giftedviz.com
giftedviz.com July 21, 2018


FDA approves its first marijuana-derived drug

26 June 2018, 03:26 | Rodolfo Wallace

He added that the drug offers families "the first and only FDA-approved cannabidiol medicine to treat two severe, childhood-onset epilepsies".

The FDA says this is the first drug approved in the USA that contains a purified substance derived from marijuana.

Patients with Lennox-Gastaut and Dravet syndromes, which typically emerge in the first few years of life, can suffer from debilitating and recurrent seizures, sometimes dozens a day.

With the historic approval, the London-based company behind the drug, GW Pharmaceuticals plc, is expecting another consequential decision in the coming weeks: getting the US Drug Enforcement Administration to reclassify CBD. That so-called "high" comes from a different compound in marijuana, known as tetrahydrocannabinol (THC).

Once the DEA gets the FDA recommendation for how CBD should be scheduled, it has 90 days to decide.

A phase three clinical trial is underway for a third seizure-related condition called tuberous sclerosis complex, which begins in infancy and causes a sudden stiffening of the body, arms and legs, with the head bent forward.

The European Medicines Agency is now reviewing Epidiolex for treating seizures associated with LGS and Dravet Syndrome, with a decision on whether or not to recommend approval expected early next year. The agency may ignore the FDA's position, but that is considered unlikely in this case. The new drug is anticipated to become available to patients later this fall.

Zimbabwe President, Mnangagwa survives explosion
Witnesses said the blast occurred as Mnangagwa had just finished addressing the crowd and was leaving the podium. Footage from Zimbabwe state television showed the explosion took place near Mnangagwa as he waved to supporters.


Argentina take player power to new level ahead of Nigeria clash
It will not be an easy game for Nigeria since Argentina have good players but confidence will be high in the camp of the African side.


Mexico Sinks South Korea, Stay Perfect At 2018 World Cup
Carlos Vela gave El Tri the lead in the first half from the penalty spot which was doubled by Javier Hernandez in the second half. Mexico is the fifth team to reach six points this World Cup , and just the second non-European club to do it (joining Uruguay).


A drug made from a derivative of marijuana has been approved for patients with certain forms of epilepsy.

Fox hailed Monday's FDA action as a win for the broader medical marijuana community, in that it will facilitate more clinical research into the drug's medical benefits.

In a statement accompanying Monday's approval announcement, the FDA hastened to note that it's not signing off on the safety or medical utility of marijuana in general ― just this one compound and only for this limited use. But it's not quite medical marijuana.

Called Epidiolex, the drug is created to treat two rare forms of childhood epilepsy using a cannabis compound called cannabidiol (or CBD). And Epidiolex could well be the first in a wave of marijuana-based therapies; agency officials said they have implemented regulatory processes to help drug developers test marijuana or its components in their own clinical trials. Despite the medication's approval, cannabis remains a Schedule I substance, which, according to the federal government, means it has "no accepted medical uses".

"The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases", Gottlieb said.

Across the board, the drug was shown to be effective in cutting the frequency of seizures.

"For a maligned substance like cannabis, I think the vindication tour will ultimately be years long", said Ricardo Baca, a former marijuana editor at the Denver Post, and the founder of Grasslands, a cannabis PR agency.



Other News

Trending Now

Brazil boots Costa Rica, 2-0
They had just a single goal in the game, a attractive strike by Philippe Coutinho , which earned him man of the match honors. In danger of ending in a draw, Brazil seemed nervous but composed itself through the seven minutes of injury time .

Spain win group despite Morocco draw but defence remains a real concern
Spain however, failed to win their last group game of the World Cup for the first time since 1982. We must fix these details, as every chance they make is unsafe .

Deport without ‘judges or court cases’
Trump signaled in his tweet that he doesn't want migrants and asylum seekers to have to be processed through the court system. But Trump's frustration over the issue only grew.

Colombia’s triple hammer blow dumps Poland out of World Cup
With the second round of Group H games in the books, the Kwese Sports panel examine the three-horse race between Colombia , Senegal and Japan.

Heather Locklear arrested for 'attacking police officer'
She had just returned from a trip to Boston at the time when she and boyfriend Chris Heisser began to fight. The incident comes after Locklear was hospitalized last week following an emergency call to the police.

'Fixer Upper' stars Chip and Joanna Gaines welcome baby No. 5
He also added that, "Big momma is doing great". "Thank you for all your thoughts and prayers". Joanna and her husband Chip Gaines announced they welcomed their child Saturday morning.

Parted at US Border by Family Separation Policy, Migrants Seek Their Children
House members are touring immigration facilities for a firsthand look at the Trump administration's "zero tolerance" policy. He previously insisted Mexico would pay for the separation barrier, a notion Mexico has repeatedly and adamantly rejected.

Here's why Cristiano Ronaldo turns to the side during Portugal's national anthem
Despite having won both of their games so far, there is still a very slim chance Mexico could be going home. France are through to the knockout round - a point against Denmark would see them finish as group winners.

Mother of Murdered Bronx Teen: Mayor De Blasio Never Reached Out
A GoFundMe account for Junior's family has raised nearly $160,000 with the help of donations from famous including Cardi B. The leader of the Trinitarios gang apologized on Facebook, PIX11 reports, admitting Guzman-Feliz was wrongly targeted.

Egypt's Essam El-Hadary now World Cup's oldest-ever player saves penalty
El-Hadary pulled off a stunning stop, making him the oldest goalkeeper to save a penalty at the tournament. And El Hadary enjoyed a moment to savour when he saved a penalty from Al-Muwallad with 41 minutes played.