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Approval

  • Harvoni (ledipasvir 90MG and sofosbuvir 400MG, oral) for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection was approved on 10-October-2014 (Gilead Sciences). The combo, just like Sovaldi, is very expensive (> $1000 per pill).
  • Trulicity (dulaglutide 0.75MG and 1.5MG/0.5ML, once weekly, injection) for the treatment of type 2 diabetes was approved on 18-September-2014 (Eli Lilly). Like albiglutide, dulaglutide is a GLP-1 agonist to enhance insulin secretion by beta cells in the pancreas.
  • Cerdelga (eliglustat 84MG, oral) for the treatment of type 1 form of Gaucher disease was approved on 19-August-2014 (Genzyme).
  • Jardiance (empagliflozin 10MG and 25MG, oral) for the treatment of type 2 diabetes was approved on 1-August-2014 (Boehringer Ingelgeim and Eli Lilly). Like dapaglifozin, empagliflozin inhibits the sodium-glucose transport proteins subtype 2(SGLT2), to reduce the reabsorption of glucose in the kidney. It is indeed a new mechanism for the management of type 2 diabetes, but it may not have sufficient benefits for patients with kidney diseases (as we know, diabetes is a major risk factor for patients with kidney diseases in general).
  • Zydelig (idelalisib) for the treatment of chronic lymphocytic leukaemia was approved on 23-July-2014 (Gilead). Idelalisib is a phosphoinositide 3-kinase inhibitor.
  • Beleodaq (belinostat 500MG/vial, infusion) for the treatment of peripheral T-cell lymphoma was approved on 3-July-2014 (orphan drug/fast track, Spectrum Pharmaceuticals). Belinostat is a histone deacetylase inhibitor.
  • Tanzeum (albiglutide 30MG, injection) for the treatment of type 2 diabetes was approved on 15-April-2014 (GlaxoSmithKline). Albiglutide is a glucagon-like peptide-1 (GLP-1) agonist, which was designed as a GLP-1 dimer fused to human albumin, to improve glycemic control.
  • Farxiga (dapaglifozin 5MG and 10MG, oral) for the treatment of type 2 diabetes was approved on 8-January-2014 (Bristol-Myers Squibb and AstraZeneca). Dapaglifozin inhibits the sodium-glucose transport proteins subtype 2(SGLT2), which reabsorb >90% glucose in the kidney, and thus it can improve glycemic control, along with diet and exercise. Still, for those patients with kidney diseases, these SGLT2 drugs are questionable.
  • Sovaldi (sofosbuvir 400MG, oral) for the treatment of chronic hepatitis C virus (HCV) infection was approved on 6-December-2013 (Gilead Sciences). Sofosbuvir was designed as a prodrug and it inhibits the RNA polymerase that is required for HCV to replicate its RNA. The cost of sofosbuvir has been controversial (~ $100,000 for a course of treatment in the United States). See an illustration...

Withdrawal and Black Boxed Warning

  • Acetaminophen (>325 mg) On 14-January-2014, FDA recommended to discontinue dosage 325 mg or more acetaminophen to protect consumers for increased risks of liver injury, liver failure, liver transplant, and death. The mechanisms of its hepatotoxicity have been studied for decades, and one of them is related to the metabolism and bioactivation by cytochrome P450s for the formation of qunione imine reactive intermediates which in turn can covalently bind to protein and DNA for toxicity.
  • Advances in Medicine

    • Genome for Human Origin and Ebola New African genome may shed light on human origins and susceptibility of infectious diseases like Ebola and HIV. Read More...
    • Drug Industry News

      • Merck to buy Cubist On 8-December-2014, Merck announced to buy Cubist Pharma for Cubicin (daptomycin), an antibiotic to fight 'superbugs'. See an illustration...