biotech biotechnology biology technology

Tuesday, May 1, 2012

Whether you live in San Diego, Orange County, in the farming areas of the Coachella Valley and Central California, or in high tech areas such as La Jolla and Irvine, biotechnology and patent law is vital to business.

I've been asked, "What is biotechnology really about and does it mean the end of civilization as we know it."

It is often referred to as genetic engineering, which will cause the average person to go into a sweat fearing that he may have just eaten some genetically altered food for breakfast.

But biotechnology is so much more, and in this writer's opinion, it is the hope of mankind if it is developed with an abiding respect for nature and a doctor's creed of ensuring no harm is done.

Today, biotechnology is broken down into four main areas: red biotechnology is applied to the medical field, green biotechnology is applied to agriculture, white biotechnology is in the industrial field and blue refers to the aquatic field.

In the medical field, biotechnology helps develop new medicines, new therapies, and can be used to use normal genes to target or replace defective genes or boost immunity.

In agriculture, biotechnology can be used to boost the yield from crops, reduce the vulnerability of crops to disease or weather, and to increase the nutritional values of foods. It can even be used to improve the taste or texture of foods. A benefit of biotechnology in agricultural applications is to reduce the need for pesticides or other harmful chemicals on crops that go into the nation's water supply.

A new area in which biotechnology is developing rapidly is in biological engineering such as in the development of bio processes from the laboratory to the manufacturing or industrial scale.

Biotechnology is not without criticisms and raises moral dilemmas. What biotechnology can solve, sometimes produces unwanted results such as residues and super resistant foods that may contaminate other non-genetically modified crops. Cloning has also stirred much controversy each time it is in the news.

But biotechnology in the future may also lead to new ways to clean up contaminated environments and the pollutants and wastes mankind produces. And as the world does harm to its environment, much must also be done to reverse these effects before it is too late.

Call Attorney R. Sebastian Gibson at (800) 589-3202. Or visit our website at http://www.SebastianGibsonLaw.com to learn more about patents, trademarks, copyrights, intellectual property and biotechnology.

If you have an intellectual property issue, want to apply for a patent, trademark, copyright or biotechnology patent, or need legal defense for an infringement matter, our experienced attorneys can serve as your Palm Springs Patent Lawyer or your intellectual property attorney anywhere in Southern California. We have nearly thirty years of experience and have represented clients from San Diego to Orange County, from Newport Beach and Laguna Beach to San Luis Obispo, from Anaheim and Irvine to Carlsbad and La Jolla, from Ontario to Victorville, and from Temecula and Yorba Linda to Palm Springs, Palm Desert, Indian Wells and throughout the Coachella Valley.

Sebastian Gibson graduated cum laude at UCLA in 1972 and later received two law degrees in the U.S. and the U.K., graduating with an LL.B. magna cum laude from University College, Cardiff in Wales and a J.D. from the University of San Diego School of Law in Southern California.

The Sebastian Gibson Law Firm serves all of San Diego, Orange County, Palm Springs and Palm Desert, the Coastal Cities from La Jolla and Del Mar to Laguna Beach, Newport Beach, Irvine, Santa Ana and Irvine and up to Ventura, Santa Barbara and San Luis Obispo, Ontario, Rancho Cucamonga, Temecula, Riverside and San Bernardino and all the cities in the Coachella Valley.

Article Source: EzineArticles.com

BioBytes 104 - What is personalized medicine?

Bio Tech U.S. Blogger

What is Biotechnology

The UN Convention on Biological Diversity states, "Biotechnology is any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use". The OECD (the Organization of Economic Co-operation and Development) defines biotechnology as "...the application of scientific and engineering principles to the processing of materials by biological agents". Thus, "Biotechnology" basically means using biology as the basis for a technology that is applied to research and product development in areas such as agriculture, food science, and medicine.

The Academic Standards for Science and Technology defines Biotechnology as the ways that humans apply biological concepts to produce products and provide services. This is very true if we consider a section of biotechnology in which the directed manipulation of organisms is used for the product of organic products such as beer, milk products, food etc.

Biotechnology had already been performed long before the term itself was coined, though on a very basic level. For example, man had already learnt the method of fermenting fruit juices to concoct alcoholic beverages during the period around 6000 BC. However, it was considered more of an art then. Biotechnology became a real science only about two decades ago when genes were found to contain information that would enable the synthesis of specific proteins. This was in the 1970s, when new advances in the field of molecular biology enabled scientists to easily transfer DNA - the chemical building blocks that specify the characteristics of living organisms - between more distantly related organisms.

