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5110 Kali Era, Sarvadhari
Vikramarka Era, Sarvadhari
for More Teeth
Rep. John Dingell's House Energy and Commerce Committee released a "discussion
draft", planning to convene hearings over the next few weeks and draw up
the real bill after that. Some points:
Drug and device plants making products for the U.S. market would register
annually with the FDA
would have to inspect all drug and device facilities every two years; no
drug, ingredient, or device could be sold until its plant had been inspected
at least once--and FDA approval could be yanked if this rule was violated
Importers without documentation that they'd complied with all safety rules
could only ship into ports with federal testing labs.
Drug and API makers would have to test their products for contaminants.
Drug labels would identify the source of active ingredients and specify where
a drug was made.
The bill would give the FDA stronger enforcement powers, including the ability
to recall drugs unilaterally and destroy counterfeit or contaminated imports.
The agency would also be able to issue fines for violations.
Lying to Feds Gets You in
The Department of Justice announced that the former senior vice president
of Bristol-Myers Squibb Company (BMS), Andrew Bodnar, was indicted for his
role in lying to the federal government about a patent deal involving the
popular blood-thinning drug, Plavix, used by heart attack, stroke and other
patients. The Department said that the alleged illegal actions of Bodnar
related to the possible introduction of a generic drug that would compete
On June 11, 2007, BMS agreed to plead guilty and pay a $1 million criminal
fine for misleading the government about the Plavix patent deal. BMS paid
the maximum fine permitted by statute for committing two violations under
the federal False Statements Act.
According to the one-count indictment filed in the U.S. District Court in
Washington, D.C., in 2006, BMS and another company, Apotex Inc., were engaged
in litigation over the validity of the patent for Plavix and were negotiating
a settlement of that litigation. At the time, BMS was subject to a separate
consent decree, for unrelated conduct, with the Federal Trade Commission
(FTC) that required BMS to submit any proposed patent settlements for review
and advisory approval by the FTC. The FTC warned BMS that if BMS agreed with
Apotex not to launch BMS's own generic version of Plavix -- meaning that
BMS would not compete against Apotex for generic sales -- then the FTC would
not approve a settlement of the Plavix litigation.
Environmentally Friendly Jobs
While many companies are cutting down, Danish drug maker Novo Nordisk and
New Jersey Gov. Jon S. Corzine have plans to expand its North American headquarters
with an environmentally friendly building that will add hundreds of new jobs.
Novo Nordisk, one of the world's largest producers of insulin for diabetes
treatment, intends to add 400 workers to its West Windsor facility that now
employs 700, said a spokeswoman for Corzine. The building will
be environmentally sensitive, with recycled water, long-life light bulbs
and other features.
The move comes at a key time for New Jersey, which has lost about 10,300
jobs so far this year, according to state labor department figures.
Wyeth notified employees that still more jobs are going. This follows an
announcement last month that 1,240 sales positions would be eliminated as
part of what Wyeth execs are calling ‘Project Impact.’ However, Wyeth
announced it will invest $96 million (SGD $134 million) to expand its existing
nutritional manufacturing facility in Tuas, Singapore. The expansion
was officially announced during a groundbreaking ceremony at the site attended
by Company officials and representatives from the Singapore Economic Development
Board, which is partnering with Wyeth to support the successful completion
of the project.
In Michigan, massive expansion of a life sciences research company in the
Kalamazoo area, expected to create 3,300 jobs over the next five to seven
years. The Michigan Economic Growth Authority (MEGA) board unanimously
approved an $86 million high-tech tax credit to MPI Research Inc. over 15
years to expand its campus in Mattawan and employ 400 new workers in downtown
Kalamazoo. The downtown move could begin in late summer and the expansion
in Mattawan, which is about 10 miles west of Kalamazoo, is ongoing, company
Alendronate, a medication used to prevent fractures in women with osteoporosis,
may be associated with an increased risk of atrial fibrillation, a type of
abnormal heart rhythm, according to a report in the April 28 issue of Archives
of Internal Medicine, one of the JAMA/Archives journals. Other recent studies
have reported atrial fibrillation as an unexpected adverse effect of bisphosphonates,
a class of drugs that includes alendronate and other medications that affect
the body’s calcium levels, according to background information in the article.
