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Thursday, April 9, 2015

Teva files new FDA petition against generic Copaxone

Copaxone


Teva is battling against possible generic competition from September for the multiple sclerosis treatment.

Teva Pharmaceutical Industries Ltd. has filed another citizen's petition with the US Food and Drug Administration (FDA) against planned generic versions of its multiple sclerosis treatment Copaxone. On each of the previous seven occasions that Teva filed such a petition, the FDA ruled that it was too early to discuss such a matter.
The latest petition was filed at the end of last week in line with FDA instructions that any new Teva research data on Copaxone must be made public.

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Tuesday, April 7, 2015

MedDay provides update on pioneering pivotal Phase III study design in Progressive Multiple Sclerosis

~ Phase III data to be disclosed at AAN Annual Meeting in Clinical Trials Plenary Session on April 24th 2015 ~

APRIL 7, 2015
PARIS--(BUSINESS WIRE)--
MedDay, a biotechnology company focused on the treatment of nervous system disorders, today provided further information about the design of its pivotal clinical trial (MS-SPI) to investigate the efficacy and safety of MD1003 in the treatment of primary and secondary progressive multiple sclerosis, a major area of unmet medical need. Data from the MS-SPI study will be presented at the Clinical Trials Plenary Session at The American Academy of Neurology (AAN) Annual Meeting, Washington DC, on Friday April 24th at 1200 EST.
MS-SPI is a randomized, double-blind, multicenter, placebo-controlled (2:1) trial of MD1003, 300 mg/day, in patients with progressive MS who have demonstrated progression in the 2 years prior to enrolment.
A total of 154 patients with a baseline EDSS (Expanded Disability Status Scale) score of between 4.5 and 7 were enrolled from 16 MS reference centers across France. Treatment duration was one year.
The primary endpoint for the study was defined as the proportion of patients who improved at nine months (M9), with confirmation at 12 months (M12). Improvement was defined as either a decrease in EDSS (by at least 1 point for baseline EDSS ≤5.5 and 0.5 points for EDSS ≥6) or an improvement in TW25 (a timed 25-foot walk) of at least 20%. The comparison for each outcome was the best EDSS and TW25 scores obtained at the screening and randomisation visits.
The main secondary endpoints evaluate the effect of MD1003 in stabilizing or slowing down the rate of progression. These endpoints include the change in EDSS between M0 and M12, the proportion of patients with progression at M9 confirmed at M12 and the change in TW25.
Frédéric Sedel, MD, Chief Executive Officer of MedDay, commented: “This trial was particularly ambitious. This is the first time that a study in progressive MS has evaluated the proportion of patients improved at M9 and confirmed at M12. This challenging clinical endpoint was designed during discussions with European and US regulators. We look forward to presenting the results of the trial at AAN later this month.”
Another important objective of the trial is to evaluate the safety of long-term treatment with MD1003 300 mg/day. Serious and non-serious adverse events recorded during the trial will also be presented.
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Multiple sclerosis patients could benefit from brain boost study

Date:
April 6, 2015
Source:
University of Edinburgh
Summary:
Multiple sclerosis patients could one day benefit from treatments that boost their brain function, a study suggests. Increasing the activity of neurons could be beneficial in people with the disease, researchers say. It could stimulate the production of a substance that protects nerve fibres, the researchers say.


Increasing the activity of neurons could be beneficial in people with the disease, researchers say. It could stimulate the production of a substance that protects nerve fibres.
The finding could pave the way for new treatments, researchers say. Multiple sclerosis affects the brain and spinal cord and can cause problems with balance, movement and vision.
Information in the brain is transmitted along nerve fibres known as axons. A material -- called myelin -- forms a layer around axons, which keeps them healthy and helps speed up the transfer of information.
Damage to myelin contributes to diseases of the brain such as multiple sclerosis.
Until now, it was not known how brain activity controls production of myelin by specialist cells, researchers say.
Researchers examined how changes in the activity of neurons affects how much myelin is produced in the brains of zebrafish. Decreased brain function reduced the amount of myelin made, while production was increased by around 40 per cent when the neuronal activity of fish was increased, the team says.
Before they can develop new therapies, the team says it needs to learn more about how brain function controls the complex processes by which axons are coated with myelin.
The study, published in the journal Nature Neuroscience, was funded by The Wellcome Trust, the Biotechnology and Biological Sciences Research Council, and the Lister Research Prize.


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Jack Osborne educates public about realities of living with MS

Jack Osbourne and regionally-known MS Neurologist, Brian Steingo, educate others about Multiple Sclerosis

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Monday, April 6, 2015

Seeking Answers for Progressive MS

An invitational meeting in Boston marks a step forward in a concerted international push to find effective therapies to target disease mechanisms, manage symptoms, and improve rehabilitation

A meeting in Boston early in March drew more than 80 scientists and clinical researchers to address the vexing question of how to speed treatments for progressive MS. The meeting showcased a cross section of potential disease mechanisms, new animal and computer models, and the scientific underpinnings of clinical trials by drugmakers.

In most countries, a dozen drugs are now available for relapsing-remitting MS (RRMS), the most common form of MS. Yet, none of the disease-modifying therapies for RRMS has been proven to be effective in progressive MS, of which there are two types. In some people, MS begins as primary progressive disease (PPMS). And among people with RRMS, more than half eventually develop secondary progressive MS (SPMS).

“Developing treatments for progressive MS is probably the biggest challenge facing the MS world,” Alan Thompson, M.D., told 1800 people signed up for a postmeeting webcast. The one-hour archived presentation and transcript is available at the website of the U.S. National Multiple Sclerosis Society.  “People with progressive MS, primary and secondary, have been waiting for decades. I can’t emphasize how much things have changed, and how much progressive MS is at center stage,” said Thompson, a neurologist at University College London, who cautiously predicted that two or three new treatments may be available within the next 10 years.




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Sunday, April 5, 2015

NY issues regulations for medical marijuana program in works

There is concern over how much marijuana patients would be allotted each month. (4/2/15)
ALBANY, N.Y. - (AP) -- Cancer, AIDS, Lou Gehrig's disease, Parkinson's disease and multiple sclerosis are among the conditions for which New Yorkers can apply for the statewide medical marijuana program expected to start next year.
Also included in the final regulations posted by the New York Health Department are certain spinal cord injuries, epilepsy, inflammatory bowel disease, neuropathies and Huntington's Disease and symptoms including severe or chronic pain, seizures, severe nausea, persistent muscle spasms and wasting syndrome.
Under the law signed last July, patients with those diseases will be able to obtain non-smokeable versions of the drug, which can be ingested or vaporized. The regulations posted Tuesday night authorize the health commissioner to add other conditions, symptoms or complications.
Approved products will be limited to liquids, oils or capsules, according to the regulations set to take effect when published April 15 in the State Register.
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