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The biotech industry has made tremendous strides towards the development of novel and effective therapeutics in most areas of pharmaceutical research, especially in the antiviral and anticancer areas. The recent intensive research efforts in the stem cell research is bound to produce significant breakthroughs in several therapeutic areas.
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March 2, 2009 Volume 87, Number 09 p. 12
Microbiology
Drug Combo Kills Resistant TB
Inhibitor and antibiotic work together against tuberculosisCelia Henry Arnaud
A COMBINATION of two commercially available drugs is effective against extensively drug-resistant (XDR) Mycobacterium tuberculosis, lab tests show (Science 2009, 323, 1215). XDR strains are resistant to all the drugs typically used to treat TB.
© 2009 Science
Meropenem (gray) binds in the active site of the TB β-lactamase BlaC.Biochemist John S. Blanchard of Albert Einstein College of Medicine at Yeshiva University, in New York City, and coworkers tested the drugs meropenem, a β-lactam antibiotic, and clavulanate, a β-lactamase inhibitor. β-Lactam antibiotics have not found use as TB drugs because mycobacterial β-lactamase enzymes normally hydrolyze them before they can reach their target.
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Latest News
March 2, 2009 Volume 87, Number 09 p. 12
Pollution
EPA Must Rethink Air Standard
Agency failed to explain why particulates limit protects health, court says
Cheryl Hogue
THE ENVIRONMENTAL Protection Agency has an opportunity to make the national air quality standard for fine particulate matter more protective because of a federal appeals court ruling on Feb. 24.
Fine particulate pollution, a by-product of combustion, is found in smoke and haze.In its decision, the U.S. Court of Appeals for the District of Columbia Circuit instructed EPA to reconsider the Bush Administration's 2006 decision to maintain, and not tighten, the 1997 standard for fine particulates. That annual standard is 15 µg of fine particulate matter per cubic meter of air.
Exposure to fine particulate matter, defined as particles with a diameter of 2.5 µm or smaller, is linked to cardiovascular problems and premature death. Sources of fine particulates include power plants, industrial processes, vehicle exhaust, and forest fires.
EPA set the 15 µg/m3 standard in 1997 and reviewed it in 2006, as required by the Clean Air Act. During the review, EPA's Clean Air Scientific Advisory Committee recommended lowering the fine particulate standard to between 13 and 14 µg/m3 to protect health, on the basis of studies conducted since 1997.
In September 2006, EPA's then-administrator, Stephen L. Johnson, a Bush appointee, chose not to heed the recommendation of the science advisers and decided to maintain the 15 µg/m3 standard.
The court faulted EPA for not describing how the 15 µg/m3 standard would be protective of health. "EPA failed adequately to explain why, in view of the risks posed by short-term exposures and the evidence of morbidity resulting from long-term exposures, its annual standard is sufficient to protect the public health," the court said.
The court returned the standard to the agency for reconsideration, providing the Obama Administration with an opportunity to tighten it.
Environmental activists and 16 states challenged the 15 µg/m3 standard in court, saying it was not protective. Paul Cort, an attorney with the nonprofit environmental law firm Earthjustice, called the decision a "victory for anyone who breathes."
Attorneys representing electric utilities and the American Chemistry Council, a trade association, did not respond to requests for comment.
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March 2, 2009 Volume 87, Number 09 p. 9
POLICY
Climate Change, Energy Priorities
President links issues to nation's economic future as Congress takes action
Jeff Johnson and Cheryl Hogue
RATHER THAN BEMOANING the high cost of combating climate change, President Barack Obama in his first address to Congress laid out a vision tying America's future economic growth to its success in developing carbon-free energy technologies. Recent activity in Congress also underscores the high priority that climate change and clean energy have achieved.
In his Feb. 25 speech, Obama stressed that three areas—energy, health care, and education—are "absolutely critical to our economic future."
"It begins with energy," he continued. "We know the country that harnesses the power of clean, renewable energy will lead the 21st century.
"And yet, it is China that has launched the largest effort in history to make their economy energy efficient," the President pointed out. "We invented solar technology, but we've fallen behind countries like Germany and Japan in producing it. New plug-in hybrids roll off our assembly lines, but they will run on batteries made in Korea."
Obama then noted that his stimulus package has "made the largest investment in basic research funding in American history" (C&EN, Feb. 16, page 7).