Atrial fibrillation occurs when the atria, the smaller upper chambers of
the heart, begin to beat irregularly and rapidly.
“In conclusion, all drugs have benefits and adverse effects,” the authors
continue. “When new information becomes available about a previously unrecognized
benefit or adverse effect, physicians and patients must reweigh the current
knowledge about benefits and risks in making treatment decisions for each
patient. The benefits of fracture prevention in patients at high risk for
fracture will generally outweigh the possible risks of atrial fibrillation.
However, it is important to carefully weigh the benefits against the possible
risk of atrial fibrillation in women who have only modestly increased fracture
risk and in women who have risk factors for atrial fibrillation, such as
diabetes mellitus, coronary disease or heart failure.” Arch Intern Med. 2008;
to Smuggle Proteins
A gel that can smuggle insulin past the stomach and slowly release the drug
into the blood could do away with diabetics' daily injections. Pills made
from the new material could also deliver other protein-based drugs, such
as human growth hormone, that must be protected from being digested in the
stomach. The gel is also designed to stick onto the intestine wall, buying
time to deliver its insulin payload. An outer coating, composed of a wheat-germ
protein called agglutinin, forms structures that grab hold of intestinal
cells. Mysteriously, the agglutinin also appears to help the insulin get
through the intestinal wall and into the blood stream. Animal trials of the
gel are planned to start soon. Biomacromolecules (http://pubs.acs.org/cgi-bin/abstract.cgi/bomaf6/2008/9/i04/abs/bm701274p.html)
Celgene International Sàrl announced that Thalidomide Pharmion has
been granted full marketing authorization by the European Commission for
use in combination with melphalan and prednisone as a treatment for patients
with newly diagnosed multiple myeloma. In June 2007, the European Commission
granted the Company’s REVLIMID® full marketing authorization as the first
oral treatment in more than 40 years for patients with multiple myeloma who
have received at least one prior therapy.
From 1956 to 1962, approximately 10,000 children were born with severe malformities,
including phocomelia, because their mothers had taken thalidomide during
pregnancy. In 1998, the FDA approved the use of thalidomide for the
treatment of lesions associated with erythema nodosum leprosum. In 2006,
the U.S. Food and Drug Administration granted accelerated approval for thalidomide
(Thalomid, Celgene Corporation) in combination with dexamethasone for the
treatment of newly diagnosed multiple myeloma (MM) patients.
Thalidomide was chiefly sold and prescribed during the late 1950s and early
1960s to pregnant women, as an antiemetic to combat morning sickness and
as an aid to help them sleep, with catastrophic results for the children
of women who had taken thalidomide during their pregnancies.
Abbott announced that it has received approval from the Japanese Ministry
of Health, Labour and Welfare for HUMIRA® (adalimumab) for the treatment
of rheumatoid arthritis in patients with inadequate response to conventional
therapy. This approval is the first for HUMIRA in Japan, where Abbott co-developed
and will co-market HUMIRA with Eisai Co., Ltd. HUMIRA is now approved in
75 countries for rheumatoid arthritis and other autoimmune disease indications.
Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by
joint inflammation, joint pain and stiffness, which can lead to long-term
joint damage. The joints most commonly affected early in the disease are
the smaller joints of the fingers, feet and wrists. The elbows, knees, ankles
and hips can also be affected. Although there is no cure for RA, people continue
to seek treatments that help alleviate pain and inflammation and slow disease
More information on RA and current treatment options can be found at http://www.RA.com.
