The Japanese regulatory authority has approved Faslodex (fulvestrant), an oestrogen receptor antagonist, for metastatic breast cancer which has recurred or progressed following prior endocrine therapy, according to the developer, AstraZeneca Plc.
Scientists from the Roche group have reported generating the first draft genome sequence of the cynomolgus monkey, Macaca fascicularis, the most frequently used nonhuman primate in drug safety studies.
The US Food and Drug Administration has approved the tumour necrosis factor blocker, Remicade (infliximab), for the treatment of ulcerative colitis in children older than six years who have had inadequate response to conventional therapy.
The US Food and Drug Administration has issued a ‘complete response letter’ to GlaxoSmithKline Plc, effectively rejecting its application to market a new combination vaccine for children against three types of bacteria.
Corporate venture capitalists increasingly are looking for early biotech investment opportunities that will support the strategic objectives of their parent companies. And they are reserving funds to support these companies until the assets in question mature. This was one conclusion from a panel discussion among venture capitalists that took place at the Sachs Investor Forum in Zurich, Switzerland on 13 September 2011.
Seven new medicines, including a new diabetes treatment, an antibiotic for C. difficile, two drugs for HIV, and combination treatments for hypertension, have received positive opinions from the European Medicines Agency.
The US Food and Drug Administration has approved the monoclonal antibody, Soliris (eculizumab), for a rare paediatric blood disorder called atypical hemolytic uremic syndrome while the EMA has recommended approval of the same indication.
The European Medicines Agency is recommending approval of a new macrocyclic antibiotic for Clostridium difficile, Dificlir (fidaxomicin). Developed by Optimer Pharmaceuticals Inc, the antibiotic was approved by the FDA in May 2011.
The European Medicines Agency has recommended restrictions on the use of Multaq (dronedarone), an anti-arrhythmic medicine marketed by Sanofi SA, due to an increased risk of liver, lung and cardiovascular adverse events.
The European Medicines Agency has started a review of orlistat-containing medicines, which are used to treat obesity, to determine whether very rare cases of liver injury affect the medicines’ overall benefit-risk profile.