UPDATE 1-FDA halts trials of Amgen drug in children, cites death

* FDA does not know if Sensipar had role in patient death

* Drug approved for adults to remove calcium from blood

Feb 26 (Reuters) - The U.S. Food and Drug Administration said on Tuesday it has stopped all pediatric clinical trials of Amgen Inc's Sensipar after the death of a 14-year-old patient taking part in a study of the drug.

Sensipar, which is approved for adults, is used to lower dangerously high calcium levels in the blood.

The agency said it was collecting information on the circumstances of the teenager's death. It said it does not know if the Amgen drug had any role in the death.

"This communication is intended to inform health care professionals that we are evaluating the information and will communicate our final conclusions and recommendations when our review is complete," the FDA said in a statement posted on its website.

Amgen, the world's largest biotechnology company, said it had sent a letter last week to healthcare providers alerting them to the trials' halt and the patient death.

"Amgen is working as rapidly as possible to understand the circumstances of what happened. This analysis is ongoing and will be concluded as quickly as possible," the company said in a statement.

Sensipar works by decreasing the release of parathyroid hormone from the parathyroid gland to lower calcium levels in the blood. High levels of calcium in the blood can lead to serious health problems.

Sensipar, which had worldwide sales of $950 million in 2012, is approved to treat adults 18 and over. The trials were being conducted to determine the safety and efficacy of the drug in younger patients.

Drugmakers also often conduct pediatric trials because they are rewarded with an additional six months of patent protection for testing medicines in children.

View the original article here

UPDATE 1-FDA halts trials of Amgen drug in children, cites death

* FDA does not know if Sensipar had role in patient death

* Drug approved for adults to remove calcium from blood

Feb 26 (Reuters) - The U.S. Food and Drug Administration said on Tuesday it has stopped all pediatric clinical trials of Amgen Inc's Sensipar after the death of a 14-year-old patient taking part in a study of the drug.

Sensipar, which is approved for adults, is used to lower dangerously high calcium levels in the blood.

The agency said it was collecting information on the circumstances of the teenager's death. It said it does not know if the Amgen drug had any role in the death.

"This communication is intended to inform health care professionals that we are evaluating the information and will communicate our final conclusions and recommendations when our review is complete," the FDA said in a statement posted on its website.

Amgen, the world's largest biotechnology company, said it had sent a letter last week to healthcare providers alerting them to the trials' halt and the patient death.

"Amgen is working as rapidly as possible to understand the circumstances of what happened. This analysis is ongoing and will be concluded as quickly as possible," the company said in a statement.

Sensipar works by decreasing the release of parathyroid hormone from the parathyroid gland to lower calcium levels in the blood. High levels of calcium in the blood can lead to serious health problems.

Sensipar, which had worldwide sales of $950 million in 2012, is approved to treat adults 18 and over. The trials were being conducted to determine the safety and efficacy of the drug in younger patients.

Drugmakers also often conduct pediatric trials because they are rewarded with an additional six months of patent protection for testing medicines in children.

View the original article here

San Diego Mayor Halts Prosecutions Of Medical Marijuana Dispensaries

San Diego Mayor Bob Filner ordered city officials to cease crackdowns of medical marijuana dispensaries Thursday, reiterating his support to “ensuring the people who legitimately need [medical marijuana] for relief of pain are not kept from accessing it.” The city’s police and code compliance officials had been cracking down on the dispensaries for violating city zoning rules, and Filner’s order will halt pending prosecutions against a dozen dispensaries. But about 100 others have already been shuttered by the effort, and the order will not affect those dispensaries.

Although medical marijuana has been legal in California since 1996, the city of San Diego never implemented zoning rules for where dispensaries may locate. Filner told an audience from the city’s chapter of Americans for Safe Access earlier last week that he would work to pass a zoning law, and halted prosecutions pending the proposal of such an ordinance. The order does not affect federal officials’ authority to crack down on dispensaries, as they have in more than 200 cases in San Diego and the surrounding areas, in the continuing federal-state showdown over both medical and recreational marijuana.

View the original article here