Sun, 8 November 2009
A century and a quarter after a cutler set out to supply Swiss soldiers with a survival tool, the Swiss Army knife adapts to the urban jungle.
Read Jessica of Swisstory's adventure in obtaining her Swiss driver's licence, with helpful checklist.
Expatica reader Carolyn Moncel searches for the best salons in Paris and Switzerland serving black women.
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A Swiss drugs firm files claims against Johnson & Johnson for delaying ceftobiprole, an antibiotic for dangerous skin infections.TRENTON — Johnson & Johnson's experimental antibiotic for dangerous skin infections had two more setbacks — a delay from European regulators, followed by legal action from its Swiss partner in developing the drug.
New Brunswick, New Jersey-based Johnson & Johnson long publicised ceftobiprole as a promising treatment for complicated skin and soft tissue infections, including MRSA, a deadly drug-resistant staph germ.
But the Food and Drug Administration twice delayed approval, most recently saying it wants more audit work done at clinical-investigator sites and answers to questions related to the monitoring done at these sites, where the drug was tested on patients.
In late February, Johnson & Johnson's Jansen-Cilag International NV unit said that the Committee for Medicinal Products for Human Use, an advisory panel of the European Medicines Agency, delayed approval pending completion of what's called a "good clinical practice inspection".
That mainly involves reviewing records at the European hospitals and other sites where patient testing was conducted, said J&J spokesman Ernie Knewitz.
On Tuesday, Basel, Switzerland-based Basilea Pharmaceutica, claiming financial damages from the repeated delays, submitted a request for arbitration to the Netherlands Arbitration Institute. A company statement said the arbitration request also involves milestone payments.
"In this environment, for small biotechs, any delay is absolutely devastating," said analyst Steve Brozak of WBB Securities.
"What is absolutely essential for" Basilea is just one of many projects for Johnson & Johnson, he added.
The company said it could win approval of seven other new drugs in 2009 alone.
Basilea, which discovered ceftobiprole, granted Johnson & Johnson an exclusive worldwide license in 2005 for the drug, which would be sold under the brand name Zevtera in European Union countries.
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