The US Food and Drug Administration (FDA) has approved a chicken that has been genetically engineered to produce a drug in its eggs.
The drug, Kanuma (sebelipase alfa), is a recombinant human enzyme marketed by Alexion Pharmaceuticals. It replaces a faulty enzyme in people with a rare, inherited condition that prevents the body from breaking down fatty molecules in cells.
Following its approval by the FDA on 8 December, Kanuma joins a small group of ‘farmaceuticals’ on the US market. In 2009, the agencyapproved genetically modified goats that produce an anticoagulant called ATryn (antithrombin) in their milk. And last year, the FDA authorized a drug for treating hereditary angioedema that is produced by transgenic rabbits.
The FDA’s latest decision “shows that the ATryn goats weren’t just a one-off”, says Jay Cormier, a lawyer at Hyman, Phelps and McNamara in Washington DC and a former scientific reviewer for the FDA. “The process can function for more than just one particular unique case.”
The agency moved quickly to consider Kanuma, giving it a priority review, orphan-drug status and a breakthrough-therapy designation. The disease that it is designed to treat, lysosomal acid lipase deficiency, causes fat to accumulate in the liver, spleen and vasculature. A form of the disease that strikes infants is quickly fatal. A second form that affects older patients causes liver enlargement, fibrosis and cirrhosis, as well as cardiovascular disease.
“Before we had this drug, we didn’t have any treatment for the patients that really addressed the underlying biochemical defect in the disorder,” says Barbara Burton, a paediatrician with the Northwestern University Feinberg School of Medicine in Chicago, Illinois. Clinicians could only provide nutrition and supportive care to infants, says Burton, who worked with Alexion to conduct the clinical trials. Older patients are treated with statins—which do not address the fatty build-up in the liver.
Federal prosecutors in New York say a top aide to the Silk Road drug website's founder has been arrested in Thailand.
Manhattan U.S. Attorney Preet Bharara (buh-RAH'-ruh) says 54-year-old Canadian citizen Robert Thomas Clark awaits extradition to the U.S.
IRS Special Agent Gary Alford writes in a complaint unsealed Friday that Clark helped sell heroin, cocaine and other drugs online between January 2011 and October 2013.
Doctors and scientists want drug regulators and research funding agencies to consider medicines that delay ageing-related disease as legitimate drugs. Such treatments have a physiological basis, researchers say, and could extend a person’s healthy years by slowing down the processes that underlie common diseases of ageing — making them worthy of government approval. On 24 June, researchers will meet with regulators from the US Food and Drug Administration (FDA) to make the case for a clinical trial designed to show the validity of the approach.
Current treatments for diseases related to ageing “just exchange one disease for another”, says physician Nir Barzilai of the Albert Einstein College of Medicine in New York. That is because people treated for one age-related disease often go on to die from another relatively soon thereafter. “What we want to show is that if we delay ageing, that’s the best way to delay disease.”
Barzilai and other researchers plan to test that notion in a clinical trial called Targeting Aging with Metformin, or TAME. They will give the drug metformin to thousands of people who already have one or two of three conditions — cancer, heart disease or cognitive impairment — or are at risk of them. People with type 2 diabetes cannot be enrolled because metformin is already used to treat that disease. The participants will then be monitored to see whether the medication forestalls the illnesses they do not already have, as well as diabetes and death.
On 24 June, researchers will try to convince FDA officials that if the trial succeeds, they will have proved that a drug can delay ageing. That would set a precedent that ageing is a disorder that can be treated with medicines, and perhaps spur progress and funding for ageing research.
During a meeting on 27 May at the US National Institute on Aging (NIA) in Bethesda, Maryland, Robert Temple, deputy director for clinical science at the FDA’s Center for Drug Evaluation and Research, indicated that the agency is open to the idea.
A drone packed with methamphetamine crashed into a parking lot in Mexico close to the California border, according to Tijuana Public Safety Secretariat.
The incident happened about 10 p.m. Tuesday, when the unmanned aircraft, which was carrying more than 6 pounds of meth, came down in the parking lot of a supermarket in Zona Rio, near the San Ysidro Port of Entry, according to authorities. The aircraft may have crashed because it was overloaded, officials said.
The drone was identified as a Spreading Wings S900 model, which had six propellers, authorities said. The incident was under investigation.
This is not the first time a drone has been used in an attempts to smuggle drugs over the border, authorities said.
When the cryptocurrency darkcoin launched earlier this year, it distinguished itself from dozens of bitcoin copycats by promising to keep users’ transactions far more anonymous than its predecessor. Now that promise is being tested in the Internet’s fastest-growing proving ground for privacy technologies: the online black market for drugs.
Over the last month, two of the dark web markets selling an anonymous, mail-order catalog of narcotics and other contraband have begun supporting darkcoin transactions. On a site called Nucleus, visitors can now use darkcoin to buy LSD, MDMA, and marijuana. On the competing market Diabolus, dealers accept it for cocaine, synthetic stimulants like ethylone and alpha-PVP, and even counterfeit Euros. Those two markets still represent only a tiny fraction of the growing dark web drug economy—most of which uses bitcoin exclusively. But darkcoin’s entrance could signal a new means of transaction in that underground industry, and one that’s far harder for law enforcement to trace.