Then in the mid-eighties and early-nineties, it was confirmed that the transformation or modification of the genetic structure of plants and animals was very possible. The introduction of "Transgenic" animals and plants also led to more resistance to disease and increased the rate of productivity etc. Modern biotechnology is also now more often than not associated with the use of genetically altered microorganisms such as E. coli or yeast for the production of substances like insulin or antibiotics. New innovative biotechnology application such as plant-made pharmaceuticals has also now been developed.

Sub-fields in Biotechnology:

Red Biotechnology is the use of genetically altered microorganisms for the production of substances like insulin, antibiotics, vitamins, vaccines and proteins for medical use, and is thus related to medical processes. Genomic manipulation is also an example of Red Biotechnology.

Biomanufacturing or White Biotechnology is emerging field within modern biotechnology which involves the designing of organisms such as moulds, yeasts or bacteria, and enzymes to produce certain useful chemicals, and is related to the industrial sector. It is also known as Grey Biotechnology.

Green Biotechnology or agricultural Biotechnology, like the name suggests, is the area of biotechnology involving applications to agriculture. This basically involves the genetic manipulation of plants and animals in order to create more productive, environmentally friendly, disease resistant species. An example of traditional agricultural biotechnology is the development of disease-resistant wheat varieties by cross-breeding different wheat types until the desired disease resistance variety is achieved.

http://biotechnology-hq.com/ Biotechnology HQ: articles and information about the science of biotechnology.

Article Source: EzineArticles.com

Wednesday, January 4, 2012

Fwd: | 12.19.11 | Top 10 deal terminations; Russian groups back two biotech venture funds

-------- Original Message --------

Subject:	\| 12.19.11 \| Top 10 deal terminations; Russian groups back two biotech venture funds
Date:	Mon, 19 Dec 2011 12:44:22 -0500 (EST)
From:	FierceBiotech <editors@fiercebiotech.com>
Reply-To:	editors@fiercebiotech.com
To:	nbrauchitsch@yahoo.com

December 19, 2011
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Editor's Corner: The top 10 biotech deal terminations of 2011

Also Noted: Spotlight On... Sharer gets mediocre grade for Amgen tenure
GSK plans new hires; NIH helps bankroll Raptor trial; Alkermes launches Phase III; and much more...

More Fierce Life Sciences News:
1. Harvard plays money ball with biotech--and baseball--data
2. Blood cancer group lights way to 28% faster trial starts
3. Video gamers shed new light on 521 disease genes

The top 10 biotech deal terminations of 2011

By John Carroll

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In biotech, the right partnering deal can make a company, bringing in cash, expert help and a major league endorsement for the science involved. If deals go bad, as they often do, the subsequent turmoil can break a company.

Anyone with any doubts about the stakes involved should take a close look at the top partnering deals that went bad in 2011. A number of the companies that had to watch their pharma mates walk away from the development marriage have openly struggled to survive the fallout. At least one won't survive the breakup, and more could follow.

This year's list, which we asked Deloitte Recap to crunch for us, includes a number of top deals from '07 and '08. So it's no wonder that some high profile partnerships went astray in the meantime. As Big Pharma retools its pipeline, shifts disease focuses and starts to demand a better return on the billions invested in drug development, it's not surprising to see more licensing deals breaking up under the pressure.

See the top 10 deal terminations of 2011 >>

Events

> BIOCOM Global Life Science Partnering Conference - Jan 31- Feb 2,2012 - La Jolla, CA
> BioConference Live ? Laboratory Animal Sciences ? Virtual Online-only Event - February 15-16, 2012
> Webinar: JHU's Master's in Biotechnology Enterprise & Entrepreneurship
> Online GMP Courses Priced as Low as $75 for Individual Learners
> New Paradigms to Fund & Move Biotech - January 11-12, 2012 - San Francisco, CA
> Partnerships in Clinical Trials 2012 - March 4-7 - Orlando, FL
> Comparative Effectiveness: A Real-World User's Guide - March 14-15, 2012 - Washington, DC

Jobs

> Director, Reagent Manufacturing & Operations - San Francisco, CA - Fluidigm
> Sr. Product Manager – NJ – Celgene Corporation
> Manager, Strategic Forecasting & Analytics Job – NJ – Celgene Corporation
> Tools Engineer - Gaithersburg, MD - MedImmune
> Telecommunications Engineer - Gaithersburg, MD - MedImmune
> Manager, Telecomm/Facilities - Gaithersburg, MD - MedImmune
> Telecom Management Engineer - Gaithersburg, MD - MedImmune
> IT Account Administrator - Gaithersburg, MD - MedImmune
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Today's Top News

1. Russian billionaire bankrolls early-stage biotech VC group

By John Carroll

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Russian billionaire Len Blavatnik is bankrolling a new venture capital company which will troll the academic labs in Cambridge, MA for promising early-stage therapeutics that can be used to launch new biotech companies. Daniel Behr, the former outlicensing chief at Harvard, will head up the new venture, with $75 million in Blavatnik chips to gamble.

