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Drugs from Genetically
The drug, GTC Biotherapeutics Inc's anti-clotting therapy Atryn, is an intravenous
therapy made using a human protein gathered from female goats that have been
genetically altered to produce extra antithrombin, a protein that acts as
a natural blood thinner. The U.S. Food and Drug Administration (FDA)
approved the first drug made using genetically engineered animals, clearing
the way for a new class of medical therapies.
Vaccines Do Not Cause Autism
Vaccines did not cause autism in three children whose families filed claims
with the U.S. government, a special court ruled this week. The U.S. Court
of Claims ruled that the scientific evidence does not support the idea that
vaccines can cause autism. The parents' case was "speculative and unpersuasive,"
the court said in one case. More than 5,500 claims related to autism have
been filed through the government's Vaccine Injury Compensation Program.
This program makes payments to families who can show that a child was killed
or injured by a vaccine. Suits against the vaccine makers are not allowed.
Pills Laced with Drugs
The Food and Drug Administration says the weight-loss capsules, such
as StarCaps, promoted as natural dietary supplements using papaya, could
be hazardous to your health. In violation of the law, the agency has found,
the capsules also contained a potent pharmaceutical drug called bumetanide,
which can have serious side effects. In a continuing investigation
that has prompted consumer warnings and recalls by some distributors, the
F.D.A. has determined that dozens of weight-loss supplements, most of them
imported from China, contain hidden and potentially harmful drugs.
Besides StarCaps, which were made in Peru and which Balanced Health Products,
the American distributor, has voluntarily withdrawn, the agency’s warning
list includes more obscure pills sold under the names Sliminate, Superslim
and Slim Up, among many others. So far, the F.D.A. has cited 69 tainted weight-loss
If a weight-loss supplement does contain an undeclared active pharmaceutical,
the F.D.A. considers the product to be an illegal, unapproved drug. Doctors
said undeclared drugs could cause problems on their own, like elevated blood
pressure or seizures, could have toxic interactions with other medications
and could make it difficult for physicians to diagnose patients.
The main law on dietary supplements of 1994 gives the F.D.A. jurisdiction
only after the products go on the market. Rather than reviewing the supplements
and approving them for sale, as the agency does with drugs, the F.D.A. is
limited to spot-checking manufacturers and distributors, and testing products
already on store shelves. Even the F.D.A. acknowledges there may be hundreds
of other drug-contaminated weight-loss supplements for sale that the agency
does not have the resources to identify. But even when the agency identifies
contaminated products, it does not have the ability to remove the pills from
stores, because it is initially up to companies to issue a recall. Eventually,
though, if contaminated products stay on the market, the F.D.A. can seek
injunctions, seize products or file criminal charges.
Of the nearly $24 billion spent on dietary supplements in this country in
2007, about $1.7 billion went for weight-loss pills, according to Nutrition
Business Journal, a market research firm. About 15 percent of American adults
said they had used weight-loss supplements and the majority failed to inform
their doctors about it, according to a phone questionnaire of 9,500 adults
conducted by the Centers for Disease Control and Prevention.
1. Follow The Golden Rule
Assume that your e-mail will be printed on the front page of the New York
Times. If you would be embarrassed or concerned, don't send it.
2. Don't E-Mail If You Can Telephone Or Meet In Person
E-mail is not a replacement for personal conversation. Comments and suggestions
can be said in a conversation that suddenly and surprisingly become misinterpreted,
embarrassing or harmful in an e-mail.
3. Never Ever Send E-Mail When You Are Angry Or Tired
Fatigue will cause you to lose patience and send something you will later
regret. Never send an e-mail when tired or angry.
4. Never Joke In E-Mails
What you are sending may seem hysterical to you, but don't do it. You never
really know the mood of the person receiving the e-mail.
5. Take Your Time In Writing E-Mails
The more quickly you send out an e-mail, the more likely it will miss the
mark. Communication is an art.
