| This week's sponsor is The Jackson Laboratory. |  |
Today's Top Stories
1. Can Denner's new hedge fund replicate Icahn's golden biotech touch?
2. Texas rustles Dana-Farber science team to spearhead $75M cancer R&D effort
3. Affymax investors bullish on FDA review of Amgen anemia drug rival
4. UK offering $280M catalyst fund, patient data access for biotech R&D
5. Abbott chief says biopharma ops not for sale (at bargain price) Also Noted: Novella Clinical
Spotlight On... AZ opens drug portfolio to academic investigators
FDA flags concerns on Pfizer kidney cancer drug; Momenta gets Virdante tech in $56M deal; Regeneron slides on head-to-head data; and much more... More Fierce Life Sciences News:
1. Microsoft co-founder Allen urges open science to speed breakthroughs
2. NYT: Data bottleneck stymies progress in genomics
3. Whose sales reps get the highest ratings--and where?
| This week's sponsor is PPD. |  | | Considerations for establishing comparability, the regulatory landscape, and program design. |
| Sponsor: Biotech Primer FierceLive! Webinars > Drug Development: An Overview of the Regulated Clinical Trials Process Used to Bring a New Drug to Market Dec 13, 1 pm ET/10 am PT
Events > Patheon Seminar: Moving from Molecule to Clinical Trial - December 13, 2011 - San Diego, CA
> Just Released: New Trends in Preventive and Therapeutic Vaccine
> Webinar: The Benefits of Web-Based ePRO for Phase IV Clinical Studies - December 15, 2011
> CBI's 2nd CT Budgeting and PM Forum - Dec 6-7 - San Francisco, CA
> CMAC 2011 - December 6-7, 2011 - Philadelphia, PA
> Online GMP Courses Priced as Low as $75 for Individual Learners
> New Paradigms to Fund & Move Biotech - January 11-12, 2012 - San Francisco, CA
> Pharmacovigilance and Risk Management Strategies 2012 - January 22-25, 2012 - Arlington, Virginia
> Partnerships in Clinical Trials 2012 - March 4-7 - Orlando, FL
> The Industry's Best Kept Secret: BioNetwork East - March 5-7 2012 - Miami, Florida
Marketplace > Biomarkers: Lab to Clinic. An eBook from FierceBiotech
> Digital Health Technology: A Guide to Medtech's Biggest New Player
> Companion Diagnostics: The Future of Medicine
Jobs > Director, Reagent Manufacturing & Operations - San Francisco, CA - Fluidigm
> Sr. Product Manager – NJ – Celgene Corporation
> Manager, Strategic Forecasting & Analytics Job – NJ – Celgene Corporation
> Business Analyst - Gaithersburg, MD - MedImmune
> IT Infrastructure Portfolio & Planning Analyst - Gaithersburg, MD - MedImmune
> Senior Manager, Information Architect - Gaithersburg, MD - MedImmune
> Systems Analyst - Gaithersburg, MD - MedImmune
> Data Center Fac.Engineer– Gaithersburg, MD - MedImmune
> Need a job? Need to hire? Visit FierceBiotech Jobs
* Post a classified ad: Click here.
* General ad info: Click here | Today's Top News 1. Can Denner's new hedge fund replicate Icahn's golden biotech touch?
After reportedly adding $2 billion to Carl Icahn's treasure chest, Alex Denner is now off on his own, setting up a new hedge fund that presumably will set out to follow the same biotech blueprint that has worked so well in the past. The game plan: Buy into a company experiencing some major turbulence and then try to seize control of the board to push through a restructuring, if not a sale. Then cash in on the big jump in the share price. And today Bloomberg is helping to burnish Denner's image in the industry with a laudatory profile on the high-profile predator's hands-on experience in drug development. Denner has plenty of investment successes to boast about. He succeeded at ImClone, where he headed an executive committee that steered the troubled company to a $6.5 billion buyout with Lilly ($LLY). And after joining Icahn's team he did even better with the Biogen Idec ($BIIB) turnaround a nd Genzyme's $20 billion sale to Sanofi ($SNY). "Alex actually understands the science--and how to build that into a business," ex-con and ImClone founder Sam Waksal tells Bloomberg. "When a company is broken, he knows what should be done to fix it." This morning the main question on many investors' minds is likely to be which "broken" biotech Denner will focus on first. - here's the article from Bloomberg Related Articles:
Icahn biotech whiz Denner jumps ship after 5 turbulent years
Icahn makes fresh inroads at Biogen and Genzyme
Biogen's Scangos earns Icahn's (rare) blessing Read more about: Biogen Idec, ImClone, Genzyme, Sanofi
back to top |
 | Drug Development: An Overview of the Regulated Clinical Trials Process Used to Bring a New Drug to Market
Dec 13, 1 pm ET/10 am PT - Early Bird Rate Ends Dec 1
Join us for a one-hour overview of the regulated clinical trials process used to bring a new drug to market.
