| This week's sponsor is Myriad RBM. |  |
Today's Top Stories
1. Alexza shares spike after antipsychotic wins weak embrace from FDA panel
2. Cambridge, MA startup snags $20M for therapeutic vaccine program
3. Catabasis boosts Series A to $47.6M as it zeroes in on Amarin rival
4. Setbacks force AVI BioPharma to ax staffers in restructuring effort
5. YM gets boost after posting promising anemia data on myelofibrosis drug Also Noted: Samsung Biologics
Spotlight On... Quintiles launches CRO in booming China drug market
Merck gains rights to diabetes drug portfolio; 5-year Velcade data points to improved survival benefit for myeloma patients; and much more... More Fierce Life Sciences News:
1. Protein 'switch' could be key to fighting obesity, diabetes
2. Supreme Court considering crucial gene patent case
3. Pfizer elects CEO Read as company chair
| This week's sponsor is The Jackson Laboratory. |  |
| Sponsor: Perceptive Informatics 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
> Rutgers Mini MBA: BioPharma Innovation & BioPharma Entrepreneurship Programs
> Webinar: JHU's Master's in Biotechnology Enterprise & Entrepreneurship
> Online GMP Courses Priced as Low as $75 for Individual Learners
> Partnerships in Clinical Trials 2012 - March 4-7 - Orlando, FL
> The Industry's Best Kept Secret: BioNetwork East - March 5-7 2012 - Miami, Florida
> Comparative Effectiveness: A Real-World User's Guide - March 14-15, 2012 - Washington, DC
Marketplace > Digital Health Technology: A Guide to Medtech's Biggest New Player
Jobs > Director, Reagent Manufacturing & Operations - San Francisco, CA - Fluidigm
> Sr. Product Manager – NJ – Celgene Corporation
> Manager, Strategic Forecasting & Analytics Job – NJ – Celgene Corporation
> Business Analyst - Gaithersburg, MD - MedImmune
> IT Infrastructure Portfolio & Planning Analyst - Gaithersburg, MD - MedImmune
> Senior Manager, Information Architect - Gaithersburg, MD - MedImmune
> Systems Analyst - Gaithersburg, MD - MedImmune
> Data Center Fac.Engineer– Gaithersburg, MD - MedImmune
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* General ad info: Click here | Today's Top News 1. Alexza shares spike after antipsychotic wins weak embrace from FDA panel
Alexza Pharma ($ALXA) just barely managed to clear one of the big hurdles that threatened to once again block its marathon effort at winning an FDA approval of the inhaled antipsychotic treatment Adasuve (formerly AZ-004). An expert FDA committee voted 9 to 8 in favor of an approval yesterday evening, with a number of critics clearly remaining unhappy with the safety issues that have hobbled the program before. Just days ago investors were dumping 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. "This product offers the potential to be a significant contributor to an important need," noted Andrew Winokur, director of psychopharmacology at the University of Connecticut School of Medicine in Farmington, according to a report from Bloomberg. Alexza provided "impressive efficacy data." Adasuve is a vaporized version of the old antipsychotic loxapine. Inhaling it with the use of a new device developed by Alexza offers a quick method for dealing with bouts of schizophrenia and bipolar mania. But a number of specialists in the FDA remain worried that the drug could wind up in the wrong hands, or administered without all the necessary precautions. Investors, who have alternately fled and embraced Alexza's shares, initially responded to the positive vote by pushing its battered shares up more than 70%. By mid-morning some of those gains had been given up as analysts considered Alexza's chances at finally winning an approval from a skeptical FDA. Some analysts say an approval could pave the way to a market worth about $150 million in annual revenue. Alexza now faces a PDUFA deadline on February 4. - read the press release
- here's the report from Bloomberg Related Articles:
Alexza Pharma shares tank on FDA's safety concerns about Adasuve
Alexza shares plunge after it offers new timetable for AZ-004 Read more about: schizophrenia, Alexza Pharmaceuticals, Bipolar disorder, Adasuve
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2. Cambridge, MA startup snags $20M for therapeutic vaccine program
After importing the IP for a new therapeutic vaccine that promises to desensitize celiac disease patients to the toxic effects of gluten, the newly established ImmusanT has rounded up $20 million from a single investor to back its mid-stage clinical development work. Launched in Cambridge, MA last March, ImmusanT quickly attracted attention from the biotech community for Nexvax2, which pooled three gluten-derived peptides into an injection for celiac patients. Drawing on the work of the company's scientific founder, the Australian Bob Anderson, who folded his biotech down under and relocated to the U.S. to work with ImmusanT co-founder Leslie Williams, the startup quickly pushed through Phase I with the backing of angel investors. All the money for the Series A is coming from Vatera Healthcare Partners, which also backed Pearl Therapeutics. And ImmusanT is working with Inova to develop a diagnostic that can be used to ID the celiac disease patients able to benefit from the therapeutic vaccine. "There is tremendous enthusiasm for Nexvax2 from celiac patients and clinicians who want a therapy that allows patients to resume a normal diet and return to good health and improved quality of life," Williams said in a statement. "The financial backing and support of Vatera Healthcare Partners will allow us to round out our team and advance our research and development programs to bear out this hypothesis." - here's the press release Read more about: celiac disease, ImmusanT
