Friday, August 08, 2008

More meds doubling in price By Tracy Staton



NEW Clinical Drug Trials listed on

A phase 3 study of Alemtuzumab infusion once a year vs. Rebif for patients with Relapsing Remitting multiple sclerosis who have been on prior ABC treatment and have relapsed.




Conference News & Views: Independently Reported Highlights From the AAN 60th Annual Meeting - Multiple Sclerosis
This interactive CME newsletter highlights key data in multiple sclerosis presented at the 2008 AAN Annual Meeting. Benjamin Greenberg, MD, MHS, Co-director, Johns Hopkins Transverse Myelitis Center, provides audio commentaries regarding implications to practice.
Scienta Healthcare Education [more]




Accelerated Cure Project informal status for the month of July 2008

The first published paper using samples from our repository has been

published. Genes influencing the severity of MS have been found:

o We have now enrolled 1146 participants into our repository.
o We approved two new requests:  a request for samples and data from
  Glycominds, an Israeli company, and a request for data from St. John's
  University in Minnesota.
o We sent out samples and data to several scientific teams this month:
  - We distributed samples and data from 889 subjects (cases and controls)
    to University of California, Irvine.
  - We distributed data from all of the MS cases in the database to St.
    John's University.
  - We distributed additional data to the Harvard School of Public Health.
  - Finally, we distributed additional data to the Broad Institute.
o We continued preparing for the longitudinal extension of the
  repository, including discussing kit contents and user testing the
  electronic data capture system.

Other Science Efforts:
o Sara had a call with Helena Judge Ellis to help facilitate a new
  biobank being set up in Rhode Island.
o Our summer interns YingFei Li and Jasmine Park worked on repository
  projects (adding MRIs to our database and performing an internal
  evaluation of our operations) and Cure Map research (updating our
  pathogens, nutrition, and mitochondrial DNA analyses).

>>> Education
o Poll - How many medications are you taking for your MS?

o We continue our daily MS News updates

>>> Fundraising
o Our Summer Fellow, Elena, continues to work on developing leads for
  alternate fundraising strategies
o Thank you to the Montel Williams Foundation for MS for the grant we
  received for our Repository Program.  And thank you to Melissa
  O'Shea for making that possible by writing the grant proposal.

>>> Community Building
o We had meetings with the following people:
  - Alzforum/SWAN project regarding possible MS research info portal
  - Discussions with Novartis about pitching use of repository to them
o As always, a few more T-shirt pictures are available:


>>> Upcoming Events
Detailed information about all of our upcoming events can be found on
our web site:
o August 24, Springfield, MA: Grab your bikes for the Blunt Park
   Cyclocross Race, part of the Accelerated Cure Project Cyclocross
   Series.  Register now!

o September 6 from 2pm - 5pm, San Francisco, CA:  Dogs drink free at
    Canine Happy Hour to raise funds for Accelerated Cure Project.

o September 18 to September 21 - Tyler Hamilton Foundation MS Global
    2008 - a 500 mile cycling tour through Colorado with American
    professional bicycle rider and Olympic gold medalist Tyler Hamilton.

o October 11, Cincinnati, OH: We're excited to announce the 3rd Annual
   Canine Happy Hour to Benefit Accelerate Cure Project. Mark your
   calendar and stay tuned for more details!

o October 26, Arlington, MA: This year's grant from the MA Cultural
   Council makes the 6th Annual Sing To Cure MS Concert set-to-go!
   Members of Boston Lyric Opera, Opera Boston, and other classical
   singers donate their glorious talents; win gift certificates and
   snack on refreshments: enjoy a concert to cure MS!

o November 7, Windham, NH: TICKET SALES OPEN for the 2nd Annual Dance to
   Cure MS, a fun night out for adults coming together to socialize,
   dance and eat, but most importantly to give hope and support to
   those who have Multiple Sclerosis. For details and tickets:

o November 22, Waltham, MA: Save the date for the 2008 Accelerated
   Cure Project Annual Event which will be held in a NEW LOCATION: The
   Doubletree Guest Suites in Waltham, MA.  See the website for more

o November 23, Easthampton, MA: Mark your calendars and grab your
   bikes for the 2nd Annual Nonotuck Cyclocross Race, part of the
   Accelerated Cure Project Cyclocross Series!  Registration coming

o November 30, Palmer, MA: Get that bike cleaned up from last weekend
   and come back out for the Palmer Cyclocross Race to Cure MS, also
   part of the Accelerated Cure Project Cyclocross Series.  More
   details to come...

