| This week's sponsor is AMRI. |
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Today's Top Stories
1. Analyst sees blockbuster openings for new lupus drugs
2. OrbiMed launches $600M fund for royalty, debt deals
3. Amgen backs $30M venture round for IBS-focused Ardelyx
4. Argonne preps $34.5M lab to support protein projects
5. E&Y: India's biotech industry hits the fast lane Also Noted: Novella
Spotlight On... Tiny U.K. Pfizer spinouts start to pop up
Do developers need a system for compensating research victims?; Eisai cites new round of positive Ph3 epilepsy data; and much more... More Fierce Life Sciences News:
1. Abbott makes new lung-cancer biomarker test kit available
2. MonoSol, KemPharm partner on second ADHD thin-film drug
3. Lantos aims to help military, consumers with 3D ear-mapping
| Sponsor: DPT FierceLive! Webinars > Inside the mHealth Revolution with Welch Allyn: Realizing the Potential of Connected Devices, September 22, 11am ET / 8am PT
Events > Roche Colorado Peptide Symposium - September 12 -14 - Boulder ,CO
> Disruptive Innovations in Clinical Trials - September 15-16, 2011 - Philadelphia, PA
> Pharmaceutical Strategic Alliances - Sept 21-23, 2011 - New York, NY
> Partnership Opportunities in Drug Delivery - October 5-6, 2011 - Boston, MA
> 2nd Annual "Cancer Immunotherapy: A Long-Awaited Reality" - Oct 6, 2011
> 19th Annual BioPartnering Europe - 9-11 October 2011 - London, UK
> US Conference on Rare Diseases and Orphan Products - October 11-13, 2011 - Washington, DC
> LES Meeting: Network with Top Licensing & BD Execs 10/16-19 in San Diego! - October 16-19 - San Diego, CA
> BioNetwork West 2011 - Oct. 24-26 - The Ritz Carlton Laguna Niguel, CA
> Canadian Annual Meeting 2011: New Models - New Frameworks - New Partnerships - November 1-2, 2011 - Ottawa Ontario, Canada
Marketplace > Capitalizing on the Outsourcing Option - New Fierce eBook
Jobs > Associate Director/Director - Translational Medicine - Nonclinical Safety Assessment - Regulus Therapeutics
> Need a job? Need to hire? Visit FierceBiotech Jobs
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* General ad info: Click here |
Today's Top News 1. Analyst sees blockbuster openings for new lupus drugs
Any drug developers looking to push a late-stage program for lupus may want to pay close attention to a new note from Citi analyst Yaron Werber covering some unexpected problems for Human Genome Sciences' ($HGSI) Benlysta. With no real options to replace the first new lupus drug in a half century, doctors are content to prescribe it for now, says the analyst. But they aren't very enthusiastic about the drug's benefits and will be easily persuaded to switch to a new entry from a developer who studies the Benlysta research and learns how to produce better results from better designed studies. "While docs are happy that Benlysta is now available, they are clearly looking for better options down the line," Werber said, according to the AP story. The analyst lowered his sales estimates for later in the year, along with his projected price for HGS stock. But that didn't seem to scare off any of the company's investors as its shares hovered around $13.45, up a bit. - here's the AP report Related Articles:
Blockbuster antibodies face a unique set of challenges
Benlysta: Timeline of a lupus drug
FDA hands GSK, Human Genome Sciences landmark Benlysta approval Read more about: lupus, Human Genome Sciences, Benlysta
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2. OrbiMed launches $600M fund for royalty, debt deals
OrbiMed, a big venture investor in the biotech industry, has assembled a $600 million fund to lure life sciences companies looking for some quick cash on royalty streams or a fresh source of debt capital. And they're styling the new deal-making group as a ready alternative to equity markets. "Life sciences companies are typically dependent on equity markets to raise new capital," said Tadd Wessel, a managing director on the "Royalty Opportunities" team. "With this fund, OrbiMed can offer a minimally dilutive capital alternative to fund product launches, M&A opportunities, new product research and general corporate purposes." The fund will be operated by three OrbiMed partners--Samuel D. Isaly, Sven H. Borho and W. Carter Neild--and a dedicated team which includes Tadd S. Wessel, Matthew S. Rizzo, Matthew L. Wotiz and J. Christopher LiPuma. - see the OrbiMed release Related Articles:
Ambit bounces back from dropped IPO with $30M round
Venture group building a $50M fund for new biotech investments
Lilly prepares to inject $150M into three new biotech funds Read more about: Venture Capital fund, OrbiMed Advisors
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3. Amgen backs $30M venture round for IBS-focused Ardelyx