Access BridgeGap Ventures will also be led by Ben Bronstein, who was a co-founder of Peptimmune (acquired by Genzyme and then spun out, filing for bankruptcy liquidation earlier this year) and a managing director of Zero Stage Capital. "Our focus is on early-stage therapeutics--treating or preventing disease--not devices or diagnostics or imaging,'' Behr told The Boston Globe's Scott Kirsner. The fund plans to back three to 5 companies a year.

The two VC execs also plan to spread a wide net for new therapeutics. They will look in academic labs as well as early-stage developers and some pharma companies which are spinning off programs as they restructure their pipelines. The money, not a huge sum by VC standards, is expected to last a few years and Blavatnik has the option of adding money along the way. Behr told the Globe that he's close to announcing their first investment.

"Commercially promising innovations being developed in research institutions and in young startups are often deemed too early for partnering by industry or for investment by traditional venture capital," says Bronstein in a prepared statement. "Our focus is to translate early-stage science into commercially relevant products and companies."

According to their web site, the new venture group also has a few high-profile advisers to call on. They include William Koster, the former early stage R&D chief at Bristol-Myers Squibb ($BMY) and Isaac Kohlberg, the chief technology development officer of Harvard's Office of Technology Development.

- here's the release
- read the story from The Boston Globe
- here's the link to the group's web site

2. Trius shares surge as antibiotic matches Zyvox in pivotal PhIII

By John Carroll

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Shares of Trius Therapeutics ($TSRX) surged on the news that its late-stage antibiotic tedizolid closely matched Zyvox (linezolid) in one of a series of pivotal studies, helping nail down support for its case that the experimental antibiotic is just as good as the blockbuster with a once-daily dosing schedule over a shorter period. The antibiotic hit its primary endpoint for acute bacterial skin and skin structure infections as well as all secondary goals. The news helped push up Trius shares a little more than 10% this morning in early trading.

Trius also bolstered its case that its antibiotic is safer than the mainstay product, which had worldwide sales of $1.2 billion in 2010. Investigators reported that about one in four of the tedizolid patients experienced "drug-related treatment emergent adverse events" compared to 31% of linezolid treated patients. Gastrointestinal adverse events were the most commonly reported events and were statistically significantly lower in tedizolid patients than in linezolid patients.

"We are very pleased the trial demonstrated that a 6-day course of once daily oral tedizolid is as efficacious as a 10-day course of twice daily oral linezolid while showing an improved tolerability profile," said Jeffrey Stein, Ph.D., the CEO of Trius. "We look forward to presenting the detailed results of this study, the first Phase 3 study to be conducted under the new regulatory paradigm, both in a peer reviewed journal and at a major conference in 2012."

Trius is one of a handful of biotechs like Rib-X, Tetraphase and Achaogen which are pushing ahead with experimental antibiotics despite a tough regulatory environment and years of neglect by Big Pharma. Last July Bayer Pharma stepped up with a $94 million deal for the antibiotic, paying $ 25 million upfront for the Asian, African and Latin American rights to tedizolid (formerly torezolid) while the biotech held on to the key U.S. and European rights.

- here's the Trius release

Special Report: Trius Therapeutics - 10 Biotech IPOs of 2010

3. Alexza readies "significant" layoffs, brings in Lazard to review asset sale

By John Carroll

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Just days after eking out an FDA expert panel vote in favor of its inhaled antipsychotic Adasuve, Alexza Pharma ($ALXA) has brought in Lazard to investigate the possible sale of assets as it prepares to drop the budget axe on an uncertain number of employees.

Mountain View, CA-based Alexza announced that Lazard would look at a "possible sale or disposition of one or more corporate assets, a strategic business combination, partnership or other transactions." And the biotech said that it would "significantly reduce" its workforce as it pushed for a formal agency approval. Alexza shares were largely unaffected by the news this morning, with the stock trading at 66 cents.

An expert FDA committee voted 9 to 8 in favor of Adasuve on December 12, with a number of critics clearly remaining unhappy with the safety issues that have hobbled the program before. That vote came after investors dumped shares in Alexza after reading regulators' concerns about the potentially lethal pulmonary effects of the treatment in patients with asthma or COPD. Those same risks persuaded the FDA to reject Alexza's initial try at an approval. But a majority of the FDA panel felt that the biotech's risk mitigation strategy, which would demand that patients are carefully screened and then monitored for the first hour after treatment, satisfied their safety concerns.

- here's the press release
- read the Bloomberg report

Read more about: Alexza Pharmaceuticals, Adasuve
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4. Burrill raises $313M for new life sciences venture fund

By John Carroll

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The high-profile biotech analyst and investor Steven Burrill has rounded up more than $300 million for a new life sciences fund, which reportedly includes a big cache of cash from a Russian bionano investment group. The investment group announced this morning that Burrill Capital Fund IV is open for business and plans to keep gathering cash with a goal of bumping its total to $500 million by next summer.

