Editor's Corner  About two weeks ago, the biggest-selling drug of all time fell off patent. The flurry of news coverage wasn't just about Lipitor and Pfizer's future without that $10 billion-plus in annual sales. It was the symbolic end of an era, a sort of mourning-the-passing of a time when Big Pharma stocks flew high and companies were hiring by the hundreds in the U.S. and Europe rather than China.
Of course, some pundits pointed out that mass-market blockbusters aren't completely passé. But much of the talk focused on another approach to the drug business: treatments for small populations. In some cases, those patients are easy to spot; they're the ones with rare, debilitating diseases, and payers are willing to spend tens of thousands--even hundreds of thousands--on their treatment. Others aren't so obvious. They can't be picked out of a lineup without a diagnostic test. Many can't even be identified that way yet, because the biomarkers that distinguish their disease haven't been found. But these patients promise a way forward for drugmakers that can find those markers and treat the patients who have them--and the diagnostics companies that can develop tests to identify those patients. Consider this: Just as Pfizer was preparing to turn the page on Lipitor, it won approval for a lung cancer drug that works in less than 5% of patients. Xalkori fights the disease in patients with a variant of the ALK gene. It's priced at $9,600 per month, or $115,200 per year of treatment. Analysts expect it to peak at an enviable $2.5 billion in annual sales. On the same day that Pfizer won the FDA's approval for Xalkori, Abbott Laboratories got the OK for a diagnostic test that identifies appropriate patients. The diagnostic-and-drug team, and its tandem approval, are just the sort of developments the FDA says it wants to encourage. But for a variety of reasons--from regulatory snarls to cultural stumbling blocks--the Xalkori success is more of an exception than a rule. That's changing, thanks to some forward-thinking companies, advocacy groups, payers, investors, and, yes, even regulators. In a new ebook, we've taken a look at the development of targeted drugs and companion diagnostics, from the successful projects to the not-so-successful, and at the obstacles that remain. What's being done to overcome them? What can companies themselves do? And what's the potential payoff of all that work? We invite you all to check it out. Click here to download the free ebook on companion diagnostics. - Tracy Staton (twitter | email) Publishers Note: This complimentary e-book PDF download made possible by our sponsor Myraqa. And watch this space on Wednesday for Kindle, Nook, and iBooks optimized versions. - Arsalan Arif, Publisher (twitter | email) Read more about: companion diagnostics | 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
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| |  | 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. | | Today's Top Stories | By Liz Jones Hollis |  Comment |  Forward | < a href="http://links.mkt1985.com/ctt?kn=2&ms=MzgxNTI0NwS2&r=MjM2NzI3MjAzMjcS1&b=0&j=MTE4MTExMDIwS0&mt=1&rt=0" name="api_addthis_com_oexchange_3iQHqgzIwgVQvMomz558Hg" > Twitter |  Facebook |  LinkedIn | Symmetry Medical ($SMA) has agreed to buy the surgical instruments business of Codman & Shurtleff, a unit of Johnson & Johnson ($JNJ), for $165 million in cash. The transaction includes Codman's reusable stainless steel and titanium surgical hand-held instruments and retractor systems, sterile disposable surgical products and sterilization containers. These products are typically used in the surgical specialties of spine, general/OB-GYN, microsurgery/neurosurgery, orthopedics, laparoscopy, cardiovascular, thoracic and general surgery. The surgical instruments line will be combined with Symmetry's hospital direct business, Specialty Surgical Instrumentation. The combined business will be re-named Symmetry Surgical and based in Nashville, TN. "The acquisition achieves several strategic objectives for Symmetry, including diversification of our revenue base with higher margin, intellectual property-backed products that generate strong cash flow," Thomas Sullivan, president and CEO of Symmetry Medical, said in a statement. "The acquired assets include a strategic capability in instrument procurement and add scale and a robust international presence to our hospital direct business. When combined with SSi as Symmetry Surgical, they will allow us to expand our global geographic footprint with products that are complementary to our core OEM supplier business."
The transaction is expected to close by the end of the year, subject to customary closing conditions and any necessary government approvals.
