Sunday, August 28, 2011

Beta amino acid allows salmonella to cause disease & resist antibiotics

---

25 August 2011

"The inclusion of an atypical amino acid in their proteins allows Salmonella bacteria to resist certain antibiotics.

"University of Toronto scientists found that salmonella carries a beta version of an amino acid that produces proteins to allow the bacteria to cause infections, according to a study published in the journal Nature Chemical Biology."

http://www.nature.com/nature/journal/v476/n7361/full/476374e.html

http://researchnews.osu.edu/archive/betaversion.htm

--------

POSTED 26 August 2011 by:

David Palella
BIOSCIENCE VENTURES Inc.
San Diego, California
cell: 619-787-5767
email:  dpalella@gmail.com
http://www.linkedin.com/in/davidpalella

web site:  http://www.BSVpartners.com

blog:  http://biobizdev.blogspot.com

& Group Founder:

Infectious Disease R&D and Business Network
http://www.linkedin.com/e/-ubgx8c-godydbie-43/vgh/3937807/

Japan Biotech/Biopharma Partnering Forum
http://www.linkedin.com/e/vgh/2857975/

Biotech / Pharma Business Development, Licensing & Dealmaking
http://www.linkedin.com/e/-ubgx8c-gp40f4dt-22/vgh/3964633/

& Co-founder:

Stem Cells & Regenerative Medicine
http://www.linkedin.com/e/vgh/3921448

-----------

"'More bang for buck' from GSK's Cervarix; Findings suggest more uses for HPV vaccines"

---

Cervarix reduces long-term incidence of anal & cervical cancers in women caused by HPV strains 16 and 18

23 August 2011 - From FiercePharma.com

"Is another indication for GlaxoSmithKline's HPV shot in the cards?  A new study published in Lancet Oncology found Cervarix protected women from anal cancer, which can be caused by the two strains of human papillomavirus targeted by the vaccine, HPV 16 and 18.

"There was strong protection with the vaccine against anal infection," lead author Aimee Kreimer of the National Cancer Institute told Reuters, adding, "We know anal HPV 16, but also 18, cause the bulk of anal cancers.  We know if we remove the infection, it will greatly reduce the likelihood for the cancer."

The researchers analyzed tissue specimens in 4,210 healthy women, half of whom then received the vaccine.  The other half got a placebo injection. Four years later, the women were tested for HPV 16 and 18 infections in the anus and cervix.  The vaccine prevented 62% of anal cancers and 77% of cervical cancers caused by HPV infection, compared with cancer rates in the general population, Reuters reports.  The shot prevented 84% of anal infections with HPV and 89% of cervical HPV infections.

The researchers also found cross-protection from the vaccine against three other cancer-causing HPV strains.  "We're getting more bang for our buck than we realized with this vaccine," Kreimer said.

Merck's Gardasil, Cervarix's competitor, has already won FDA approval to prevent anal cancers in men and women.  But that approval came on the basis of a study in men.  Kreimer told Reuters she isn't sure her data would be enough to justify broader use of Cervarix, but that the study does add to evidence that HPV vaccination protects women from anal cancer.  "I do think it is getting close to a tipping point," she said, "but I don't know if we're there yet."

Original Reuters source:

http://www.msnbc.msn.com/id/44234436/ns/health-cancer/?ocid=twitter#.TlO0VXMXcXh

See also:  http://www.cervarix.com

---------

POSTED 24 August 2011 by:

David A. Palella
BIOSCIENCE VENTURES Inc.
San Diego, California
cell: 619-787-5767
email:  dpalella@gmail.com
http://www.linkedin.com/in/davidpalella

web site:  http://www.BSVpartners.com

blog:  http://biobizdev.blogspot.com

& Group Founder:

Infectious Disease R&D and Business Network
http://www.linkedin.com/e/-ubgx8c-godydbie-43/vgh/3937807/

Japan Biotech/Biopharma Partnering Forum
http://www.linkedin.com/e/vgh/2857975/

Biotech / Pharma Business Development, Licensing & Dealmaking
http://www.linkedin.com/e/-ubgx8c-gp40f4dt-22/vgh/3964633/

& Co-founder:

Stem Cells & Regenerative Medicine
http://www.linkedin.com/e/vgh/3921448

---------

Researchers discover body's natural defense against C. difficile toxins: S-nitrosoglutathione

---

Newly discovered cell mechanism uses amplified nitric oxide to fight C. difficile

22 August 2011

By Howard Lovy -- FierceBioResearcher.com

"Clostridium difficile, or C. difficile, is a nasty bit of business.  It can be the scourge of hospitals, striking patients when antibiotics kill all the "good bugs" that dwell in the gut -- like the ones that aid in digestion -- and leave only the dreaded harmful bacteria.

But as it turns out, the body has a natural way of defending against C. difficile by inactivating the toxin that spreads it.  And researchers describe how this knowledge can create new treatments in Nature Medicine.

C. difficile enters the gut through what Reuters colorfully describes as "molecular guillotine called cysteine protease."  The bacteria can easily fit into cells lining the intestine, release their toxin and do their damage.

However, the team discovered the body has a natural mechanism involving a nitric oxide-based molecule, S-nitrosoglutathione, which binds to the toxins secreted by C. difficile and prevents them from damaging cells.  It gums up the guillotine; therefore, the next step is to come up with a way to bottle up that natural mechanism with a treatment that mimics the process.

"Understanding how this mechanism deactivates toxins provides a basis for developing new therapies that can target toxins directly and thereby keep bacterial infections, like C. difficile, from spreading," Jonathan Stamler, a Case Western Reserve University researcher, said in a release.  The researchers tried the new treatment on mice and saw promising results; however, more research is needed."