The San Francisco-based fund--which currently has $313 million--has a broad scope. Burrill plans to use the cash to invest in early- to late-stage investments in therapeutics, diagnostics, medical devices, healthcare delivery, wellness and digital health.

"We are pleased to have surpassed our initial goal of $300 million in capital commitments for the first close," says Burrill, CEO of Burrill & Company. "We look forward to achieving our final goal of $500 million in capital commitments by June 2012."

Burrill told MedCityNews back in August that $200 million of his new fund's cash was coming from RusNano, a bionano investment group which has been making some hefty investments in U.S. biotech companies. He also told the news group that he'd have $350 million in short order, maintaining a tradition of bold pronouncements that sometimes fall short of the mark. More than two years ago he promised to put together a $1 billion fund to invest in Elk Run, an ambitious biotech development in Minnesota which has yet to materialize.

- here's the press release

5. Somaxon to axe HQ staffers as adviser explores possible sale

By John Carroll

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Plagued by weak sales of the sleep drug Silenor, San Diego-based Somaxon ($SOMX) laid out plans to lay off a majority of its headquarters staff as a financial adviser reviews its options, including a potential sale of the company. Stifel Nicolaus Weisel has been hired as a strategic advisor.

"This process will focus on strategic alternatives, which may include one or more of a sale of the company or assets relating to Silenor, or partnering or other collaboration transactions relating to U.S. or ex-U.S. prescription or over-the-counter rights to Silenor," said CEO Richard Pascoe. "While we are conducting this process, we will continue to market Silenor in the U.S. to existing prescribers through our 30-person sales force and non-personal promotion, and to protect the intellectual property position of the product," continued Pascoe. "We will also undertake measures to minimize our cash burn rate, including through a reduction in force involving approximately 60% of our current non-field-based employees."

Somaxon said in its release that it will terminate 60% of its non-field workforce, underscoring lingering doubts about the biotech's future. Silenor has helped illustrate how an FDA approval is no panacea for a biotech company. Its third quarter 2011 sales amounted to only $3.7 million in a crowded market of competing therapeutics. Somaxon's stock was trading at 52 cents a share this morning, down 12%.

- here is the Somaxon release

Read more about: Somaxon, layoffs, Silenor
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Also Noted

SPOTLIGHT ON... Sharer gets mediocre grade for Amgen tenure

Xconomy's Luke Timmerman assesses Amgen CEO Kevin Sharer's tenure this morning, giving him a gentleman's "C" for leadership, new product development, vision and other key factors. As Timmerman notes, C is the definition of mediocrity. His best grades come for leadership and vision, but there's an "F" for his rich salary and poor grades on industry relations and acquisitions. Column

@FierceBiotech: The top 10 biotech deal terminations of 2011. GSK/Targacept break-up takes top spot. Report | Follow @FierceBiotech

@JohnCFierce: Somaxon axing staffers, calling in the "strategic advisers." Anyone want to buy a sleep drug? Release | Follow@JohnCFierce

@RyanMFierce: Cornell U. won a competition involving Stanford and NYU to be NYC's pick to set up a science grad school in Gotham.Item | Follow @RyanMFierce

@MaureenFierce: Using neti pots for sinus relief could cause amoebas to eat your brain. News | Follow @MaureenFierce

@MarkHFierce: There's a way now to keep a cancer patient's healthy cells and tumor cells alive in the lab. Two ingredients help. Release | Follow @MarkHFierce

> GlaxoSmithKline says an R&D grant from Scottish Enterprise will allow the pharma company to hire 25 new workers. Story

> A division of the NIH has agreed to help bankroll a Phase IIb study of Raptor Pharma's delayed-release tablet formulation of cysteamine bitartrate, a potential treatment of non-alcoholic steatohepatitis. Release

> Alkermes has launched a Phase III clinical trial of ALKS 9070 for the treatment of schizophrenia. Release

> The ALS Therapy Development Institute has forged a pact with Biogen Idec and UCB Pharma to investigate the use of an anti-CD40L antibody as a potential therapy for Amyotrophic Lateral Sclerosis (ALS). Release

> Agenus (formerly Antigenics) says it struck a "license, development and manufacturing technology transfer agreement" for its Oncophage vaccine. The therapy is only available in Russia. Release

> Pfizer is selling its last properties in Brooklyn, where it once maintained a manufacturing facility. Story

Pharma News

@FiercePharma: Bausch + Lomb eyes pharma ops expansion. Story | Follow @FiercePharma

