Once the world’s leader in the market, it has been losing ground to Boston Scientific and Abbott Laboratories. Its subsidiary, Cordis, will stop making the Cypher stent by the end of 2011 and will discontinue the clinical development program for its Nevo stent. Sales of Cypher were $627 million in 2010, down from $2.62 billion in 2006, according to data compiled by Bloomberg. In a second statement, J&J said it expects to record an after-tax charge in the range of $500 to $600 million in the second quarter of 2011 as a result of the restructuring. Cordis will close plants in Ireland and Puerto Rico and consolidate its R&D in California, reports Bloomberg, which may result in cuts of as many as 1,000 jobs.

The U.S. Food and Drug Administration said that use of Takeda’s diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Takeda is working with FDA to make appropriate updates to the prescribing information and said in a statement that it is committed to the drug and confident in its therapeutic benefits as a treatment for type 2 diabetes. The company is currently supporting a ten-year epidemiological study, started in 2002 by the University of Pennsylvania and Kaiser Permanente Diabetes Registry, Northern California, investigating the questions raised about Actos and bladder cancer. Takeda has been working with the FDA and the European Medicines Agency and has provided them with interim data from this study on a regular basis. An interim analysis of data from this study showed that treatment with Actos was not associated with a statistically significant increase in the incidence of bladder cancer. However, investigators said use of the drug for more than two years was weakly associated with increased risk.

iPierian Chairman Corey Goodman and co-founder Doug Melton have left the South San Francisco stem cell biotech, Xconomy reported. The company, Goodman, and Melton all did not respond to requests for comment. The departures follow the board’s termination of iPierian’s former CEO Mike Venuti in April, followed by the termination of several other executives in the company. The company has raised more than $50 million from a bevy of venture capital firms. Formed in 2009 by the merger of iZumi Bio, a San Francisco startup focused on induced pluripotent stem cells and Pierian, which was co-founded by researchers at the Harvard Stem Cell Institute, including Melton, its plan was to develop its iPS technology as a tool for use in screening new drug candidates and partnerships with big pharmaceutical companies.

The U.S. Food and Drug Administration issued a second warning to Dr. Reddy’s Laboratories for failing to stem problems at its manufacturing facility in Mexico. During an FDA inspection in November, the agency found that Dr. Reddy’s did not validate analytical methods used to test active pharmaceutical ingredients, which led to adulterated ingredients circulating in the United States. Although Dr. Reddy’s responded to the first warning in December, the FDA, in its June warning letter, said that the response “lacks sufficient corrective actions,” partly because it did not address the active pharmaceutical ingredients already on the market. The letter said that only two thirds of the 106 compounds manufactured at the Mexican plant are listed in the drug compendia submitted by the drugmaker with no method validation for the rest. The FDA asked for a new plan within two weeks, warning that it may withhold approval of any new applications or supplements listing Dr. Reddy’s as the manufacturer and refusing to admit any ingredients manufactured at the Mexican plant to the United States.

Array BioPharma is reducing its staff by 20 percent in a restructuring effort to extend its financial resources and focus on the development of its key partnered clinical programs in cancer, including MEK162 in co-development with Novartis. The company will cut 70 employees, primarily in discovery research and support positions. Array will focus on advancing its partnered programs with Amgen, Celgene, and Genentech as well as select wholly owned late-stage discovery programs. The cuts are expected to reduce annual net operating cash burn by approximately $20 million in 2012, compared with fiscal 2011.
It also expects a number of potentially value-creating events during the second half of 2011 including phase 2 combination data on selumetinib in patients with melanoma or non-small cell lung cancer and phase 2 data on ARRY-520 in multiple myeloma patients.

Novo Nordisk issued a letter reminding healthcare professionals of important safety information about type 2 diabetes drug Victoza after a recent assessment showed that some primary care providers were not fully aware of the serious risks associated with its use. The pharmaceutical company issued the letter as required by the U.S. Food and Drug Administration’s Risk Evaluation and Mitigation Strategy. In its letter, the drugmaker warned that potential serious risks of thyroid C-cell tumors thyroid C-cell tumors, including medullary thyroid carcinoma, which was found in rats but could not be ruled out in humans. Additionally, in clinical trials studying Victoza, there were more cases of pancreatitis in patients treated with Victoza than in patients treated with comparators. Because of these risks, Victoza is not recommended as a first-line therapy for patients for who diet and exercise do not adequately control their blood sugar.