|To join The Indian American Chemical Society (TIACS),
please send an email to: TIACSemail@example.com
5110 Kali Era, Sarvadhari
Vikramarka Era, Sarvadhari
Biotechnology companies have approximately 633 drugs in development, according
to a report by the Pharmaceutical Research and Manufacturers of America.
Biotech drugs account for nearly one-third of the 2,000 drugs under development
in the United States. Companies based or having branch offices in San Diego
County playing a role in 44 of them, according to the report. The number
of biotech drugs in development nationally is nearly 50 percent greater than
two years ago and nearly double the number in 2004, according to the report.
Biotech refers to the development of products from or by living creatures.
Cancer is the biggest disease target, with 254 biotech drugs under development,
and the infectious diseases category ranks second, with 162 drugs. Large
pharmaceutical companies for years have looked to alliances with biotech companies
to find new drugs. Biotechs are smaller and have less cash than big pharmaceutical
companies, but they are renowned for their science and entrepreneurial spirit.
Pharmaceutical drugs with annual sales totaling $60 billion are due to come
off patent by 2011 and thus face competition from generic drugs, adding urgency
to the search for new medicines among big pharmaceutical firms, according
to a report this year by IMH Health, a health care consulting firm in Fairfield,
San Diego companies on the list include: BioVascular Inc., Cardium Therapeutics,
Neurocrine Biosciences and Optimer Pharmaceuticals, Advantagene, Amylin Pharmaceuticals,
Applied Molecular Evolution, Celladon, Ceregene, CovX, Ichor Medical Systems,
Inovio Biomedical, Kirin Pharma USA, NexBio, NovaRx, Nventa Biopharmaceuticals,
Pacira Pharmaceuticals, Pharmexa-Epimmune, Isis Pharmaceuticals, Orchestra
Therapeutics and Vical.
According to another report, Georgia ranked first in the nation for medical
scientists' salaries at $130,000, and salaries for animal scientists, zoologists,
foresters and microbiologists were all in the top 10. In terms of volume,
metro Atlanta led the state with 213 biotech firms. Athens ranked second with
23, followed by metro Augusta with 16. The report was released during
the Georgia Life Sciences Summit. Growth in the state's life sciences
industry has until now outpaced expansion in the economy by two-to-one and
supports nearly 15,200 private sector jobs, according to the report.
Biotechnology drugs that can be tailored more closely to individual patient
needs and networks that speed drug development will become keys for big Pharma
such as Lilly as the patents expire for several top sellers. Biotechnology
products already account for about a third of Lilly's annual revenue, which
totaled $18.6 billion last year. Broader problems like the cost of developing
drugs and the decrease in new drug approvals play more of a role in pharmaceutical
Obama and McCaine presidential campaigns both pledged their support to help
create a market for generic biologics, a long-sought goal of generic makers
such as Mylan Laboratories and Teva Pharmaceuticals, which released a commissioned
report. Biotechs, you may recall, do not face generic competition in the
US, because the FDA lacks authority to approve copies. Three bills have been
introduced, but behind-the-scenes bickering over immunogenecity and interchangeability
has thwarted compromise. The generic and biotech industries, meanwhile, paid
millions of dollars lobbying Congress over how generic biotech drugs should
be approved. Perhaps the greatest disagreement is over how long a biotech
drug should be on the market before a generic drugmaker can challenge its
patent. The BIO trade group wants 14 years of data exclusivity, while generics
say no more than five years. Biotechs such as Amgen and Genentech will
face strong push-back no matter which candidate next occupies the White House.
After conducting case studies in India, Brazil, Canada, Kenya the United
States, the European Union, Japan and Australia, experts have said that the
world’s biotechnology patent system is broken. The study by an international
coalition of experts has claimed that the crisis in biotechnology has led
not only to economic problems but to endemic mistrust among its various actors
that is stopping lifesaving technologies from reaching the people who need
them most in developed and developing countries.
Today's monoclonal antibodies are large proteins that act as footsoldiers
for the immune system. They are already the fastest-growing section of the
global drugs market, with sales expected to hit $49 billion in 2013 compared
with $26 billion in 2007, according to market analysis group Datamonitor.
And by the middle of the next decade, Genentech Inc and Roche AG's cancer
drug Avastin is predicted by analysts to be the biggest-selling medicine of
any type in the world. But conventional antibodies, which must be injected,
are limited in the parts of the body they can reach.