Contact:  Kevin Mayhood
Case Western Reserve University
kevin.mayhood@case.edu
216-368-4442

http://www.reuters.com/article/2011/08/21/us-prosunday-bacteria-treatment-idUSTRE77K1TR20110821

http://www.fiercebiotech.com/press-releases/newly-discovered-cell-mechanism-uses-amplified-nitric-oxide-fight-c-diff

-----------

POSTED 23 August 2011 by:

David A. Palella
BIOSCIENCE VENTURES Inc.
San Diego, California
cell: 619-787-5767
email:  dpalella@gmail.com
http://www.linkedin.com/in/davidpalella

web site:  http://www.BSVpartners.com

blog:  http://biobizdev.blogspot.com

& Group Founder:

Infectious Disease R&D and Business Network
http://www.linkedin.com/e/-ubgx8c-godydbie-43/vgh/3937807/

Japan Biotech/Biopharma Partnering Forum
http://www.linkedin.com/e/vgh/2857975/

Biotech / Pharma Business Development, Licensing & Dealmaking
http://www.linkedin.com/e/-ubgx8c-gp40f4dt-22/vgh/3964633/

& Co-founder:

Stem Cells & Regenerative Medicine
http://www.linkedin.com/e/vgh/3921448

----------

Digital Outcomes & Zero-sum Games in the Japanese Pharma Market

---

Can the world's most indebted, cronyistic, deflationary -- and fragile ! -- OECD country (Japan) be an asset to your biotech company ? -- or save itself from sclerotic metastatic pernicious end-stage economic stagnation ?

The short answer ? -- probably not, so recalibrate your expectations.

More than likely, the Japanese market will not "viagrafy" your company's sales or biz dev goals for the next 3 - 5 years.  Why ? -- because in Japan, past results are indeed a guarantee of future performance !

Or non-performance !

Just as Japanese stock-market investors have on average lost 80 % of their investment for the past 21++ years (since December 1989), your company too should expect good business results in Japan to take time.  A loooooooooooooong looooooooong Time.

Doubtful ?  Although 12+ years old, this short New York Times article below reifies (makes concrete) everything above and still says it all:


"Japan's Tale of Two Pills:  Viagra and Birth Control"
By Sheryl Wu-Dunn

Published: April 27, 1999

http://www.nytimes.com/1999/04/27/science/japan-s-tale-of-two-pills-viagra-and-birth-control.html

------

In short, it took 40 (forty) years for the birth-control pill to be accepted / approved in Japan, but it took less than 6 months for Viagra's approval by the Japanese MHW (Ministry of Health & Welfare).  Excuse me, come again ?  Only 6 months ?  Versus 40 years ?  Yes !

In sum, unless your biotech/pharma product or service improves the sex lives of Japanese men, don't expect fast business results in Japan !

Moreover, when there is another major earthquake in the Tokyo region -- the now overdue Daini Kanto Dai-jishin -- which is the ineluctable tectonic "Manifest Destiny" of Japan -- then business outcomes for foreign companies in Japan will be Zero for many many years. 

Yes, Zero.  Or negative, sadly.

Thus, yes, you should address the Japanese market in your business plans, but the mathematical or statistical Expected Value (EV) in your spreadsheet should be ......... Zero.  Lamentably.

That's what a conservative planner or observer would say.

----------

POSTED 21 August 2011 by:

David Palella
Founder
BIOSCIENCE VENTURES Inc.
“Global Business Development & Licensing since 1991”

San Diego, California
cell: 619-787-5767
email:  dpalella@gmail.com
http://www.linkedin.com/in/davidpalella

web site:  http://www.BSVpartners.com

blog: http://biobizdev.blogspot.com

& Group Founder:

Japan Biotech / Biopharma Partnering Forum
http://www.linkedin.com/e/vgh/2857975/

Asia Business & Finance Roundup
http://www.linkedin.com/e/vgh/3132759/

Infectious Disease R&D and Business Network
http://www.linkedin.com/e/-ubgx8c-godydbie-43/vgh/3937807/

Biotech / Pharma Business Development, Licensing & Dealmaking
http://www.linkedin.com/e/-ubgx8c-gp40f4dt-22/vgh/3964633/

& Co-founder:

Stem Cells & Regenerative Medicine
http://www.linkedin.com/e/vgh/3921448

-------

Sunday, August 21, 2011

"Got Vaccines ? -- New Business Opportunities & Product Development Challenges" -- a panel discussion, 24 August 2011 (Weds), 6-8 PM, San Diego

---

If you have sincere interest, please join us for the 2nd *FREE*, in situ plasmid-swapping meeting in San Diego of the new LinkedIn.com group:


-->>  Infectious Disease R&D and Business Network

-->>  http://www.linkedin.com/e/-ubgx8c-godydbie-43/vgh/3937807/


And we encourage group members not near San Diego to organize and hold their own similar quorum-sensing plenary all-hands meetings in other cities around the world.


PANEL ABSTRACT:

After decades of getting no respect from BIG Pharma, vaccines got their mojo again ! -- with several attaining, or close to, blockbuster status (US$ 500 million - $ 1 billion in annual sales) including Wyeth's (now Pfizer's) Prevnar, Merck's Gardasil, and GlaxoSmithKline's Cervarix.

Moreover, vaccines are just not for breakfast bugs anymore ! -- rather, vaccine strategies are also being applied to non-I.D. indications such as stroke, Alzheimer's, diabetes, cancers, hypertension, multiple sclerosis, smoking cessation, obesity and Parkinson's.

A new Piribo.com market research report states that the overall global vaccines market was valued at $28 billion in 2010, and is expected to grow at a compound annual rate of 11.5% -- reaching about $57 billion by 2017.

The top vaccine companies include GlaxoSmithKline, Pfizer, Novartis, Merck & Co., SP-MSD and Sanofi.

So if you love the smell of infectious diseases in the morning -- join us for this **FREE** meeting kindly sponsored by the law firm of Sheppard Mullin.


