Current Articles | Archived Articles
Archived OBR Journal Articles
DDMAC and the Debate Over Off-Label Communications
Mon, Sep 01, 2008
“Off-Label Promotion.” There we said it. Don’t be afraid to read this article. What are the opposing views on this contentious topic? What does DDMAC consider a violation? Are MSLs different from sales reps? We use an oncology warning letter as a jumping off point to explore DDMAC’s position on off-label communications.
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The Oncology Pipeline: Maturing, Competitive, and Growing?
Mon, Sep 01, 2008
The oncology R&D arms race is in full swing, and with the investment comes unparalleled risk. IMS offers a look at the trends in the oncology pipeline, the saturated market segments, and how the blockbuster model is changing.
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Targeting Therapy: New Approaches to Finding the Next Great Cancer Drug
Mon, Sep 01, 2008
Shrinking pipelines and incremental gains are leading to a pessimistic view of the future of cancer drug development. However shifts in policy and attitude among industry, academia, government, and investors are conspiring to change that.
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Companion Biomarkers and Cancer Treatment: Lessons Learned for Oncology New Product Planning
Mon, Sep 01, 2008
It’s no secret that biomarkers are divvying up tumor types into niche patient segments. On the 10 year anniversary of the approval of Herceptin® and its companion biomarker, HercepTest®, we review the status of biomarkers today and provide insight into incorporating them into clinical and commercial planning.
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Tearing Down Walls: Payers and Providers Align Quality Care and Reimbursement
Mon, Sep 01, 2008
The overriding concern for oncologists is without a doubt providing quality care to their patients. And, while payers have the same interests in mind, they have a responsibility to reign in the cost of quality care where appropriate. We explore several examples of how “tearing down the wall” between provider and payer has benefitted both parties, and ultimately the health
care system.
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Onmark 3rd Annual Office-based Oncology Business Benchmarking Survey: 2008 Report on 2007 Data
Mon, Sep 01, 2008
In the spring of 2008, Onmark, a McKesson Specialty Company, conducted its 3rd Annual Office-based Oncology Business Benchmarking Survey. The survey follows Onmark’s 2006 and 2007 surveys and allows practices to benchmark three years of consecutive financial and operational data. A portion of the survey results are presented here.
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Perceptions in Oncology Drug Strengths and Weaknesses: Zitter Group Survey Shows Similarities and Disparities Between Payers and Providers
Tue, Jul 01, 2008
n an effort to better understand the difference in oncology drug perception between payers
and oncologists, The Zitter Group conducted research that included 100 medical and pharmacy
directors and 100 medical oncologists. The report herein demonstrates that the two groups
don’t see eye to eye on important traits like “survival benefit”, but often agree on which oncology
agents bring high value and which may be overhyped.
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As the Importance of Biomarkers Increases, Academia and Industry Consider How Best to Respond
Tue, Jul 01, 2008
Did you know that Phase 3 studies of oncology agents fail 59% of the time? In case you didn’t hear about it at ASCO (read: K-ras), biomarkers have the potential to increase success rates of therapies benefitting all stakeholders: patients, oncologists, payers, and industry. We explore the paradigm shift taking place and review some of the accomplishments in this field coming out of ASCO ’08.
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The Physician’s Role in Securing Patient Access to Appropriate Therapies: Sharing the Stage with Patients and Payers
Tue, Jul 01, 2008
Whether it’s getting involved in local advocacy by speaking with your state’s Medicare Carrier Advisory Committee, discussing the complexities of oncology with the medical director at a health plan, or having a frank discussion about cost of therapy with patients, oncologists can play an active role in advocating and securing access to therapies for their patients.
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ASCO '08: Media, Giveaways, and Foot Traffic
Tue, Jul 01, 2008
One writer spent a significant amount of time on the floor of the exhibit hall and came away with distinct impressions of the competition for share of voice at this year’s annual meeting.
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ASCO '08: A Look at the Progress in 3 Different Cancer Types
Tue, Jul 01, 2008
Rather than try to review the overwhelming amount of science at ASCO ’08, we picked three tumor types that seem to be getting a lot of attention and reviewed some of the findings and progress discussed at this year’s meeting.