> EU brings Bayer's Xarelto into German market. News

> ISTA rebuffs Valeant bid. Story

> Pfizer and GSK boost pneumonia vaccine price cuts for developing world. Report

Biotech IT News

> Blood cancer group lights way to 28% faster trial starts. Item

> Elsevier scoops up scientific software outfit Ariadne. Story

> Harvard plays money ball with biotech--and baseball--data. Article

> EU program backs Linguamatics and ChemAxon's informatics work. News

Medical Device News

> Lawmakers seek recall info from Medtronic, four others. News

> TransEnterix closes $15M in 2nd tranche of Series B. Article

> CSA scores $20.5M in Series B. More

> FDA looks to improve the representation of women in device studies. Story

And Finally... A Massachusetts General Hospital research team says that increased expression of Sirt1, one of a family of enzymes called sirtuins, in the brain of a mouse model of HD protected against neurodegeneration. Report

Events

* Post listing: Click here.
* General ad info: Click here.

> BIOCOM Global Life Science Partnering Conference - Jan 31- Feb 2,2012 - La Jolla, CA

Exclusive global partnering and networking forum that brings together senior executives and business development professionals from leading pharmaceutical and biotech companies. Speakers include Roger Pomerantz, SVP and Head Worldwide Licensing, Merck/ Jeremy Levin, Senior Vice President, Strategy, Alliances and Transactions, Bristol-Meyers Squibb/ Brian McVeigh, Vice President, WWBD Transactions and Investment Management, GlaxoSmithKline Pharmaceuticals and many more. Register today.

> BioConference Live ? Laboratory Animal Sciences ? Virtual Online-only Event - February 15-16, 2012

The Veterinary Bioscience Institute and LabRoots, Inc. announce this inaugural event. The theme is Animal Well being and Welfare Science. It is free to participants, with no out-of-pocket expenses for travel. Register and learn more at www.bioconferencelive.com.

> Webinar: JHU's Master's in Biotechnology Enterprise & Entrepreneurship

Learn more about Johns Hopkins University's 10-course graduate program that is designed for those seeking to pursue a biotechnology entrepreneurial career beyond the laboratory. The entire degree can be completed online. Available On-Demand | REGISTER NOW

> Online GMP Courses Priced as Low as $75 for Individual Learners

Our web-based GMP courses can be purchased online and taken at your own pace. Once completed with adequate proficiency, you'll receive a certificate of completion. Developed by GMP experts and taken by thousands, these courses provide quality GMP training for far less than other alternatives. Click Here

> New Paradigms to Fund & Move Biotech - January 11-12, 2012 - San Francisco, CA

New Paradigms is guided by key individuals from biotech, pharma and the investment community to advance R&D through alternative sources of funding, non-traditional partnering strategies and innovative approaches to drug approval for the successful commercialization of new therapies. The conference is backed by an exceptionally distinguished speaking faculty with diverse experience and expertise. Co-located at the same time as the JP Morgan Healthcare event, on-site networking partnering services available to registered attendees. Register today!

20% off registration fee for Fierce Readers with code FBNP

> Partnerships in Clinical Trials 2012 - March 4-7 - Orlando, FL

Partnerships is the largest clinical trial operations, development and outsourcing meeting in the world with over 1500+ attendees and 200 exhibitors. This leading event is a unique senior leadership meeting focused on overcoming challenges clinical trial executives face. Visit www.cliicaltrialpartnerships.com.

> Comparative Effectiveness: A Real-World User's Guide - March 14-15, 2012 - Washington, DC

Moving from Policy to Practice in Research and Delivery! Push beyond basic questions to evaluate the importance of comparative effectiveness research (CER) and provide participants with actionable understandings of how CER evidence can be better managed and developed within their own organizations. This event will provide participants with a "what does it mean for me" perspective on CER and HTA, providing take-aways to apply within day-today drug development and marketing positions. Register Today!

Jobs

* Post listing: Click here.
* General ad info: Click here.

> Director, Reagent Manufacturing & Operations - San Francisco, CA - Fluidigm

Directly reporting to the VP of Manufacturing, the Director will be responsible for managing and directing Fluidigm's Reagents and Assays Manufacturing operations. This includes formulating manufacturing operations strategies in support of business goals and objectives, developing and mentoring manufacturing employees and driving continuous improvements to achieve optimal operational efficiency. He or she will set up the systems and tools to deliver quality products and services that will meet customers' expectations in the most cost-effective manner. The Director will also lead and manage the supply chain operations in South San Francisco which includes but is not limited to: purchasing, inventory management, supplier management... Learn more.

