Gentium Shares Falling as Defibrotide Faces Delay Again

Sheridan, Cormac
February 2013
BioWorld Today;2/25/2013, Vol. 24 Issue 36, p1
The article reports that share prices for Gentium SpA has fallen 20 percent due to the delayed approval of the drug defibrotide. The drug is developed for the treatment and prevention of hepatic veno-occlusive disease (VOD) in patients undergoing hematopoietic stem cell transplant. Preliminary feedback indicates that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) would adopt a negative stance on the application after its oral presentation.


Related Articles

  • Gentium's Defibrotide Brings 2Q Sales Record as Launch Looms. Sheridan, Cormac // BioWorld Today;8/14/2013, Vol. 24 Issue 155, p1 

    The article reports on the high sales record posted by Gentium SpA for its Defitelio (defibrotide) drug product in the second quarter of 2013. It describes the mechanism of action of the drug used for the prevention or treatment of hepatic veno-occlusive disease (VOD) in patients undergoing...

  • Gentium Announces NDA Submission for Defibrotide.  // Worldwide Biotech;Aug2011, Vol. 23 Issue 8, p2 

    The article reports on a new drug application (NDA) submitted by Gentium SpA to the U.S. Food and Drug Administration (FDA) for Defibrotide for the treatment of hepatic veno-occlusive disease (VOD) in patients undergoing hematopoietic stem-cell transplantation (HSCT). The drug has allegedly been...

  • Gentium Shares Falling as Defibrotide Faces Delay Again. Sheridan, Cormac // BioWorld International;2/27/2013, Vol. 18 Issue 9, p1 

    The article reports on the 20% decline of shares in Gentium SpA as the approval process for defibrotide, which is a drug treatment for hepatic veno-occlusive disease (VOD) in patients undergoing hematopoietic stem cell transplant, faces delay. Salvatore Calabrese, chief financial officer at...

  • Jazz buys out new drug rights. Investor's Business Daily // Investors Business Daily;7/3/2014, pA02 

    The specialty drug maker inked a deal for Gentium partner Sigma-Tau's rights to market defibrotide in the Americas for $75 mil upfront, plus up to $175 mil in milestone payments if the FDA approves the drug.

  • EMBT calls for innovation through cooperation. Lyon, Sue // British Journal of Hospital Medicine (17508460);May2014, Vol. 75 Issue 5, p251 

    The article discusses the launch of the drug defibrotide for severe hepatic veno-occlusive disease after haematopoietic stem cell transplantation, which is regarded as a model for cooperation of investigators, international scientific societies, and industry. Topics include the view of European...

  • Antifungal approved for new indication.  // Drug Topics;2/11/2008, Vol. 152 Issue 3, p10 

    The article reports on the approval of Astellas Pharma's Mycamine for Injection to treat patients with candidemia, acute disseminated candidiasis, candida peritonitis and abscesses. According to the article, the antifungal was approved in 2005 to treat esophageal candidiasis. The antifungal is...

  • Industry Pipeline.  // Ocular Surgery News;2/25/2011, Vol. 29 Issue 4, p30 

    The article offers news briefs related to pharmaceutical industry in the U.S. including Advanced Cell Technology Inc.'s MA09-hRPE drug which was granted an orphan drug designation by the Food and Drug Administration (FDA), FDA's approval of the Zymaxid anti-infective drug from Allergan Inc., and...

  • EMA and EUnetTHA publish joint 3-year plan.  // PharmacoEconomics & Outcomes News;Nov2013, Issue 691, p14 

    The article discusses the release of a joint three-year plan by the European Medicines Agency and the European network for Health Technology Assessment setting out the organizations' plans for collaboration in medicine approval.

  • EMA adopts transparency policy.  // Nature Biotechnology;Nov2014, Vol. 32 Issue 11, p1076 

    The article reports about the transparency policy by European Medicines Agency (EMA) which requires the drug companies to disclose clinical data about drug approvals.


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics