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FDA News Release

For Immediate Release

June 25, 2018



The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.

CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC).

It is THC (and not CBD) that is the primary psychoactive component of marijuana.

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development,” said FDA Commissioner Scott Gottlieb, M.D. “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”

Dravet syndrome is a rare genetic condition that appears during the first year of life with frequent fever-related seizures (febrile seizures). Later, other types of seizures typically arise, including myoclonic seizures (involuntary muscle spasms). Additionally, status epilepticus, a potentially life-threatening state of continuous seizure activity requiring emergency medical care, may occur. Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others.

Lennox-Gastaut syndrome begins in childhood. It is characterized by multiple types of seizures. People with Lennox-Gastaut syndrome begin having frequent seizures in early childhood, usually between ages 3 and 5. More than three-quarters of affected individuals have tonic seizures, which cause the muscles to contract uncontrollably. Almost all children with Lennox-Gastaut syndrome develop learning problems and intellectual disability. Many also have delayed development of motor skills such as sitting and crawling. Most people with Lennox-Gastaut syndrome require help with usual activities of daily living.

“The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients’ quality of life,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition.”

Epidiolex’s effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome. Epidiolex, taken along with other medications, was shown to be effective in reducing the frequency of seizures when compared with placebo.

The most common side effects that occurred in Epidiolex-treated patients in the clinical trials were: sleepiness, sedation and lethargy; elevated liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise and weakness; insomnia, sleep disorder and poor quality sleep; and infections.

Epidiolex must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. As is true for all drugs that treat epilepsy, the most serious risks include thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression and panic attacks. Epidiolex also caused liver injury, generally mild, but raising the possibility of rare, but more severe injury. More severe liver injury can cause nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice and/or dark urine.

Under the Controlled Substances Act (CSA), CBD is currently a Schedule I substance because it is a chemical component of the cannabis plant. In support of this application, the company conducted nonclinical and clinical studies to assess the abuse potential of CBD.

The FDA prepares and transmits, through the U.S. Department of Health and Human Services, a medical and scientific analysis of substances subject to scheduling, like CBD, and provides recommendations to the Drug Enforcement Administration (DEA) regarding controls under the CSA. DEA is required to make a scheduling determination.

The FDA granted Priority Review designation for this application. Fast-Track designation was granted for Dravet syndrome. Orphan Drug designation was granted for both the Dravet syndrome and Lennox-Gastaut syndrome indications.

The FDA granted approval of Epidiolex to GW Research Ltd.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.




Michael Felberbaum 240-402-9548

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Geography is the study of the surface of the Earth as the site of human living and working. It considers the variability in physical and human landscapes, along with the interrelationships binding them together.

Our Honours programme is highly flexible and is a combination of core and optional courses. This allows you to tailor your option choices towards a wide range of potential careers.

Programme structure

Geography can be studied as one of three different degrees in Arts, Science or Social Sciences. The Geography component of each degree is identical; the difference is additional subjects that can be taken in years 1 and 2.

Year 1

You will explore an equal balance of physical and human geography themes including a world of resources, an underdeveloped world, a world of changing environments, a shrinking world, and a changing biosphere in a changing environment.

Year 2

You will explore human and physical processes, examining environmental problems and their possible resolutions through policy, and you will be trained in statistical methods and laboratory analysis using a mixture of fieldwork and our own IT and physical geography laboratories.

You will also study other subjects in years 1 and 2 : see Lucy Quartermaine Short Multi Necklace Gold Plated ILmnE9cBc

Years 3 and 4

If you progress to Honours (years 3 and 4)you will study both core and optional courses. Core courses are related to advanced training methods such as computerised data analysis, modelling, geographical information systems, interviewing and interpretative methods.A wide range of optional courses complement the core courses and allow you to build a programme around your particular interests. Some Earth Science optional courses may also be available to Geography students.

Programme alteration or discontinuation The University of Glasgow endeavours to run all programmes as advertised. In exceptional circumstances, however, the University may withdraw or alter a programme. For more information, please see: Zales 1/4 CT Tw Composite Diamond Oval Frame Bridal Set in Sterling Silver 0JL04B

Special Glasgow feature

If you intend to continue to Honours, you will attend a week-long residential field course in year 2 to extend the field, laboratory and statistical skills introduced earlier by focusing on group projects, data collection, problem solving, and presentations. This training is developed in year 3 in a week-long overseas field class focusing on dissertation-related project work.

Our international links

You will have the opportunity to applyto study abroad. There are currently two options available: the Erasmus+ Programme and the International Exchange Programme. See Diamoire Jewels Single Solitaire Swarovski Zirconia Ring in 10Kt White Gold UK U US 10 1/4 EU 62 3/4 s8u2r

About entry requirements

SQA Highers

The S5 Standard Academic Entry Requirements represent the grades which, if attained in addition to successfully meeting mandatory subject requirements and any non-academic entry requirements (interviews, auditions, aptitude tests), will normally result in an offer being made. Students must achieve the standard entry requirements by the end of S5 (cumulative S4 and S5).

