June 01, 2016 – Are first-in-man (FIM) clinical trials unsafe? This question can certainly be answered with no, first-in-man (FIM) clinical trials (clinical Phase I studies) are generally not unsafe. In spite of this notion, and in the wake of …

Are first-in-man (FIM) clinical trials unsafe? Read more »

May 30, 2016 – According to its News and Events section of the homepage, the European Medicines Agency (EMA) has recommended the granting of marketing authorisations in the European Union (EU) for two new combination therapies against chronic (long-term) hepatitis C virus (HCV) infection, namely …

EMA: Two new combination therapies against chronic hepatitis C recommended for approval Read more »

April 02, 2016 – The European Medicines Agency (EMA) has recommended granting a marketing authorisation in the European Union (EU) for a new gene therapy for the treatment of patients with adenosine-deaminase-deficient severe combined immunodeficiency (ADA-SCID), who have no matching donor for a stem cell …

New hope for children with the ultra-rare immune disorder ADA-SCID: Gene therapy Strimvelis recommended for approval by EMA’s CHMP Read more »

 March 20, 2016 – The European Medicines Agency (EMA) has, at the request of the European Commission, has started a review of the cancer medicine Idelalisib (Zydelig), which is authorised in the European Union to treat two types of rare blood cancers called …

Under scrutiny: The EMA reviews cancer medicine Idelalisib (Zydelig) after the occurrence of serious adverse effects, some of them fatal, in three clinical trials Read more »

November 13, 2015 – The American Food and Drug Administration (FDA) just approved Cobimetinib (Cotellic) to be used in combination with Vemurafenib (Zelboraf) to treat advanced melanoma that has spread to other parts of the body or can’t be removed by …

Cobimetinib (Cotellic) is now approved as part of a combination treatment with Vemurafenib (Zelboraf) for advanced melanoma Read more »

October 02, 2015 – Recently, the American Food and Drug Administration (FDA) approved Sacubitril/Valsartan (Entresto) for the treatment of heart failure. Similarly, a few days ago, the European Medicines Agency (EMA) recommended granting a marketing authorisation for Sacubitril/Valsartan (Entresto) for the treatment of adults with symptomatic chronic heart failure …

New medicine to treat heart failure: Sacubitril/Valsartan (Entresto) brings a new mechanism of action to the treatment of heart failure Read more »

July 6. 2015 – The American Food and Drug Administration (FDA) is once more investigating the safety of using codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for serious side effects, including …

Codeine cough-and-cold medicines in children: A never ending story – FDA evaluating potential risk of serious side effects Read more »

 May 22, 2015 – The European Medicines Agency (EMA) has recommended authorising Evolocumab (Repatha) as treatment to lower high levels of cholesterol in the blood of people who are unable to control their cholesterol despite taking optimal doses of statins …

Evolocumab (Repatha), a novel first-in-class treatment to lower cholesterol Read more »

On 18 December 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Xadago, 50 mg and 100 mg, film-coated tablet intended for the treatment of Parkinson’s disease. The active substance of Xadago is safinamide, …

Parkinsons Disease: Positive opinion by the CHMP issued recommending the granting of a marketing authorisation for Safinamide (Xadago) 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 »