CHMP rejects MAA of Basilea’s/J&J’s ceftobiprole


Basel – The EMA Committee for Medicinal Products for Human Use (CHMP) has rejected Basilea Pharmaceutica‘s Marketing Authorisation Application for ceftobiprole, intended for the treatment of complicated skin and soft tissue infections. This 5th generation cephalosporin antibiotic was seen as effective against methicillin-resistant S. aureus, penicillin-resistant S. pneumoniae, P. aeruginosa, and Enterococci, and had been shown to be statistically non-inferior to the combination of vancomycin and ceftazidime for the treatment of skin and soft tissue infections (more...). However, the CHMP stated that inspections showed that the registration phase III trials had not been conducted in compliance with GCP in some sites. The CHMP indicated that, although the study results suggested that the medicine was beneficial to patients, it was concerned about the reliability of results and in that light could not grant marketing authorisation. The MAA was originally filed by Basilea’s marketing partner Janssen-Cilag International, a Johnson & Johnson company, in June 2007. The CHMP initially gave a positive opinion in November 2008, however the EMA halted the European Commission authorisation process pending completion and assessment of Good Clinical Practice (GCP) inspections.



Basel/Hinxton (UK) – Two European teams have created huge repositories of cancer genomics data that help predict drug response. Swiss Novartis and the Boston-based Broad Institute have combined data obtained from large-scale...



London/Lausanne – The global private equity firm Celtic Therapeutic L.L.L.P. believes in the power of antibody-drug conjugates (ADCs). It is investing $50m in a new Switzerland-based company called ADC Therapeutics Sarl which...



Basel/Vienna - Following promising results from a Phase III study, Roche has submitted a regulatory application to EMA for subcutaneous Herceptin (trastuzumab) to treat HER2-positive breast cancer. Roche said subcutaneous...



After the US Food & Drug Administration forced Swiss generics giant Sandoz AG to update its production facilities in Quebec, there are now fears that supplies of some medicines could grow tight in Canada. The regulatory authority...



The hepatitis C space has seen a string of large deals in the last weeks that include a US$11bn buyout of Pharmasset by Gilead. Now Novartis is also trying to get in the game with the purchase of a global exclusive licence from...



Allschwil – Swiss Actelion Ltd. has strengthened its commercial offerings by securing rights in certain countries to Auxilium’s biotech drug Xiaflex for treating tissue buildup under the skin. The US pharma is to receive US$10m...



Zug – Life Sciences specialist HBM partners has raised €90m in the first close of its HBM BioCapital II fund, which will invest in revenue-generating companies in the pharmaceuticals, medical device and diagnostics sectors....



Stans – Mondobiotech, a drug discovery company in troubled waters, could soon be under Italian ownership: The Swiss biotech announced it has entered into exclusive negotiations with Milan-based provider of pharmaceutical and...

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