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Cochrane review: Computerized advice on drug dosage
By: Felice Musicco
on: Wed 27 of Aug, 2008 [14:29 UTC]
(11 reads)
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Conclusion changed in "Computerized advice on drug dosage to improve prescribing practice" Cochrane Database of Systematic Reviews, Issue 3, 2008.
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EMEA update on progressive multifocal leukoencephalopathy (PML) and Tysabri
By: Felice Musicco
on: Sat 23 of Aug, 2008 [11:23 UTC]
(22 reads)
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The risk of PML with Tysabri is known and is kept under close monitoring by the EMEA. The product information advises healthcare professionals that the medicine must not be used in patients who have PML and that patients taking Tysabri should be regularly monitored for signs and symptoms suggestive of PML.
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NICE technology appraisal guidance: Cetuximab for ASCC of the head and neck
By: Felice Musicco
on: Tue 19 of Aug, 2008 [06:56 UTC]
(49 reads)
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Cetuximab for the treatment of locally advanced squamous cell cancer of the head and neck. "The Committee concluded that cetuximab in combination with radiotherapy is clinically and cost effective in patients with locally advanced squamous cell cancer of the head and neck who have a Karnofsky performance-status score of 90% or greater and for whom platinum-based chemoradiotherapy treatment is contraindicated."
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FDA List of Approved Oncology Drugs with Approved Indications
By: Felice Musicco
on: Thu 14 of Aug, 2008 [14:54 UTC]
(78 reads)
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The list may be sorted by the drug's generic name, trade name, or manufacturer. Entries also link to an approval summary, a product label, and a sponsor portfolio.
(Note: the data are still incomplete).
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NEW SIGN Guideline: Antibiotic prophylaxis in surgery
By: Felice Musicco
on: Tue 12 of Aug, 2008 [14:43 UTC]
(85 reads)
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This guideline makes recommendations on best practice in the use of peri-operative prophylactic antibiotics to prevent surgical site infections (SSI). SSI is a major cause of healthcare acquired infection.
The Scottish Intercollegiate Guidelines Network (SIGN) was formed in 1993. Their objective is to improve the quality of health care for patients in Scotland by reducing variation in practice and outcome, through the development and dissemination of national clinical guidelines containing recommendations for effective practice based on current evidence.
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July's Drug Safety Update by CKS: biphosphonates and atrial fibrillation
By: Felice Musicco
on: Sat 09 of Aug, 2008 [14:35 UTC]
(83 reads)
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The monthly newsletter from the Medicines and Healthcare products Regulatory Agency and its independent advisor the Commission on Human Medicines.
"Clinical trial results have suggested an increased risk of atrial fibrillation for
zoledronic acid (Aclasta), pamidronic acid, and possibly for alendronic acid.
The balance of risks and benefits for bisphosphonates remains favourable"
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EMEA Negative opinion for extension of indication for docetaxel
By: Felice Musicco
on: Wed 06 of Aug, 2008 [14:25 UTC]
(83 reads)
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The CHMP adopted a negative opinion for an extension of indication of Taxotere (docetaxel) and Docetaxel Winthrop (docetaxel), both from Aventis Pharma S.A. Both medicines were intended to be used to treat operable breast cancer whose tumours overexpress the protein HER2.
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EMEA Extensions of indication for zoledronic acid and bortezomib
By: Felice Musicco
on: Sun 03 of Aug, 2008 [14:21 UTC]
(83 reads)
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Aclasta (zoledronic acid), from Novartis Europharm Ltd, to extend the indication to include treatment of osteoporosis in post-menopausal women and men at increased risk of fracture, including those with a recent low-trauma hip fracture.
Velcade (bortezomib), from Janssen-Cilag International NV, to extend the indication for its use in combination with melphalan and prednisone for the treatment of patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with bone marrow transplant.
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EMEA CHMP: final positive opinion for Ceplene (histamine dihydrochloride)
By: Felice Musicco
on: Thu 31 of Jul, 2008 [14:17 UTC]
(98 reads)
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Following the re-examination of the negative opinion adopted on 19 March 2008, the CHMP adopted a final positive opinion for Ceplene (histamine dihydrochloride), from EpiCept GmbH, intended to be used as maintenance treatment in combination with interleukin-2 in adults with acute myeloid leukaemia. Ceplene is the 48th orphan medicine to receive a positive opinion.
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EMEA:no increased risk of developing cancer for patients who have taken Viracept
By: Felice Musicco
on: Mon 28 of Jul, 2008 [13:49 UTC]
(112 reads)
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Press Release - Studies assessed by the EMEA indicate no increased risk of developing cancer for patients who have taken Viracept contaminated with ethyl mesilate
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ISOPP HOPA 2008

Click on the Logo above to link to the ISOPP/HOPA
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