Topics include: Clinical Trial Considerations, Phase 1, Phase 2a and 2b, Phase 3 and 3b, Phase 4, Pharmacoeconomics, Risk Management Plan and more. Register today. |
2. Texas rustles Dana-Farber science team to spearhead $75M cancer R&D effort
With an eye to ramping up some ambitious new R&D work on a new generation of cancer therapies, Houston's renowned MD Anderson Cancer Center has poached 55 scientists from the equally well known Belfer Institute at Dana-Farber, including a big part of its leadership group, to run a new cancer drug research center that promises to help fill what it sees as a growing void in early-stage research efforts. Backed with a $75 million pledge, MD Anderson is launching "The Institute for Applied Cancer Science" with a plan to get directly involved in drug development work. The move to rustle top scientists from Boston comes just weeks after the Belfer Institute's Ron DePinho was brought in to run it. "Pharmaceutical companies have downsized their internal research programs," DePinho tells the local public radio station. "Biotechnology companies, which serve as the pipeline from academia to large pharma, are under significant stress due to the economic crisis." So he says the new institute will step in to help fill the gap, as he sees it. Several years ago, Texas lawmakers agreed to back an ambitious public effort to support cancer drug research in the state. MD Anderson is part of the University of Texas system. It will be interesting to see if DePinho and his relocated team can attract the interest of pharma companies, some of which have been ramping up operations in Boston specifically to get closer to the academic work under way at Dana-Farber. - read the story from Houston Public Radio and Kaiser Health News Related Articles:
TX, MD consider incentives following stimulus
Texas - Top Five Regions Targeting Biotech Companies
Failed Texas biotech exec gains from state tech fund Read more about: Texas, Dana-Farber Cancer Institute
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3. Affymax investors bullish on FDA review of Amgen anemia drug rival
Facing an expert panel review for peginesatide on Wednesday, FDA staffers gave Affymax ($AFFY) a solid boost in confidence this morning with an agency review that backed the once-monthly anemia treatment as equivalent to Amgen's ($AMGN) blockbuster treatments Epogen and Aranesp. And investors quickly picked up on the positive spin, boosting the biotech's stock more than 25% this morning. "Data from the clinical program support the efficacy of peginesatide administered once monthly for the treatment of anemia of CKD in dialysis patients," the staffers noted in a detailed review of the data. "The Phase III Dialysis Studies 12 and 14 demonstrated peginesatide could be used to maintain stable Hb levels as successfully as epoetin." The agency has its reservations about the drug's safety, though, and wants the committee to take a close look at the benefits and risks for patients with chronic kidney disease, "given the safety findings and in light of the prior history with agents that stimulate the erythropoietin receptor." Affymax and its partner Takeda are seeking approval of the drug for CKD patients on dialysis. But as Adam Feuerstein at The Street noted this morning, the FDA's safety concerns appear relatively muted in the report, which helped to further ignite the biotech's share price. Agency reviews typically contain a sharp focus on any safety or efficacy concerns for a new drug. And investors have been acutely sensitive to some late-stage data on the drug's cardio risks seen in a group of patients. Today they seem to be at least temporarily satisfied that Affymax has taken one more step toward a potential approval for the first direct competitor to Amgen's more frequently administered treatments. - get the FDA review (.pdf)
- here's the story from The Street