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ASCO '08: The Competition for Share of Voice Descends Upon Chicago,
Tue, Jul 01, 2008
In a survey of 100 US oncologists that attended ASCO, Market Strategies International tells
us why oncologists attend ASCO and which companies made the “biggest splash” at this
year’s meeting.
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ON-CONOMY: Medicare Policies Change ESA Use and Payment
Tue, Jul 01, 2008
We dig into the ESA topic from a different vantage point—by looking at paid remittance claims from 1,500 physicians over the last six quarters. By analyzing this data, we can see three distinct financial problems for practices relating to ESA usage: lower volume, high denial rate, and poor cash flow.
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Pioneers in Personalized Medicine—Agendia and Genomic Health Are Changing the Way Patients with Breast Cancer Are Treated
Thu, May 01, 2008
It is not news that genomic diagnostics—the ability to use a patient’s genomic profile to help determine the best therapeutic approach to breast cancer—have been used successfully. As this field grows in the United States, as evidenced by the emergence of another breast cancer genetic profiling test, we look into the intriguing history, data, scientific approach, and mechanisms behind these two different but similar diagnostic products that represent the future of personalized medicine in oncology.
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Cutting Through the Noise: Gaining and Maintaining Share of Voice in Today’s Oncology Marketplace
Thu, May 01, 2008
It can be described through any number of overused, imprecise analogies: the shifting sands, a disturbance in the force, the winds of change, etc. But, however you slice it, today’s oncology marketplace is a challenge for pharmaceutical companies everywhere.
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Patient Assistance Programs: Good Business & Good Will Go Hand in Hand
Thu, May 01, 2008
A cancer drug today can’t be marketed without a good patient assistance program. While these programs can be a burden on the practice, managed properly, PAPs can have a positive impact on patients, company image, and—surprise—profit.
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Oncology Drug Denials Slow Payment in Q4 ‘07
Thu, May 01, 2008
Reimbursement denials are a common problem for practices. A look at denial rates, based on remittance data, demonstrates trends that provide insight on the problem and perhaps leads to a solution.
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Emerging mTOR Inhibitors Make Good on Their Initial Promise
Thu, May 01, 2008
On the heels of the FDA’s first approval of an mTOR inhibitor, all eyes are on the pipeline for the next breakout agent in this emerging class of targeted therapies.
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Back to the Future: Original Liquid Leukine® Coming Soon
Thu, May 01, 2008
Bayer Healthcare Pharmaceuticals, with concurrent guidance from the FDA, is reintroducing the previously marketed liquid formulation of its recombinant human granulocyte-macrophage colony-stimulating factor, Leukine® (GM-CSF; sargramostim)—and it does not contain the EDTA (edentate disodium) component.
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Behind Closed Network Doors: Oral Cancer Drugs and the Rise of Specialty Pharmacy
Sat, Mar 01, 2008
Specialty pharmacies provide more than just a pill, but as the drug companies and oncology offices become more dependent on them the model has created friends and enemies. As you’ll see, the evolution of the specialty pharmacy reflects the evolution of the industry. We talked to physicians and industry to learn how this industry is changing cancer patient care giving.
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Weathering the Storm: How Genentech Looks to Rebuild Confidence and Ride on to Continued Success in 2008
Sat, Mar 01, 2008
What do you do when your historical performance is so strong that you’ve created expectations nothing short of a miracle maker? The answer is you go back to the thing that got you there in the first place: research. Genentech is the clear leader in the industry and recently their CEO, Dr. Arthur Levinson, outlined the research strategy that they think will allow them to remain on top for the long term.
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Celebrating 25 Years of the Orphan Drug Act
Sat, Mar 01, 2008
A boon to patients and biotech alike, the Orphan Drug Act has stimulated the development
of several of the biggest blockbuster drugs in oncology.
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ESA Policy Raises Hospital Admissions for Transfusions
Sat, Mar 01, 2008
In the saga playing out over CMS’s decision last summer to restrict treatment using erythropoietin stimulating agents (ESAs), we’ve cast Sharon Bromley as the analyst. “You want hemoglobin at 13 or 14—not wait until it’s at 10,” Bromley, administrator at Summit Cancer Care in Savannah, Ga., begrudgingly told us last August in the wake of CMS’ national policy decision. Six months after Bromley’s prognostication, a national poll of 300-plus medical oncologists and hematologists conducted by the KJT Group and commissioned by US Oncology revealed anecdotal evidence to support her claim.