"But to truly transform our economy, to protect our security, and save our planet from the ravages of climate change, we need to ultimately make clean, renewable energy the profitable kind of energy," he stated.
To spur that technological development, Obama called on Congress to move legislation that places a market-based cap on carbon pollution and "drives the production of more renewable energy in America."
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March 2, 2009 Volume 87, Number 09 p. 10
BUDGET
Spending Bill Advances
Science agencies' funding rises in 2009 appropriations
Jeff Johnson and Susan Morrissey
THE HOUSE has cleared a $410 billion omnibus appropriations bill to continue funding the federal government through fiscal 2009. In line with the Obama Administration's focus on energy and science, the bill includes increased funds for R&D. The Senate is expected to take up the bill quickly, as Congress must pass it by March 6, when current government funding runs out.
R&D Funding Ominbus bill swells budgets for key science agencies
NOTE: Fiscal years. The 2009 Department of Defense budget, which includes R&D funding, has already been approved. DOE = Department of Energy. a Amounts given in House omnibus bill; does not include funds appropriated in the stimulus package for 2009. SOURCE: House Appropriations Committee
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Last year, Congress and President George W. Bush were unable to reach agreement on appropriations for most government agencies, except for the Departments of Defense, Veterans Affairs, and Homeland Security. Instead, Congress passed legislation last September continuing federal funding at 2008 levels for five months, forcing the new Administration to address the 2009 budget.
Overall, the House-approved bill provides an 8% increase over last year's funding level. Democrats and a smattering of Republicans backed the bill, but Republican House leaders objected to the price tag and urged that government funds be frozen at last year's level.
The bill boosts the budgets of key science agencies. For example, the Department of Energy's Office of Science will see its 2009 funding grow by $755 million to $4.8 billion. This includes $765 million, $268 million above the 2008 level, for "advanced energy research," such as batteries and fusion energy.
To support climate, ocean, and weather research, NOAA will get $4.4 billion, up $469 million. NASA also will get a boost of $385 million to $17.8 billion for climate-change research, space exploration, and other activities.
NSF and NIH will see increases of $363 million and $938 million, respectively, to support more research. Funding for NIST will also grow by $63 million to $819 million.
The bill does not include funds from the $787 billion stimulus package. The House Appropriations Committee did not provide details about how the two packages will be merged, saying only that the bill "works in harmony with the economic recovery package."
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USATODAY Feb. 23, 2009
Chance side effect creates thick eyelashes, market for Latisse
By Janice Lloyd, USA TODAY
Another drug is getting a second life because of desirable side effects.
Botox was originally approved by the Food and Drug Administration to reduce eye spasms. Then the world realized it also made people look younger by eliminating wrinkles.
Human growth hormone was intended for children with growth disorders, but older people seeking the fountain of youth and athletes wanting a boost started finding illegal suppliers of HGH for muscle growth and overall toning.
The latest development involves Lumigan, a drug Allergan produced to treat glaucoma. The disease can lead to blindness if left untreated. The medication decreases pressure within the eye either by slowing the production of a fluid in the eye or by increasing fluid drainage. One of the side effects of Lumigan is longer, thicker and darker eyelashes.
Allergan developed a spinoff called Latisse, which the FDA approved for eyelash enhancement in December. Lumigan drops are used in the eyes; Latisse is applied to the upper eyelid. Bimatoprost is the active ingredient common to both drugs.
"Forget about fake lashes, they end up on your cheeks," says Liz Weber of Washington, D.C. "This is my favorite stuff ever."
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GILEAD
Gilead Sciences Announces Record Fourth Quarter and Full Year 2008 Financial Results
- Full Year Total Revenues of $5.34 Billion, Up 26 Percent over 2007 -
- Full Year Product Sales of $5.08 Billion, Up 36 Percent over 2007 -
- Fourth Quarter EPS of $0.60 per Share -
- Fourth Quarter Non-GAAP EPS of $0.63 per Share -
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 27, 2009--Gilead Sciences, Inc. (Nasdaq:GILD) announced today its results of operations for the fourth quarter and full year of 2008. Total revenues for the fourth quarter of 2008 were $1.43 billion, up 30 percent compared to total revenues of $1.09 billion for the fourth quarter of 2007. Full year 2008 total revenues were $5.34 billion, up 26 percent compared to full year total revenues of $4.23 billion for 2007. Net income for the fourth quarter of 2008 was $568.2 million, or $0.60 per diluted share, including after-tax stock-based compensation expense of $30.3 million. Non-GAAP net income for the fourth quarter of 2008, which excludes after-tax stock-based compensation expense, was $598.5 million, or $0.63 per diluted share, compared to non-GAAP net income for the fourth quarter of 2007, which excludes after-tax stock-based compensation expense of $25.1 million, of $426.8 million, or $0.44 per diluted share. As more fully described under the discussion of "Income Taxes," we recorded certain income tax benefits in the fourth quarter of 2008 that had the effect of increasing earnings by $0.04 per diluted share.
