February 14th 2025
Approval of Adcetris provides a new treatment option for patients with relapsed or refractory large b-cell lymphoma who are ineligible for autologous stem cell transplantation.
February 13th 2025
Kid Tested, Government Approved?
May 1st 2007As the industry focuses its attention on the upcoming renewal of the Prescription Drug User Fee Act (PDUFA), there is a tendency to overlook two other significant pharmaceutical programs coming up for renewal and a related piece of legislation that has been introduced:
Critical Mass for Critical Path?
May 1st 2007Innovation in science is no quick trick, and neither is collaboration. Back in March 2004, FDA sounded a now-famous alarm: Despite the drug industry's 250 percent jump in spending on R&D, drug-development productivity had plunged by 50 percent over the previous decade. The report, which became known as the Critical Path Initiative (CPI), last year yielded an industry-wide call to arms regarding 76 action items (aka, the "Opportunities List") in six key areas: biomarker development, the streamlining of trials, the harnessing of informatics, improving drug manufacturing, public health initiatives against infections and bioterrorism, and special programs for adolescents, children, and other at-risk populations.
Get a Grip on the Supply Chain
April 1st 2007The Sarbanes-Oxley Act-or SOX, as it is dubbed (not always so affectionately)-requires companies to provide greater control and quality assurance across a vast spectrum of business processes. In practice, SOX plays out differently industry by industry and even company by company. But for pharma, one of the most pressing consequences is the need to improve the accuracy of revenue recognition.