- read the Bloomberg report Special Report: Amgen - Biotech's Biggest Spenders 2011 Related Articles:
Potential rival to Amgen's anemia drug faces big day with FDA advisers
Affymax readies blockbuster alternative to Epogen
Medicare affirms rule expected to erode Epogen sales
Affymax gets $10M milestone, PDUFA date on anemia drug Read more about: Amgen, Affymax, Aranesp, Epogen
back to top |
4. UK offering $280M catalyst fund, patient data access for biotech R&D
The UK's conservative PM is offering the country's swooning biotech industry a shot in the arm today. In what is being billed as a major new initiative, David Cameron is pledging $280 million to support a "biomedical catalyst fund" to back early-stage academic and biotech R&D at small and medium-sized development outfits. And he's vowing to speed up access to experimental drugs while putting the country's massive NHS database to use for drug development efforts. The idea of providing patient data to biopharma companies immediately drew political flak from the opposition, which called it a violation of patients' privacy. But Sarah Chan, deputy director of Manchester University's institute for science, ethics and innovations, quickly shrugged off the notion. "The wealth of data collected by the NHS represents a vast and potentially very valuable resource that could be used to facilitate highly beneficial research. The concerns over privacy and confidentiality...are perhaps overblown," she noted to Reuters. "As I understand it, the data that is to be released will be anonymized, and so cannot be used to target individual patients." "The most crucial, fundamental thing we're doing is opening up the NHS to new ideas," Cameron plans to say, according to the Guardian. "I want the great discoveries of the next decade happening in British labs, the new technologies born in British startups." Over the past year, the UK's substantial R&D industry has had to weather a number of setbacks, most significantly Pfizer's ($PFE) plans to close its big hub in Sandwich, Kent. Those setbacks, though, helped set the stage for today's new initiative. - read the Reuters story
- here's the article from The Guardian Related Articles:
UK's biotech stars may be fading, but new hopefuls shine
Flush with cash, U.K. biotech preps new discovery effort in Oxford
U.K. officials fault Pfizer in Sandwich closure
Is the U.K.'s cancer-drugs fund unfair? Read more about: United Kingdom, R&D spending, R&D
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5. Abbott chief says biopharma ops not for sale (at bargain price)
Ever since Abbott Laboratories ($ABT) announced plans to spin off its pharma business into a separate company, analysts have been buzzing about the pros and cons of a possible buyout. So when Abbott CEO Miles White stood up today to address a Financial Times conference in London, they paid particularly close attention to White's circuitous nondenial that a buyout could be worked out--for the right price. First, he made it clear that there's no "for sale" sign planted on the pharma company's front lawn. "Is one or other (of the two companies) an acquisition candidate? The answer is 'no,'" he told attendees, according to Reuters. But, of course, White left the door open for anyone out there willing to come to him with a checkbook in hand and an offer he couldn't refuse. Split in half, the two units would be worth in the range of $40 billion to $45 billion, he estimated. "We're not offering them for sale ... somebody would have to have an awful lot of cash and they'd have to have a 'yes' from a CEO and that would be a tough 'yes' to get." In the meantime, as Bloomberg notes, White also talked up plans to do more R&D work in emerging markets, a favorite new playing field for the world's Big Pharma companies. - read the Reuters story
- here's the Bloomberg item Related Articles:
Abbott split creates an $18B biopharma deal-maker with deep pockets
Will Abbott spinoff become Big Pharma's next big M&A target?
