Rochester,NY 9/1/2009 11:11:14 PM
Johnson & Johnson JNJ, Basilea respond to FDA antibiotic concerns
Johnson & Johnson
U.S. regulators have accepted a response from Johnson & Johnson (JNJ.N) addressing concerns about antibiotic ceftobiprole, the U.S. group's partner, biotech company Basilea (BSLN.S), said on Tuesday.
J&J's "complete response" submission addresses Food and Drug Administration concerned about data integrity and the sites where clinical tests were carried out, Basilea said.
U.S. regulators had delayed a decision on approval of the broad-based spectrum antibiotic to treat deadly superbug MRSA last year, saying they needed further audits of clinical sites, prompting a sharp fall in Basilea shares. [ID:nLQ688988]
The Swiss group then filed a claim against J&J over the delays after the approval process hit a setback in Europe.
The emergence of hospital superbugs such as MRSA, which are resistant to existing medicines, has increased the need for alternative treatments and re-focused attention on antibiotics.
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