6. Don't Gossip In E-Mail
Don't use e-mail to gossip about friends or colleagues. More often than not,
some "well-meaning friend" will thoughtlessly forward it to someone you would
not have wanted to see it, or worse, to the person you are gossiping about.
7. Be Gentle
The old adage "sticks and stones may break my bones, but names will never
hurt me" does not apply to e-mail. Keep a business tone in your e-mails.
Praise others publicly, but criticize privately and in-person.
8. Don't Copy Everyone
Keep your distribution groups small. Send e-mails on a need-to- know basis.
Don't hit "reply to all" without thinking.
9. Edit E-Mails Yourself Or Ask A Colleague To Look Over Important E-Mails
E-mail is a form of written communication. Writing has rules, they work,
use them. Stick with proper grammar.
10. Don't Assume That Spell Check Will Catch Every Error
Use Spell Check, but don't rely on it. Carefully read all emails before hitting
the Send button.
11. Don’t Use abbreviations
You may know the abbreviation, but recipient may not.
FDA halts review of
drugs from Ranbaxy plant
Associated Press, 02.25.09, 11:24 AM EST
U.S. regulators say India's largest drugmaker has falsified test results
for some of its generic drugs.
The Food and Drug Administration says it is halting any consideration of
new drugs from a plant owned by Ranbaxy Laboratories, saying officials there
falsified data on drugs submitted to the agency. Yahoo! BuzzRegulators
say some of the drugs are already on the market. Despite the fraudulent data,
regulators say they have no evidence the drugs are dangerous and recommend
patients continue taking their prescriptions.
The action comes six months after the FDA closed U.S. borders to more than
30 generic drugs made by Ranbaxy after uncovering quality problems at two
Neurons from Stem Cells
The formula scientists concocted to make adult stem cells work like embryonic-like
stem cells is now much more simple to perform. For the first time,
a new report in the journal Cell, shows how neural stem cells taken from
adult mice can take on characteristics of embryonic stem cells.
In another report, researchers said they had made a type of nerve cell out
of ordinary skin cells in a new approach to stem cell research. They made
motor neurons out of induced pluripotent stem cells, or iPS cells.
Scientists hope that iPS cells might offer a substitute for embryonic stem
cells and a short-cut to tailored medical therapy for a range of diseases.
Motor neurons make muscles contract, and being able to make new motor neurons
might help treat diseases such as amyotrophic lateral sclerosis, or ALS.
"IPS-derived cells appeared to follow a normal developmental progression
associated with motor neuron formation," they wrote in the journal Stem Cells.
They looked like neurons taken from human embryonic stem cells, the researchers
added. Stem cells are the body's master cells, and a type taken from
days-old embryos, called embryonic stem cells, have the ability to morph
into any cell or tissue type in the body.
to Deliver Vaccines
Lactobacillus acidophilus, the good bacteria, are naturally found in dairy
products like yoghurt and cheese. They are used in food fermentation and
are safe for consumption. Some are considered as probiotics that
contribute to our general health and well-being. Researchers at North
Carolina State University have discovered that the good bacteria found in
dairy products and linked to positive health benefits in the human body might
also be an effective vehicle for an oral vaccine that can provide immunity
to anthrax exposure. The approach could possibly be used to deliver any number
of specific vaccines that could block other types of viruses and pathogens.
The oral vaccine riding inside the good bacteria makes it way through the
stomach and into the small intestine, an important immunological organ, where
it easily and efficiently binds to cells that trigger an immune response
– in this case, protection against anthrax in mice. The finding, published
in the Proceedings of the National Academy of Sciences, shows that an oral
vaccine can be as effective as one given by needle, a potentially huge advance
in drug delivery. Most vaccines are proteins, and as such normally won't
maintain their effectiveness after being digested in the stomach. The
study was funded by a grant from the National Institutes of Health and the
North Carolina Dairy Foundation.
Constipation in Japan
Sucampo Pharmaceuticals, Inc. announced that its subsidiary, Sucampo Pharma,
Ltd., has entered into a license and commercialization agreement with Abbott
Japan Co. Ltd. for Sucampo’s lubiprostone (trade name Amitiza®) in Japan.
