Category Archives: Regulatory

Allergy Shots in a Pill?

Allergy season’s dank fecundity might be welcomed in many parts of America this year. Anything that’s warmer. But the worst allergy sufferers might soon be headed back to the doctor’s office for another round of allergy shots. Or perhaps not. ALK-Abelló, a Denmark-based specialty pharmaceuticals company focused solely on allergy immunotherapy products, expects FDA to […]
Also posted in Biotech, Europe, FDA, R&D, Strategy, Technology | Tagged , , , , , , , , , | Leave a comment

FDA, Sponsors Seek Study Endpoints Earlier in Development

As payers demand more evidence documenting medical product value, biopharma companies are responding by moving sooner to decide key clinical outcomes to measure. While clinical trials still have to document product safety, efficacy and quality, sponsors also look to demonstrate suitability for formulary placement and reimbursement. Food and Drug Administration officials support these strategies to […]
Also posted in FDA, Marketing, R&D, Strategy | Tagged , , , , | 1 Comment

Adaptive Licensing: The Start of a Slow Revolution in Europe

By Peter O’ Donnell. So at last it’s happened. Adaptive licensing has leapt from the pages of learned journals into the real world of European regulation. Is this the beginning of the end of binary decision-making on the merits of a new medicine? Has a half-century of the “yes/no” authorization process peaked, to be replaced […]
Also posted in Europe, Global, Guest Blog, Op-Ed, R&D, Safety | 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, Legal, Market Access, R&D, Technology | Tagged , , , , , , , , , | Leave a comment

Europe Approves First Medicine for Castleman's Disease

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Sylvant (siltuximab) for adult patients with multicentric Castleman’s disease.
Also posted in Europe, Global, Orphan Drugs | Tagged , , , | 2 Comments
  • Categories

  • Meta