Next-generation antibody fragments, which are a fraction of the size, are
potentially more flexible, cheaper to make and could lead to the development
of drugs that are inhaled, used as eyedrops or given by mouth. A host of biotech
companies are developing different technologies to shrink tomorrow's antibody
drugs. Among them are Bristol-Myers Squibb, Novartis AG, Wyeth, Boehringer
Ingelheim, ESBATech, Trubion Pharmaceuticals Inc and Genmab. At the moment,
the jury is out on how well the new generation of products will work, since
even the most advanced are only now starting mid-stage Phase II clinical
in India and Useless Vaccines
Encephalitis usually spreads in eastern parts of Uttar Pradesh during and
after the June-to-September monsoon season, when pools of stagnant water provide
breeding grounds for mosquitoes. The mosquitoes transmit the virus
from pigs and birds to humans. Since most infected people never develop symptoms,
many adults are immune from earlier exposure — leaving young children most
vulnerable. Indian federal government sent thousands of ineffective
vaccines to a northern Indian state, resulting in halting a planned immunization
drive against the deadly outbreak of Japanese encephalitis that has killed
more than 200 children since June. The mistake, compounding delays in
starting the immunizations, raises chances that hundreds more children could
die of the disease this year. Japanese encephalitis can be prevented
by the vaccine, but stocks sent by the federal government to the state showed
in testing that they were "unfit for human use."
Gardasil for Other Indications
The cervical cancer vaccine Gardasil also works to prevent cancers of the
vagina and vulva, federal health officials said, as they approved expanding
its use to protect against those diseases as well. The Food and Drug Administration
first approved Gardasil in 2006 for the prevention of cervical cancer in
girls and women ages 9 to 26. The vaccine works by protecting against strains
of the human papillomavirus, or HPV, that cause about 70 percent of cervical
cancers. The HPV virus, transmitted by sexual contact, causes genital warts
that sometimes develop into cancer. The government estimates
that there are 3,460 new cases of vulvar cancer and 2,210 new cases of vaginal
cancer each year. Cervical cancer is more common, with an estimated 11,070
new cases each year and nearly 3,900 deaths.
Ranbaxy Under the
The government is closing U.S. borders to more than 30 generic drugs, including
popular antibiotics and cholesterol medicines, made by India's drug giant
Ranbaxy Laboratories because of poor quality in two of its factories. The
Food and Drug Administration says consumers who already have the drugs shouldn't
worry: Repeated testing hasn't found any contamination, and Ranbaxy can continue
selling medicines made at any of its other factories.
The showdown is over what the FDA says is Ranbaxy's failure to correct significant
manufacturing problems that could lead to subpotent drugs, allergic reactions
or other problems. The move also may affect a U.S. program sending AIDS
drugs to Africa, as Ranbaxy is a leading supplier. The Indian generic
drugmaker, which is under investigation for allegedly falsifying records
that resulted in the production and sale of generic meds that didn’t meet
FDA standards, has hired Rudy Giuliani “to provide advice and review compliance
issues,” according to a statement. This is the second time the former
New York City mayor has acted as a paid consultant to a troubled drugmaker.
He also worked for Purdue Pharma, which was fined for its Oxycontin marketing,
and he helped negotiate a deal with federal prosecutors that kept company
execs out of jail. Ironically, when he was a US Attorney in Manhattan, Rudy
didn’t hesitate to send junk bond dealers to jail because they preyed on
the system. Of course, Rudy is a private consultant now and paid to serve
The President's Emergency Plan for AIDS Relief suspended funding for three
Ranbaxy generic drugs until the Food and Drug Administration says deficiencies
have been resolved in one of the plants in India where they're produced, a
spokeswoman for the program said. The program provided $8.9 million for Ranbaxy's
AIDS drugs last fiscal year, according to the spokeswoman.
Indian drugmakers Aurobindo Pharma Ltd. of Hyderabad and Cipla Ltd. of Mumbai
are among companies that have been cleared by the U.S. to supply the three
AIDS drugs under the government program, according to the FDA's Web site.
The program plans to provide $1.9 billion in support of antiretroviral treatment
programs for AIDS during this fiscal year, according to the program spokeswoman.
Daiichi Sankyo agreed in June to buy the 34.8 percent stake
held by Ranbaxy's founding family, and to make an open offer for a further
20 percent of Ranbaxy shares, as per Indian regulations, in a deal worth up
to 198 billion Indian rupees ($4.3 billion). But payment for the stock purchase
has been delayed until an unspecified time from an original deadline of Sept.