WHEN:  24 August 2011 (Weds), 6-8 PM


Confirmed PANELISTS:

David WHITACRE, Ph.D.
Vice President
Scientific Operations
VLP BIOTECH, INC.
[ VLP = virus-like particle ]
San Diego, CA 92121


PLUS ! -- other PANELISTS INVITED FROM:

Synthetic Genomics Vaccines
Cato Research
Pfizer
Inovio -- and more !


MODERATOR:

David Palella
BIOSCIENCE VENTURES Inc.
San Diego, California
http://www.linkedin.com/in/davidpalella
blog:  http://biobizdev.blogspot.com


WHERE -- & Your host for the evening:

Ms. Amy ROMAKER
Client Service Team
SHEPPARD MULLIN
12275 El Camino Real
Suite 200
San Diego CA 92130-2006

direct tel: 858-720-7403
main tel: 858-720-8900
email:  aromaker@sheppardmullin.com
http://www.sheppardmullin.com


REMINDER:  This is a *FREE* meeting, courtesy of Sheppard Mullin.


NOTA BENE:  NO formal registration is needed; we don't complicate your lives!


For more info & to RSVP, contact:

David A. Palella
BIOSCIENCE VENTURES Inc.
“Global Business Development & Licensing since 1991”
San Diego, Calif.
cell: 619-787-5767
email:  dpalella@gmail.com

---------


POSTED 11 August 2011 by:

David A. Palella
BIOSCIENCE VENTURES Inc.
San Diego, California
cell: 619-787-5767
email:  dpalella@gmail.com
http://www.linkedin.com/in/davidpalella

web site:  http://www.BSVpartners.com

blog:  http://biobizdev.blogspot.com


& Group Founder:

Infectious Disease R&D and Business Network
http://www.linkedin.com/e/-ubgx8c-godydbie-43/vgh/3937807/

Japan Biotech/Biopharma Partnering Forum
http://www.linkedin.com/e/vgh/2857975/

Asia Business & Finance Roundup
http://www.linkedin.com/e/vgh/3132759/

& Co-founder:

Stem Cells & Regenerative Medicine
http://www.linkedin.com/e/vgh/3921448


-----

"Biotech Company Success Strategies? -- in the New New Normal ?!" -- a Licensing Executives Society (LES) panel discussion, 13 Sept 2011, Tuesday, 6-8 PM, San Diego

---

Join us for an interactive panel discussion about survival -- and success ! -- strategies for biotech companies in the Darwinian New New Normal U.S. economy !

This is a monthly meeting of the San Diego chapter of Licensing Executives Society (LES) -- a worldwide non-profit professional society.

If you have interest in business development, licensing and I.P. (intellectual property) related to **ANY** field of business, you should join LES.  More details here for those in North America:

-->>  http://www.lesusacanada.org


Not in San Diego ?  Then find your closest North American chapter by clicking on the locator map here:

-->>  http://www.lesusacanada.org/MainNav/LocalChapters.aspx


Not in North America ?  Find your closest country organization here:

-->>  LES International
-->>  http://www.lesi.org


For those in San Diego, you can learn about the local chapter here:

-->>  http://www.lesusacanada.org/MainNav/LocalChapters/LES-USA-West/SanDiego.aspx


NOTA BENE:  This is **NOT** a free meeting; you will need to *PAY* to play. 
Pricing will be announced later on the chapter web page.


WHEN:  13 Sept 2011, Tuesday, 6 - 8 PM


WHERE -- At a law firm office in San Diego -- TBD.


Confirmed PANELISTS:

Karen DOW
Attorney at Law
SUGHRUE
San Diego, Calif.
http://www.sughrue.com


Glenn DOURADO, MSc., MBA
Director
Bus. Dev. & Commercial Strategy
SANFORD-BURNHAM Medical Research Institute
La Jolla, Calif.
http://www.sanfordburnham.org


& OTHERS TBA (to be announced).


MODERATOR:

David Palella
BIOSCIENCE VENTURES Inc.
San Diego, California
http://www.linkedin.com/in/davidpalella
blog:  http://biobizdev.blogspot.com

---------------------

For more info, contact:

David A. Palella
BIOSCIENCE VENTURES Inc.

San Diego, California
cell: 619-787-5767
email:  dpalella@gmail.com
http://www.linkedin.com/in/davidpalella

web site:  http://www.BSVpartners.com

blog: http://biobizdev.blogspot.com


& Group Founder:

Biotech / Pharma Business Development, Licensing & Dealmaking
http://www.linkedin.com/e/-ubgx8c-gp40f4dt-22/vgh/3964633/

Japan Biotech / Biopharma Partnering Forum
http://www.linkedin.com/e/vgh/2857975/

Infectious Disease R&D and Business Network
http://www.linkedin.com/e/-ubgx8c-godydbie-43/vgh/3937807/

Biofuels & Sustainable Chemicals Networking Group
http://www.linkedin.com/e/vgh/3891375/

& Co-founder:

Stem Cells & Regenerative Medicine
http://www.linkedin.com/e/vgh/3921448


--------

Innocent BioSimilars "fingerprinted" by FDA ! -- Assumed guilty a priori !

---

Foreign-born BioBetters waterboarded at U.S. ports-of-entry by FDA longshoremen and fitted with Phase IV concrete boots !


A recent article in the New England Journal of Medicine written by FDA employees stated that the FDA may take a "fingerprint" approach to racially profiling biosimilar proteins to ensure genetic conformance with Aryan regulatory principles.

Thus meaning that more biochemically diverse and so-called "biosimilar" Rx mAbs (monoclonal antibodies) -- and so-called "BioBetters" of any protein class -- will face even more regulatory bio-equivalent waterboarding and autoclaving by FDA officials at American ports-of-entry.

Still, almost weekly we hear of another Mom & Pop biotech company from Timbuktu entering the biosimilars and biobetters field with a business plan that calls for exporting their putative "identical" bio-products to the U.S. market (or to European markets, whose regulatory agencies may follow the FDA's lead).