>>> Recent Events
o An MS Social in SF and a Rock Concert
>>> Operations
o All smooth - but if you really need a dose of Operation

>>> Volunteers Reporting Time Last Month

o Contributed Goods and Services
  Clockwork Design Group, Inc
  Mail Perfect, Inc.
o Sing to Cure MS
    Marion Leeds Carroll
    Gigi Patel
    Emily Becker
    Michael Zimmer
o Cyclocross Race Series
    Mark Stotz
o Cincinnati Canine Happy Hour
    Debbie Mann
    Amy Groff
    Christina Urbanowicz
    Peggy Shannon
    Steve Rawlins
    Sonia Teixeria
o Dance to Cure MS
    Deb DuFault
o Community Building
    Martine Assaf
    Pat Phelps
o Wellness Resolution
     Cher Kore
     Ama Allara
o Fundraising
     Ashley Mittman
     Brad Feld
o Admin
    Jane Shapiro
    Kelly Novak
o San Francisco Canine Happy Hour
    Katrina Lewis
    Sonia Teixeria
o MS Social
    Katrina Lewis
    Steven Johnson
o Sense of Purpose
    Will Adams
o UK Walk
    Andy Monk

How Cells Communicate Discovered By Johns Hopkins Scientists
Cells rely on calcium as a universal means of communication. For example, a sudden rush of calcium can trigger nerve cells to convey thoughts in the brain or cause a heart cell to beat. A longstanding mystery has been how cells and molecules manage to appropriately sense and respond to the variety of calcium fluctuations within cells.


Stanford Fruit-Fly Study Adds Weight To Theories About Another Type Of Adult Stem Cell
It turns out that an old dog - or at least an old fruit-fly cell - can learn new tricks. Researchers at the Stanford University School of Medicine have found that mature, specialized cells naturally regress to serve as a kind of de facto stem cell during the fruit-fly life cycle.


What now for Teva? T1 The Israeli pharmaceutical giant stumbled ...
Therapeutics Daily (subscription) (press release) - Newtown,PA,USA
... Copaxone 40 mg dosage for the treatment of multiple sclerosis. The investors' reaction was ferocious and Teva's market cap was slashed by $3.4 billion. ...
See all stories on this topic



Latest News, Developments and Drug Pipelines for Central Nervous ...
Earthtimes (press release) - London,UK
... extensive information in tabular format on a company’s full product pipeline and products by phase of development with regard to the therapy area. ...
See all stories on this topic



American Journal of Clinical Nutrition, Vol. 88, No. 2, 500S-506S ...
Am J Clin Nutr (subscription) - Davis,CA,USA
For example, epidemiologic evidence has linked poor vitamin D status to osteoporosis, osteoarthritis, tuberculosis, diabetes mellitus, multiple sclerosis, ...
See all stories on this topic



NY Stem Cell Foundation Plays Critical Funding Role In Major New ALS Research
In a breakthrough discovery, Dr. Kevin Eggan, Chief Scientific Officer of The New York Stem Cell Foundation and Principal Faculty Member of the Harvard Stem Cell Institute, has produced human stem cell lines from the cells of patients afflicted with a version of amyotrophic lateral sclerosis (ALS), commonly known as Lou Gehrig's disease.


Brain Regulates Free Radicals, Plays Key Role In Appetite
Researchers at Yale School of Medicine have found the brain's appetite center uses fat for fuel by involving oxygen free radicals - molecules associated with aging and neurodegeneration. The findings, reported in the journal Nature, suggest that antioxidants could play a role in weight control.
Dermatology News


Research Team Creates Human ALS Motor Neurons: First Disease-Specific Stem Cells From Human Skin Cells
A team of researchers from the Harvard Stem Cell Institute (HSCI) and Columbia University, in a collaboration catalyzed by the Project A.L.S./Jenifer Estess Laboratory for Stem Cell Research, has demonstrated that pluripotent stem cells generated from a patient with ALS (amyotrophic lateral sclerosis) can be directed to differentiate into motor neurons - the very brain cells destroyed by ALS.