Amgen's venture arm has chipped in to a $30 million B round for Fremont, CA-based Ardelyx. The biotech plans to use a good deal of the cash to complete a Phase II study of a lead drug for constipation-predominant irritable bowel syndrome. NEA, CMEA and "certain individual investors" also joined in the venture funding. Ardelyx has high hopes that its lead program--RDX5791, an NHE3 sodium transport inhibitor--can go on to become a first-in-class IBS treatment. Researchers said that in Phase I the drug triggered a "loosening of the stools and decreased time-to-first-stool similar to that seen in healthy adults with other approved IBS-C and constipation drugs." The current study is slated to wrap in early 2012. "This Phase II trial data evaluating RDX5791 in patients with constipation-predominant irritable bowel syndrome are strategically important to Ardelyx because they will be our first efficacy results in a disease with significant un-met needs and an important demonstration of our unique approach to drug development," added Mike Raab, Chairman and CEO of Ardelyx. "Given the significant opportunities in our pipeline, our next priority is to establish partnerships in the US and abroad to advance our programs." Founded four years ago, Ardelyx focuses much of its work on minimally-absorbed molecules designed to target the GI system, muffling any side effects. The biotech has raised $56 million. - here's the press release Related Articles
Top scientists at UK cancer drug upstart raise $10M A round
Top 5 biotech venture capital deals, H1 2011
VC group hunts for biotech seed investments as $125M fund takes shape Read more about: Amgen, Venture Capital
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4. Argonne preps $34.5M lab to support protein projects
The Argonne National Laboratory has begun construction of a $34.5 million facility that will offer researchers near its home base in Illinois and around the world some cutting edge technology to support their lab work on proteins. The blueprints call for a 50,000-square-foot center which will offer robotics support to accelerate protein crystallization, with a key focus on new antibiotics. Crystallizing proteins with contemporary technology can be a slow and laborious effort, says Andrzej Joachimiak, director of the structural biology center at Argonne. For every 100 attempts, only one or two usable crystals typically form. "It's a very low-probability event," he adds. "We've designed the APCF to shorten the time it takes from producing a protein to making viable crystals from it." The facility is slated to come online in 2014 and will house some 550 researchers and support staffers. "If you know the 3-D structure of a given protein," says Carol Giometti, director of the biosciences division, "you can work more efficiently to come up with drugs that will interact with that protein. If that protein is involved in a disease, you can accelerate the development of a drug to fight it by knowing where the sites on the protein are for that drug to attach to and interfere with it. You could use computational methods to predict what's going to happen, but the bottom line is that you're going to need to prove it experimentally, and that's what the APCF will permit us to do." - here's the Argonne release
- read the story from Patch Read more about: antibiotic, Argonne National Laboratory
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5. E&Y: India's biotech industry hits the fast lane
India's biotech industry is small but it's growing fast as vaccines, diagnostics, devices and personalized medicine offer some new opportunities to the sector, according to Ernst & Young's local analysts in the subcontinent. The biotech industry shot up from the $3 billion registered in 2009 to $4 billion last year, but the big accounting firm notes that the large companies had the best records while smaller outfits struggled to find sufficient financing. "While the biotech industry's aggregate performance improved in 2010, there is now a widening gap between large, established companies and those at earlier stage for whom access to capital continues to be difficult," said Ernst & Young's India partner for the life sciences, Ajit Mahadevan. "The domestic biotech firms will need to adapt creatively to this environment by doing more with the funding that is available and by working from the earliest stages of development to demonstrate the potential value of their products to investors, prayers and regulators." E&Y went on to note in its Beyond Borders report that while other R&D sectors were struggling, biotech appears poised to continue its big surge, with its improving capabilities feeding further expansion. - check out the story from the Economic Times Related Articles:
Study: India's R&D efforts should turn to drug collaborations
India's biotech efforts rip page from U.S. playbook
India's biotech industry plans for frenzied growth Read more about: India
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Also Noted | This week's sponsor is Novella. |
 | Your goal is to enable people to enjoy life's special moments, and we're proud to join you in your pursuit. Our promise is to match your clinical trial specifics with resourcing insight and strategy that moves your program's potential forward.
