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Alzheimer’s Disease Test
Washington University researchers recently developed a test to find whether
an Alzheimer's drug given to healthy volunteers could reduce production of
a substance known as amyloid beta. Called A-beta for short, the substance
is a normal byproduct of human metabolism that builds up to unhealthy levels
and forms plaques in the brains of Alzheimer's patients. Scientists believe
it is this buildup of plaque tangles that causes the disease's characteristic
mental deterioration. The drug currently being tested is made by Eli
Lilly and is in the third phase of clinical trials. Using stable isotope-lined
kinetics (SILK), researchers found the drug reduced the production of the
Until now, determining whether a drug is working has meant measuring a patient's
mental functioning over a long period of time. The new measurement tool SILK
takes just 36 hours, which should accelerate the development of new treatments,
the scientists say. The study was released online in Annals of Neurology.
Washington University licensed its pending patents on SILK to C2N Diagnostics,
a St. Louis company started by Bateman and Dr. David Holzman, the school's
chair of neurology.
Doctors usually first try either propylthiouracil or methimazole to treat
children with Graves' disease, the most common cause of an overactive thyroid.
Other treatments are surgery and radioactive iodine. But over the past
60 years, reports have popped up linking the use of propylthiouracil in children
to liver failure, sometimes fatal or requiring a liver transplant.
Propylthiouracil, or PTU, is also a primary treatment for adults with Graves'
disease, but there appear to be fewer liver complications in adults, according
to Donald R. Mattison of the Eunice Kennedy Shriver National Institute of
Child Health and Human Development.
In a letter published in New England Journal of Medicine, the doctors urged
colleagues not to give propylthiouracil as an initial treatment to children
for an overactive thyroid. They estimate that five to 10 children die each
year from complications of the drug, based on reports to the Food and Drug
Administration and others. Methimazole, sold both as a generic and
under the brand name Tapazole, also can hurt the liver, but the damage is
less severe and causes obvious symptoms. The damage is reversible once use
of the drug stops, unlike with propylthiouracil.
New Arthritis Drug
The Food and Drug Administration has approved a potential blockbuster drug
from Johnson & Johnson that fights three forms of arthritis caused by
immune-system deficiencies. The injectable medication is called Simponi.
It is essentially a follow-up to the multibillion-dollar medication Remicade,
which is marketed in the U.S. by J&J and in Europe by Schering-Plough
Corp. Marketing rights for the new drug would be similarly split between
the two companies. Simponi is marketed by Centocor Ortho Biotech Inc.,
All three forms of arthritis are chronic disorders in which the immune system
attacks joints, causing stiffness, pain and restricted motion. Other
similar drugs include Amgen's Enbrel and Abbott Laboratories' Humira. Simponi
is injected under the skin. It is intended for use in combination with the
immunosuppressant drug methotrexate in patients with rheumatoid arthritis.
It also may be used with or without methotrexate for psoriatic arthritis
and alone in patients with ankylosing spondylitis, a chronic inflammatory
arthritis of the spine.
Simponi is in a class of drugs that target and neutralize tumor necrosis
factor-alpha (TNF-α), a protein that, when overproduced in the body due to
chronic inflammatory diseases, can cause inflammation and damage to bones,
cartilage and tissue. Like other TNF- α blockers, Simponi labeling includes
a boxed warning alerting patients and health care professionals to the risk
of tuberculosis and invasive fungal infections with use of the drug. The
FDA also required a risk evaluation mitigation strategy (REMS) for Simponi,
as it required for other TNF-α blockers. The REMS for Simponi includes a
Medication Guide for patients and a communication plan to help prescriber’s
understand the drug’s risks. The most common adverse reactions to Simponi
include upper respiratory tract infection, sore throat and nasal congestion.
Research in India
In January 2008, global pharma major Novartis announced that it would ramp
up operations at its India Development Centre located in Hyderabad and would
hire 700 over the next year or so. However, the company reiterated
that these were not R&D jobs: “This is not a high-end work and the nature
of job is similar to business process outsourcing. We will think of doing
high-end R&D work in India only when the patent laws are made totally
compatible with WTO norms.” At issue is efficacy requirement
for new salts and other derivatives. As part of corporate social responsibility,
Novartis was spending huge amounts on disease prevention and focusing on
comprehensive leprosy care, tuberculosis and cancer with an annual budget
of $927 million.
However, a recent partnership between Merck and India’s Nicholas Piramal
(NPIL), potentially worth more than $300mm, suggests that Merck is unfazed.
