Category Archives: Legal

FDA Takes First Amendment Issues "Seriously"

Several legal cases have challenged the Food and Drug Administration’s approach to regulating industry communications about medical products, and agency officials now are acknowledging the importance of addressing these developments head-on. In the wake of U.S. v. Caronia and IMS v. Sorrell, the spotlight is on speech-related activity, including product labeling and advertising and promotion […]
Also posted in FDA, Op-Ed | Tagged , , , | Leave a comment

The United Kingdom: Rx for America's Pharma Tax Blues?

by Tom Norton The dizzying flurry of press releases from both Pfizer Inc. and AstraZeneca over a possible PFE acquisition of AZN have Rx experts on both sides of the Atlantic buzzing… From the US side, the most frequent thing that I have heard over the last 48 hours is, “You have got to be […]
Also posted in Corporate Responsibility, Deals, Europe, FDA, Global, Guest Blog, leadership, People, Strategy | Tagged , , , , , , , , | 1 Comment

Medicare Payment Data Raises Questions About Drug Costs

Even though the just-released Medicare data on payments to individual doctors doesn’t provide specifics on prescription drug outlays, it opens the door to sharp scrutiny of Medicare reimbursement for medicines delivered in physician offices. The Centers for Medicare and Medicaid Services (CMS) has released data on payments to some 880,000 health care providers who collectively […]
Also posted in healthcare, pricing, Regulatory | Tagged , , , | Leave a comment

After Delays, Project DataSphere Rolls Out

An industry and academic data-sharing project went live on Tuesday, nearly a year after the platform was expected to launch. Visitors to the site – no credentials needed – can register and access de-identified clinical data from the comparator arms of nine oncology trials, with more to come. Project DataSphere, the newest data transparency and […]
Also posted in Biotech, Corporate Responsibility, Europe, FDA, Global, IP, leadership, R&D, Strategy, Technology | Tagged , , , , , , , , , | Leave a comment

Drug-Diagnostic Development Stymied by Payer Concerns

The shift to personalized medicine, which supports medical treatment tailored to individual patient characteristics, has been hindered by uncertainty over the value, accuracy and clinical utility of companion diagnostic tests. Even for the handful of drugs approved by the Food and Drug Administration with labeling that links prescribing to specific biomarker measures, health plan operators, […]
Also posted in FDA, Gene therapy, Market Access, R&D, Regulatory, Technology | Tagged , , , , , , , , , | Leave a comment
  • Categories

  • Meta