But common sense dictates that even Merck, Sandoz/Novartis, Teva and Samsung will be challenged by this inchoate and emerging segment of the biotech drug industry.

Read the epitaph of the biosimilars / biobetters field here:


"Is the FDA writing a recipe for the failure of biosimilars in the U.S.?"

August 8, 2011

By John Carroll of www.FierceBiotech.com


"Will FDA officials raise the regulatory bar on biosimilars so high they can't be competitive in the U.S.?  Longtime researcher and clinical trial consultant Dr. Saurabh Aggarwal seems to think there's a very high risk of that."

...

http://www.fiercebiotech.com/story/fda-writing-recipe-failure-biosimilars-us/2011-08-08

-----------


And here is the earlier related post on this group:


FDA confirms pursuit of “Biosimilars” will be a fool’s errand

Biosimilars industry trapped for 3 – 5 years at least in horrific FDA Hall of Mirrors !


“FDA sketches a complex instruction manual for biosimilars”

FierceBiotech.com -- 04 Aug 2011

“A group of top FDA regulators has penned an article in the New England Journal of Medicine intending to give drug developers a clearer picture of the agency's thinking on the "abbreviated pathway" lawmakers demanded for biosimilars.  But anyone hoping for a simple instruction manual with crystal clear goals and relatively low-cost data demands will be sorely disappointed.  The regulations for developing biosimilars will come with its own complex set of customized instructions, complete with demands on animal and human data and new ground rules for initial talks with regulators."

...

http://www.fiercebiotech.com/story/fda-sketches-complex-instruction-manual-biosimilars/2011-08-04?utm_medium=nl&utm_source=internal

Original article here:

http://www.nejm.org/doi/full/10.1056/NEJMp1107285

------

Posted by:

David A. Palella
BIOSCIENCE VENTURES Inc.

San Diego, California
cell: 619-787-5767
email:  dpalella@gmail.com
http://www.linkedin.com/in/davidpalella

web site:  http://www.BSVpartners.com

blog: http://biobizdev.blogspot.com


& Group Founder:

Infectious Disease R&D and Business Network
http://www.linkedin.com/e/-ubgx8c-godydbie-43/vgh/3937807/

Japan Biotech / Biopharma Partnering Forum
http://www.linkedin.com/e/vgh/2857975/

Biotech / Pharma Business Development, Licensing & Dealmaking
http://www.linkedin.com/e/-ubgx8c-gp40f4dt-22/vgh/3964633/

& Co-founder:

Stem Cells & Regenerative Medicine
http://www.linkedin.com/e/vgh/3921448


--------

Bio-engineered strain of E. coli targets drug-resistant Pseudomonas aeruginosa

---

Study: Biotech strain of E. coli targets drug-resistant P. aeruginosa

16 August 2011


"Singaporean scientists said they have developed a bioengineered strain of E. coli bacteria that proved effective in stopping the growth of Pseudomonas aeruginosa, a drug-resistant microbe usually found in hospitals, by 90%.

The biotech E. coli works by producing and releasing a toxin that targets the pathogen, the scientists reported in the journal Molecular Systems Biology. 

The formula used to re-engineer the bacteria could be used to bioengineer other microbes against infectious pathogens, said the lead author of the study."

Reuters article:

http://www.reuters.com/article/2011/08/16/us-bacteria-singapore-bug-idUSTRE77F35B20110816


Original source:

http://www.nature.com/msb/journal/v7/n1/full/msb201155.html

---

http://www.nature.com/msb/index.html

-------------------

Posted 18 Aug 2011 by:

David A. Palella
BIOSCIENCE VENTURES Inc.

San Diego, California
cell: 619-787-5767
email:  dpalella@gmail.com
http://www.linkedin.com/in/davidpalella

web site:  http://www.BSVpartners.com

blog: http://biobizdev.blogspot.com


& Group Founder:

Infectious Disease R&D and Business Network
http://www.linkedin.com/e/-ubgx8c-godydbie-43/vgh/3937807/

Biotech / Pharma Business Development, Licensing & Dealmaking
http://www.linkedin.com/e/-ubgx8c-gp40f4dt-22/vgh/3964633/

Japan Biotech / Biopharma Partnering Forum
http://www.linkedin.com/e/vgh/2857975/

Biofuels & Sustainable Chemicals Networking Group
http://www.linkedin.com/e/vgh/3891375/

& Co-founder:

Stem Cells & Regenerative Medicine
http://www.linkedin.com/e/vgh/3921448


--------

FREE Biotech Networking event -- 24 August 2011 (Weds), 6-8 PM @ the offices of Sheppard Mullin, San Diego

---

Happily ! -- the "Got Vaccines?" meeting scheduled for 24 August 2011 (Weds), 6-8 PM in San Diego -- has been changed to a free and **pure-play** summer biotech networking party kindly sponsored by the law firm of Sheppard Mullin !

This party will be a combined event for members of the following LinkedIn groups:


-->>  Infectious Disease R&D and Business Network
-->>  http://www.linkedin.com/e/-ubgx8c-godydbie-43/vgh/3937807/

-->>  Stem Cells & Regenerative Medicine
-->>  http://www.linkedin.com/e/vgh/3921448

-->>  Asia Business & Finance Roundup
-->>  http://www.linkedin.com/e/vgh/3132759/

-->>  Biotech / Pharma Business Development, Licensing & Dealmaking
-->>  http://www.linkedin.com/e/-ubgx8c-gp40f4dt-22/vgh/3964633/

-->>  Biofuels & Sustainable Chemicals Networking Group
-->>  http://www.linkedin.com/e/vgh/3891375/


Non-members of these groups may attend too, but membership does have its privileges.

! Bring lots of business cards ! -- at least 30 - 40 !

One is required to enter the drawing for prizes -- various bottles of not tooo shabby wine will be given away.


