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FDA approves imatinib (Gleevec) for a new indication: GIST tumors.
FDA press relase about the approval of imatinib (Gleevec) for the treatment of GIST tumors: FOR IMMEDIATE RELEASE December 19, 2008 FDA Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer The U.S. Food and Drug Administration today approved Gleevec (imatinib mesylate) for a new indication –
EMEA press release: CHMP positive opinion about degarelix (Firmagon) for prostate cancer
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE SUMMARY OF POSITIVE OPINION for FIRMAGON International Nonproprietary Name (INN): degarelix (as acetate) On 18 December 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending to grant a marketing authorisation for the medicinal product Firmagon, 80 mg and 120 mg, powder and
FDA approves plerixafor (Mozobil) for use in multiple myeloma and non Hodgkin’s lymphomas
From the FDA’s newsroom: FDA Approves Drug that Boosts Stem Cell Yield for Bone Marrow Transplants The U.S. Food and Drug Administration today approved Mozobil (plerixafor), a drug that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer. Mozobil is intended to be used
CHMP positive opinion for lasofoxifene (Fablyn), a new SERM
Press release about the positive opinion of the CHMP for Fablyn (lasofoxifene): COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE SUMMARY OF POSITIVE OPINION for FABLYN International Nonproprietary Name (INN): lasofoxifene On 18 December 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending to grant a marketing authorisation for the
CHMP positive opinion for new indication of miglustat (Zavesca)
Press release from the CHMP about a new indication for Zavesca (miglustat): COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE POST-AUTHORISATION SUMMARY OF POSITIVE OPINION for ZAVESCA International Nonproprietary Name (INN): miglustat On 18 December 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion to recommend the variation to the terms
EMEA positive opinion for prasugrel (Efient)
Press release about the positive opinion of the CHMP for the antiplatelet agent Efient (prasugrel): COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE SUMMARY OF POSITIVE OPINION for EFIENT International Nonproprietary Name (INN): prasugrel On 18 December 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending to grant a marketing
EMEA press release: CHMP adopted a positive opinion about japanese encephalitis vaccine (Ixiaro)
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE SUMMARY OF POSITIVE OPINION for IXIARO Common Name: Japanese Encephalitis vaccine, inactivated, adsorbed On 18 December 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending to grant a marketing authorisation for the medicinal product IXIARO, containing a target total protein amount of
EMEA press release: CHMP adopted a positive opinion for pandemic influenza vaccine H5N1 (Celvapan)
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE SUMMARY OF POSITIVE OPINION for CELVAPAN Common Name: Pandemic Influenza Vaccine (H5N1 whole virion, Vero cell derived, inactivated) On 18 December 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Celvapan, 7.5
Paliperidone (Invega) manufacturer withdraws application for its use in bipolar disorder
Reproduction of EMEA’s press release about the Janssen-Cilag International application withdrawal for an extension of indication for Invega (paliperidone): PRESS RELEASE Janssen-Cilag International N.V. withdraws its application for an extension of indication for Invega (paliperidone) The European Medicines Agency (EMEA) has been formally notified by Janssen-Cilag International N.V. of its decision to withdraw its application
Antiepileptic drugs (AEDs): FDA requires warnings about suicidal thoughts and behaviors (suicidality)
The FDA will require manufacturers of antiepileptic drugs (AEDs) to inclued a warning about the increased risk of suicidal thoughts and behaviours when using these drugs. This is a transcript of the original press release dated Dec. 16, 2008: FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications The U.S. Food
Pharmacology mnemonic. Beta 1 and beta 2 receptor location.
Beta-1 vs Beta-2 receptor location “You have 1 heart and 2 lungs”: Beta-1are therefore primarily on heart Beta-2 primarily on lungs Thanks to Medexcel
Pharmacokinetics topics. What is a generic drug?
This generic drugs definition has been taken from the Pharmacology and Experimental Therapeutics Department Glossary at Boston University School of Medicine . Generic Drugs: Drug formulations of identical composition with respect to the active ingredient, i.e., drugs that meet current official standards of identity, purity, and quality of active ingredient. Drug dosage forms considered as
Pharmacodynamics topics. What is intrinsic efficacy (intrinsic activity)?
A definition of the pharmacodynamic concept of intrinsic efficacy (intrinsic activity).
Video animation on renal physiology and diuretics mechanism of action.
Mechanism of action of loop diuretics ( Source: Bertram Katzung, Basic and Clinical Pharmacology, Mc Graw Hill Medical, 2007): Pharmacodynamics These drugs inhibit NKCC2, the luminal Na+/K+/2Cl– transporter in the thick ascending limb of Henle’s loop. By inhibiting this transporter, the loop diuretics
Pharmacology mnemonic. Thrombolytic agents
Thrombolytic agents USA: Urokinase Streptokinase Alteplase (tPA) Thanks to MedExcel