Tysabri Lawsuit to Stay in State Court - New York,NY,USA
A lawsuit over injuries allegedly caused by the multiple sclerosis drug, Tysabri, is staying in Massachusetts state court. The decision in the Tysabri case ...
See all stories on this topic



Biogen Loses Preemption Argument In Tysabri Case
Pharmalot - Newark,NJ,USA
... who had been treated with their Tysabri multiple sclerosis med, from a state court in Boston, where Biogen is based, to a federal court in Iowa. ...
See all stories on this topic

A disease cell line library

Researchers have created 20 disease-specific pluripotent cell lines from skin and bone marrow cells of patients with genetic disorders

By Andrea Gawrylewski

McMaster Daily News
Aug 7, 2008 ... Dr. Jon Draper, a scientist in the McMaster Stem Cell and Cancer Research Institute. Dr. Jon Draper, a scientist in the McMaster Stem Cell ...


Stem Cells Created From Skin May Help In the Fight Against Multiple Diseases ...
HealthNews - Carslbad,CA,USA
Using a new method known as induced pluripotent stem (iPS), ordinary cells have been re-programmed to look and act like embryonic stem cells. ...
See all stories on this topic


Research to Advance with New Human Stem Cell-Based Models CME (with audio)
BOSTON -- Ten pluripotent stem cell lines derived from human skin or bone marrow cells are now available for research on disorders with genetic components, ranging from Down’s syndrome to Parkinson’s disease, said researchers here. full story



More meds doubling in price

By Tracy Staton


Prices have ballooned by 100 percent or more for a growing number of drugs, according to a new study. In fact, the number of branded meds whose prices have grown that much could double this year from four years ago. In 2007, the average wholesale price of 26 brand-name meds jumped 100 percent or more in a single price increase, up from 15 in 2004. In the first half of 2008, 17 made that list.


Many of the price increases have come on drugs that treat rare but serious conditions. For example, Questcor Pharmaceuticals boosted the price of Acthar, which treats spasms in babies, to $23,000 from $1,650 a vial.

- read the story in USA Today


Related Articles:
Congress decries drug price-gouging
Obama, McCain united against drug costs
Americans prioritize medication prices
PBMs profit off expensive niche meds

Read more about: Questcor, drug prices


Judge strikes down Biogen preemption case
By Maureen Martino

Biogen and Elan--along with proponents of preemption--were dealt a setback today as a federal judge declined to transfer a case from Massachusetts to a federal court in Iowa.

The lawsuit stems from the death of a patient who contracted PML after taking Tysabri; the drug was pulled from the market 11 days later. The patient's wife sued the drugmakers in Massachusetts, where Biogen is based. But drugmakers are waiting for the Supreme Court to rule on the issue of preemption, which asserts that the FDA's approval of a drug shields companies from lawsuits. They're expected to hear a precedent-setting case--Wyeth v. Levine--this fall. Biogen and Elan argued that the Massachusetts case should be moved to federal court because the fundamental question is whether the FDA's word protects drugmakers.

However, Judge Douglas Woodcock ruled against the developers, saying that preemption is not part of the law at this time and as such, the suit should stay in state court where it was filed. "The Defendants are essentially proposing that I exercise federal jurisdiction given the unsettled nature of the law in this area. I decline their offer," he said in his opinion. "Present posture of case law does not justify removal from state court to this [federal] court.

- here's the Wall Street Journal article
- check out the Pharmalot post for more


Related Articles:
Reps introduce anti-preemption bill

Dems plan anti-preemption bill for devices

Quaid: Preemption unfair to patients

Preemption debate heats up

Bush: FDA's word shields against lawsuits

Read more about: Wyeth v. Levine, Tysabri, preemption, lawsuit

Pharma fights Mass. disclosure bill

By Tracy Staton
Drugmakers are kicking back at a Massachusetts marketing-and-disclosure bill that we reported on a few days ago. The outright ban on gifts to docs didn't make it into the compromise measure, but pharma isn't happy nonetheless. The bill would require disclosure of any payment or gift of $50 or more--and companies are saying that handing over that info would have a "chilling effect" on life sciences in the state.

