to May 25. A final report is expected to be presented to the UN General Assembly in 2013.

Meanwhile, the Japanese government has asked the IAEA to open an office in Fukushima to assist with the recovery efforts. "The IAEA is giving careful consideration to a request from Japan to open an office in Fukushima, but nothing has been decided yet," an IAEA spokesperson said on Monday. "The IAEA will consult as necessary on this matter."

At least 15,845 people were killed as a result of the earthquake and tsunami while 3,380 others remain missing. There are still tens of thousands of people who are staying in shelters in 21 prefectures across Japan.

health

الثلاثاء، 31 يناير 2012

Lincoln Tribune

Lincoln Tribune

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