Pfizer submits regulatory application for rheumatoid arthritis drug to FDA
NEW YORK — Pfizer is seeking approval from the Food and Drug Administration for its investigational treatment of moderately to severely active rheumatoid arthritis.
The company said the FDA accepted a new drug application for tofacitinib for review. The agency also has provided an anticipated Prescription Drug User Fee Act action date of August 2012. Tofacitinib, which is a novel, oral JAK inhibitor, currently is under review by the European Medicines Agency.
“Pfizer is pleased to have achieved this regulatory milestone, which reflects our commitment to advancing treatments for inflammatory conditions, and constitutes a significant step toward bringing tofacitinib to RA patients who are in need of additional therapeutic options,” said Geno Germano, president and general manager of specialty care and oncology at Pfizer. “We are proud of the comprehensive phase-3 clinical program that we have completed and believe that, if approved by the FDA, tofacitinib has the potential to improve the lives of people with RA.”
Prescription drug access remained stable between 2007 and 2010, study finds
WASHINGTON — One-in-eight Americans didn’t fill prescriptions last year because they couldn’t afford to, but despite difficulties with the economy, that proportion remained level, according to a new study conducted by the Center for Studying Health System Change and funded by the Robert Wood Johnson Foundation.
The study, which tracked 17,000 Americans’ access to prescription drugs between 2007 and 2010, found that low-income people, those without insurance, those in fair or poor health and those with multiple chronic conditions continued to have the most serious problems with access to prescription drugs. Meanwhile, uninsured, adults between the ages of 19 and 64 saw a "significant" decrease in unmet prescription drug needs, from 35.9% in 2007 to 29.4% in 2010, the study found, but one reason was likely that fewer people without insurance reported visiting a healthcare provider in 2010 than in 2007. For elderly people eligible for Medicare and Medicaid, prescription drug access problems dropped from 21.7% in 2007 to 8% in 2010, after doubling between 2003 and 2007.
"About one out of two uninsured people in fair or poor health couldn’t afford a prescription drug in 2010, almost double the rate of insured people in the same health," study coauthor and health research analyst Ellyn Boukus said.
Valeant launches hostile takeover bid for ISTA
MISSISSAUGA, Ontario — Drug maker Valeant Pharmaceuticals has launched a hostile takeover bid for ISTA Pharmaceuticals, the company said.
The company announced Friday the offer of $6.50 per share for ISTA, an Irvine, Calif.-based maker of eye drugs. ISTA stock had a closing price of $3.89 per share on Thursday.
Valeant originally offered to acquire ISTA on Dec. 2, but ISTA’s management rejected the deal last Wednesday. Valeant noted that its offer represented a 68% premium over ISTA’s 60-day trading average, and ISTA had a net debt of $13 million that brought its total enterprise value to about $327 million.
"We would be willing to consider improving our offer price if we were allowed to conduct due diligence and found additional value," Valeant chairman and CEO J. Michael Pearson said. "Given the importance of the proposed transaction to shareholders of both companies, we have decided to make our proposal public."