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Restricted Access: What Happens If the Door Closes to Industry?
Sat, Mar 01, 2008
The halls of academic medical centers and private oncology practices are increasingly being restricted to industry sales representatives. Large medical centers, such as Stanford, have either closed their doors to industry representatives altogether or placed stringent restrictions on industry interactions with physicians and other healthcare professionals. How are these restrictions--and blocked access--changing the strategies and tactics of the industry?
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On–Conversation with Daniel Swisher, CEO and President, Sunesis Pharmaceuticals Inc.
Sat, Mar 01, 2008
In this continuing series we speak with industry leaders to gain insight into recent events at their respective companies.
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Compendia: The Bridge Between FDA Approved Indications and Off-label Drug Usage
Tue, Jan 01, 2008
With no successor to USPDI and many inefficiencies within the process, the compendia are in need of some attention. We explore the unmet need, proposed solutions, differing perspectives, and provide an interesting survey for our readers.
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The Appeal of Genasense: The Drug, the Data, and the Tangled Web that its FDA Review has Become
Tue, Jan 01, 2008
Three years after its first review by the FDA, Genasense may finally have the data to warrant approval in CLL. But will the regulatory powers-that-be agree? A look at the various factors at play in the saga that the Genasense review has become.
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How Does Drug Pricing Drive Therapeutic Choice? A review of a symposium held in conjunction with the American Society of Hematology (ASH)
Tue, Jan 01, 2008
A review of a symposium held in conjunction with the American Society of Hematology (ASH), December 9, 2007 in Atlanta, Georgia.
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’07: In Review. The OBR Top 10 Media Stories & Top 10 Deals of 2007
Tue, Jan 01, 2008
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’08: Forecast (Part 2) The View From the Office: How Community Oncologists See 2008
Tue, Jan 01, 2008
A survey conducted by Market Strategies International provides insight into the coming year.
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Tasigna®: An Innovative TKI from Novartis for Patients with CML
Tue, Jan 01, 2008
Where will Tasigna fit in the CML market alongside Gleevec and Sprycel?
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Zero Sum Game
Thu, Nov 01, 2007
The economics of the oncology industry have never been better, but changes are looming. A confluence of market forces is adjusting the commercial equation for oncology companies, rendering them potential victims of their own success. Pamela Santoni and Thomas Foster of IMS Health consider the unintended consequences of progress.
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Rituxan® Anniversary: 10 Years of Progress
Thu, Nov 01, 2007
We celebrate the 10 year anniversary of the first FDA approved targeted therapy by tracking its advances and speaking to physicians about how Rituxan has changed the treatment of NHL.
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The Future of the Present: A Look at the Current and Proposed State Legislature to Regulate and Disclose Gifts
Thu, Nov 01, 2007
How is the regulation on the practice of gift-giving affecting pharma? While the focus seems to be on federal law, it is the individual states that are actively passing legislation to restrict the practice of gift-giving by the drug industry.
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Evolution of the Oncology GPO
Thu, Nov 01, 2007
It’s more than price. As oncology GPOs become more integrated into the economic management of the practice, GPO-distributor relationships play a key role in the oncology practice’s drug acquisition decision. We looked back in time and tracked the shifting GPO strategies to see if history’s lessons could help meet the unique needs of today’s oncology practice.
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A New Kind of Cancer Warfare Agent: Next Generation Monoclonal Antibodies
Thu, Nov 01, 2007
Large pharmaceutical companies have certainly taken notice of next-generation MAb technologies. As this technology grows and continues to help revolutionize the way cancer treatments evolve there are still hurdles to overcome. We take a look at some of these hurdles to help keep things in perspective as well as discuss where the technology is heading.
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On-Conversation with Paolo Paoletti, MD, Senior Vice President, Oncology Medicine Development Center, GlaxoSmithKline
Thu, Nov 01, 2007
We speak with industry leaders to gain insight into recent events at their respective companies.
