Congressional Committee Finds J&J Uncooperative: Biotech's Latest Mishaps

by: The Burrill Report

Johnson & Johnson (NYSE:JNJ) has used delaying tactics in its dealings with a Congressional committee looking into the recent recall of children’s Tylenol and other pediatric medicines, the chairman of the committee told The New York Times. Rep. Edolphus Towns, D-New York and chair of the House Committee on Oversight and Government Reform, said in some instances the company has provided misinformation. J&J has denied these allegations. The newspaper said Congressional investigators may turn to subpoenas to force the company to cooperate. Already, the U.S. Food and Drug Administration, which is investigating violations in quality controls behind the recalls, is considering criminal penalties and other actions against McNeil Consumer Healthcare, the J&J unit that produced the drugs.

The U.S. Food and Drug Administration has sent a 12-page warning letter to Pfizer (NYSE:PFE) for failing to quickly notify the agency of serious and unexpected potential side effects from some of its top drugs including Viagra, Lipitor, Lyrica, Reuters reported. The delays date back to 2004 and have grown worse in recent years, the FDA said. The agency told Pfizer it had not properly documented or investigated reported problems in patients after the drugs were approved for use. The agency has requested a meeting with the company to discuss the violations.

Myriad Pharmaceuticals (NASDAQ:MYRX) said it is cutting its staff as part of a number of strategic initiatives it is instituting to focus its efforts on its oncology pipeline and to conserve its financial resources. The moves, the company said, would extend its projected cash beyond 2013. Myriad said it has reduced its headcount by 21 employees, which when combined with attrition, results in a total reduction of 30 employees since July 1, 2009. Among the employees who are leaving the company are the commercial operations team and two company officers, Ed Swabb, senior vice president of development and Barbara Berry, vice president of human resources.
Human Genome Sciences (HGSI) said its experimental drug mapatumumab in combination with bortezomib (Velcade) in patients with advanced multiple myeloma failed in a mid-stage clinical trial. The results showed no difference in disease response or progression-free survival for the combination that included mapatumumab vs. the control group receiving bortezomib alone, and showed that mapatumumab was well tolerated in this study. HGS said it expects to present the results in full at an appropriate scientific meeting later this year.

Chelsea Therapeutics International (NASDAQ:CHTP) said that the U.S. Food and Drug Administration requested that the company delay the initiation of its proposed mid-stage clinical study of its experimental rheumatoid arthritis drug CH-405. The agency wants additional detail from the preclinical studies previously submitted as part of the company's investigational new drug application. Chelsea anticipates specific written comments from the FDA in the next few weeks, but expects the data requested should be readily available, should not require additional studies and could be provided to the agency shortly after receiving the written response.
Discovery Laboratories (DSCO) said preliminary results from its mid-stage clinical trial of Surfaxin in children with Acute Respiratory Failure, a critical condition often caused in children by severe respiratory infections, failed to show statistically significant superiority to a placebo. The objective of the study was to evaluate the safety and tolerability of intratracheal administration of Surfaxin and to assess whether Surfaxin treatment could decrease the duration of mechanical ventilation in children with ARF. Relative to the control treatment group, Surfaxin treatment reduced time on mechanical ventilation by approximately 10 percent, although this observation was not statistically significantly different.

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