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European Scientific Committee Positive Recommendation From For A New Once Daily Mirapexin(R) Formulation For The Treatment Of Parkinson's Disease
Boehringer Ingelheim announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending the approval of a once daily formulation for Mirapexin®/ Sifrol® (pramipexole), in all countries of the European Union, Norway, Iceland and Liechtenstein. The CHMP recommendation states that the new prolonged-release formulation is indicated for treatment of the signs and symptoms of idiopathic Parkinson"s disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or "on off" fluctuations).

Second Strokes Often Follow Within Hours Of A Mild Stroke
About half of all people who have a major stroke following a warning stroke (a transient ischemic attack or mild stroke) have it within 24 hours of the first event, according to research published in the June 2, 2009, print issue of Neurology®, the medical journal of the American Academy of Neurology.
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Obama Administration's Filings On Asylum For Abused Foreign Women Brings 'Overdue Dose Of Clarity,' Editorial Says
The Obama administration recently laid out "a clear but narrow pathway" toward asylum for foreign women who have experienced severe physical or sexual abuse, a New York Times editorial states, noting that the U.S. government has debated the issue for 15 years. According to the editorial, the "question is not the fact of persecution, but whether the women would qualify for protection under the law, which limits asylum to those who suffer due to their race, religion, nationality, political opinion or "membership in a particular social group."" It adds that attorneys general under former Presidents Clinton and George W. Bush "have gone both ways and in circles" in their decisions.Although "[n]ot all victims will qualify," the Obama administration "made it clear that some could," the editorial states. "A petitioner would have to demonstrate to a judge that domestic violence was widely tolerated by society and government in her country, that women were viewed as subordinate to men and that she had no place within its borders to find a safe haven," the editorial adds.Department of Homeland Security lawyers say the new definition could apply to a severely abused Mexican woman, identified only by her initials, whose asylum petition is before a San Francisco immigration court. The editorial notes that DHS "did not immediately recommend asylum" for the woman, but "it did urge that she be allowed to continue to gather evidence and to refine her case according to the standards it proposed." The editorial concludes, "Advocates who have fought for years to advance women"s rights are celebrating the department"s action, which brings reasoned compassion, and an overdue dose of clarity, to an issue of anguish and difficulty" (New York Times, 7/19).
Medical Devices

Gefitinib Receives European Licence For The Treatment Of Lung Cancer For Patients With EGFR Activating Mutation Positive Tumours