> Sr. Product Manager – NJ – Celgene Corporation

Celgene Corporation is a global biopharmaceutical company that is helping to turn incurable cancers into chronic, manageable conditions. An ideal candidate for this position will have BS/BA degree and a minimum of 7 years' pharma/biotech industry and 3 years product management/marketing research. Sales experience in the pharmaceutical industry required. The Sr. Product Manager assists in the development and implementation of marketing and educational programs, leading segments of the projects as appropriate. Also participates in the development of business plans, product strategies, and tactical implementation.....Learn more.

> Manager, Strategic Forecasting & Analytics Job – NJ – Celgene Corporation

Celgene Corporation is a global biopharmaceutical company that is helping to turn incurable cancers into chronic, manageable conditions. An ideal candidate for this position will have BS/BA degree. The Manager, Strategic Forecasting & Analytics will provide ongoing forecasting and long-range analytical support for the Americas Hematology/Oncology business. The Manager will participate on cross-functional teams including marketing, market research, new product planning, sales operations, business development, manufacturing, finance, and strategic planning....Learn more.

> Tools Engineer - Gaithersburg, MD - MedImmune

MedImmune is a company that shares your passion for helping to improve human health around the world. Explore a MedImmune career as we strive to better more lives, more often, around the world. As a Tool's Automation Engineer one will be required to have advanced knowledge in Network and Systems Management processes and tools. This position exists to evaluate, analyze, design, coordinate, direct, and implement complex engineering solutions using existing and new technologies to meet infrastructure and monitoring application requirements...Read More.

> Telecommunications Engineer - Gaithersburg, MD - MedImmune

MedImmune is a company that shares your passion for helping to improve human health around the world. Explore a MedImmune career as we strive to better more lives, more often, around the world. The Telecom Engineer provides level 2/3 support for all VoIP related activities, including the design, implementation, support and maintenance of MedImmune's VoIP and network infrastructure, performing other duties as required...Read More.

> Manager, Telecomm/Facilities - Gaithersburg, MD - MedImmune

MedImmune is a company that shares your passion for helping to improve human health around the world. Explore a MedImmune career as we strive to better more lives, more often, around the world. The Manager, Telecom/ Facilities Engineer plans and directs the staff, comprising of technical workers, in the installation, maintenance and operation of telecom networks and equipment, and will supervise the development and installation of new sites and facilities, and performs other management-related duties as and when required...Read More.

> Telecom Management Engineer - Gaithersburg, MD - MedImmune

MedImmune is a company that shares your passion for helping to improve human health around the world. Explore a MedImmune career as we strive to better more lives, more often, around the world. The Telecom Management Engineer reports directly to the Manager of Telecom / Facilities. The successful candidate manages the IT organization's relationship with the Telecom providers, including the planning and provisioning of all carrier circuits, reconciliation of carrier invoices and other carrier-related duties as required...Read More.

> IT Account Administrator - Gaithersburg, MD - MedImmune

MedImmune is a company that shares your passion for helping to improve human health around the world. Explore a MedImmune career as we strive to better more lives, more often, around the world. The Account Administration team primary function is to safeguard and manage access to MedImmune IT resources while adhering to MedImmune IT Controls guidelines. As a team member, the IT Account Administrator is responsible for the day-to-day administration of systems accounts such as Microsoft Active Directory, Microsoft Exchange, Blackberry Enterprise Server as well as other critical business applications...Read More.

> Need a job? Need to hire? Visit FierceBiotech Jobs

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Fwd: | 12.22.11 | Roche CEO outlines acquisition strategy; Biotech plans new hires, move

-------- Original Message --------

Subject:	\| 12.22.11 \| Roche CEO outlines acquisition strategy; Biotech plans new hires, move
Date:	Thu, 22 Dec 2011 12:42:04 -0500 (EST)
From:	FierceBiotech <editors@fiercebiotech.com>
Reply-To:	editors@fiercebiotech.com
To:	nbrauchitsch@yahoo.com

December 22, 2011
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Also Noted: Spotlight On... Biotech IPOs: It's just a flesh wound
Neuraltus raises $10M for Lou Gehrig's work; Roche submits vismodegib app; PTC banks $5M grant; and much more...

In biotech, the right partnering deal can make a company, bringing in cash, expert help and a major league endorsement for the science involved. If deals go bad, the subsequent turmoil can break a company. Anyone with any doubts about the stakes involved should take a close look at the top partnering deals that soured in 2011. Top 10 deal terminations >>

More Fierce Life Sciences News:
1. Canadian researcher gets FDA approval for HIV vaccine trial
2. Oxford researchers find malaria vaccine target
3. J&J pulls 12M Motrin bottles as recalls lawsuit gets green light