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SPOTLIGHT ON... Tiny U.K. Pfizer spinouts start to pop up A small group of ex-Pfizer ($PFE) employees are launching their own little spinout from the giant R&D complex in Sandwich, which they call a kind of "dating service" for scientists. And they say they are the first of many tiny startups that will launch in the wake of Pfizer's decision to evacuate the drug development hub. "We've certainly learned a lot over the last 5 or 6 months," says Andrew McElroy, the CEO of The Research Network, which will match scientists with biopharma companies. "We've had a lot of help and support as well from government agencies and Pfizer in terms of learning how to set up a new company." Rep ort  @FierceBiotech: New R&D culture at GSK forces a challenging showdown. News | Follow @FierceBiotech
@JohnCFierce: Argonne has begun construction of an advanced protein crystallization lab for drug research. Report | Follow @JohnCFierce @RyanMFierce: Virtual drug discovery MT @BioWorld: "We're trying to digitalize biotech," says Zymeworks CEO after $187M deal with Merck Item | Follow @RyanMFierce @MaureenFierce: Can targeted drugs save Big Pharma? Article May help wean Big Pharma off of big blockbusters. | Follow @MaureenFierce > The subcommittee of a presidential bioethics commission believes that drug developers should have a system in place to compensate research victims. Many other countries require developers to carry insurance or have some other requirement to meet to ensure that any victims are properly compensated. In the U.S., anyone victimized by researchers can only hire an attorney and sue. Story > The third in a string of three late-stage studies of Eisai's experimental epilepsy drug perampanel demonstrated positive results compared to a placebo. Investigators reported that 33.3% of patients taking an 8 mg dose of perampanel showed a reduction in seizure frequency of more than 50%. The rate was 33.9% for patients in the 12 mg arm and 14.7% for patients taking a placebo. Story > Three North Carolina biotech upstarts each landed a $30,000 low-interest loan from the N.C. Biotech Center. Report > Selecta Biosciences has won a contract from the SAIC to develop a new malaria vaccine using their nanoparticle technology. Release Pharma News
@FiercePharma: Judge tosses all but one claim in Fosamax patient suit against Merck. No punitive damages allowed. News | Follow @FiercePharma > Citi slashes Human Genome target on slow Benlysta sales. Report > Crestor-Lipitor match-up results anticipated soon. More > Valeant emerges as Afexas $76M white knight. Article > European CMO snaps up Virginia Pfizer plant. Story > Eye-sized Avastin doses caused blindness, FDA says. News > Judge jettisons claims in bellwether Fosamax case. Details Drug Delivery News > FDA gives orphan OK to Pluristem's delivery platform for Buerger's disease. More > Unilife aims prefilled syringes at patients who self inject. Story > Newer drug-eluting stents reduce restenosis by 38%, thrombosis by half. Report > MonoSol, KemPharmpartner on second ADHD thin-film drug. Details > QLT reports successes with eye drug delivery, analyst skeptical. Article > A more precise method of making micelles. News Medical Device News > Cardiox raises $8M in Series C. Report > Lantos aims to help military, consumers with 3D ear-mapping. News > S&N takeover rumors rekindled. Story > B. Braun, CareFusion in patent disputes. Details > Medtronic, NuVasive clash over patents. More > GI dynamics raises $85 in Australian IPO. Article And Finally... All the market turmoil this month scuttled 15 IPOs, making August the worst month for spiked IPOs since April, 2001. Report > Inside the mHealth Revolution with Welch Allyn: Realizing the Potential of Connected Devices, September 22, 11am ET / 8am PT After launching a line of connected devices, Welch Allyn immediately viewed it as an opportunity to transform their business. In addition to leveraging connectivity to reduce costs and improving device uptime, Welch Allyn could now generate new sources of revenue with value-added services based on their collected device data. Learn how Axeda enabled Welch Allyn to transform successfully. Register Now!
