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5110 Kali Era, Sarvadhari
Vikramarka Era, Sarvadhari
An experimental malaria vaccine is the most promising yet, protecting up
to 65 percent of infants from infection in two studies in Africa, researchers
reported in the New England Journal of Medicine. While the vaccine
is far from perfect, it is the best yet against the mosquito-borne parasite,
the researchers agreed. They said they would begin phase III clinical tests,
the last stage before seeking regulatory approval, next year. The World
Health Organization estimates malaria killed 881,000 people and infected
247 million worldwide in 2006. Some malaria experts say those numbers underestimate
Cheaper Female Condom
A new, potentially less expensive version of the female condom is being reviewed
by U.S. regulatory when a Food and Drug Administration advisory panel weighs
whether they adequately prevent pregnancy, HIV and other sexually transmitted
diseases. The FC2 Female Condom, made by Female Health Co, is made
with a synthetic rubber using a process similar to male condoms that the
company says is less labor intensive and should reduce its current cost.
Male condoms, which come in a variety of brands and cost consumers between
50 cents and $2 a piece, are far more widely used than their female counterpart,
which costs between $2.80 and $4. Chicago-based Female Health is seeking
FDA approval to market the new version. FDA approval could help boost
sales in the United States, which make up just 10 percent of the female condom's
34.7 million unit sales in 2008, according to Female Health Co. The
female version gives women their own option for protection and allows them
to insert a condom before intercourse. Most other countries have already
adopted the newer version, the company has said. It also offers other
advantages over the male condom, according to the company, including greater
protection by covering part of a woman's outer genitals.
Bailout for Biotech
Representatives from the U.S. biotech industry traveled to Congress to seek
a government bailout. Industry execs led by BIO want to exchange future tax
credits from future profits in exchange for cash now to support research
and development. It could add up to only few hundreds of millions, but not
billions of dollars as is the case with auto and financial sectors.
The appeal comes at a time that small and medium-sized biotechs are running
out of cash, fresh funds are hard to come by, and as the daily carnage continues
unabated as developers shed workers and programs in a desperate attempt to
In fact, it’s so bad that BIO, the main lobbyist for the industry, is saying
that a quarter of the 370 publicly traded U.S. biotech companies have less
than six months of cash on hand. And, of course, creating an effective drug
can take billions of dollars and decades to accomplish. Not to mention that,
if clinical trials go badly, it’s back to the drawing board, making biotech
one of the riskiest industries out there. And risk is not something lawmakers
are loving these days. Still, the potential health benefits of the drugs
biotechs produce are massive, and we do have that whole aging population
and health care crisis to contend with. So if we’re already writing $850
billion checks, we may as well throw a little biotech’s way.
While making copies of biologic medicines available is not yet possible under
U.S. law, President-elect Barack Obama supports biosimilars and Congress
is expected to debate next year how to establish a regulatory pathway to
get such products on the market.
Drugmakers are struggling to find new sources of revenue as regulators approve
fewer medicines and patents expire on best-selling products. Merck, based
in Whitehouse Station, New Jersey, earlier this month said it will start
a new division to copy products based on living proteins and enzymes instead
of chemicals. Indianapolis-based Eli Lilly said this month it would also
explore making copies of biologics that have lost patent protection.
Novartis AG’s generic-drug unit-- Sandoz unit-- two years ago became the
first company to have a biosimilar product approved: the growth hormone Omnitrope.
The European Commission last August cleared Novartis’s anemia drug that is
similar to Johnson & Johnson’s Eprex and Amgen’s Epogen. AstraZeneca
is joining the club. Biologic drugs became a key focus for AstraZeneca
after the company paid $15.2 billion in cash for MedImmune Inc. in 2007.
Biosimilar competition is led by generic companies such as Teva Pharmaceutical
Industries Ltd. And Novartis.
New Drug Test
An international team of scientists has introduced a breakthrough in the
use of polymer research that will make it easier to detect drug use and promote
faster and more efficient medicines, which was published in the December edition
of the Royal Society of Chemistry (RSC) Journal. A polymer is placed
onto an electrical probe to detect molecules in the blood. The probe
would then send a signal indicating the presence of the drug, allowing the
results to be accessed almost instantaneously. The technology will
also enable medicines to be directed to specific areas of the body, increasing
their effectiveness and reducing side effects. It could take another
five to 10 years for the technology to be widely available.