WHEN:  24 August 2011 (Weds), 6-8 PM


**RSVP** by email to the Organizer:

David Palella
BIOSCIENCE VENTURES Inc.
San Diego, CA
email: dpalella@gmail.com


PARTY LOCATION -- & Your generous host for the evening:

Ms. Amy ROMAKER
Client Service Team
SHEPPARD MULLIN
12275 El Camino Real
Suite 200
San Diego CA 92130-2006

direct tel: 858-720-7403
main tel: 858-720-8900
email:  aromaker@sheppardmullin.com
http://www.sheppardmullin.com


REMINDER:  This is a *FREE* meeting, courtesy of Sheppard Mullin !


NOTA BENE:  NO formal registration is needed; we don't complicate your lives!


For more info, contact:

David A. Palella
BIOSCIENCE VENTURES Inc.
“Global Business Development & Licensing since 1991”
San Diego, Calif.
cell: 619-787-5767
email:  dpalella@gmail.com

---------


POSTED 20 August 2011 by:

David A. Palella
BIOSCIENCE VENTURES Inc.
San Diego, California
cell: 619-787-5767
email:  dpalella@gmail.com
http://www.linkedin.com/in/davidpalella

web site:  http://www.BSVpartners.com

blog:  http://biobizdev.blogspot.com


& Group Founder:

Infectious Disease R&D and Business Network
http://www.linkedin.com/e/-ubgx8c-godydbie-43/vgh/3937807/

Japan Biotech/Biopharma Partnering Forum
http://www.linkedin.com/e/vgh/2857975/

Asia Business & Finance Roundup
http://www.linkedin.com/e/vgh/3132759/

& Co-founder:

Stem Cells & Regenerative Medicine
http://www.linkedin.com/e/vgh/3921448


-----

"Drugmakers take a hit on Greek [ junk ] bonds" -->> Is Japan next ?

---

Japan is the most indebted country in the world with outstanding debt of about U.S.$ 14 trillion, equal to about 230 % of its GDP -- much worse than Italy, Greece or Ireland -- and well over twice as bad on a percentage basis as us slacker Americans !

So when will Japan take a page from the high-drama fiscal Odyssey of Greece and pay its international drug bills with risky Japanese [ junk ? ] bonds ?  Perhaps sooner than any of us think.  Remember the book ? -- "Japan: The Fragile Superpower" ?

Read the bitter tea leaves below:


"Drugmakers take a hit on Greek bonds"

[ Source:  FiercePharma.com -- 19 Aug 2011 ]


"After carrying the public health system's debt on their books for many months -- in some cases, more than a year -- drugmakers are finally getting paid by the Greek government.  Good news, right?  Well, there's just one drawback: Greece is paying its drug bills in zero-coupon government bonds.

You don't have to be an economics professor to know that Greece's bonds aren't high-grade securities.  So, converting those debts into bonds is costing drugmakers money.  Australia's CSL took a $26 million charge against earnings to account for losses in the value of securities it accepted in lieu of cash payments.  Some of those securities came from other hospitals in southern Europe, but they're mostly from Greece.  "You would have to describe it as collateral damage," CSL Managing Director Brian McNamee said (as quoted by Bloomberg).

Greece paid Roche with a bond, too.  The company sold it -- at a discount of 26%, CFO Alan Hippe said.  "But we have now the cash," Hippe said on a conference call last month, Bloomberg reports.  "And cash is what counts.  We are monitoring our exposure, especially in Southern Europe, very, very diligently."

The long wait -- and discounted payments -- have some companies cutting off supplies, or threatening to.  Bloomberg reports that Novo Nordisk has stopped selling some products in the country.  Roche stopped delivering some drugs to hospitals in arrears, Dow Jones reported back in June. 

And Nycomed's chief executive, disgusted by the bonds-as-payment strategy, said his company can't operate on faith.  'If the situation gets totally out of hand and we don't think we will get paid in the end, we simply cannot continue to deliver products,' he has said."

Original sources:

http://www.bloomberg.com/news/2011-08-19/greek-arrears-give-drugmakers-collateral-damage-correct-.html

---

http://www.fiercepharma.com/story/drugmakers-take-hit-greek-bonds/2011-08-19?utm_medium=nl&utm_source=internal


----------

POSTED 21 August 2011 by:

David A. Palella
Founder
BIOSCIENCE VENTURES Inc.
“Global Business Development & Licensing since 1991”

San Diego, California
cell: 619-787-5767
email:  dpalella@gmail.com
http://www.linkedin.com/in/davidpalella

web site:  http://www.BSVpartners.com

blog: http://biobizdev.blogspot.com


& Group Founder:

Japan Biotech / Biopharma Partnering Forum
http://www.linkedin.com/e/vgh/2857975/

Asia Business & Finance Roundup
http://www.linkedin.com/e/vgh/3132759/

Infectious Disease R&D and Business Network
http://www.linkedin.com/e/-ubgx8c-godydbie-43/vgh/3937807/

Biotech / Pharma Business Development, Licensing & Dealmaking
http://www.linkedin.com/e/-ubgx8c-gp40f4dt-22/vgh/3964633/

& Co-founder:

Stem Cells & Regenerative Medicine
http://www.linkedin.com/e/vgh/3921448


------

Saturday, August 13, 2011

"Superbug antibiotics: New drugs advance amid R&D investment shortfall"

---

By Howard Lovy -- Fierce Biotech Research

19 July 2011

"It sounds like something out of a science fiction B-movie or a Steven King novel.  Out-of-control superbugs that are resistant to anything humans can throw at them.  Unfortunately, it's no fiction.  It's deadly serious.

The problem is so serious that the World Health Organization recently warned of an impending drug-resistance crisis if humanity does not do something quickly. 

WHO Director-General Margaret Chan forecasted the approach of a "post-antibiotic era, in which many common infections will no longer have a cure and, once again, kill unabated." 

The WHO called on governments and researchers to step up funding and discovery of new medicines to take the place of antimicrobial drugs that have been rendered ineffective or useless through the evolution of drug-resistant diseases.  At the moment, there is not much to take the place of current antibiotics that are increasingly ineffective. 