In this partnership, NPIL is responsible for essentially the entire drug
discovery chain, from candidate identification through pre-clinical and early-stage
clinical trials. Pfizer is also investing strongly in India, announcing
their intentions to develop drugs for conditions endemic to India.
Pfizer Inc in April to pay about $136 million to boost its stake in its Indian
arm Pfizer Ltd to 75 percent. Pfizer,which announced plans to buy rival
Wyeth for $68 billion earlier this year, said that it would launch a tender
offer to buy a 33.77 percent stake in the Indian business at a price of 675
rupees per share. The offer represents a premium of more than 8 percent
to the April 9 closing price for Pfizer Ltd. Pfizer already owns 41.23
percent of the Indian company. It expects the offer, which is subject to
regulatory approvals, to open in June.
Although female oral contraceptives were developed over 40 years ago and
have proven very effective for family planning, no similar pharmacological
contraceptive has been developed for males. Surveys conducted by the Medical
Research Council Reproductive Biology Unit in the United Kingdom, suggest
that men would be willing to use a pharmacological contraceptive if one was
available. Presently the only contraceptives available for men are condoms
or a vasectomy. A newly discovered genetic abnormality that appears to prevent
some men from conceiving children could be the key for developing a male
contraceptive, according to University of Iowa researchers reporting their
findings in the April 2 online edition of the American Journal of Human Genetics.
Harvard University studies on mouse models that lack the CATSPER1 gene reveal
how sperm is affected when the protein is missing or abnormal. These studies
show that CATSPER1 mutations affect sperm motility, specifically the very
vigorous hyperactive motion the sperm uses when it is entering the egg during
fertilization. Several approaches to male contraception are currently
under investigation at other institutions. One approach that could potentially
target CATSPER1 is immunocontraception where antibodies are developed that
bind to a targeted protein and block its function. Immunocontraception is
still in early stages of development and in order to be useful it will need
to be proven effective, safe and reversible.
in Pharmaceutical Industry
Big companies often point to their rivals to set (and justify) CEO pay. That
may explain the close clustering of pay in the $16 million to $18 million
range for most of the Big Pharma CEOs included in the WSJ’s 2008 CEO compensation
survey, which is out on April 3, 2009 and includes 200 companies with revenues
of more than $5 billion.
Still, when you have a pack of alpha males like this, you want to know who’s
No. 1. This year, it’s Abbott’s Miles White (pictured at right, smiling),
whose compensation was valued at just over $18 million. J&J’s Bill
Weldon, Merck’s Dick Clark and Bristol-Myers Squibb’s Jim Cornelius were
close behind, with packages valued at more than $17 million. Pfizer’s Jeff
Kindler had a package of more than $16 million. After that, there’s
a bit of breathing room. Eli Lilly’s John Lechleiter, who took over mid-year
as CEO, had a package valued at more than $10 million. The CEOs of Amgen
and Gilead — both drug companies, but not typically considered among the
ranks of Big Pharma — had packages valued at more than $13 million and more
than $12 million, respectively. While Citigroup CEO, Vikram Pandit
makes 39 million, Disney CEO Robert Iger makes 50 million and Motorola
CEO Dr. Sanjay Jha makes 104 million.
Harvard scientists say they've found a possible way to prevent brain cells
from falling victim to the ravages of Huntington's disease. The work
is still in the preliminary stages, and the researchers don't know if the
strategy will work in humans. Still, a Huntington's disease expert said the
findings could lead to a way to combat the incurable condition.
Huntington's disease is inherited, and children of parents with a single
faulty gene have at least a 50 percent chance of developing it. The condition
typically develops in middle age, causing the body to move involuntarily,
leading to symptoms such as balance and coordination problems, slurred speech,
swallowing problems and dementia. Death typically occurs within 10
to 30 years. There's no treatment to stop the progression of Huntington's
disease or cure it, although patients can take drugs to control their symptoms.
Drugs known as HDAC inhibitors have the same effect and are already being
tested as treatments for Huntington's disease and cancer. The drugs are currently
used to treat psychiatric disorders.
Alzheimer's disease, for example, is also caused when cells become clogged
and fail to function properly.
A chemical best known for cementing the bond between a mother and her newborn
child could also play a part in picking mister (or miss) right. A new study
shows that men and women who inhale a whiff of the hormone oxytocin rate
strangers as more attractive. This effect adds to the hormone's known role
in human relationships. One study found that oxytocin levels spike after
new mothers look at or touch their newborns and may help bonding. Other
work has hinted at the importance of oxytocin in social situations between
adults too. People administered the hormone make overly generous offers in
an economic game that measures trust, while men who got a dose of oxytocin
proved better at remembering the faces of strangers a day later, compared
to subjects who got a placebo.