Lubiprostone is the only FDA-approved treatment for chronic idiopathic constipation
(CIC) in adults and for the treatment of irritable bowel syndrome with constipation
(IBS-C) in adult women. In September 2008, Sucampo reported results from
a phase 2b dose-ranging study of lubiprostone for CIC in Japanese patients.
Based on these results, Sucampo plans to initiate phase 3 clinical testing
of lubiprostone for CIC in Japan in the second quarter of 2009. Lubiprostone
is a selective activator of type-2 chloride channels through which negatively
charged chloride ions flow out of the cells lining the small intestine and
into the intestinal cavity. As these negatively charged chloride ions enter
the intestine, positively charged sodium ions move through spaces between
the cells into the intestine to balance the negative charge of the chloride
ions. As these sodium ions move into the intestine, water is also allowed
to pass into the intestine through these spaces between the cells. This movement
of water into the small intestine promotes fluid content, which in turn softens
the stool and facilitates its movement, or motility, through the intestine.
Antibodies have provided some of biotech's biggest blockbusters. But they
have a distinct limitation. They are big, complex and rather fragile. Scientists,
though, are now studying the small antibodies found in llamas and camels
that promise to be able to offer better therapies for some of the world's
biggest diseases, including cancer, Alzheimer's, arthritis and more.
Belgium's Ablynx is collaborating with Novartis exploring nanobodies, which
are smaller than antibodies but easier to use. Novartis has the commercial
rights to nanobody products developed in the partnership. Ablynx has struck
deals with Wyeth, Boehringer Ingelheim and Novartis. Ablynx is developing
a new approach to deliver antibodies that can be delivered orally instead
of injected. If it works, production costs will drop. And researchers have
the potential to assemble antibodies into a molecule that can target a variety
of proteins--potentially offering a new approach to fighting cancer. Haptogen
is researching shark antibodies and Domantis is re-engineering larger antibodies
into smaller packages. To the winner of this race goes a very big market.
Generic Migraine Drug
Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug
Administration has granted final approval for the Company’s Abbreviated New
Drug Application (ANDA) to market its generic version of GlaxoSmithKline’s
Imitrex® Tablets, 25 mg, 50 mg and 100 mg for treatment of acute migraine
attacks. Shipment of this product has commenced. As one of the first
companies to file an ANDA containing a paragraph IV certification for this
product, Teva has been awarded a 180-day period of marketing exclusivity.
Annual sales of this product were approximately $1 billion in the United
States for the twelve months that ended December 30, 2008, based on IMS sales
Counter Cold Medicines Under Scrutiny in Britain
The effectiveness of some over-the-counter cough and cold medicines for children
under 12 has been placed in doubt by a British government watchdog. A review
by the Medicines and Healthcare products Regulatory Agency (MHRA) found "no
robust evidence" that many popular remedies work in children. The MHRA
has said 36 medicines should no longer be sold for children aged under six.
It has named eight cough mixtures that can be used for this age group.
In very rare cases some of the medicines can cause allergic reactions and
RECOMMENDED FOR UNDER 6s
Baby Meltus Cough Linctus
Beechams Veno's Honey and Lemon (not to be given under one year)
Benylin Children's Tickly Coughs (not to be given under three months)
Benylin Tickly Coughs (non-drowsy) (not to be given under one year)
CalCough Tickly Care Glycerin Lemon & Honey with Glucose (not to be given
under one year)
Lemsip Cough Dry Tixylix Baby Syrup (not to be given under three months)
Pain relief products such as Calpol are not affected by the new advice.
Source: The primary
sources cited above, BBC
News, New York Times (NYT), Washington
Post (WP), Mercury News, Bayarea.com,
Chicago Tribune, CNN, USA Today, Intellihealthnews,
Deccan Chronicle (DC),
the Hindu, Hindustan Times, Times
of India, AP, Reuters, AFP, Biospace
content of the articles is intended to provide general
information. Specialist advice should be sought about
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