Product Sales
Product sales increased 35 percent to a record $1.39 billion for the fourth quarter of 2008, compared to $1.03 billion in the fourth quarter of 2007. For 2008, product sales increased 36 percent to $5.08 billion when compared to 2007. This was driven primarily by Gilead's antiviral franchise, including the strong growth in sales of Atripla(R) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), as well as the continued growth in sales of Truvada(R) (emtricitabine and tenofovir disoproxil fumarate).
Antiviral Franchise
Antiviral product sales increased 35 percent to $1.27 billion in the fourth quarter of 2008 from $941.1 million for the same period in 2007. For 2008, antiviral product sales increased 36 percent to $4.67 billion when compared to 2007. The increases were driven primarily by the sales volume growth of Atripla and Truvada, as well as a favorable foreign currency exchange impact.
-- Truvada
Truvada sales increased 25 percent to $562.1 million for the fourth quarter of 2008 from $448.8 million in the fourth quarter of 2007. For 2008, Truvada sales increased 33 percent to $2.11 billion from $1.59 billion in 2007. The increase in Truvada sales in the fourth quarter and full year of 2008 compared to the same periods of 2007 was driven primarily by sales volume growth in the United States and Europe and a favorable foreign currency exchange impact.
-- Atripla
Atripla sales increased 79 percent to $465.5 million for the fourth quarter of 2008 from $259.7 million in the fourth quarter of 2007. For 2008, Atripla sales increased 74 percent to $1.57 billion from $903.4 million in 2007. The increase in Atripla sales in the fourth quarter and full year of 2008 compared to the same periods of 2007 was driven primarily by the continued uptake in the United States, as well as launches of the product in most European countries.
-- Other Antiviral Products
Other antiviral product sales, including Viread(R) (tenofovir disoproxil fumarate), Hepsera(R) (adefovir dipivoxil) and Emtriva(R) (emtricitabine), increased five percent to $245.3 million for the fourth quarter of 2008 from $232.5 million in the fourth quarter of 2007. For 2008, these other antiviral product sales increased five percent to $993.3 million from $947.4 million in 2007.
AmBisome
Sales of AmBisome(R) (amphotericin B) liposome for injection for severe fungal infections increased 12 percent to $76.0 million for the fourth quarter of 2008 from $67.8 million for the fourth quarter of 2007. For 2008, AmBisome sales increased by 10 percent to $289.7 million from $262.6 million in 2007. The increase in sales of AmBisome in the fourth quarter of 2008 compared to the same period of 2007 was driven primarily by sales volume growth in certain European markets. The increase in sales of AmBisome for the full year of 2008 compared to the same period of 2007 was driven primarily by a favorable foreign currency exchange impact and sales volume growth in certain European markets.
Letairis
Sales of Letairis(R) (ambrisentan) for the treatment of pulmonary arterial hypertension increased two-fold to $36.2 million for the fourth quarter of 2008 from $14.8 million for the fourth quarter of 2007. For 2008, Letairis sales increased five-fold to $112.9 million from $21.0 million in 2007. The increase in sales of Letairis in the fourth quarter and full year of 2008 compared to the same periods of 2007 was driven primarily by sales volume growth in the United States as Letairis was launched in June 2007.
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Upcoming events:
March 4 - 5, 2009
Credit Suisse Global Biotechnology, Biopharma and Generics One-on-One Conference
London, U.K.
March 10 - 11, 2009
Barclays Capital Global Healthcare Conference
Miami Beach, FL
March 16 - 19, 2009
Cowen 29th Annual Healthcare Conference
Boston, MA
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