Honduras approves shooting down suspected drug planes

TEGUCIGALPA (Reuters) - Honduran lawmakers on Friday approved legislation allowing the government to shoot down planes suspected of trafficking illegal drugs through the poor nation that has been hit by deepening gang violence.

The legislation authorizes progressive use of force to make unidentified aircraft land. Only the country's defense minister can order that a plane be shot down, the legislation said.

Most of the cocaine destined for the United States moves though Honduras, where Mexican drug gangs have moved in as they take increasing control over the drug trade from Colombian traffickers.

The Honduran military shot down two small planes in 2012 that were suspected of carrying drugs. The incident pushed the United States to suspend anti-drug radar support to Honduran authorities for about three months.

Conservative Juan Hernandez was elected president last November after promising a tough militarized response to drug gang violence that has driven Honduras' murder rate to the world's highest.

Honduras has said it will buy three radar systems from Israel that it can use to track planes suspected of carrying illegal drugs.

(Reporting by Gustavo Palencia; Editing by Ken Wills)

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U.S. approves first artificial pancreas system for diabetics

(Reuters) - The U.S. Food and Drug Administration has approved the first artificial pancreas system for diabetics that reads blood sugar levels and automatically shuts off the flow of insulin.

The device, made by Medtronic Inc, could help the 3 million Americans living with type 1 diabetes better manage their disease, which causes the immune system to destroy cells in the pancreas that make insulin.

Patients suffering from type 1 diabetes, the inherited version of the disease, have to regularly monitor their blood sugar levels and take insulin several times a day.

Too little or too much of insulin can lead to several health problems, ranging from kidney failure and heart disease to brain damage.

The device includes an insulin pump and a glucose sensor that stops insulin delivery when blood glucose reaches a preset level.

The system has been approved for use by diabetics aged 16 years and older. Medtronic said it would conduct a post-approval study that would include children aged 2 years and older.

The Minneapolis, Minnesota-based company said it would begin ramping up production immediately to prepare for a launch in the next few weeks.

The company will also directly follow up with patients and make certain manufacturing changes according to the requirements of the approval and an accompanying warning letter it was issued on September 19.

Medtronic said it has already addressed many of the observations in the warning letter and was committed to resolving the remaining issues as quickly as possible.

(Reporting by Esha Dey and additional reporting by Natalie Grover in Bangalore; Editing by Kirti Pandey)

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FDA Approves New Drug for Advanced Lung Cancer

FRIDAY, July 12 (HealthDay News) -- A new drug to treat advanced lung cancer has been approved by the U.S. Food and Drug Administration.

Gilotrif (afatinib) is approved to treat patients with a specific subtype of of non-small cell lung cancer (NSCLC). About 85 percent of lung cancers are NSCLC, making it the most common type of lung cancer.

Gilotrif is approved to treat tumors that carry key deletions on the epidermal growth factor receptor (EGFR) gene, long a target for lung cancer therapeutics. Mutations in the EGFR gene are thought to occur in about 10 percent of non-small cell lung cancers, and most of those mutations are targeted by Gilotrif, the FDA said.

Experts were pleased with the drug's approval.

"This drug represents a new important alternative to standard chemotherapy in the 10 to 15 percent of lung cancer patients who have EGFR mutations," said Dr. Jorge Gomez, medical director of the thoracic oncology program at Mount Sinai Medical Center in New York City. The new medication "is the first drug to be developed and approved for patients selected for EGFR mutations," he pointed out.

Dr. Len Horovitz is a pulmonary specialist at Lenox Hill Hospital in New York City. He explained that the "genetic evaluation of lung cancer tissue has evolved so that newer mutations can be targeted in treatment," and new drugs such as Gilotrif "complement standard chemotherapy [and] give hope of increased survival even in late stage lung cancer."

Gilotrif is in a class of cancer drug called tyrosine kinase inhibitors. These drugs block proteins that promote the development of cancerous cells.

According to the FDA, Gilotrif was approved alongside the therascreen EGFR RGQ PCR Kit -- a companion diagnostic that helps determine if a patient's lung cancer cells express these EGFR mutations.

Gilotrif's approval was based on a clinical study of 345 patients who were randomly assigned to receive either Gilotrif or up to six cycles of the chemotherapy drugs pemetrexed and cisplatin. Patients who received Gilotrif had a delay in tumor growth (progression-free survival) that was more than four months longer than those who received chemotherapy. However, there was no statistically significant difference in overall survival between the two groups of patients, the FDA said.

Along with common side effects such as itching, bladder inflammation, low blood potassium levels, fever, and eye inflammation, serious side effects associated with Gilotrif include diarrhea that can result in kidney failure and severe dehydration, severe rash, lung inflammation and liver toxicity, the agency said.

Gomez said the speed of the FDA's approval was encouraging.

"The development and approval of afatinib was significantly shorter [than that seen with prior lung cancer drugs] and reflects a clear focus toward individualizing lung cancer therapy to specific patients who are most likely to have a significant benefit," he said. "This is a clear push toward more personalized medicine."

Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, agreed.

In an agency statement, he said that Gilotrif's approval shows "how a greater understanding of the underlying molecular pathways of a disease can lead to the development of targeted treatments."

In May, the FDA approved Tarceva (erlotinib) for treatment of patients with non-small cell lung cancer. That drug was approved at the same as the cobas EGFR Mutation Test, a companion diagnostic to identify patients with tumors having the EGFR gene mutations.

Gilotrif is marketed by Boehringer Ingelheim Pharmaceuticals Inc. of Ridgefield, Conn. The companion diagnostic test is marketed by Qiagen.

More information

The U.S. National Cancer Institute has more about non-small cell lung cancer.

SOURCES: Jorge Gomez, M.D., medical director, thoracic oncology program, Mount Sinai Medical Center, New York City; Len Horovitz, M.D., pulmonary specialist, Lenox Hill Hospital, New York City; U.S. Food and Drug Administration, news release, July 12, 2013

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