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3. Catabasis boosts Series A to $47.6M as it zeroes in on Amarin rival
Cambridge, MA-based Catabasis Pharmaceuticals has scored an additional $8 million for its Series A, pushing the first round to $47.6 million as the developer advances a second omega-3 drug program through a Phase I study ahead of schedule. Back in 2010, when Catabasis was named a Fierce 15 company, CEO Jill Milne's timeline called for a second program to get underway in 2012. But backers at SV Life Sciences, Clarus Ventures, MedImmune Ventures and Advanced Technology Ventures have opted to gas up early to fuel clinical work on CAT-2003, an early-stage omega-3 conjugated compound designed to fight hypertriglyceridemia--the same cardiovascular target Amarin ($AMRN) is zeroing in on with the closely watched AMR101. Catabasis's first omega-3 drug program is focused on diabetes, which is slated to move into a mid-stage study in the first half of next year. "In CAT-2003 we identified a molecule in preclinical studies which is superior to anything we've seen out there in the clinic," says company co-founder Mike Jirousek, making it clear that the biotech believes it has the potential to take on Amarin's treatment if AMR101--designed to extract high levels of fat in the blood--goes on to win an approval. "This is a new option for hypertriglyceridemia. The data has been so exciting around the second program, it's something I think everyone wants us to pursue in parallel rather than in tandem." Catabasis has been growing at a brisk pace, bringing their staff numbers up to 20 over the past year and planning another 10 hires or so by the end of next year, says Milne. Next year the biotech will look for a potential partner on the diabetes program, and the CEO notes that the deal numbers would influence whether--and how much--Catabasis might seek in a Series B round. - here's the press release Special Report: Catabasis Pharmaceuticals - 2010 Fierce 15 Related Article:
Catabasis lands $14.5M tranche for Omega-3 drug development Read more about: Diabetes, Amarin, Catabasis Pharmaceuticals
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4. Setbacks force AVI BioPharma to ax staffers in restructuring effort
RNA drug developer AVI BioPharma buried the lead in a press release Friday. After touting a new hire--Jayant Aphale, Ph.D.--at some length, the Bothell, WA-based biotech tersely noted that 28% of the company's workforce was being axed in a restructuring. That move will cost the jobs of about 35 of the 125 staffers at the company, which has been dealt a pair of painful setbacks in recent months. AVI missed out on a $500 million government contract for an RNA-based pandemic flu treatment, notes Xconomy's Luke Timmerman, who first ferreted out the news yesterday. And then the biotech was dealt another blow when it failed to overturn a patent claim by Prosensa that it owns a stake in AVI's lead muscular dystrophy program. "With our stock price at 52-week lows, and the recent disappointing news of not getting the flu contract, combined with Prosensa's success in defending their patent in Europe related to Exon 51 (our lead program), we felt it was important to reprioritize/refocus on the primary value-driving programs of DMD, Ebola, and Marburg," AVI CEO Chris Garabedian told Timmerman in an email. In its statement, AVI noted that the layoffs will help the developer focus more on rare and infectious diseases. Its lead RNA program is targeted at Duchenne muscular dystrophy and AVI is pursuing other programs for Ebola and the Marburg virus. A number of RNA companies have been struggling to raise funds recently as Big Pharma players exited the field. - read the press release
- here's the Xconomy story from Timmerman Related Article:
Investigators herald antisense breakthrough on muscular dystrophy Read more about: AVI Biopharma
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5. YM gets boost after posting promising anemia data on myelofibrosis drug
