Popular reports
Breakthrough Therapy Designation: Paving the Way for Innovation$499.00With the passage of the FDA Safety and Innovation Act of 2012 (FDASIA), the Breakthrough Therapy Designation (BTD) was introduced as the newest mechanism to facilitate expedited development and review. Here we provide an overview of the BTD pathway and its evolution over the past three years.
U.S. Markets for Pharmacologic and Device-Based Approaches to Pain Management$4,750.00More than 40% of people in the U.S. say they have experienced recent pain, with 8% suffering from chronic pain. Direct healthcare costs associated with the treatment of pain total nearly $300 billion annually.
Brexit and the life sciences: What lies ahead?$700.00The UK’s surprise decision to leave the EU has caused a great deal of uncertainty about the country's future, not least among those working in the UK biopharmaceutical and broader life sciences industry.
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PD-1/PD-L1 Inhibitors: The First Major Wave of Immuno-Oncology$7,500.00Since Opdivo (nivolumab; Bristol-Myers Squibb/Ono Pharmaceutical) first gained Japanese regulatory approval for the treatment of metastatic melanoma in July 2014, programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) inhibitors have grown to become the leading class of immunotherapies in oncology worldwide.
Pharma-Payer Partnerships in Emerging Markets$5,000.00Payer partnerships are becoming widespread as emerging markets become wealthier, but access challenges remain. Partnerships with proven success include “strategic philanthropy,” patient access programs, tiered pricing, and service support models.
Regenerative Medicine Landscape$5,000.00The competitive landscape for regenerative medicine continues to evolve. As private sector investment in active players continues, efforts by governments in the US and EU are helping to advance the field, including the recent passage of the 21st Century Cures Act in the US, providing a special status pathway for regenerative medicine advanced therapies.
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