- see the Symmetry statement Read more about: Johnson & Johnson, medical device mergers & acquisitions, Symmetry Medical, Codman & Shurtleff
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STERIS ($STE) and Toshiba America Medical Systems are teaming up to develop advanced vascular, cardiovascular, pediatric and neurosurgical hybrid surgical suites. Under the collaboration, Toshiba will provide tableside digital information and imaging technologies, and STERIS will deliver custom-designed high-definition integrated surgical suites featuring LED surgical lighting and visualization systems, and Harmony iQ advanced integration and OR equipment management solutions. "Hybrid operating rooms offer tremendous opportunities to advance care, but designing and building these complex rooms is a huge task," explained Robert Popilock, senior market development manager, STERIS Surgical Solutions. "Challenges such as how to eliminate collision points for equipment, optimize circulator pathways and provide ergonomic and intuitive tools at the surgical field, must be addressed. We are pleased to be able to help streamline the decision, design and integration processes for customers through collaboration with Toshiba America Medical Systems, a leader in the hybrid OR space." Hybrid suites have been in the news lately. Recently, Maquet, a unit of Sweden's Getinge Group, discussed its restructuring plans for its U.S. sales and services organization to meet the needs of hybrid operating rooms. Hybrid ORs combine minimally invasive cardiac surgery with percutaneous coronary interventions, eliminating the need to move a patient to a different room, according to the statement. - see the STERIS release
- check out the Maquet release Read more about: Steris, Toshiba, Maquet Cardiovascular
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Tissue Regenix will raise £25 million ($39 million) through a share placing, leading to the potential creation of 30 jobs in the U.K. Tissue Regenix was incorporated in May 2006 to commercialize the research of University of Leeds professors Eileen Ingham and John Fisher in the field of tissue decellularization. Its dCELL technology comprises a process that removes cells and other components from human and animal tissue, allowing it to be used to replace worn out or diseased body parts. The company is looking at sites in York and Leeds for expansion, managing director Antony Odell told The Press. Within the next 6 months or so, the company hopes to identify the site. "We have been looking for a while, because we have to look at the further expansion of the company and make sure any site suits us for the future," Odell said, as quoted by the paper. Tissue Regenix Chairman John Samuel said the money will allow the company "to develop a range of products simultaneously following the established medical device regulatory route, [and] this commitment from both existing and new investors is a significant endorsement of the commercial potential of our broad product pipeline," according to the Post. - get more from the Yorkshire Post
- check out the story from The Press Read more about: Tissue Regenix
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Patient enrollment has begun in Bluegrass Vascular Technologies' study of its Surfacer inside-out access catheter system. The study will evaluate the safety and effectiveness of the Surfacer in up to 10 patients with upper extremity venous occlusion. The Surfacer is designed to provide an option for patients with upper extremity venous occlusions that make veins impenetrable by a guide wire or standard access techniques. Using the system, physicians insert a guide wire through the femoral vein in the groin area and navigate up through the torso with an exit point in either the jugular or subclavian vein using fluoroscopy. Bluegrass estimates that more than 3 million patients require central venous access for medical treatment in the U.S. alone. "The commencement of our first clinical study of the Surfacer is a significant achievement that moves us closer to our goal of offering physicians and their patients game-changing technologies that save veins and save lives," said James Clifton, president of Bluegrass Vascular Technologies. "We are thrilled to be under way with this important research and look forward to announcing the study findings in 2012." Bluegrass is a spinoff of Therix Medical, which was founded in late 2007 to capitalize on the opportunity to commercialize product concepts from clinicians at the University of Kentucky and other regional medical centers. - see the Bluegrass release Related Article:
Therix Medical spins off vascular access company Read more about: Bluegrass Vascular Technologies