Events

> BIOCOM Global Life Science Partnering Conference - Jan 31- Feb 2,2012 - La Jolla, CA
> BioConference Live â€“ Laboratory Animal Sciences â€“ Virtual Online-only Event - February 15-16, 2012
> Webinar: JHU's Master's in Biotechnology Enterprise & Entrepreneurship
> Online GMP Courses Priced as Low as $75 for Individual Learners
> New Paradigms to Fund & Move Biotech - January 11-12, 2012 - San Francisco, CA
> PCC 2012 - CBI's 9th Pharma Compliance Congress - Jan 24-25 - Washington, DC
> Partnerships in Clinical Trials 2012 - March 4-7 - Orlando, FL
> Comparative Effectiveness: A Real-World User's Guide - March 14-15, 2012 - Washington, DC
> Leading the Business of BioPharma for Women - Mar 19-23 - Smith College

Jobs

* Post a classified ad: Click here.
* General ad info: Click here

Today's Top News

1. Roche CEO Schwan outlines drug/diagnostic acquisition strategy

By John Carroll

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Roche CEO Severin Schwan is in a deal-making mood, and he has some serious cash to gamble on new acquisitions that fit the pharma giant's overarching strategy for developing drugs that rely on a diagnostic test to identify a target patient population.

In an interview with Bloomberg's Naomi Kresge, Schwan outlined Roche's acquisition strategy, highlighting an appetite for new drugs and diagnostic technologies that could be picked up in the range of $100 million to $320 million. And a mid-size buyout along the lines of Roche's $3.4 billion Ventana buy makes sense as well.

Roche has invested billions in its diagnostics arm to make sure that the pharma giant can position its therapeutics as carefully targeted and effective, making an argument for coverage that payers of all stripes would have a hard time ignoring. As PricewaterhouseCoopers noted in a recent report on the in vitro diagnostics business, Roche is a global leader in the field and an active buyer of new technologies.

"We see the synergies between pharma and diagnostics coming to life," Schwan told Bloomberg.

- here's the story from Bloomberg

Read more about: Roche, Ventana, Severin Schwan, diagnostics
back to top

2. Vivus sinks after delivering oral cleft data on obesity drug ingredient

By Ryan McBride

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Vivus' ($VVUS) data released Wednesday show how any perceived chink in an experimental drug's armor seems to give investors the jitters. The drug developer's stock sank in after-hours trading on retrospective study data linking one of the key ingredients in its experimental diet drug Qnexa with oral cleft defects in the offspring of mothers who took the pill early in their pregnancies.

It appears that analysts are all over the board as to how the data might factor into the FDA's review of Vivus' application to market the weight-loss drug, which goes in front of an expert panel of FDA advisers early next year, and that was enough for traders to wipe out all of the Mountain View, CA-based developer's stock gains this year and then some. The stock, which had been up about 11% on the year, is down about 15.5% as of 12:06 pm ET today.

In Vivus' retrospective study dubbed "Fortress," 5 out of 1,740 babies of mothers who took topiramate during their pregnancy to prevent migraines were born with oral cleft. The prevalence rate of 0.29% in this group was higher than the 0.16% rate among the 13,512 women whose babies were born with oral cleft and who took the drug before becoming pregnant. Qnexa is a combination of topiramate and the hunger blocker phentermine.

"We view the data disclosed as mostly in-line with investors' expectations and as ranging from neutral to incrementally positive for [Vivus]," Cowen analysts wrote in a note to investors. Cowen's analysts, however, noted that reviewers of Vivus' drug application could recommend cardio safety studies, which the FDA could require before deciding whether to approve Qnexa.

MLV & Co. analyst Christopher James told Bloomberg that he believed that the data from the Fortress study was unlikely to factor into the FDA's decision on whether to approve Qnexa.

An advisory committee weighs in on whether the FDA should give a green light to Qnexa in the first quarter of 2012, and Vivus' message about the Fortess data was that there weren't really any surprises. "The prevalence ratio for oral clefts in FORTRESS is within the recently reported range for topiramate from several large studies," Vivus President Peter Tam stated.

- here's the release
- see Bloomberg's article

Related Articles:
FDA gives new shot to Vivus obesity drug
Vivus gets back in the race for weight-loss drug OK, resubmits Qnexa
Vivus shares buoyed as FDA allows early resubmission on Qnexa

Editor's Note: This story was corrected to say that Vivus' data was released on Wednesday, not Thursday, as it was incorrectly reported in the original version of this article. Also, the stock price has been updated.

Read more about: FDA, obesity, Vivus, Qnexa
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3. Ipsen-backed Inspiration Biopharma leaving California for Boston area

By Ryan McBride

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Score one for the Boston-area biotech scene. With a newly appointed chief executive from Genzyme, Inspiration Biopharmaceuticals is relocating from Laguna Niguel, CA, to the biotech-rich Kendall Square section of Cambridge, MA. And the move comes amid the company's planned transformation from a development-stage outfit to a commercial provider of bleeding-disorder drugs.