Trouble over Bextra
A Santa Clara County jury ordered Pfizer to pay $38 million to a leading
San Bruno medical research firm for stealing trade secrets to develop a pain
relief drug that eventually was taken off the market. Concluding a six-week
trial, the Superior Court jury also found that Pfizer and a former employee
of the research firm could be liable for punitive damages, which could triple
the judgment and catapult the verdict beyond $100 million. Judge Gregory
Ward, who presided over the trial, will eventually decide the punitive damage
The hefty damage award stems from a lawsuit filed by Dr. Dennis Mangano,
head of the nonprofit Ischemia Research and Education Foundation, an outfit
that has gained national attention in recent years for studies on the risks
posed by certain medications during heart bypass surgery.
The lawsuit alleged that Pfizer approached the foundation in 2002 to use
its renowned database in clinical trials on Bextra, a potential blockbuster
drug to treat acute pain caused by arthritis and other maladies. Mangano's
data on cardiovascular issues was considered crucial because of concerns
the drug might pose heart risks; in fact, Bextra was eventually pulled from
the market as a result of those concerns. But according to court documents,
Pfizer and the foundation could not agree on terms for use of the database.
The lawsuit alleged that Pfizer arranged a side contract with Hsu, a lead
statistician who provided the data without approval. The lawsuit further
alleged that Pfizer and Hsu destroyed evidence when confronted about stealing
the trade secrets, a centerpiece of the trial.
to Help Drug Development
Drug development is an incredibly expensive and protracted process. Typically,
it costs around $1 billion to bring a new drug to market and the whole process
usually takes about ten years. Before new drugs can go forward for clinical
trials, it's necessary for the chemical compounds which make up a drug to
undergo thousands of tests for toxicity before beginning trials on animals
-- initially on rodents and then often on dogs. It's here, at this
ethically sensitive and very expensive stage, that Professor Mummery believes
stem cell research could transform drug development. Stem cell based
drug testing is already being promoted in the UK with the public/private
initiative "Stem Cells for Safer Medicine" which was set up in 2007. A 2007
sabbatical at the Harvard Stem Cell Institute in Cambridge, Massachusetts
gave Mummery first-hand experience of the ethical debates that have engulfed
stem cell research debates in the U.S. "I was shocked at the light years
we are away from the way people think about embryonic stem cells in the States,"
she said. "It's very mixed up with the abortion issue. It's put into the
same category." "You go into a lab in the States and they say; 'this
is our NIH lab, and this is our other lab'. They have to buy one microscope
to look at NIH lines and another to look at other lines. They have to administer
all the stem cells separately. There are even dotted lines in a lab which
you can and cannot cross. It's completely ridiculous," she said. In
addition to public outdated thinking, lack of public funding under President
George W. Bush has also stymied research in the US. http://www.cnn.com/2008/HEALTH/12/22/stem.cell.drug.tests/
Glaxo to buy BMS
Glaxo, like many big pharmaceutical companies, faces a slowing pipeline of
drugs from its R&D efforts as well as increased competition from generic
drugmakers. In response, continuing a small buying spree in emerging
markets, Glaxo has agreed to pick up Bristol-Myers Squibb's Pakistani business
for about $36.5 million. Glaxo says it will acquire a portfolio of more than
30 pharmaceutical brands, including antibiotics, vitamins and dermatology
products. Total sales of the portfolio in 2007 were about $19 million. Already
this year, GSK has purchased a portfolio of drugs from Bristol-Myers Squibb
in Egypt. The company also announced a drug commercialization deal with the
South African pharmaceutical company Aspen. GlaxoSmithKline, which
has headquarters in London, employs more than 5,000 people in Research Triangle.