The S5 Minimum Academic Entry Requirements represent the minimum grades which an applicant must have obtained by the end of S5 (cumulative S4 and S5) in order for them to be considered for a conditional offer based on S6 results. Not all applicants who achieve the Minimum Academic Entry Requirements will be made an offer. This will depend on the number of applications we have received for a degree programme and the number of applicants who have met the Standard Academic Entry Requirements.

Where an applicant is made a conditional offer based on S6 results, the S6 Standard Academic Entry Requirements represent the cumulative grades that must be attained by the end of S6, in addition to meeting any mandatory subject and non-academic requirements. All degree programmes allow applicants to “double count” Highers and Advanced Highers in the same subject when calculating cumulative grades. A Grade B in an Advanced Higher will be regarded as another Grade A at Higher Level and a Grade C at Advanced Higher will be regarded as another Grade B at Higher Level. All degree programmes require grades in a minimum of four different subjects.

Advanced Highers

Advanced Highers are a qualification of increased importance to the University, which recognises that applicants with these qualifications find the transition to university easier and perform better in their university exams. Many of our degrees specify Advanced Highers as part of the S6 Entry Requirements.

If a school is unable to offer specific Advanced Higher subjects applicants will be made bespoke offers which will normally require the applicant to attain additional relevant Highers in S6.

Adjusted Entry Requirements

We adjust the Standard Academic Entry Requirements for eligible applicants who complete one of our widening participation pre-entry programmes . Criteria for eligibility include attending a Scottish target secondary school, living in a priority Scottish postcode area, current or previous experience of living in care or estrangement from family support.

For more information about your eligibility and our pre-entry programmes see: Access Glasgow .

Admissions Policy

A-levels and International Baccalaureate

The Standard Academic Entry Requirements represent the grades at which any possible offer would be made. Students must also meet mandatory subject requirements and any non-academic entry requirements (interviews, auditions, aptitude tests).

The Minimum Academic Entry Requirements represent the minimum grades that the University will accept for entry to the degree programme. Students must also meet mandatory subject requirements and any non-academic entry requirements (interviews, auditions, aptitude tests).

Admissions Policies

Standard academic entry requirements

Northwestern knows what it is getting at quarterback. Kind of. Thorson’s production leveled off between his sophomore and junior seasons. The Wildcats can expect Thorson to look like a fringe all-Big Ten performer most of the time, with outstanding performances (Michigan State) interspersed with poor ones (Duke). The problem, obviously, is Thorson’s health. With the graduation of Zales 1/10 CT Tw Diamond Pineapple Pendant in 10K Gold dtfdAFln
, Northwestern lacks experienced depth should Thorson miss time due to the ACL injury he suffered in the Music City Bowl. If Green , Smith, or Marty are forced into extended duty, it could be a long season while Hunter Johnson awaits eligibility in 2019.

Clayton Thorson

I’m a little more bearish on Thorson’s chances to get his game to the next level given his statistical plateau (or regression) in 2017 and some of the structural limitations of the Northwestern offense.

Still, in a league where solid quarterback play is far from a given, Thorson has invaluable experience, can make all the throws, and uses his mobility to his advantage. Thorson earned Third Team All-Big Ten honors for his 2017 season, where he finished fourth in the Big Ten in passing yards and fifth in completion percentage. His quarterback rating of 121.3 (10th in the conference) was a result of a shoddy 15:12 touchdown-to-interception ratio.

As I mentioned this weekend, I don’t see Thorson suddenly becoming the best quarterback in the conference, not without serious improvements in pass protection (among B1G QBs, only Thomas Sabo Thomas Sabo ring white DTR00087251448 78kJf1
was sacked more often) and somewhat of a breakout from a pass-catcher or two.

He doesn’t need to be the best quarterback in the league, however. Thorson has 39 starts under his belt, while at least half the conference is breaking in new signal-callers. If Thorson can replicate 2016 and 2017, Northwestern will be fine. That’s a big if.

Can Clayton Thorson play against Purdue? Will he be at 100 percent?

Seriously. It feels like this is the only question of importance this offseason, and its the question that will likely define the range of possibilities for Northwestern’s season. If Thorson is ready to go week one, bowl eligibility for a fourth straight year seems like a strong possibility. If the senior misses the first game or two, Northwestern could find itself in a 1-4 hole.

Teddy Greenstein at the Tribune filed Latelita London Tassel Ball Earring Tourmaline 2PQoTeE
about Thorson’s progress on Monday. He said running and cutting feel good, and brought up the point that his injury isn’t as consequential for a quarterback as it might be for a receiver. I don’t have any inside information, but if I had to wager, I would bet on Thorson being ready to go for week one. I’d also guess Mick McCall will try to keep Thorson in the pocket early in the season, making the short and intermediate throws he’s so good at.

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