"We're building a fully integrated company,'' Inspiration CEO John Butler, who was previously president of the rare genetic disease unit of Cambridge-based Genzyme, said in an interview with The Boston Globe. "Ultimately, we're a bricks-and-mortar company as of Jan. 1. Going forward, Cambridge is our address. We expect to have two products on the market in the second half of 2013.''

Ipsen's partnership with Inspiration, which is 40% owned by the French biotech, played a role in the relocation to Massachusetts as well, according to the Globe's article. Inspiration recently filed for approval of its experimental factor IX product for hemophilia B patients in Europe, where Ipsen has rights to market the drug. The company is also planning an FDA app for approval of the drug early next year. Ipsen has set up a bioprocessing operation in Massachusetts where the treatment will be made, and the Paris-based biotech has an option to acquire Inspiration which is tied to whether the developer'' two lead bleeding-disorder drugs pan out, the Globe reported.

Inspiration's move to Massachusetts, of course, won't really improve its chances of getting market green lights for its hemophilia products. Yet there's no shortage of biotech talent walking the streets of Kendall Square, where Novartis ($NVS), Biogen Idec ($BIIB), Pfizer ($PFE) and others are building up their existing hubs and adding to their teams of scientists and business groups. And Ipsen recently revealed plans to plow $45 million into and add 100 worker s to its R&D operation in Milford, MA. Inspiration is unlikely to have problems beefing up its own work force as it readies for potential commercial releases of its products.

- here's the company's release
- get more in the Globe article

4. Will AstraZeneca get out the checkbook in search of new programs?

By John Carroll

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Within 24 hours of the news that AstraZeneca ($AZN) had experienced back-to-back pipeline setbacks, the pharma giant had countered the news with new deals aimed at adding early- and mid-stage therapies to its roster of R&D programs. But it's going to take more than that to satisfy the analysts who follow AstraZeneca and who clearly don't like the pattern of failures that has long plagued the company's development efforts.

"AstraZeneca seems to have had more than its fair share of misfortune when it comes to the development pipeline," noted analysts at Barclays Capital following the news. "Additional development failures increase the probability that management will reassess the likely return on investment from additional R&D investment and cut costs further." For now, says Barclay, fostamatinib--slated for a potential 2013 approval in the U.S. and Europe--looks like the only big commercial contender, Barclays' analysts said.

Another analyst says that AstraZeneca's dealmakers are going to need to get busy finding promising experimental drugs to partner on.

"It's a setback in a pipeline that's already relatively thin, at a company that does need pipeline products because of the patent expiries on the horizon," Berenberg Bank's Alistair Campbell told Bloomberg. "There are still some pipeline options, though I have to say my hopes aren't high for many of those."

- here's the article from Bloomberg

Read more about: AstraZeneca, R&D spending, R&D, fostamatinib
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5. Chelsea Therapeutics reports positive efficacy results in PhII fibromyalgia study

By John Carroll

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Chelsea Therapeutics ($CHTP) has racked up some more positive efficacy data for its lead drug droxidopa, which is now up for review at the FDA. Investigators reported the drug spurred a statistically significant response on some key measures of fibromyalgia in the Phase II study, which was designed to test a range of doses as well as a combo approach with carbidopa. The biotech recruited 120 patients for the study, ultimately zeroing in on 7 separate arms.

Charlotte, NC-based Chelsea designed the trial with the understanding that droxidopa, a synthetic amino acid, is converted by the body into norepinephrine. By boosting levels of norepinephrine, Chelsea believes it can directly address some of the disease's severe side effects. Shares of Chelsea were up slightly this morning.

"Since norepinephrine is a key neurotransmitter involved with the modulation of chronic pain, we were not surprised to see evidence of droxidopa's therapeutic benefit in treating patients with fibromyalgia," stated Dr. Art Hewitt, Chelsea's chief scientific officer. "As we continue to evaluate potential indications for droxidopa such as fibromyalgia and adult attention deficit disorder, trials like this provide insight into how to optimize dosing for more robust future clinical evaluations. Given the broad biologic activity of norepinephrine, we continue to believe there are wide-ranging therapeutic applications for a first-in-class oral prodrug of norepinephrine. We also continue to be encouraged by the remarkable safety profile of droxidopa which, even at its highest dose, again proved not to be associated with any serious or significant adverse events."

A few weeks ago the FDA accepted Chelsea's application for droxidopa as a new treatment for hypotension. The drug, in-licensed from Japan's Dainippon Sumitomo 5 years ago, flunked its first Phase III, but Chelsea regrouped and announced positive data in 2010. Regulators are expected to make its final decision on the program by March 28 under a priority review.

- here's the press release
- read the Reuters story

Also Noted

SPOTLIGHT ON... Biotech IPOs: It's just a flesh wound

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