On Return To Work, Valeant CEO Faces Questions About Business Practices
Just back from a two-month medical leave, Valeant Pharmaceutical's Michael Pearson sought to reassure Wall Street analysts over the drugmaker's financial disclosures. In other pharmaceutical news, the FDA approves orphan designation for a BioMarin gene therapy. And Johnson & Johnson and Bayer face charges that the firms mislead medical journals over the safety of Xarelto.
The Wall Street Journal:
Valeant CEO Races To Repair Drug Maker’s Reputation
Valeant Pharmaceuticals International Inc. Chief Executive Michael Pearson just got back from a two-month sick leave, and immediately faced a fresh round of criticism and doubts about the company’s financial disclosures and business practices. In response, Mr. Pearson spoke with a select group of Wall Street analysts. In one-on-one calls Tuesday with some who have generally stuck by the drug company, Mr. Pearson indicated he was bullish about Valeant’s prospects and predicted performance not too far off what the company had initially forecast, but later took back, according to the analysts. (Rockoff and Farrell, 3/1)
The Wall Street Journal:
BioMarin Gets Orphan Designation For Hemophilia-Focused Therapy
BioMarin Pharmaceutical Inc. received orphan drug designation from the U.S. Food and Drug Administration for a gene therapy intended for hemophilia A patients. The biotechnology company is conducting a Phase 1/2 study to evaluate the safety and efficacy of the gene therapy, known as BMN 270, which is designed to restore plasma concentrations. BioMarin shares were up 2.8% to $90 in after-hours trading. (Beckerman, 3/1)
The New York Times:
Document Claims Drug Makers Deceived A Top Medical Journal
It is a startling accusation, buried in a footnote in a legal briefing filed recently in federal court: Did two major pharmaceutical companies, in an effort to protect their blockbuster drug, mislead editors at one of the world’s most prestigious medical journals Lawyers for patients suing Johnson & Johnson and Bayer over the safety of the anticlotting drug Xarelto say the answer is yes, claiming that a letter published in The New England Journal of Medicine and written primarily by researchers at Duke University left out critical laboratory data. They claim the companies were complicit by staying silent, helping deceive the editors while the companies were in the midst of providing the very same data to regulators in the United States and Europe. (Thomas, 3/1)