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From the News Editor
With bated breath...
Through centuries of misinterpretation, this Shakespearean expression has come to mean being left in limbo, which is exactly the state in which the cardiovascular industry was left when the FDA decided to further postpone its decision on prasugrel.
Three months ago, the agency sets its action date for last Friday, and yet, on decision day, chose not to act. However, Dr. Victor L. Serebruany, who was a principal investigator on one of the drug’s first trials, told Cardiovascular Business News that prasugrel may have passed through the regulatory process with more ease if it were not for the high dosing maintenance. He suggested this also led to the instances of higher bleeding rates compared to clopidogrel during the pre-market clinical trials.
Despite these considerations, the FDA has not set a new timeline for its decision on the much-anticipated antiplatelet drug, which means the cardiology community, in the meantime, will have to wait with bated breath. Read more > |
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| Top Stories |
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FDA’s delay of prasugrel decision raises dosing questions for researcher
Three months ago, the FDA said it would make a decision about prasugrel, an oral antiplatelet agent, by Sept. 26. Late that Friday afternoon, Daiichi Sankyo and Eli Lilly issued a statement saying the FDA’s review was still ongoing. |
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Class-action lawsuits mount against Spectranetics following fed probe
Two separate law firms have filed class-action suits in the U.S. District Court of Colorado against Spectranetics, on behalf of all persons or entities that purchased or acquired securities or company stock between April 19, 2007 and Sept. 4 of this year, claiming the company and its officers violated U.S. securities laws. |
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Medtronic, Bos Sci ordered to pay J&J about $1.2B for stent patents
The U.S. District Court in Delaware has awarded Johnson & Johnson (J&J) damages totaling $406.7 million and pre-judgment interest totaling $296 million from Boston Scientific and $521 million from Medtronic, in a case involving a stent patent owned by J&J. |
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Pfizer abandons heart drug pipeline
Pfizer has decided to abandon its efforts to develop medicines for heart disease, as part of a broad research reshuffling. |
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Industry News
FDA: Statins do not increase the risk of Lou Gehrig’s Disease
The FDA Monday published new evidence suggesting that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease, often referred to as Lou Gehrig's Disease.
Medtronic to buy CryoCath for $380M
Medtronic has agreed to acquire CryoCath Technologies for about $380 million, giving the Minneapolis-based Medtronic access to its cryoablation technologies.
Cardinal creates spin-off, reshuffles execs
Cardinal Health, a provider of healthcare products and services, today announced plans for a tax-free spin-off of its clinical and medical products businesses as a separate public company that will be led by its current vice chairman David L. Schlotterbeck.
GlaxoSmithKline to ax 850 R&D positions
GlaxoSmithKline (GSK) will eliminate 850 research and development (R&D) positions company-wide, including an undisclosed number in Research Triangle Park, N.C.
Ultrasound contrast gains a champion with new society
A new international and cross-disciplinary professional society, the International Contrast Ultrasound Society (ICUS), has been formed to overcome challenges in the field of contrast ultrasound and increasing contrast’s role in improving patient care worldwide.
FDA nets nearly $300M more funding for 2009
Congress has assured increased funding for the FDA in fiscal year 2009, with the passage of the continuing resolution (CR) by the House of Representatives last Wednesday and by the Senate on Saturday.
Financial News
Cardiac rhythm device market could rebound to $11.5B by 2013
The cardiac rhythm management (CRM) device market has recovered after a slump caused by several device recalls that began in 2005, according to a new report from Millennium Research Group (MRG).
Top 20% of endocrinologists drive new-to-brand diabetes market
The top 20 percent of endocrinologists, who wrote prescriptions for oral diabetes therapies from September 2007 through August of this year, were responsible for 95 percent of new-to-brand prescriptions in that specialty, specifically, new product starts, add-on therapy, or product switches, according to a report from SDI, a healthcare data research firm.
Clinical Studies
NEJM: DES reduces mortality, revascularization, based on 2-year data
In patients presenting with acute MI, treatment with drug-eluting stents (DES) is associated with decreased two-year mortality rates and a reduction in the need for repeat revascularization procedures as compared with treatment with bare-metal stents (BMS), according to a registry published in the Sept. 25 issue of the New England Journal of Medicine.
Radiology: CTA more cost-efficient than MPI SPECT
The utilization of CT angiography (CTA) in individuals without known coronary artery disease (CAD) results in lower healthcare costs compared to myocardial perfusion imaging (MPI) with SPECT, according to research published this month in Radiology.
Circulation: Operating risk lowers for PMR after MI
Prompt diagnosis and aggressive therapeutic approach is important for patients incurring papillary muscle rupture (PMR) after acute MI, according to a study published online Sept. 22 in Circulation.
e-Health: Monitoring heart failure remotely can reduce costs
Although heart failure (HF) telemonitoring will require an initial financial investment, it will substantially reduce costs in the long term, particularly by reducing rehospitalization and travel costs, according to an analysis in the September issue of Telemedicine and e-Health.
JASH: Potassium-sparing blood pressure therapy reduces MI deaths
Thousands of patients with high blood pressure could benefit from changing their drug treatment regimen to reduce their risk of cardiac death, according to a study in the September/October issue of the Journal of the American Society of Hypertension.
JACC: High platelet reactivity with Plavix linked to more incidence of MACE
High pre-PCI platelet reactivity might predict 30-day events, and the use of a rapid point-of-care assay for monitoring residual platelet reactivity after clopidogrel administration might help identify patients in whom individualized antiplatelet strategies might be indicated with coronary intervention, based on a study in the Sept. 30 issue of the Journal of the American College of Cardiology.
Mergers & Acquisitions
GE makes two healthcare acquisitions
GE Healthcare has acquired MicroCal, a provider of instruments for the study of molecular interactions in pharmaceutical, biomedical and life science research, as well as Agility Healthcare Solutions, which focuses on hospital workflow and patient care management.
Partnerships & Alliances
Aeolus secures nearly $200K from ARCA over heart failure drug
Aeolus Pharmaceuticals has received $175,000 from ARCA Biopharma, a cardiovascular-focused company.
GE, Living Independently partner for telecare, remote monitoring
GE Healthcare has entered into a distribution and technology collaboration agreement with Living Independently Group, a provider of telecare and passive monitoring systems used to assist in the care of seniors.
New Products
Tryton launches of stent system for bifurcation lesions in Europe
Tryton Medical, a developer of stent systems for the treatment of cardiovascular disease, has initiated launch of its Side Branch Stent System in Europe.
Regulatory News
FDA greenlights Bos Sci DES for small-vessel stenting, in-stent restenosis
Boston Scientific has received approval from the FDA to market its Taxus Express2 Atom paclitaxel drug-eluting stent (DES), designed for treating small coronary vessels.
BIOTRONIK nets EU clearance for cardiac home monitoring system
BIOTRONIK has received CE Mark approval for its newest generation of its home monitoring system, which uses a traffic light system to identify patients with the relevant events. |
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| TCT 360˚ Complete Conference Coverage |
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Our complete conference coverage of the upcoming TCT meeting will begin next week. Stay tuned for technology previews prior to the show, daily news coverage & a post show wrap-up. |
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| Cardiovascular Business | Current Issue |
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