HUMIRA is the only fully human monoclonal antibody approved for the treatment
of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis
(AS), Crohn.s disease and plaque psoriasis (Ps) in the United States and
Europe. HUMIRA is also approved for the treatment of juvenile idiopathic
arthritis (JIA) in the United States, and review for JIA in Europe is ongoing.
Clinical trials are underway evaluating the potential of HUMIRA in ulcerative
colitis. To date, HUMIRA has been approved in 75 countries and more than
250,000 people worldwide are currently being treated with HUMIRA. HUMIRA
resembles antibodies normally found in the body. It works by blocking tumor
necrosis factor alpha (TNF-alpha), a protein that, when produced in excess,
plays a central role in the inflammatory responses of many immune-mediated
India's top biotechnology firm, Biocon Ltd, is in talks to acquire a U.S.
firm in a deal valued at $400 million to boost its overseas pharmaceutical
distribution network. Biocon which makes insulin, cholestrol-lowering statins
and other branded drugs bought 70 percent of German marketing firm Axicorp
GmbH for 30 million euros ($47 million) in February to boost its distribution
network in Europe.
Many top-selling drugs used to treat cancer and lower cholesterol are made
from organic compounds called polyketides, which are found in nature but
historically difficult for chemists to alter and reproduce in large quantities.
For the first time, scientists at UC Irvine have discovered how polyketides
form their ringlike shape, making it easier for chemists to manipulate them
into new drugs. The key, they found, is an enzyme called aromatase/cyclase,
which forms a C-shape mold in which polyketides can form one molecule at
a time. By changing this mold, chemists can control the size and shape of
the polyketide, resulting in the formation of new drugs. The research appears
online in the Proceedings of the National Academy of Sciences.
Dr. Reddy’s Laboratories Ltd announced that it has acquired Jet Generici
Srl, a company engaged in the sale of generic finished dosages in Italy.
The deal has been completed via Dr. Reddy’s Italian subsidiary, Reddy Pharma
Italia SpA, which has been engaged in building a pipeline of registrations
since its incorporation. The acquisition provides access to an essential
product portfolio, a pipeline of registration applications, and a sales and
marketing organization. Financial terms and conditions of the transaction
are not being disclosed.
Dr. Reddy’s Laboratories also announced that it has entered into a definitive
agreement with The Dow Chemical Company to acquire a portion of Dowpharma
Small Molecules business associated with its United Kingdom sites in Mirfield
and Cambridge. The financial terms and conditions of the transaction are
not being disclosed at this point in time. The transaction is scheduled to
close on April 30, 2008 pending regulatory approval.
Dr. Reddy’s Laboratories was established in 1984 in Hyderabad, India, and
is a global pharmaceutical company with proven research capabilities. Dr.
Reddy’s conducts research in the areas of diabetes, obesity, cardiovascular
diseases, anti-infectives and inflammation.
Sequencing is Faster and Cheaper
The first full genome to be sequenced using next-generation rapid-sequencing
technology is published in Nature, marking another milestone in the field
of human genome sequencing. It took just four months, a handful of scientists
and less than US$1.5 million to sequence the 6 billion base pairs of DNA
pioneer James Watson. The achievement is first proof of principle that these
rapid-sequencing machines can decipher large, complex genomes (see Nature,
page 819). Made in this case by Connecticut-based 454 Life Sciences, a division
of Roche Diagnostics, they allow many more sequencing reactions to proceed
at the same time, on the same surface, than the previous generation of machines
that produced the inaugural human genomes. That change has had big pay-offs
in speed, efficiency and, ultimately, cost (see Table 1).
James Watson's is not the first full genome to be published; that distinction
goes to genomics entrepreneur J. Craig Venter, whose genome was sequenced
using previous-generation machines at a cost of $100 million.
Source: The primary sources
cited above, BBC News, New York
Times (NYT), Washington Post (WP), Mercury
News, Bayarea.com, Chicago Tribune,
USA Today, Intellihealthnews, Deccan
Chronicle (DC), the Hindu, Hindustan
Times, Times of India, AP, Reuters,
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