Prozac for Cancer
In animal models, a mild doxorubicin-fluoxetine treatment combination slowed
down tumor progression significantly. These results suggest that pairing
Prozac with chemotherapeutic drugs to curb drug resistance warrants further
clinical study, says Dr. Peer. His research was published in Cancer
Letters, and his suggestions are now listed as recommendations in the latest
version of Cancer Encyclopedia.
According to U.S. researchers, a review of nine studies that examined
the effectiveness of three popular cholinesterase inhibitors in managing
Alzheimer's patients' behavioral and psychological symptoms, found the drugs
were effective at the same dosage used to improve cognitive impairment.
The study was published in the December issue of Clinical Interventions in
Aging. About 90 percent of Alzheimer's patients have behavioral and
psychological symptoms. Cholinesterase inhibitors boost levels of a brain
chemical called acetylcholine, which assists memory, thought and judgment.
The U.S. Food and Drug Administration (FDA) approved Abbott's TRILIPIX(TM)
(fenofibric acid) delayed-release capsules for use along with diet to help
lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in
patients with lipid problems. TRILIPIX is the first and only fibrate to be
approved for use in combination with a statin. In certain patients, treatment
guidelines recommend the combination of a fibrate with a statin to further
improve lipid levels. TRILIPIX has not been shown to prevent heart disease
or heart attack.
Pharmaceutical & Biotech Industry
The then Indian Prime Minister Narasimharao Pamulaparti (PVN Rao) opened
the Indian economy and started dismantling the license Raj in early
1990s, which had the most significant impact in the area of pharmaceuticals
and computer industries. With the new regime and India's Patents (Amendment)
Act 2005, the $8 billion Indian pharmaceutical industry has been forced to
adapt and recast its business models. The introduction of product patents
has provided a reason to start domestic research programs. The pharmaceutical
industry has unprecedented opportunities for both foreign and local companies
as India remains the second fastest growing emerging economy in the world
and pharmaceuticals remain one of the strong sectors of growth.
In December 2008, Union Minister of Science and Technology Kapil Sibal announced
20 more biotech parks to be set up throughout the country for promoting research
in the field of life sciences. At present, besides Lucknow, there are
only three "functional" biotech parks at Hyderabad, Pune and in Punjab. In
order to produce "high quality human resource", an agreement would be signed
with the Welcome Trust of Britain. The Department of Biotechnology
(DBT) will form a 10-year pact with the Welcome Trust for ensuring high quality
human resource, which is one of the key elements for scientific leadership.
In addition, a regional UNESCO centre would come up in Faridabad in Haryana
to help bring academia, industrialists and government officials on a common
platform for promoting utility-based research. Expressing concern
over the shortage of the number and quality of human resource needed to take
the biotechnology revolution forward, Sibal called the scientists to undertake
research projects for countering diseases that are considered a "burden for
the poor", food security, new varieties of crops, vaccines, and to mitigate
industrial pollution. An investment of Rs 15 crore (~ USD 3 million)
has been made into the Lucknow Park, which is nothing compared to what biotech
industry elsewhere in the world is investing. Cost of developing a new drug
is more than USD 1 billion and cost of developing a biologic is even more.
Perhaps, the Indian politician forgets that the scientists are not sages
living in ashrams in forests, but are professionals who need to be paid for
their work and expensive research facilities.
The Lucknow Biotech Park is a joint venture of the central and the state
governments, with assistance from the Council of Scientific and Industrial
Research (CSIR) and the Indian Institute of Technology (IIT), Kanpur, and
some other educational institutions and industries. Although set up
in 2002, the Lucknow Biotech Park was officially inaugurated in December
2008. This, of course, shows the Indian government’s interest in such projects.
Poor people can only hope and vote!
for Patentability of Process Claims
The Federal Circuit in In re Bilski explained that subject matter
eligibility is a threshold determination for patentability separate from
novelty or non-obviousness. The inquiry begins with determining whether
a claim falls into one or more categories of invention listed in § 101:
process, machine, article of manufacture or composition of matter. Under
the Federal Circuit's previous precedents, including State Street, if a claim
fell into one of the four broad categories, it was deemed patentable subject
matter unless it fell under one of several exceptions defined by the Supreme
Court: laws of nature, natural phenomena and abstract ideas. The Court rejected
the State Street test as "inadequate." Under Bilski, "[a] claimed process
is surely patent-eligible under § 101 if: (1) it is tied to a particular
machine or apparatus, or (2) it transforms a particular article into a different
state or thing."
