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Teva Pharmaceutical reported $460 million in earnings for the fourth quarter of 2006, reflecting a 51 percent increase from the $305 million posted in the same period a year earlier.
Sanofi-aventis has filed a patent infringement lawsuit in federal court to block the manufacturing and marketing of zolpidem tartrate, a generic version of its blockbuster sleep drug Ambien CR.
Federal investigators from the FDA’s Office of Criminal Investigations unexpectedly showed up Feb. 14 to conduct a full-scale search of Ranbaxy offices and a manufacturing plant in New Jersey, company sources said.
Motivated by lower co-payments for inexpensive alternatives to brand drugs, more Medicare Part D participants selected generic drugs to fill prescriptions covered by the drug benefit program last year than in 2005, according to new data from the Centers for Medicare & Medicaid Services (CMS).
The reintroduced “Access to Life-Saving Medicine Act,” a bill that would establish a clear and effective pathway for the FDA to approve generic copies of biologic drugs, may be attached to the Prescription Drug User Fee Act (PDUFA), congressional lawmakers said.
Members of the Senate Judiciary Committee unanimously approved Sen. Herb Kohl’s (D-Wis.) reverse-payment legislation — bringing the prohibition of that practice a step closer to becoming law.
While the generic drug industry expressed support for recommendations in the Bush administration’s proposed fiscal year 2008 budget that would speed up the approval process by collecting fees from manufacturers, the White House should focus on resolving key obstacles that impede bringing generic drugs to market, industry sources say.
A pathway for creating and marketing generic biologics could help health plan sponsors and patients save $71 billion over the next 10 years, according to an Express Scripts report.
Members of the Senate Judiciary Committee unanimously approved Sen. Herb Kohl’s (D-Wis.) reverse-payment legislation — bringing the prohibition of that practice a step closer to becoming law.