Sat, 20 March 2010
Jackie gives us the lowdown on being the proud member of her local CSA.
Kerrin of MyKugelhopf visits the working dairy museum where visitors can learn all about the region's world-famous cheese.
This week on Landlockedblues, Kaki King is a must-see in Geneva and Fribourg, and the Shout Out Louds and James Yorkston are previewed too.
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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.
Meeting the educational, legal and financial needs of those with disabilities.
Expatica’s selection of Language Schools, specialised in German for foreigners.
Information on searching for an apartment, visiting prospective homes, gathering necessary paperwork and signing the lease.
Information about the Swiss health care system, health insurance, pharmacies and emergency numbers.
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