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Drugmakers spent $155 million lobbying Congress between January 2005 and June 2006, trying to influence legislation on Medicare, drug importation and patent protection, according to a study by The Center for Public Integrity.
As Capitol Hill contemplates proposed legislation to establish approval mechanisms and analytical processes at the FDA to facilitate biogeneric entry, biotech firms are urging federal lawmakers to reject assertions in two highly publicized studies that claim follow-on biologics would save billions in healthcare costs.
The Biotechnology Industry Organization (BIO) is praising President Bush’s proposed fiscal 2008 budget, but requested that Congress increase funding for the FDA.
The SEC has agreed Aug. 9 to give smaller public companies additional time to comply with the internal control requirements under the Sarbanes-Oxley Act (SOX), prompting the Biotechnology Industry Organization’s (BIO) praise.
The SEC has taken another step toward reforming its Sarbanes-Oxley (SOX) reporting and auditing requirements by requesting public comments on proposed changes.
The SEC has taken an intermediate step in its effort to reform Sarbanes-Oxley (SOX) reporting and auditing requirements by requesting public comments on proposed changes.
More venture capital-backed biotech firms could become eligible for federal research funding under a compromise being worked out by Senate Republicans.
A provision in pending legislation granting extended market exclusivity for drugs used to address potential bioterrorism threats could undercut current law, is unnecessary and must be removed, patient advocates say.
Sandoz’s generic human growth hormone Omnitrope has finally been approved by the FDA after a nearly three-year delay, making it the first follow-on biologic approved under the 505(b)(2) statute of the Federal Food, Drug and Cosmetic Act (FDCA).
In a citizen petition opposing FDA approval of Sandoz’ follow-on human growth hormone Omnitrope, biotechnology firm Genentech asked the agency to notify drugmakers of any potential use of their drugs’ safety and efficacy data, a move that would stymie the agency’s efforts to draft a guidance for the manufacture of follow-on biologics.