Today, there are only two Big Pharma companies, GlaxoSmithKline and AstraZeneca, with active antibiotic R programs, UPI recently reported, citing the Infectious Diseases Society of America.  In 1990, there were nearly 20."


Read the full superbug antibiotics report:

http://www.fiercebiotechresearch.com/special-reports/superbug-antibiotics-new-drugs-advance-amid-rd-investment-shortfall?utm_medium=nl&utm_source=internal

&

http://www.fiercebiotechresearch.com/special-reports/superbug-antibiotics-new-drugs-advance-amid-rd-investment-shortfall/superbug-antibio

--->> & Etc.

-----------

Dateline -- San Diego, Calif.: 20 July 2011 -- 12:40 AM


Posted by:

David A. Palella
BIOSCIENCE VENTURES Inc.

San Diego, California
cell: 619-787-5767
email:  dpalella@gmail.com
http://www.linkedin.com/in/davidpalella

web site:  http://www.BSVpartners.com

blog: http://biobizdev.blogspot.com


& Group Founder:

Infectious Disease R&D and Business Network
http://www.linkedin.com/e/-ubgx8c-godydbie-43/vgh/3937807/

Japan Biotech / Biopharma Partnering Forum
http://www.linkedin.com/e/vgh/2857975/

Biotech / Pharma Business Development, Licensing & Dealmaking
http://www.linkedin.com/e/-ubgx8c-gp40f4dt-22/vgh/3964633/

& Co-founder:

Stem Cells & Regenerative Medicine
http://www.linkedin.com/e/vgh/3921448

------

FINAL REMINDER: "Emerging & Resistant Infectious Diseases" -- a panel discussion, 27 July 2011 (Weds), 6-8 PM, San Diego

---

"Emerging & Resistant Infectious Diseases: R&D Strategies and Business Opportunities" -- a panel discussion, 27 July 2011 (Weds), 6-8 PM, San Diego, Calif.

If you have sincere interest, please join us for the first FREE, in situ plasmid-swapping meeting in San Diego of the new LinkedIn.com group:

-->>  Infectious Disease R&D and Business Network

-->>  http://www.linkedin.com/e/-ubgx8c-godydbie-43/vgh/3937807/

And we encourage group members not near San Diego to organize and hold their own similar quorum-sensing plenary all-hands meetings in other cities around the world.


ABSTRACT:

Few areas of drug & vaccine development offer such unlimited business opportunities as Infectious Diseases. 

In addition to vast unmet medical needs for well-recognized pathogens such as HCV, HBV, HIV, HPV, HSV, VZV, EBV, CMV and DPV -- and in addition to burgeoning drug resistance as evidenced by methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococci (VRE), and the fatal endemic pathogenic E. coli strains now rampant in Germany -- new infectious agents now appear almost annually somewhere worldwide, such as novel influenza strains -- the bird flu, swine flu and Hong Kong flu -- as well as the Ebola & Marburg viruses in Africa.

This panel discussion will highlight new R&D and business opportunities arising from emergent pathogens and discuss possible strategies for their containment prior to the approval of countervailing therapeutic agents.

If you love the smell of infectious diseases in the morning, please join us for this **FREE** meeting kindly sponsored by the law firm of Sheppard Mullin.


WHEN:  27 July 2011 (Weds), 6-8 PM


Confirmed PANELISTS:


Michael DUDLEY, Pharm.D., FCCP, FIDSA
SVP, R & D  & CSO
REMPEX PHARMACEUTICALS, INC.
[ spun out from Mpex Pharmaceuticals ]
San Diego, CA
http://www.mpexpharma.com


Victor NIZET, Ph.D.
Division of Pediatric Pharmacology & Drug Discovery
UCSD School of Medicine
Cellular & Molecular Medicine
UCSD
La Jolla, CA
http://nizetlab.ucsd.edu


Karen Joy SHAW, Ph.D.
SVP, Biology
TRIUS THERAPEUTICS
San Diego, CA
http://www.triusrx.com


PLUS ! -- other PANELISTS INVITED FROM:

Optimer Pharmaceuticals
Scripps
Sofinnova Ventures
Sanofi
Synthetic Genomics Vaccines


MODERATOR:

David Palella
Founder
BIOSCIENCE VENTURES Inc.
San Diego, California
cell: 619-787-5767
email:  dpalella@gmail.com
http://www.linkedin.com/in/davidpalella
web site:  http://www.BSVpartners.com
blog:  http://biobizdev.blogspot.com


WHERE -- & Your host for the evening:

Ms. Amy ROMAKER
Client Service Team
SHEPPARD MULLIN
12275 El Camino Real
Suite 200
San Diego CA 92130-2006

direct tel: 858-720-7403
main tel: 858-720-8900
email:  aromaker@sheppardmullin.com
http://www.sheppardmullin.com


REMINDER:  This is a *FREE* meeting, courtesy of Sheppard Mullin.


NOTA BENE:  NO formal registration is needed; we don't complicate your lives!


