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pharmafile | March 5, 2008 | News story | Sales and Marketing |
APP Pharma granted approval for generic anticancer drug
APP Pharmaceuticals has received final approval from the FDA of its abbreviated new drug application or ANDA for irinotecan hydrochloride injection, 40mg/2mL and 100mg/5mL.
The drug is the generic equivalent of Pfizer's Camptosar injection, a chemotherapy drug used to treat advanced cancer of the large intestine and rectum. It is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic colorectal cancer. APP has immediately commenced marketing and shipping the product.
Tom Silberg, president of APP, said: "Since receiving tentative approval for this product in October 2007, we have worked to secure a number of contracts and are pleased to be one of the first pharmaceutical companies to market and ship irinotecan in the US. Irinotecan represents the fourth ANDA approval APP has received thus far in 2008."
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Athersys reports encouraging Phase I results of obesity drug
Biopharmaceutical firm Athersys has reported positive top-line results from its randomized, double-blinded, placebo controlled Phase I clinical trial of ATHX-105, its orally administered drug candidate for the treatment of obesity.
ATHX-105 was well-absorbed, providing good drug exposures, well-tolerated up to high doses, and had no negative effect on cardiovascular, hematology or other clinical parameters. Drug exposure and maximum drug concentrations were dose proportionate. In the fed-fasted cohort, food consumption had no apparent effect on drug exposure.
Gil Van Bokkelen, chairman and CEO of Athersys, said: "The data is in line with our expectations for ATHX-105, a highly selective 5HT2c agonist. We believe that these results support the view that better selectivity results in superior tolerability for drugs in this class, which is an important factor for achieving effectiveness and patient compliance."
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Covidien granted tentative approval for generic myocardial kit
Covidien Imaging Solutions has reported that the FDA has granted tentative approval for the company's abbreviated new drug application or ANDA for its Kit for the preparation of Technetium 99m Sestamibi Injection.
Tentative FDA approval indicates that the FDA has concluded that Covidien's generic product is safe and effective for use as recommended in the submitted labeling. Final approval of the ANDA, which was filed by the company's Mallinckrodt subsidiary, is subject to the expiration of the marketing exclusivity period for the branded product on July 29, 2008. Covidien's tentatively approved product is a generic of Cardiolite, which is a myocardial perfusion imaging agent used for detecting coronary artery disease.
Steve Hanley, president of Covidien, said: "With our investment in this product, we are enhancing our ability to provide a broad selection of nuclear cardiology and nuclear medicine products. This new generic kit underscores Covidien's commitment to delivering choice and value to help customers diagnose heart disease."
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Integra launches skull pins for brain surger
Integra LifeSciences has introduced a next generation of Mayfield titanium skull pins that are specifically designed for use with the Mayfield cranial stabilization system.
The Mayfield system is designed to maintain the stability of a patient's head during brain surgery. The Mayfield skull pins have received FDA clearance in the US, as well as CE Mark Certification in the EU. The new Mayfield skull pins allow neurosurgeons to perform MRI scans during brain surgery without compromising image quality. The new skull pins may be used with any Mayfield cranial fixation system that is compatible with these imaging modalities, and the skull pins are being offered for both adult and pediatric patients.
Christopher von Jako, senior director of marketing and product development for OR devices at Integra, said: "The new Mayfield titanium skull pins now provide a distortion free operating environment for MR imaging."
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