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> Roche Colorado Peptide Symposium - September 12 -14 - Boulder ,CO RCCPS 2011 is the premier event of its kind focusing on peptide drug development. The symposium features presentations on clinical peptides, peptide drug delivery systems and formulation and advances in synthesis and analysis of peptides. Join us at the St Julien Hotel and Spa in the Rocky Mountain foothills to learn more about developing tomorrow's peptide based therpaeutics. Full details. > Disruptive Innovations in Clinical Trials - September 15-16, 2011 - Philadelphia, PA Led by Pfizer and Novartis, this groundbreaking conference delivers only case studies that demonstrate either a disruptive or an innovative approach to advancing clinical trials. Mobile Clinical Trials, Virtual Trials, Open Source Clinical Development are just a few examples of case studies featured. Fierce readers receive 15% off with code FBEL. Register or learn more: click here > Pharmaceutical Strategic Alliances - Sept 21-23, 2011 - New York, NY IS THIS BIG PHARMA'S LAST DECADE? Hear from leading executives such as Biogen's CEO George Scangos, BMS's CEO Lamberto Andreotti and J & J's Tom Heyman at PSA, the only conference to deliver detailed strategic analysis on the biopharma subjects you need to understand now. www.windhover.com/psa > Partnership Opportunities in Drug Delivery - October 5-6, 2011 - Boston, MA Keynoted by Dr Robert Langer of MIT, this is a strategic level event for pharma and biotech BD&L executives to meet a wide range of drug delivery companies with the latest technologies. Fierce readers receive 15% off with code FBEL. Register or learn more: click here > 2nd Annual "Cancer Immunotherapy: A Long-Awaited Reality" - Oct 6, 2011 "Cancer Immunotherapy: A Long Awaited Reality" is a unique, single-day conference event that unites founding visionary researchers, clinicians, business leaders, key investors, and other stakeholders to engage in discussions, exchange information, highlight opportunities, and showcase leading companies in the field of cancer immunotherapy. For information, please email info@mdbpartners.com or contact Michael Becker or Janet Dally of MD Becker Partners at phone (267) 756-7094. To register or for more information, visit www.regonline.com/mdbpartners > 19th Annual BioPartnering Europe - 9-11 October 2011 - London, UK Take your place at the table with global leaders, put your company in the spotlight and help define the future of medicine. Join us for BioPartnering Europe in London this October. Visit: http://www.techvision.com/bpe > US Conference on Rare Diseases and Orphan Products - October 11-13, 2011 - Washington, DC The Rare Diseases and Orphan Drugs Summit 2011 is the first annual program representing a collaboration among academic researchers, clinical researchers, pharmaceutical and biotechnology companies, regulatory and health agencies, patient organizations, payors and venture capital/private equity concerns to address the need for effective therapies for rare diseases. Learn more. > LES Meeting: Network with Top Licensing & BD Execs 10/16-19 in San Diego! - October 16-19 - San Diego, CA Meet your next partner and connect with execs from Bayer, Celgene, Eli Lilly, GSK, Merck, Pfizer, Roche, Shire, Takeda and more! Featuring Roger Longman and Ed Saltzman on value creation in biopharma plus sessions on emerging markets and dealmaking. Save $100 with code FierceBiotech. Register now! > BioNetwork West 2011 - Oct. 24-26 - The Ritz Carlton Laguna Niguel, CA BioNetwork is the key industry biopharma partnering event that provide the essential meeting place for pharma and biotech companies to develop relationships and move programs forward. Get 25% off with code 10386XZ88EN. For more info and to register now, visit www.bionetworkus.com, call 888-482-6012. > Canadian Annual Meeting 2011: New Models - New Frameworks - New Partnerships - November 1-2, 2011 - Ottawa Ontario, Canada Fostering Innovation to Facilitate Market Access! Drug development, regulatory oversight, and traditional healthcare partnerships continue to evolve due to the continuous emergence of new scientific approaches such as biomarkers and individualized medicines; health care reform; technological advances; and the interplay between safety pharmacovigilance and effectiveness research. Canada must foster innovation to remain competitive and facilitate market access. Share insights and exchange information on how these changes present opportunities to those prepared to meet them. Register Today!
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> Capitalizing on the Outsourcing Option - New Fierce eBook Risk areas for many biotechs and pharmas in today's changing market include lack of expertise and infrastructure. This eBook addresses recalibration challenges and strategies to capitalize using the contract development and manufacturing (CDMO) option. Download now.
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> Associate Director/Director - Translational Medicine - Nonclinical Safety Assessment - Regulus Therapeutics Regulus Therapeutics Inc. is a biopharmaceutical company leading the discovery and development of innovative new medicines based on microRNAs. Regulus seeks a motivated 6 plus years of drug development experience to join our efforts in translating microRNA biology into human therapeutics. The position requires proven ability to work in a fast-paced biotech environment. Read more. > Need a job? Need to hire? Visit FierceBiotech Jobs |
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