19 due to a delay in India's regulatory approval process. Shares of
Ranbaxy plunged last week after the United States banned dozens of its drugs
because of procedural violations in manufacturing at Ranbaxy's plants in
Pharmaceuticals in Drinking
The state of California has a warning for its 36 million residents: Do not
flush pharmaceuticals down the toilet or drain, or they may end up in a river
near you and even in the drinking water.
State and local officials are teaming with the U.S. Environmental Protection
Agency for a "No Drugs Down the Drain Week," starting with events Oct. 2.
The program recommends that drugs be dropped at special collection sites or
tossed in the trash. Researchers have found evidence that even extremely
diluted concentrations of pharmaceutical residues harm fish, frogs and other
aquatic species in the wild. Related research reports that human cells fail
to grow normally in the lab when exposed to trace concentrations of certain
Dr. Reddy’s Laboratories formally announced its US Specialty Business with
the launch of Promius Pharma, a wholly-owned subsidiary of Dr. Reddy’s Laboratories
located in Bridgewater, NJ. Promius Pharma, which will initially focus on
the branded dermatology market, is based on a platform of strategic licensing
initiatives and internal product development activities undertaken over the
last several years. Promius Pharma’s product portfolio currently comprises
of three in-licensed and co-developed dermatological products that are scheduled
to launch within calendar years 2008-09, and a pipeline of topical products
being developed at the Integrated Product Development Facility in Hyderabad,
India. Promius Pharma’s current portfolio contains innovative topical products
for the treatment of psoriasis, atopic dermatitis and seborrheic dermatitis.
Food and Drug Administration
Drugs under investigation by the Food and Drug Administration, what they
are used for and the potential problem:
_R-Gene 10, a growth hormone, pediatric overdose due to labeling/packaging
_Suprane, an anesthetic, cardiac arrest.
_Cymbalta, for depression and other conditions, urinary retention.
_Intelence, an HIV medication, bleeding into joints.
_Carac and Kuric, creams for skin conditions and fungal infections, name
_Heparin, a blood-thinner, serious allergic reactions.
_Extraneal, used in kidney dialysis, low blood sugars.
_Humulin R (U-500), insulin for diabetes, dosing confusion.
_Stromectol and Warfarin, an anti-parasite drug and a blood thinner, drug
_Tykerb, for advanced breast cancer, liver damage.
_Revlimid, for multiple myeloma, severe skin blistering and bleeding.
_Tysabri, for multiple sclerosis, skin melanomas.
_Nitrostat, for angina, overdose due to labeling confusion.
_Sandostatin LAR, for abnormal bone growth, bowel obstruction.
_Oxycontin, a pain killer, drug misuse, abuse and overdose.
_Definity, used in cardiac imaging, cardiopulmonary reactions.
_Dilantin injection, for epileptic seizures, serious skin reaction.
_Seroquel, for bipolar disorder, overdose due to sample pack labeling confusion.
_Tyzeka, for chronic hepatitis B, nerve damage.
_Tumor Necrosis Factor (TNF) Blockers, for juvenile arthritis, cancers in
children and young adults.
Greed and Corruption
As America reels under a financial crisis, so does China under a food crisis,
both resulting from greed and corruption. While US is bailing out corrupt
firms with trillion dollar package, the list of companies facing potential
recalls grew as reports of foods tainted with the industrial chemical melamine,
which has been blamed in the deaths of Chinese infants and sickness in several
thousands of children, spread to a widening range of products - anything that
should have protein in it. Food companies around the globe are rushing
to assess their products and in some cases setting new strategies to prevent
problems. But many continued to disregard the risks.
Leaf v. Viagra
The soft green heart-shaped leaf of the horny goat weed could hold the key
to a new drug for treating erectile dysfunction. Researchers say the Viagra
alternative could be as effective as the famous blue pill, but have fewer
side-effects. Viagra's active compound, sildenafil, works by inhibiting
an enzyme called phosphodiesterase-5 (PDE5). Because PDE5 helps control blood
flow to the penis, inhibiting PDE5 promotes male erection. Dell'Agli
and his colleagues tested the four plants in vitro to see how efficient they
were at inhibiting PDE5. Just one – Epimedium brevicornum, also known as horny
goat weed and Bishop's Hat – had an effect. This confirmed previous studies
showing that icariin, a compound found in the horny goat weed, is a PDE5
inhibitor. Horny goat weed is found in the wild in China, Asia and Europe.
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, AFP, Biospace
Notice: The content
of the articles is intended to provide general information.
Specialist advice should be sought about your specific circumstances.