Abbott spotlights blockbuster hopefuls in pitching spinoff Read more about: Abbott Labs, Big Pharma, Mergers and Acquisitions
back to top |
Also Noted | This week's sponsor is Novella Clinical. |  | With an unmatched depth of oncology expertise across all functional areas, we can identify early protocol challenges
and provide risk mitigation guidance to help you bring new products to market that make a difference in the lives of
people with cancer. www.novellaclinical.com/oncology |
SPOTLIGHT ON... AZ opens drug portfolio to academic investigators AstraZeneca ($AZN) and the Medical Research Council in the U.K. have come up with a new approach to rope in some fresh thinking on new uses for their compounds. AZ will let academic researchers ponder new approaches for 22 of their compounds, with the MRC chipping in up to £10 million to finance the work. Both groups say the public-private initiative promises to spur faster development efforts. "We hope that in sharing these valuable compounds with academic scientists through the MRC, new discoveries will be made by exploring additional uses of these compounds," says AstraZeneca CEO David Brennan. Release  @FierceBiotech: Novartis aiming to impress investors, academics as it presents flurry of data on its growing cancer franchise. Article | Follow@FierceBiotech
@RyanMFierce: Profile on former Icahn biotech lieutenant Alex Denner via Bloomberg--Still not many details on his hedge fund. Item | Follow @RyanMFierce @JohnCFierce: U.K. offering $280M catalyst fund, patient data access for biotech R&D. Story | Follow @JohnCFierce @MarkHFierce: The Aussies have found a gene that stops skin cancer. Treatments could follow in 5 years? We'll see. More | Follow@MarkHFierce > Two days ahead of an advisory committee meeting, FDA staffers raised concerns that Pfizer's kidney cancer drug axitinib may help only a small group of patients and may not help much in spurring progression-free survival rates. Story > Momenta Pharmaceuticals paid $4.5 million upfront and promised up to $51.5 million more to gain the rights to the Sialic Switch technology held by Virdante Pharmaceuticals. "Virdante's Sialic Switch technology represents an exciting approach to potentially regulate anti-inflammatory activity of proteins," said Ganesh Venkataraman, the CSO at Momenta. "Sialylation complements our existing technology platform and we look forward to advancing this technology in development programs, including biobetters and novel products." Release > Japan's Takeda plans to launch a new global vaccines division next year. News > Regeneron shares slipped this morning after the biotech said that new data failed to demonstrate that its newly approved drug Eylea worked better than Roche's Lucentis after two years of treatment. Story > Watertown, MA- based EnVivo Pharmaceuticals says that it has presented positive Phase IIb data on an experimental schizophrenia drug. Release @FiercePharma: Sanofi abandons authorized Lovenox generic, now that Amphastar's copy isn't a threat to brand sales--Bloomberg. More | Follow @FiercePharma > Who's on first for Icahn departee Alex Denner? Item > Pain-drug market to stagnate on generic erosion, report says. Story > Eylea data blurs dosing advantage over Lucentis. Article > Abbott CEO: Pharma unit not for sale. Report Biotech IT News > Microsoft co-founder Allen urges open science to speed breakthroughs. Story > Startup Spiral Genetics takes shot at bioinformatics. Article > AstraZeneca taps IT outsourcing firm Cognizant. News > Singapore group touts new genome assembly method. Report > NYT: Data bottleneck stymies progress in genomics. Report Medical Device News > Integra opens Shanghai office. News > Qualcomm unit to provide wireless solutions for devices. More > Moog taps Scannell as CEO. Item And Finally... Investigators at the University of Missouri have shed new light on the way adult stem cells are attracted to the site of a muscle injury to help repair the damage. Their work could contribute to the development of new approaches to treating muscular dystrophy. Report > Drug Development: An Overview of the Regulated Clinical Trials Process Used to Bring a New Drug to Market Dec 13, 1 pm ET/10 am PT Join us for a one-hour overview of the regulated clinical trials process used to bring a new drug to market. Topics include: Clinical Trial Considerations, Phase 1, Phase 2a and 2b, Phase 3 and 3b, Phase 4, Pharmacoeconomics, Risk Management Plan and more. Register today.