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On-Conversation with Craig W. Philips, Vice President & General Manager, Bayer Healthcare
Thu, Nov 01, 2007
We speak with industry leaders to gain insight into recent events at their respective companies.
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Radiopharmaceuticals Need a Jump-STaRT
Sat, Sep 01, 2007
Three radiopharmaceuticals have been FDA approved to treat cancer or support cancer therapy. Without the market acceptance of these products by oncologists, further research and development of promising new radiopharmaceutical therapies could be compromised.
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The Alphabet Soup of Hematologic Malignancies: Current Therapies Point the Way to Future Breakthroughs
Sat, Sep 01, 2007
In honor of September being leukemia and lymphoma awareness month, Oncology Business Review takes a look at how treatments for hematologic malignancies have influenced cancer therapies and how they will pave the way for the cancer care of the future.
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Ink and Inc.: How ASCO’s Media Policies Affect the Oncology Industry
Sat, Sep 01, 2007
An exploration of the evolution of ASCO’s media policies and how these policies affect the media and the business of oncology.
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Making a Splash at ASCO
Sat, Sep 01, 2007
With oncology entering an exciting period of growth and innovation, the future success of many oncology companies will be dependent on how well they perform at the annual ASCO. Oncologists were asked to rate exhibit booths at this year’s meeting in an exclusive MSI survey. Results are tallied and presented here, but will they affect next year’s booths?
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Torisel™: The New Kid on the Block for Advanced Renal Cell Carcinoma
Sat, Sep 01, 2007
Wyeth Pharmaceuticals’ recently launched Torisel™ (temsirolimus), a targeted, first-in-class mTOR inhibitor. This new treatment for metastatic renal cell carcinoma is the third targeted therapy for RCC launched in as many years; however, Torisel is the first such targeted agent proven to extend survival.
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On-Conversation with Nancy Simonian, M.D.
Sat, Sep 01, 2007
We speak with industry leaders to gain insight into recent events at their respective companies.
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On-Conversation with Bob Oliver, VP & Global Business Manager of the Oncology Franchise at Wyeth Pharmaceuticals
Sat, Sep 01, 2007
We speak with industry leaders to gain insight into recent events at their respective companies.
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The Rising Tide of Generic Cancer Agents
Fri, Jun 01, 2007
The stakes are extremely high for biotech and pharmaceutical companies if legislators pass a bill allowing the FDA a regulatory pathway toward approval of follow-on biologics. Oncology companies are especially vulnerable due to their reliance on successful biotech drugs. We take a look at generic erosion, the current generic market, and how countries outside the US are influencing the move toward biogenerics here.
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To Dispense Or Not To Dispense
Fri, Jun 01, 2007
In consideration of reduced profits and an abundance of oral cancer agents, many offices are deliberating over whether or not to dispense oral drugs as a part of their practices. But what needs to be evaluated from an operational standpoint? What does it mean for the bottom line? And what benefit does it bring patients? We explore the many issues behind this concept.
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Understanding Operational and Financial Benchmarks In The Practice
Fri, Jun 01, 2007
In an exclusive feature, we analyze data from OTN/Onmark’s 2006 Office-Based Oncology Business Benchmarking Survey. This is a first look at the survey data and the first opportunity to compare the data with the results of the 2005 survey in hopes of establishing financial and operational benchmarks and trends.
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GPC Biotech and the Satraplatin Story
Fri, Jun 01, 2007
The right study, the right environment, and the right company: It all adds up to big market potential for GPC Biotech and their oral chemotherapy satraplatin. Just where did this company come from and what are they all about? We delve into GPC Biotech as they build an infrastructure for the impending launch of their first product.
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Q&A With David Parkinson, MD, Senior VP of R&D at BiogenIdec
Fri, Jun 01, 2007
We talk with an oncology industry veteran, Dr. David R. Parkinson, Senior Vice President, Oncology Research and Development at Biogen Idec, and get the inside story on his tenure there and on what new directions the company’s oncology R&D is taking. Dr. Parkinson also enlightens us on oncology drug discovery and development from an industry perspective.
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Oncology Sales Force Effectiveness In An Era of Unprecedented Competition (A Look Ahead)
Fri, Jun 01, 2007
This is a preview article to a more complete analysis and discussion of oncology sales force access and effectiveness that will appear in the next issue of OBR. We offer a review of ImpactRx data analyzing the impact of the four major oncology launches in ’06.
