FDA

Covidien (COV) Announces Health Canada Approval for its Generic Myocardial Perfusion Imaging Kit Jul 6, 2009 09:07AM

Covidien (NYSE: COV) announced that Health Canada has approved the Company's Abbreviated New Drug Submission (ANDS) for its Kit for the Preparation of Technetium Tc 99m Sestamibi Injection. Covidien's generic product is fully substitutable for Cardiolite(R), a myocardial perfusion imaging agent used for detecting coronary artery disease.

With Health Canada approval of the ANDS, which was filed by the Company's Canadian subsidiary, Covidien's generic product is expected to be available for customers in Canada this summer. The Company's generic product also is available in the U.S., the U.K., Denmark, Germany and Puerto Rico.

CombinatoRx (CRXX) Publishes Research Demonstrating Improved Selectivity Through Synergistic Combinations Jul 6, 2009 08:15AM

CombinatoRx, Incorporated (NASDAQ: CRXX) \announced the advance online publication by CombinatoRx scientists of an extensive analysis of their discovery screening, scheduled to appear in the August issue of Nature Biotechnology. These new findings provide evidence that multi-target synergistic combinations may be more therapeutically specific than single agents.

By performing a comprehensive synergy analysis across pairs of assays covering six different disease areas and ~100,000 combinations, CombinatoRx scientists have empirically shown that synergistic combinations may yield greater therapeutic selectivity than single drugs. Therapeutic selectivity occurs when a treatment has more beneficial than toxic effect. Additional preclinical analysis by the authors on sample combinations shows that this selectivity results from coordinated context-specific multi-target activity.

Spectrum Pharmac (SPPI) Receives Complete Response Letter from FDA for Zevalin Jul 6, 2009 08:07AM

Spectrum Pharmaceuticals (Nasdaq: SPPI) today announced that it has received a Complete Response letter from the U.S. FDA regarding its supplemental Biologics License Application for ZEVALIN(R) (ibritumomab tiuxetan) in the first-line consolidation setting for non-Hodgkin's Lymphoma (NHL) patients. The Prescription Drug User Fee Act Action Date for the ZEVALIN sBLA in the first-line consolidation setting was July 2, 2009. ZEVALIN is currently FDA approved and marketed by Spectrum for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients who have rituximab-refractory follicular NHL.

The FDA requested the Company to submit data files from the FIT study to support and verify a subset of the data that are currently under review to support the proposed labeling. Importantly:

1. No additional clinical studies have been requested;
   
2. The additional data requested do not involve new data analyses;
   
3. The Company plans to formally respond to the FDA's requests by this Wednesday, July 8, 2009.

Spectrum is confident that the data it will submit will satisfy the requirements of the Complete Response letter, and, at this time, continues to expect a favorable regulatory decision.

Lilly (LLY) Receives Fourth FDA Approval for ALIMTA Jul 6, 2009 08:06AM

Eli Lilly and Company (NYSE: LLY) announced it received a fourth approval from the FDA for ALIMTA (pemetrexed for injection). The latest approval is for ALIMTA as a maintenance therapy for locally advanced or metastatic non-small cell lung cancer (NSCLC), specifically for patients with a nonsquamous histology whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. ALIMTA is not indicated for treatment of patients with squamous cell non-small cell lung cancer.

NSCLC is the most common form of lung cancer, resulting in more than 180,000 new cases in the U.S. each year.(1),(2) It is defined as a group of histologies, that is, tumor types differentiated by cellular structure. Nonsquamous histology includes adenocarcinoma and large cell carcinoma, which account for more than half of all NSCLC diagnoses,(3) as well as histologies classified as "other."

Protalix (PLX) Approached by the FDA to Consider Submitting a Treatment Protocol for the Use of prGCD Jul 6, 2009 07:50AM

Protalix BioTherapeutics, Inc. (NYSE: PLX) announced that it was approached by the FDA and asked to consider submitting a treatment protocol for the use of prGCD in patients with Gaucher disease in order to address an expected shortage of the drug Cerezyme(R), a mammalian cell expressed version of glucocerebrosidase (GCD) and the only enzyme replacement therapy currently approved for Gaucher disease. Gaucher disease is a rare and serious lysosomal storage disorder in humans with severe and debilitating symptoms. prGCD, the Company's lead product candidate, is a proprietary plant-cell expressed recombinant form of glucocerebrosidase and is currently the subject of a Phase III clinical trial for the treatment of Gaucher disease.