December 20, 2014 – Right in time for Christmas, the American Food & Drug Admininistration (FDA) on December 19 approved three significant new drugs, namely Ceftolozane/Tazobactam (Zerbaxa), Ombitasvir/Paritaprevir/Ritonavir co-packaged with Dasabuvir (Viekira Pak) and Olaparib (Lynparza), each of which represents …

Right in time for Christmas, FDA approved Ceftolozane/Tazobactam (Zerbaxa), Ombitasvir/Paritaprevir/Ritonavir co-packaged with Dasabuvir (Viekira Pak), and Olaparib (Lynparza) Read more »

December 12, 2014 – The American Food & Drug Administration (FDA) has recently issued a warning that the antipsychotic drug ziprasidone (marketed under the brand name, Geodon, and its generics) is associated with a rare but serious skin reaction that can …

Rare But Potentially Fatal Skin Reactions (DRESS Syndrome) with Ziprasidone [Geodon] Read more »

November 27, 2014 – A drug which makes a wide range of cancers more vulnerable to the body’s immune system is “exciting” and may mark a new era, say doctors. The drug MPDL3280A strips cancer cells of the “camouflage” they use to …

Exciting new drug breakthrough in bladder cancer Read more »

November 20, 2014 –  Recent research has addressed the clinically strikingly wide variation among patients in plasma levels of Atorvastatin (Lipitor) and Rosuvastatin (Crestor), even with consistent dosing. This research proposes that the phenomenon is likely related to gene variants …

Theragenomic Medicine: Genotyping Might Cut Muscle-Pain Risk with Statin Drugs Read more »

November 7, 1014 –  This report originates from the meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) on 3-6 November 2014 at EMA. At this meeting, the PRAC took note and advised on informing about first case of PML in a patient …

First Case of Progressive Multifocal Leukoencephalopathy (PML) in a Patient Treated with Dimethyl Fumarate [Tecfidera] Read more »

October 23, 3014 – Pulmonary fibrosis is a disease in which tissue deep inside the lungs becomes thick, stiff, and scarred, decreasing the lungs’ ability to expand to take in air, and making it difficult to breathe. This is a …

FDA approved two drugs for idiopathic pulmonary fibrosis (IPF) Read more »

October 19, 2014 –  The following article originates from Reuters Health Information staff via Medscape. Copyright with the respective holders. Here the article: The genotype of primary gastrointestinal stromal tumors (GIST) of gastric origin can be used to predict the …

Genotype of Primary Gastrointestinal Stromal Tumors Predicts Outcome Read more »

October 12, 2014 – The U.S. Food and Drug Administration, on October 10,  approved Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoing cancer chemotherapy. Akynzeo is a fixed combination capsule comprised of two drugs. Oral palonosetron approved …

Netupitant/Palonosetron [Akynzeo] for nausea and vomiting associated with cancer chemotherapy approved in the US Read more »

October 10, 2014 – The European Medicines Agency recently has recommended the authorisation of Harvoni (ledipasvir / sofosbuvir) for the treatment of chronic hepatitis C virus (HCV) infection in adults. HCV infection is a major European public-health challenge. It affects between …

CHMP recommended Harvoni [Ledipasvir / Sofosbuvir] for the treatment of chronic hepatitis C Read more »

October 05, 2014 – To strengthen the safety of medical devices, the U.S. Food and Drug Administration has finalised and released recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information. The final guidance, titled “Content …

Steps to strengthen cybersecurity of medical devices Read more »