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Gaymar Industries, a manufacturer of support surface and pressure ulcer management solutions, will see its Orchard Park and West Seneca, NY, operations close by the end of 2012, a move that will cost 160 jobs. Gaymar was bought by Stryker ($SYK) last year for $150 million in an all-cash transaction. A Puerto Rican facility is "not impacted at this time," Stryker said, according to The Buffalo News. Gaymar's equipment will be moved to other Stryker sites and supply chain partners, but the parent company didn't specify where. The announcement of the closures comes roughly a month after Kalamazoo, MI-based Stryker said it will cut roughly 5% of its workforce and institute other restructuring activities to reduce pretax operating costs by more than $100 million beginning in 2013. The company cited the implementation of the medical device excise tax and a slowdown in elective procedures as reasons for the layoffs. Gaymar was founded in 1956 and had been owned by private equity firms Nautic Partners and Norwest Equity Partners prior to its acquisition by Stryker. Gaymar and Stryker had been in a 10-year original equipment manufacturer relationship prior to the buyout. The arrangement had given Stryker exclusive rights to sell support surface and pressure ulcer management products to acute care customers in North America. - get more from The Buffalo News Related Articles:
Stryker to cut 5% of workforce
Stryker to cut 142 jobs in Ireland Read more about: Stryker, medical device layoffs, Gaymar Industries
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| Also Noted Boston Scientific ($BSX) has launched its Charger PTA balloon catheter for a range of peripheral angioplasty procedures. Charger is the company's third new peripheral balloon catheter introduced in this year. "The Charger PTA Balloon Catheter is designed to deliver results in both routine and challenging cases," said Jeff Mirviss, president of the company's peripheral interventions division. "With a low profile and tapered tip, it is engineered to provide excellent push without sacrificing track. The Charger PTA Balloon Catheter complements our growing portfolio of interventional devices for peripheral vasculature procedures." Boston Scientific release > Boston Scientific ($BSX) plans to fight an IRS notice that says the company owes an additional $581 million in taxes, plus interest and penalties. Report > Ex-Olympus CEO Michael Woodford will meet with lawmakers in Tokyo to lobby for reforms to Japanese boardrooms. The camera and endoscope maker has been embroiled in one of Japan's worst accounting frauds. News > MELA Sciences ($MELA) has named several new directors to serve on its board--Robert Coradini, Mark Fabiani, John Goddard, James Noble and David Stone. MELA release > Zimmer Holdings ($ZMH) has announced the availability of its CLS Brevius hip stem with Kinectiv technology in the U.S. that enables surgeons to better match patients' individual anatomies with modular neck options designed for independent, intraoperative adjustments. Zimmer release > Soteira has received the 510(k) clearance of the Shield kyphoplasty system. "With the addition of the Shield to the existing Soteira portfolio and an active short-cycle pipeline, we are continuing to work toward offering the most comprehensive product portfolio for VCF treatment in the global market," President and CEO Larry Jasinski explained. Soteira statement And Finally... Mark Cain, CTO of MIM Software, was invited onstage at Apple's Worldwide Developer Conference in 2008 to promote his company's iPhone app, a way for doctors to view incredibly detailed scans of their patients. However, two months after the demo, the FDA told MIM Software to remove the app from Apple's store, saying it needed to be cleared. Now Cain is seeing a lot of apps being bought and sold without FDA supervision. Report | 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 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. Events > ExL Pharma's Digital Marketing for Medical Devices: Europe - 12-13 December 2011 - Kempinski Bristol ~ Berlin, Germany Join us at the first event of its kind for the European Medical Device Industry! In August ExL held the inaugural Digital Marketing for Medical Devices and the event was such a huge hit that it made perfect sense to bring the event to the EU. For the first time ever device marketers in Europe will have their very own conference to explore the most cutting edge topics and network with their peers. Featuring key sessions from: Medtronic, Zimmer, Biotronik, B.Braun Melsungen AG, Bausch + Lomb, Smiths Medical, Sharp & Dohme GMBH and many more! For more info click here. Save 10% off standard registration rates. Use discount code:C113FMD > 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 Marketplace > 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/ Jobs > 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. > Director of Operations at Pharm-Olam International Opportunity for Director of Operations, with a dynamic and growing international Contract Research Organization ("CRO"), based at our global headquarters in Houston, TX. Director will assist the executive team in developing strategic and operational initiatives and their implementation. The successful candidate will provide leadership and direction to multiple departments in various countries to continue improving efficiency, improving processes and achieving corporate goals. Must have the energy and desire to help develop the best company in its field. Learn more here. > 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. > 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. > 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. | | |