According to Mr. Moatz, the primary complaints that he receives against patent
Lack of candor (Either to client or the PTO).
Failure to make reasonably inquiry.
Failure or delay in filing application
Failure to respond to OA (even when client has not paid)
Misuse of the certificate of mailing
Failure to pay issue fee
Failure to revive
Failure to turn over files to new attorney
Failure to communicate with client
Additional reasons for ethical sanction include DUIs; unauthorized taking
of prescription meds; and disbarment.
Generics in US get
American consumers and health insurers saved about $1 billion on generic
drugs this year as “fierce” competition among drugmakers and pressure from
insurers lowered prices. Total spending on drugs from Teva Pharmaceutical
Industries Ltd., Mylan Inc. and other generic-drug makers fell 2.7 percent
to $33 billion in the 12 months ended in September, the biggest decline in
at least a decade, the health research firm IMS Health Inc. said in a report
today. The average price manufacturers charged wholesalers for the copycat
pills fell 8 percent while demand increased 5.4 percent, IMS said. The
surge in use was driven by a flood of new generic drugs that entered the
market this year after patents expired on $16 billion worth of medicines.
At the same time, insurers and retail pharmacies are pressuring generics
makers to cut prices as they compete against each other. The trends are likely
to accelerate through 2012 as half the current 20 top-selling pills get competition
from generic copies, which can cost 70 percent less than their brand-name
In addition, Wal-Mart Stores Inc., the world’s largest retailer, two years
ago began selling prescriptions for more than 300 generic drugs for $4 a
month. Target Corp., the second-largest U.S. discount retailer, and Safeway
Inc., the third-largest U.S. supermarket chain, later followed. Wal-Mart
this year reduced the price to $10 for a three-month supply.
Whooping Cough Vaccine
Whooping cough, also known as pertussis, is a serious and highly contagious
respiratory disease characterized by severe coughing fits. Whooping cough
may lead to complications such as pneumonia or rib fracture in adolescents
and adults. The illness may last for more than 100 days and can lead to lost
time at work or school. Babies who have not received all of their shots for
whooping cough are at risk of catching the illness. Preteens, teens and adults
are often the source of infection for infants.
Whooping cough starts off like the common cold, and may include symptoms
such as a runny nose, sneezing, mild fever and severe coughing fits. While
more than 3,500 cases of whooping cough were reported in U.S. adults ages
20 years and older in 2007, many more cases may go unreported. In fact, it
is estimated that over 600,000 cases occur in adults annually. According
to the CDC's 2007 National Immunization Survey, an estimated 98 percent of
adults aged 18-64 years reported that they have not received the whooping
cough booster shot.
The U.S. Food and Drug Administration (FDA) has approved GlaxoSmithKline’s
BOOSTRIX® [Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis
Vaccine, Adsorbed (Tdap)] for use in adults 19-64 years of age. BOOSTRIX
offers protection against tetanus, diphtheria and pertussis (whooping cough)
to individuals 10-64 years of age -- the broadest age range for any Tdap
vaccine. BOOSTRIX was previously approved as a booster vaccine for preteens
and teens. Whooping cough is a highly contagious respiratory disease
that can be prevented through vaccination, yet most adolescents and adults
have not received the recommended booster shot, according to the Centers
for Disease Control and Prevention (CDC).
About one in 10 doctors who vaccinate privately insured children are considering
dropping that service largely because they are losing money when they do
it, according to a new survey.
Suicide Warning for Epilepsy
Epilepsy drugs will now carry a warning about an increased risk of suicide
among people taking them. The Food and Drug Administration announced the
warning this week for 21 medications, citing a slightly higher risk for suicide
among people taking epilepsy drugs versus placebos. Manufacturers now will
be required to distribute pamphlets describing the risks for patients. The
FDA advises monitoring of all patients taking the medications for changes
in behavior that could indicate suicidal thoughts or behavior or depression.
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
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