FDA panel recommends approval for Pfizer RA drug
NEW YORK — A Food and Drug Administration expert panel has recommended approval for a drug made by Pfizer for treating rheumatoid arthritis.
Pfizer announced that the FDA Arthritis Advisory Committee voted 8-2 to recommend that the agency approve tofacitinib for moderately to severely active RA. The agency is not required to follow the recommendations of advisory committees, but usually does, and is expected to decide whether or not to approve the drug in August. Pfizer said that, if approved, tofacitinib would be the first new disease-modifying antirheumatic drug for RA in more than 10 years and the first RA treatment in a new class of medicines known as Janus kinase, or JAK inhibitors.
"We are pleased with the committee’s positive evaluation of the tofacitinib data and its decision to recommend approval," Pfizer Specialty Care SVP and head of the medicines development group Yvonne Greenstreet said. "The RA patient population needs additional treatment options, and Pfizer looks forward to working with the FDA on next steps as it completes its review of the tofacitinib application."
Mylan boosts EPS guidance
PITTSBURGH — Mylan has increased its 2012 earnings per share guidance range, the generic drug maker said.
The company boosts its EPS guidance range to $2.45 to $2.55 in adjusted diluted earnings per share, up from $2.30 to $2.50 per share. All of Mylan’s other 2012 guidance metrics remain unchanged.
In related news, Mylan also announced that its board of directors has approved the repurchase of up to $500 million of the company’s common stock in the open market.
"As we have said previously, we expect 2012 to be the best year to date in Mylan’s history. The increase in our guidance is a result of our continued strong operational performance," Mylan CEO Heather Bresch said.
NCPA ends Legislative Conference with congressional rally
ALEXANDRIA, Va. — The National Community Pharmacists Association wrapped up its three-day NCPA Legislative Conference Wednesday with a rally, the association announced.
Speakers at the rally included Sen. Mark Pryor, D-Ark., the original sponsor of the Pharmacy Competition and Consumer Choice Act (S. 1058); Rep. Tom Marino, R-Pa., the original sponsor of the Preserving Our Hometown Independent Pharmacies Act (H.R. 1946); Rep. Peter Welch, D-Vt., the original sponsor of the Medicare Access to Diabetes Supplies Act (H.R. 1936); as well as Sen. Roger Wicker, R-Miss.; and Reps. Judy Chu, D-Calif., and Ruben Hinojosa, D-Texas.
“Independent community pharmacists offer vital health care services to millions of patients across America that could be compromised without passage of S. 1058, H.R. 1946, and H.R. 1936,” NCPA CEO Douglas Hoey said. “These common-sense, bipartisan bills will rein in some of the most egregious behavior of pharmacy benefit managers help level contract negotiations between [pharmacy benefit managers] and pharmacies and ensure seniors can continue receiving essential diabetes testing supplies and face-to-face counseling from their local pharmacies," he said. “After our rally we will flood the halls of Congress to deliver our message, spurred on by the support we are receiving from Sen. Pryor, and Reps. Marino and Welch. They know independent community pharmacies are often in underserved rural and urban communities, and the bills they are championing will ensure the continuum of health care is preserved in those and other communities.”
During the previous two days Legislative Conference attendees also heard from Reps. Dave Camp, R-Mich.; Frank Pallone, D-N.J.; and Aaron Schock, R-Ill.; and Sens. Jerry Moran, R-Kansas; Al Franken, D-Minn.; and Sherrod Brown, D-Ohio. Jonathan Blum, deputy administrator and director for the Center for Medicare, Centers for Medicare and Medicaid Services and Colonel George Jones Jr., deputy chief pharmaceutical operations directorate for Tricare Management Activity, also spoke.
In addition there were panels on the Federal Trade Commission’s PBM-related decisions, efforts to combat pharmacy crimes and the challenges facing long-term care providers. Another highlight was a comprehensive media briefing with NCPA’s leadership team and Rep. Cathy McMorris Rodgers, R-Wash., who is co-chair of the Community Pharmacy Caucus.
“The Legislative Conference certainly achieved its goal of providing our members an opportunity to both hear from and advocate with members of Congress,” Hoey said. “They know the best way to address the questionable business practices of the PBM industry is through grassroots activism in support of pro-patient reforms.”