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Tykerb: In a Class By Itself
Tue, May 01, 2007
Once considered a low-priority compund at GSK, Tykerb (lapatinib) is now an exciting new treatment option with a unique mechanism of action for patients with metastatic breast cancer and offers a large market opportunity for the company.
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Therapeutic Cancer Vaccines: The Road to Commercialization
Tue, May 01, 2007
A summary and analysis of the different approaches companies are taking to develop immunotherapies and the hurdles they face when manufacturing these products.
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A Tale of Two Cancer Immunotherapy Companies: Same Tumor Target, Parallel Development, and Very Different Approaches
Tue, May 01, 2007
Deivering patient-specific therapies represents a fundamental shift in how cancer is being treated. The next two years are expected to be crucial to the development and commercial viability of Genitope's MyVax and Favrille's FavID NHL candidates.
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Challenges in Reimbursement: Communicating Non-reimbursed Costs to Payers
Tue, May 01, 2007
We present a case where an oncology practice and a payer worked together to define pay-for-quality and suggest potential solutions regarding non-reimbursed time and services.
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Of Mice and MAbs: Medarex
Tue, May 01, 2007
Medarex has a lot riding on its compound ipilimumab (MDX-010), and anti-CTLA-4 antibody that is currently being studied in patients with metastatic melanoma either alone or in combination with vaccines or chemotherapy. With Phase 3 results expected later this year, 2007 will be a defining year for this biotech company.
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Improving Compliance in the World of Biotechs: Helping Small Companies Avoid Big Problems
Tue, May 01, 2007
During the 2007 Biotechnology Industry Organization, speakers at a roundtable discussed the guidelines regulating the sales of prescription medications, the legal risks drug companies face, and provided ideas to help small companies move toward compliance.
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Dendreon Steps Up to the Plate, And Cancer Immunotherapy Companies Watch from the Sidelines
Thu, Feb 01, 2007
Many analysts believe that Dendreon is poised to be the first-to-market with a cancer immunotherapy product. We took a look inside this small biotech that is poised to stand among the giants.
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Therapeutic Cancer Vaccines: Elucidating the Differences Between Passive and Active Immunotherapy
Thu, Feb 01, 2007
Despite several cancer therapeutic agents in Phase III development, there is still confusion surrounding the meaning of the terms “passive” and “active immunotherapy” vs. “cancer vaccines.”
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The Science behind Developing Active Immunotherapies: A Look at NHL and Prostate Cancer Therapeutic Vaccines
Thu, Feb 01, 2007
Therapeutic vaccines for cancer have been “just over the horizon” for decades. Thanks to an explosion of knowledge in the area of immunology, as well as the availability of new production technologies, the prospects for bringing a therapeutic cancer vaccine to market in 2007-2008 are tantalizingly close.
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Office Practice Managers Speak Their Minds
Thu, Feb 01, 2007
OBR decided to explore the changes in the ongoing relationships with industry representatives and oncology office practice managers. We conducted a survey to provide a forum in which to discuss these changes and the impact they are having on the community oncology office.
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OBR Q&A with Michael King, Director of Research at Rodman & Renshaw
Thu, Feb 01, 2007
OBR interviewed Michael King, a biotechnology industry analyst.
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Medicare’s Competitive Acquisition Program: Stats Reveal Who’s In/Who’s Out and Why
Thu, Feb 01, 2007
Today, physicians are at a crossroads. Not only are they no longer able to withstand reductions in the cost of drugs they administer, but they are also not able to withstand the fluctuations and delays in Medicare reimbursement. For some, CAP has quietly become a smart business decision and a viable alternative to buying-and-billing drugs.
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Spotlight on Exelixis: Big Pipeline—Big Deals—Big Promise?
Mon, Jan 01, 2007
Exelixis is a biotech that presents an enviable pipeline of cancer compounds. It has a progressive company philosophy and big pharma collaborations. As its products reach late-stage development, the time is near for the company to deliver on their promise.
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Clinical Pathways: Can the Art of Oncology be Managed?