Shares of YM Biosciences ($YMI) got a bump this morning after several analysts gave the developer a pat on the back for the updated midstage results released for its myelofibrosis drug CYT387, a JAK1/JAK2 inhibitor. TheStreet's Adam Feuerstein started the round of applause this morning, noting that the developer's drug maintained a positive anemia response, with about half of the 68 myelofibrosis patients in the study who were transfusion dependent at the launch of the study becoming transfusion independent for at least 12 weeks during treatment. And of the 26 transfusion-dependent patients getting the 300 mg dose, 62% were transfusion independent for 12 weeks. Both groups maintained hemoglobin levels at or above 8 g/dl. "These '387 anemia response data are stronger and more credible than what was presented last spring because Monday's results are culled from many more patients enrolled at multiple clinical trial sites," notes Feuerstein. And producing the positive anemia response after significant doubts had been raised will help favorably position the drug against rivals on the market."We expect these results to accelerate partnership discussions, and are increasingly optimistic about the potential of CYT387 in other hematologic indications," wrote analyst Avik Roy. "In this multicenter study, CYT387 continues to demonstrate a unique ability to render and maintain myelofibrosis patients transfusion independent for clinically-relevant periods, while also producing significant and durable improvements in their splenomegaly and constitutional symptoms," said Dr. Nick Glover, the CEO of YM BioSciences. "In addition, MRI results obtained from a subset of subjects confirm the meaningful improvements in splenomegaly as measured by palpation. Moreover, CYT387 was well tolerated, with dosing up to and exceeding two years." - check out the YM release
- here's the story from TheStreet Related Articles:
YM BioSciences inks deal to acquire Cytopia
YM withdraws European app for nimotuzumab
FDA lifts clinical hold on YM therapy Read more about: YM Biosciences, CYT387, myelofibrosis
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Also Noted | This week's sponsor is Samsung Biologics. |  |
SPOTLIGHT ON... Quintiles launches CRO in booming China drug market In yet another sign of the eastward drift of clinical development work, Quintiles says it is setting up a new CRO in China to help developers with everything from clinical trial management to regulatory submissions. The move comes as Quintiles, which has a staff of 300 in the Asian country, is planning to double the number of workers it has there. "We have an aggressive growth plan for China," says Quintiles China GM Ling Zhen. Release  @FierceBiotech: Leave it to engineers to come up with a potentially novel solution to fight Alzheimer's disease. Article | Follow @FierceBiotech @JohnCFierce: Quintiles sets up a China CRO, plans to double staff in China--another step in the shift to the East. News | Follow@JohnCFierce @RyanMFierce: Avila makes progress with Btk inhibitor, same type of drug as $JNJ shelled out $150M for last week. Story | Follow@RyanMFierce @MaureenFierce: Fooling immune system reverses multiple sclerosis in mice, according to a University of Freiburg study. More | Follow@MaureenFierce @MarkHFierce: Look at this--gene therapy works! Sometimes the most interesting news comes out during the weekend. Item | Follow@MarkHFierce > Merck's grabbed worldwide licensing rights to a portfolio of Type 2 diabetes treatments held by Japan's Mochida Pharmaceutical. Release > Takeda has presented 5-year follow-up data demonstrating that Velcade added to standard treatments reduced the threat of death by 31% among untreated multiple myeloma patients. Story > Astellas and Optimer won European approval for the new antibiotic Dificlir. Story > Palo Alto, CA-based Anacor says that that it has nailed down positive Phase IIa its two PDE-4 inhibitors, AN2728 and AN2898, in mild-to-moderate atopic dermatitis, a chronic rash. Release > The FTC has approved Valeant's acquisition of units of J&J and Sanofi. Story > Fitzsimons Redevelopment Authority says it will add an $8 million, 37,000-square-foot facility at the Bioscience Park in Colorado to house startup biotech companies. Story Pharma News @FiercePharma: SEC accuses Stiefel Labs, ex-chief of fraud: NYT. News | Follow@FiercePharma > Watson takes big initial chunk of generic Lipitor sales. Report > Pfizer elects CEO Read as company chair. Report > FDA rejects citizen's petition on Plan B. News > SEC accuses ex-Stiefel CEO of fraud. Article > J&J to release new Doxil batches. Story Biotech Research News > Antibody may help fight Alzheimer's. More > Protein 'switch' could be key to fighting obesity, diabetes. Story > Gene therapy appears to work for hemophilia B patients. Report > Supreme Court considering crucial gene patent case. News Pharma Manufacturing News > Actavis, Mylan continue defense in Digitek API suits. Article > Packaging veteran urges including patient in drug pedigree chain. More > KV reports doubt about viability under decree. News > Europe issues 2nd recall of drugs made by Ben Venue. Story And Finally... Investigators at the Mayo Clinic and the University of Georgia say they have developed a new vaccine that proved highly effective at reducing breast and pancreatic cancer tumors in mice. Release > 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. > Rutgers Mini MBA: BioPharma Innovation & BioPharma Entrepreneurship Programs > 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 > 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! > 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!
| > 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/
| > 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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