How so? Well, PhRMA is pointing to language in the bill requiring disclosure of the "nature and purpose" of every doc payment. The industry association says that could be construed to mean that clinical trial data would have to be an open book if docs were paid to be part of those trials. We think that's stretching a bit--maybe to scare the governor into vetoing the bill?--but then again, we aren't lawyers.

- read the post at Pharmalot

Related Articles:
Massachusetts OKs drug marketing bill

Doc disclosure gets boost from AZ, Merck

Pharma faces payment disclosure law

Read more about: Massachusetts, Disclosure

Add 'uninsured' to pharma's problems
By Tracy Staton

We all know the challenges pharma faces: generic competition, patent expirations, sluggish pipelines and pricing pressures. Or do we? A new study suggests that the huge volume of uninsured and underinsured people may be seriously cutting into drugmakers' sales. Millions of Americans have chronic diseases such as diabetes and high blood pressure--the kind of disorders that keep patients on meds for years--but aren't being treated because they don't have insurance.

The study estimates that one in three of uninsured adults has a chronic illness that's going untreated--that's about 11 million people (and some say that's an underestimate, that it might be more like 16 million). The study's lead author notes that treatments for these illnesses are standard and widely available if you do have insurance. And we know what those treatments are: meds, meds and more meds.

- read the story in the New York Times

Related Articles:
Pharma giving away more meds to needy

Uninsured ranks could be much lower

Uninsured cancer patients die sooner

Read more about: chronic disease, uninsured

FDA: Don't blame us for sparse approvals

    By John Carroll    

Dow Jones has crunched the numbers on the FDA's approval record this year, calculating that the nine new medicines OK'd for marketing in the first half of the year puts the agency on track to match last year's dismal record of 18 approvals. The agency approved 22 new drugs in 2006.

The FDA rejects the notion--put forward by a number of developers--that the agency is getting tougher to deal with after a string of embarrassing drug safety fiascos. From their perspective, each year's record is a result of the quality of development work being done by biopharma companies. This year's crop of new approvals includes Wyeth's Pristiq, Cephalon's leukemia drug Treanda and UCB SA's Cimzia for Crohn's. But there's no annual target.

"It's not like we're trying to race through and get 20 done this year and 18 next year," said the FDA's Sandy Walsh. Applications "come in on a rolling basis and we approve them on a rolling basis."

- read the report from Dow Jones

ALSO: It happens often in drug development: a drugmaker submits an NDA, an expert panel gives the okay, everyone expects an approval--and then the FDA delivers a not-approvable letter. However, only the drug developer ever sees the letter detailing why their drug has been rejected. That's because the FDA is still required by law to keep information on unapproved therapies secret, leading some to suggest that the agency needs to be more transparent. Report

Related Articles:
Drought of approvals gets worse for developers
FDA picking up the pace on '08 approvals
2008 NME approvals no better than last year?
Dry spell or parched desert for NME approvals?
'07's drug approval record raises worries

Read more about: FDA update, NME approvals, FDA approval & regulation

Americans Opt by Landslide for Wholesale Revision of Healthcare System 
NEW YORK -- An overwhelming proportion of Americans believes the healthcare system needs a fundamental change or a complete overhaul, according to the results of a survey released today. full story

Diagnosing and Treating Osteoporosis: An Evidence-Based Approach
Listen as the expert faculty discusses information for approaching and managing patients with low bone mass and osteoporosis. Also included in complimentary CME series is the newsletter "Practical Strategies for Managing Osteoporosis: an Evidence-Based Approach to Risk Assessment and Treatment."
Med-IQ [more]

Perspectives in Central Nervous System Malignancies
These 4 podcasts provide additional insights into the PCNSM4: Perspectives in Central Nervous System Malignancies conference, which discussed trends and treatment strategies associated with the management of CNS malignancies.
Source: Johns Hopkins Advanced Studies in Medicine (JHASiM)


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