For more info & to RSVP, contact:

David A. Palella
BIOSCIENCE VENTURES Inc.
“Global Business Development & Licensing since 1991”
San Diego, Calif.

cell: 619-787-5767
email:  dpalella@gmail.com

---------

POSTED 25 July 2011 @ 8:30 AM by:

David A. Palella
BIOSCIENCE VENTURES Inc.
San Diego, California
cell: 619-787-5767
email:  dpalella@gmail.com
http://www.linkedin.com/in/davidpalella

web site:  http://www.BSVpartners.com

blog:  http://biobizdev.blogspot.com


& Group Founder:

Infectious Disease R&D and Business Network
http://www.linkedin.com/e/-ubgx8c-godydbie-43/vgh/3937807/

Japan Biotech/Biopharma Partnering Forum
http://www.linkedin.com/e/vgh/2857975/

Asia Business & Finance Roundup
http://www.linkedin.com/e/vgh/3132759/

& Co-founder:

Stem Cells & Regenerative Medicine
http://www.linkedin.com/e/vgh/3921448

-----------

Japan's Shionogi to Acquire C&O Pharmaceutical Technology for about $182 Million to expand into China

---

Shionogi takes subtle backdoor into China by acquiring Singapore-listed & Hong Kong-headquartered C&O Pharmaceutical Technology


01 August 2011

"Japan's Shionogi & Co said on Monday that it intends to acquire Hong Kong-headquartered and Singapore-listed China drug-maker C&O Pharmaceutical Technology for about S$219 million."

http://www.biospace.com/news_story.aspx?NewsEntityId=228662

The original news release:

http://www.4-traders.com/SHIONOGI-CO-LTD-6493659/news/SHIONOGI-Co-Ltd-to-Acquire-China-based-C-O-Pharmaceutical-Technology-Holdings-Limited-13733345/

-----------

Dateline -- San Diego, Calif.: 01 August 2011 -- 10:30 PM


Posted by:

David A. Palella
BIOSCIENCE VENTURES Inc.

San Diego, California
cell: 619-787-5767
email:  dpalella@gmail.com
http://www.linkedin.com/in/davidpalella

web site:  http://www.BSVpartners.com

blog: http://biobizdev.blogspot.com


& Group Founder:

Infectious Disease R&D and Business Network
http://www.linkedin.com/e/-ubgx8c-godydbie-43/vgh/3937807/

Japan Biotech / Biopharma Partnering Forum
http://www.linkedin.com/e/vgh/2857975/

Biotech / Pharma Business Development, Licensing & Dealmaking
http://www.linkedin.com/e/-ubgx8c-gp40f4dt-22/vgh/3964633/

& Co-founder:

Stem Cells & Regenerative Medicine
http://www.linkedin.com/e/vgh/3921448

---------

FDA confirms pursuit of “Biosimilars” will be a fool’s errand

---

Biosimilars industry trapped for 3 – 5 years at least in horrific FDA Hall of Mirrors !


“FDA sketches a complex instruction manual for biosimilars”

FierceBiotech.com -- 04 Aug 2011


“A group of top FDA regulators has penned an article in the New England Journal of Medicine intending to give drug developers a clearer picture of the agency's thinking on the "abbreviated pathway" lawmakers demanded for biosimilars.  But anyone hoping for a simple instruction manual with crystal clear goals and relatively low-cost data demands will be sorely disappointed.  The regulations for developing biosimilars will come with its own complex set of customized instructions, complete with demands on animal and human data and new ground rules for initial talks with regulators.

Drawing off the European biosimilar regulations established in 2005 as well as its own experience on abbreviated reviews for protein therapeutics, the regulators -- a group which includes Janet Woodcock -- say that there will be no "one size fits all" systematic assessment for biosimilars.  Instead developers will need to integrate various types of evidence "since it seems possible to exceed a current state-of-the-art analytic characterization by evaluating more attributes and combinations of attributes at greater sensitivities with multiple complementary methods."

It is possible that a "fingerprint" approach to protein structures can be used, they add.  While fingerprinting wouldn't eliminate the need for animal as well as human studies, those studies could be reduced in scope.  And the FDA likes the EMA's approach to monoclonal antibodies, with its emphasis on "populations, pharmacodynamic markers, and end points that are sensitive to the potential differences between products."

All developers are familiar with the INDA process, where they hope to glean some initial idea of the kind of data that will be needed to gain an approval for a new drug.  But the FDA warns it will need to create a new "paradigm" for its initial discussions with biosimilar developers, with a more extensive product review to detail the additional data needed for a biosimilar approval.  Rules on interchangeability, which would allow doctors to switch a branded biologic for a biosimilar, are still in the works. 

It's been well over a year since the law passed and biosimilar regulations are still very much a work in progress.  But the FDA is clearly establishing a daunting set of clinical demands for biosimilar developers.  That will limit the number of players taking the field, significantly raising the bar for researchers and pushing R&D costs to painfully high amounts.”

http://www.fiercebiotech.com/story/fda-sketches-complex-instruction-manual-biosimilars/2011-08-04?utm_medium=nl&utm_source=internal

Original article here:

http://www.nejm.org/doi/full/10.1056/NEJMp1107285

------

Posted by:

David A. Palella
BIOSCIENCE VENTURES Inc.

San Diego, California
cell: 619-787-5767
email:  dpalella@gmail.com
http://www.linkedin.com/in/davidpalella

web site:  http://www.BSVpartners.com

blog: http://biobizdev.blogspot.com


& Group Founder:

Infectious Disease R&D and Business Network
http://www.linkedin.com/e/-ubgx8c-godydbie-43/vgh/3937807/

Japan Biotech / Biopharma Partnering Forum
http://www.linkedin.com/e/vgh/2857975/

Biotech / Pharma Business Development, Licensing & Dealmaking
http://www.linkedin.com/e/-ubgx8c-gp40f4dt-22/vgh/3964633/

& Co-founder:

Stem Cells & Regenerative Medicine
http://www.linkedin.com/e/vgh/3921448



--------

China partnering conference announced: "International Summit of China Pharmaceutical Industry - Hangzhou 2011" -- (near Shanghai)

--

September 19-22, 2011 -- Hangzhou, Zhejiang, China


Potential speakers, sponsors and attendees are invited to learn more about this conference (one hour by train from Shanghai) from one of the organizers:

Ms. Hong MA (M.D., Ph.D, MBA)
Managing Partner & Founder
China Business Partners, LLC
(a BIOCOM Asia Initiative Partner)
&
Partner
BioScience Ventures, Inc

San Diego, California
cell: 858-357-4349
email:  hongma2008@gmail.com

http://www.BSVpartners.com

http://www.bio-ch.com/english/show.asp?id=3899

http://www.linkedin.com/pub/hong-ma/4/9b3/3b9

------

CONFERENCE DESCRIPTION:

"The 6th Summit this year will be held in Hangzhou Economic & Technological Development Area (HEDA), Zhejiang, China from September 19 to 22, 2011.