AstraZeneca announced that it has received a licence by the European Medicines Agency (EMEA) for its oral targeted anti-cancer drug, gefitinib, for EGFR (epidermal growth factor receptor-tyrosine kinase) activating mutation positive patients with Non Small Cell Lung Cancer (NSCLC). NSCLC is the most common type of lung cancer and accounts for 80% of all lung cancer cases. [1] The licence means that for the first time, thousands [2] of patients undergoing first line treatment of NSCLC in the UK may benefit from a more effective, [3] oral alternative to doublet chemotherapy (UK standard of care) without many of the side effects associated with chemotherapy. [3] Gefitinib is licensed for use in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (epidermal growth factor receptor-tyrosine kinase), in all lines of therapy. [4] Gefitinib is the only oral targeted therapy available for first line use, having demonstrated superior efficacy vs. doublet chemotherapy for patients with a specific genetic mutation of their tumours (EGFR activating mutation positive tumours) and is one of just a handful of anti cancer drugs already available to target only those patients most likely to benefit. EGFR mutation status of a patient"s tumour is a strong predictor of benefit with gefitinib. [3,5] When compared to standard chemotherapy, not only did significantly more patients with EGFR mutation positive tumours respond to treatment with gefitinib (71.2% v 47.3%, p=0.0001) but they also lived significantly longer without their cancer growing (progression free survival) (median PFS 9.5 months vs 6.3 months; HR 0.48, 95% CI 0.36 to 0.64, pAbout IPASS [3] IPASS was an open label, randomised, parallel-group study that assessed the efficacy, safety and tolerability of gefitinib versus carboplatin/paclitaxel as first-line treatment in a clinically selected population of patients from Asia. The study enrolled 1,217 patients in Asia with advanced NSCLC who had not received prior chemotherapy for advanced disease, whose tumours were of adenocarcinoma histology and who had either never smoked, or were former light smokers (ceased smoking at least 15 years ago and About INTEREST [6] The INTEREST (Iressa Non-small-cell lung cancer Trial Evaluating REsponse and Survival against Taxotere) study was a randomised, open-label, parallel-group, Phase III trial evaluating survival with gefitinib versus docetaxel in 1,466 patients with locally advanced or metastatic recurrent NSCLC who had previously received platinum-based chemotherapy. The primary endpoint of INTEREST was OS, with the objective of demonstrating that gefitinib was non-inferior to docetaxel chemotherapy. The INTEREST study met its primary objective, demonstrating equivalent overall survival (OS) and significant quality of life benefits for gefitinib compared to standard chemotherapy (docetaxel) in the pre-treated setting.[6] A retrospective analysis showed a significant improvement in PFS and ORR for gefitinib over docetaxel in patients with EGFR sensitising mutation positive tumours. [7] About gefitinib - Mode of Action: gefitinib is an EGFR-TKI (epidermal growth factor receptor-tyrosine kinase inhibitor), which targets and blocks the activity of the EGFR-TK, an enzyme that regulates intracellular signalling pathways implicated in cancer cell proliferation and survival. Growth factor signalling has been identified as a key driver of tumour growth and spread in a wide range of cancers - Gefitinib (250 mg) is a once-daily oral therapy. - Gefitinib is licensed in 36 countries for the treatment of patients with locally advanced or metastatic NSCLC who have previously received chemotherapy. About EGFR mutations - EGFR mutations are changes in the DNA sequence of the EGFR gene which codes for the EGFR protein, leading to the production of mutated EGFR, rather than wild-type (non-mutated) EGFR. Tumour cells with mutated EGFR seem to be drawn to signalling via the EGFR pathway. - The EGFR receptor has been shown to play an important role in NSCLC. Some patients will exhibit mutations within the gene of this receptor. - A mutation in the EGFR is a characteristic occurring in approximately 12.7% [8] of lung cancers in non-Asian patients. About lung cancer in the UK - Lung cancer is the second most commonly diagnosed cancer in the UK. Each year more than 38,000 people are diagnosed with lung cancer in the UK. [9] - There are several different types of lung cancer, NSCLC being the most common. 80% of lung cancer patients are diagnosed with NSCLC. [1] - The UK has one of the worst lung cancer survival rates in Europe, 8.6% survival at 5-years in England compared with a mean of 12.6% across Europe. [10] About gefitinib and NICE AstraZeneca will submit gefitinib to NICE for review in September 2009 References [1] Cancer Research UK, UK Lung Cancer incidence statistics. http://info.cancerresearchuk.org/cancerstats/types/lung/incidence/. Date accessed 19.03.09 [2] AstraZeneca Data on File (DOF) IRE/014/MAY09 [3] Mok T. Phase III, Randomised, Open-Label, First-Line Study Of Gefitinib Vs Carboplatin/Paclitaxel (C/P) Clinically Selected Patients With Advanced Non-Small-Cell Lung Cancer (IPASS), Presentation at ESMO 2008 [4] Gefitinib (IRESSA [TM]) SmPC. http://www.Medicines.Org.uk [5] Kobayashi et al. First-line gefitinib versus first-line chemotherapy by carboplatin (CBDCA) plus paclitaxel (TXL) in non-small cell lung cancer (NSCLC) patients (pts) with EGFR mutations: A phase III study (002) by North East Japan Gefitinib Study Group. Poster presented at ASCO 2009. (abs. 8016) [6] Kim, ES et al. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet 2008; 372: 1809-18 [7] Douillard, J. et al. Molecular and clinical subgroup analyses from a phase III trial comparing gefitinib with docetaxel in previously treated non-small cell lung cancer (INTEREST). Presentation at ASCO 2008. [8] AstraZeneca Data on file (DOF) IRE/013/APR09 [9] Cancer Research UK. Date accessed 17.03.09 [10] Berrino F, De Angelis R, Sant M et al. Survival for eight major cancers and all cancers combined for European adults diagnosed in 1995-1999: results of the EUROCARE-4 study Lancet Oncology 2007; 8:773-783 AstraZeneca


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