Mon, Jan 01, 2007
What happens when a healthcare institution creates its own clinical pathway process to optimize patient care while lowering the cost of cancer treatment? UPMC Cancer Centers has done exactly that and demonstrates how other institutions might be able to benefit from its experience.
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The Vectibix™ Launch: A Look at the Commercialization of this New Fully-Humanized Antibody for Colorectal Cancer
Mon, Jan 01, 2007
Amgen’s Vectibix™ was approved in September 2006 as a third-line agent for the treatment of metastatic colorectal cancer. Although oncologists are excited by its favorable safety profile, the licensing of this drug as a single third-line agent may hamper its use.
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Competitive Landscape: Designing the Next Cancer Drugs
Mon, Jan 01, 2007
Speakers from the 2006 Bio InvestorForum Meeting discuss strategies on entering the marketplace and how to navigate through the stiff competition of oncology drug development.
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Strategies for Gaining Cancer Drug Approval in '07
Mon, Jan 01, 2007
What should sponsors and analysts/investors be looking for in the upcoming 2007 season? A panel of experts reveals their opinions and ideas.
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Molecular Profiling: Using the Genome to Identify Effective Cancer Agents
Mon, Jan 01, 2007
With molecular profiling paving the way to identify genomic disease signatures, could better drugs with lower treatment failure rates be far behind?
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Ariad Aligns with Bellicum to Develop Novel Vaccine for Prostate Cancer
Mon, Jan 01, 2007
This section provides OBR readers with important and detailed oncology business briefs.
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Spotlight On Celgene: A Cancer Company On The Rise
Fri, Sep 01, 2006
In this issue we take a timely look at Celgene Corporation. What’s the story behind this high flyer with multiple recent approvals for Thalomid and Revlimid? How did they achieve their enviable status and what does the future look like?
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Exhibitor Bang For The Buck? A Look at ASCO Exhinit Hall Floor
Fri, Sep 01, 2006
Anybody who’s anybody in the oncology business arena knows that the American Society of Clinical Oncology (ASCO) Annual Meeting represents the vogue venue for showcasing oncology drugs, products, and services. With more than 29,000 individuals in attendance and an entire floor dedicated to exhibitor booths, funds often flow freely to finance showy exhibits with coveted giveaways in order to advertise to the clinical masses.
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Oral Cancer Agents Are Changing The Distribution Channel
Fri, Sep 01, 2006
It used to be that chemotherapy meant going to the physician’s office or the hospital once every week or so for an intravenous infusion of a chemotherapeutic drug. But with the approval of Xeloda [capecitabine; Roche] in 1998, an oral chemotherapeutic that is metabolized to 5-fluorouracil (5-FU), which usually is given IV, chemotherapy entered into the oral drug market.
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Big Pharma Has A Big ASCO ‘06
Fri, Sep 01, 2006
The biggest news at the 2006 annual meeting of the American Society of Clinical Oncology (ASCO) was Big Pharma finally joining the biotech industry in the battle against cancer.
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Interpretation Of Survival Data From Oncology Clinical Trials
Fri, Sep 01, 2006
A patient newly diagnosed with cancer immediately wants to know ‘What are my options, and how long do I have?’ The answer is often given in probabilistic and relative terms. The doctor might say, ‘Well, we’ve caught it before it has spread too far, and your chances are good.’ Or ‘There’s a new drug out which may help you live better and longer’.
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mTOR INHIBITORS: Will They Redefine The Blockbuster In Cancer Therapy
Fri, Sep 01, 2006
The stiffest competition new mTOR inhibitors will face won’t be from each other, but from their generic predecessor.
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On-Conversation with Craig Eagle, Senior Director, Global Oncology, Pfizer Global Pharmaceuticals
Wed, Dec 31, 1969
We speak with industry leaders to gain insight into recent events at their respective companies.
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’08: Forecast (Part 1). Oncology Industry Experts Provide Perspective on the Coming Year
Wed, Dec 31, 1969
Interviews with four experts provide multiple perspectives on ‘08.
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Biogen Idec: An Oasis for Employees During the Southern California Wildfires
Wed, Dec 31, 1969
With wildfires threatening Southern California families and their homes, Biogen Idec opened its campus facilities to ease the burden of their employees who were in the fires’ path of destruction.
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