The theme is "Cooperation, Service, Integration, and Innovation of China Bio-Pharm Industry Development during the Twelfth Five-Year Plan”. 

By theme speeches and interactive video conferencing panels, the Summit will make an in-depth approach to several hotspot issues such as "International Cooperation among Bio-Pharm Enterprises", "Development of Innovative Preparation Industry", and "Cooperation and Development of Bio-pharm CRO/CMO", etc.

Besides, to provide face-to-face interactive communication opportunity to conference participants and speakers, several high-end video conferencing panels will be held regarding topics on R&D of Bio-pharm, Policy Interpretation, Personalized Therapy, Translational Medicine, Innovative Preparation, and Investment/Financing, etc."

http://www.bio-ch.com/english/index.asp

http://www.bio-ch.com


Again, for more info, please contact directly:

Ms. Hong MA (M.D., Ph.D, MBA)
Managing Partner & Founder
China Business Partners, LLC
&
Partner
BioScience Ventures, Inc

San Diego, California
cell: 858-357-4349
email:  hongma2008@gmail.com

---------------------

Posted by:

David A. Palella
BIOSCIENCE VENTURES Inc.

San Diego, California
cell: 619-787-5767
email:  dpalella@gmail.com
http://www.linkedin.com/in/davidpalella

web site:  http://www.BSVpartners.com

blog: http://biobizdev.blogspot.com


& Group Founder:

Infectious Disease R&D and Business Network
http://www.linkedin.com/e/-ubgx8c-godydbie-43/vgh/3937807/

Japan Biotech / Biopharma Partnering Forum
http://www.linkedin.com/e/vgh/2857975/

Biotech / Pharma Business Development, Licensing & Dealmaking
http://www.linkedin.com/e/-ubgx8c-gp40f4dt-22/vgh/3964633/

& Co-founder:

Stem Cells & Regenerative Medicine
http://www.linkedin.com/e/vgh/3921448

--------

"Got Vaccines ? -- New Business Opportunities & Product Development Challenges" -- a panel discussion, 24 August 2011 (Weds), 6-8 PM, San Diego

---

If you have sincere interest, please join us for the 2nd *FREE*, in situ plasmid-swapping meeting in San Diego of the new LinkedIn.com group:


-->>  Infectious Disease R&D and Business Network

-->>  http://www.linkedin.com/e/-ubgx8c-godydbie-43/vgh/3937807/


And we encourage group members not near San Diego to organize and hold their own similar quorum-sensing plenary all-hands meetings in other cities around the world.


PANEL ABSTRACT:

After decades of getting no respect from BIG Pharma, vaccines got their mojo again ! -- with several attaining, or close to, blockbuster status (US$ 500 million - $ 1 billion in annual sales) including Wyeth's (now Pfizer's) Prevnar, Merck's Gardasil, and GlaxoSmithKline's Cervarix.

Moreover, vaccines are just not for breakfast bugs anymore ! -- rather, vaccine strategies are also being applied to non-I.D. indications such as stroke, Alzheimer's, diabetes, cancers, hypertension, multiple sclerosis, smoking cessation, obesity and Parkinson's.

A new Piribo.com market research report states that the overall global vaccines market was valued at $28 billion in 2010, and is expected to grow at a compound annual rate of 11.5% -- reaching about $57 billion by 2017.

The top vaccine companies include GlaxoSmithKline, Pfizer, Novartis, Merck & Co., SP-MSD and Sanofi.

So if you love the smell of infectious diseases in the morning -- join us for this **FREE** meeting kindly sponsored by the law firm of Sheppard Mullin.


WHEN:  24 August 2011 (Weds), 6-8 PM


Confirmed PANELISTS:

David WHITACRE, Ph.D.
Vice President
Scientific Operations
VLP BIOTECH, INC.
[ VLP = virus-like particle ]
San Diego, CA 92121


PLUS ! -- other PANELISTS INVITED FROM:

Synthetic Genomics Vaccines
Cato Research
Pfizer
Inovio -- and more !


MODERATOR:

David Palella
BIOSCIENCE VENTURES Inc.
San Diego, California
http://www.linkedin.com/in/davidpalella
blog:  http://biobizdev.blogspot.com


WHERE -- & Your host for the evening:

Ms. Amy ROMAKER
Client Service Team
SHEPPARD MULLIN
12275 El Camino Real
Suite 200
San Diego CA 92130-2006

direct tel: 858-720-7403
main tel: 858-720-8900
email:  aromaker@sheppardmullin.com
http://www.sheppardmullin.com


REMINDER:  This is a *FREE* meeting, courtesy of Sheppard Mullin.


NOTA BENE:  NO formal registration is needed; we don't complicate your lives!


For more info & to RSVP, contact:

David A. Palella
BIOSCIENCE VENTURES Inc.
“Global Business Development & Licensing since 1991”
San Diego, Calif.
cell: 619-787-5767
email:  dpalella@gmail.com

---------

POSTED 11 August 2011 by:

David A. Palella
BIOSCIENCE VENTURES Inc.
San Diego, California
cell: 619-787-5767
email:  dpalella@gmail.com
http://www.linkedin.com/in/davidpalella

web site:  http://www.BSVpartners.com

blog:  http://biobizdev.blogspot.com


& Group Founder:

Infectious Disease R&D and Business Network
http://www.linkedin.com/e/-ubgx8c-godydbie-43/vgh/3937807/

Japan Biotech/Biopharma Partnering Forum
http://www.linkedin.com/e/vgh/2857975/

Asia Business & Finance Roundup
http://www.linkedin.com/e/vgh/3132759/

& Co-founder:

Stem Cells & Regenerative Medicine
http://www.linkedin.com/e/vgh/3921448

-----