| > Patheon Seminar: Moving from Molecule to Clinical Trial - December 13, 2011 - San Diego, CA Four scientific leaders will help you navigate through regulatory obstacles, give you tips for getting your molecule to clinical trials more efficiently, and provide practical case studies that demonstrate how others molecules have successfully moved to clinic. Learn more here. > Just Released: New Trends in Preventive and Therapeutic Vaccine This new Insight Pharma Report analyzes current R&D activities and commercial prospects for vaccines. Sectors covered include bacterial infections; viral infections including hepatitis, HIV, influenza, and others; autoimmune diseases, cancer, and many more. For more info, www.insightpharmareports.com > Webinar: The Benefits of Web-Based ePRO for Phase IV Clinical Studies - December 15, 2011 On Dec 15, 2022, learn how to collect high quality PROs in late phase studies, and how to engage patients online to increase compliance and retention. Register for this educational webinar from CRF Health. > CBI's 2nd CT Budgeting and PM Forum - Dec 6-7 - San Francisco, CA Clinical Finance & PM Professionals: Find the balance between timeline, budget & quality management. Network, earn CPEs and hear from Arno Therapeutics, AVI BioPharma, Fibrogen, Genentech, Halozyme, Medtronic and more. Register by 11/18 to save $400 with code CTBPMW - www.cbinet.com/budgeting > CMAC 2011 - December 6-7, 2011 - Philadelphia, PA Wanted: A commercially successful product. Found: CBI's Commercialization and Market Access Congress. CMAC delivers pre and post-launch strategies, customized programming and extensive coverage of market access trends. Register at www.cbinet.com/cmac2011 by 11/18 and save $400 with code CMACFM > 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 > Pharmacovigilance and Risk Management Strategies 2012 - January 22-25, 2012 - Arlington, Virginia Get New Insights into the Current Issues and Associated Challenges Impacting Drug Safety. Join top pharmaceutical, biotech, and regulatory representatives to discuss the new and updated legislation in various ICH regions, important new harmonization initiatives, life cycle management, the impact of social media, biosimilars, and the use of other data sources and observational research, and much more! Register today and SAVE $200! > 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. > The Industry's Best Kept Secret: BioNetwork East - March 5-7 2012 - Miami, Florida BioNetwork East is an elegant and intimate retreat for BioPharma business development executives to explore opportunities in partnering & funding. Visit www.bionetworkeast.com and use code BE12Fierce to save$825 - our best offer!
| > Biomarkers: Lab to Clinic. An eBook from FierceBiotech Don't miss this in-depth look at biomarkers. What role do they play in clinical trials? How do they factor into the diagnosis of diseases such as Alzheimer's? What role does the FDA play in creating guidelines for biomarkers? Get the answers to these questions and more when you download this free eBook. > Digital Health Technology: A Guide to Medtech's Biggest New Player Are you up to date on the latest in digital health technology? Let Elsevier Business Intelligence guide you in navigating this growing field. This report covers new technology and policies that could affect your bottom line. Learn more at http://pages.elsevierbi.net/digitalhealth/ > Companion Diagnostics: The Future of Medicine This 47-page report from the editors of FierceMedicalDevices provides a detailed analysis of the companion diagnostics landscape. Download your free copy today.
| > 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. > Business Analyst - 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 Business Analyst works as a liaison among stakeholders in order to elicit, analyze, communicate, and validate requirements for changes to business processes and information systems. The role is responsible for understanding and documenting business requirements for specific business problems, translating business requirements into functional specifications, and verifying that solutions meet the requirements...Read more. > IT Infrastructure Portfolio & Planning Analyst - 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 Senior Analyst, IT Infrastructure Portfolio & Planning is responsible for the planning, management, and execution of capacity planning, forecasting, and requirements definition for all IT infrastructure domains including LANs, WANs, servers, storage, telephony, etc. Candidates should have at least five (5) years of experience in the area of analytic and/or discrete event simulation modeling...Read more. > Senior Manager, Information Architect - 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. This position requires at least 8+ years of work experience in an Information Systems and 5+ years of experience in Information management functions. Responsibilities include developing and evangelizing Enterprise Information Architecture and providing leadership for developing and maintaining the Enterprise Information Architecture...Read more. > Systems Analyst - 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 Systems Analyst enables the technical delivery of projects with adherence to defined technical standards and provides support for domain and enterprise applications. This position requires 3 or more years of relevant work experience including business analysis, testing / quality assurance, Application Development and Operations...Read more. > Data Center Fac.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 Data Center Facilities Engineer will support MedImmune, Inc. data centers (DC), main distribution frames (MDF), intermediate distribution frame (IDF), throughout MedImmune, Inc. Global Sites. This position requires 5 or more years of experience in an industrial setting. (DATA Center or Critical Environment experience Preferred)...Read more. > Need a job? Need to hire? Visit FierceBiotech Jobs | |
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