Scorpion Venom for Cancer
For more than a decade scientists have looked at using chlorotoxin, a small
peptide isolated from scorpion venom, to target and treat cancer cells. Chlorotoxin
binds to a surface protein overexpressed by many types of tumors, including
brain cancer. By combining nanoparticles with the compound already being
investigated for treating brain cancer, University of Washington researchers
found they could cut the spread of cancerous cells by 98 percent, compared
to 45 percent for the scorpion venom alone. Chlorotoxin also disrupts the
spread of invasive tumors -- specifically, it slows cell invasion, the ability
of the cancerous cell to penetrate the protective matrix surrounding the
cell and travel to a different area of the body to start a new cancer. The
MMP-2 on the cell's surface, which is the binding site for chlorotoxin, is
hyperactive in highly invasive tumors such as brain cancer. Researchers believe
MMP-2 helps the cancerous cell break through the protective matrix to invade
new regions of the body. But when chlorotoxin binds to MMP-2, both get drawn
into the cancerous cell. Other researchers are currently conducting human
trials using chlorotoxin to slow cancer's spread.
The genome of a female Hereford cow has been sequenced, which could be a
starting point for major improvements in the industry. The information is
likely to have a major impact on livestock breeding. The study, published
in the journal Science, was a six-year effort by more than 300 scientists
in 25 countries.
Cattle now join an elite group of animals to have had their genome sequenced
- a group that includes humans, other primates and rodents. Although sheep
and goats were domesticated earlier, cattle are the most important herd animals
in the world. There are about 800 distinct breeds, and together they contribute
to the nutrition or income of about 6.6 billion people.
The cow is the first livestock animal whose genome has been sequenced, part
of an effort to read and analyze the DNA of organisms that have scientific,
medical or economic importance. In addition to dozens of microbes and several
plants, those sequenced so far include the chimpanzee, mouse, rat, dog, chicken,
mosquito, fruit fly, opossum and platypus.
Of a cow's 22,000 genes, versions of at least 14,000 are common to all mammals.
Cows appear to have about 1,000 genes that they share with dogs and rodents
but that are not found in people. The most recently evolved genes tend
to be clustered in parts of the cow's 31 chromosomes where stretches of DNA
have been duplicated, copied and inserted upside down, or added to by invading
viruses. Those events are usually catastrophic and often lead to the fatal
breakage of chromosomes. Over evolutionary time, however, a few survive and
provide the raw material for new genes -- and new functions.
This clear relationship between chromosome instability and gene formation
is giving scientists a new view of one way evolutionary change happens at
the molecular level.
There are two types of cattle -- taurine, which have no humps and predominate
in Europe, Africa, the Americas and much of Asia; and indicine, which have
humps and are in the Indian Continent (South Asia) and East Africa. Both
lineages descended from aurochs, a much larger and more aggressive species.
Indicine breeds have much greater genetic diversity than taurine breeds,
evidence that they were developed from a larger number of "founder" animals.
Both types of cattle show evidence of natural selection in genes that appear
to be involved in making the animals -- large, horned and potentially dangerous
-- docile. In some breeds, specific variants of behavior-related genes are
"fixed," or seen in essentially every animal. Curiously, some of those genes
are in regions that in the human genome seem to be involved in autism, brain
development and mental retardation.
Three papers on the cow genome appeared in the journal Science.
Pharma Business is Risky
Pharma is a risky business – including actual or potential litigation on
safety as well as the continuing threat of public hostility or indifference.
Europe, once the world's pharmacy, produced seven of 10 new medicines only
a decade ago; now it's three, even though the EU accounts for 35% of global
output and its three biggest firms count among the top five in the world.
Big Pharma is in the throes of convulsive change. A spate of multibillion
mergers and acquisitions in the past few months is transforming the landscape,
with this week's $3.6bn (£2.5bn) takeover of Stiefel by GlaxoSmithKline
the latest and certainly not the last. http://www.guardian.co.uk/business/2009/apr/22/pharmaceuticals-industry-gm
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Post (WP), Mercury News, Bayarea.com,
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Deccan Chronicle (DC),
the Hindu, Hindustan Times, Times
of India, AP, Reuters, AFP, Biospace
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