Biopharma

Celebrating 30 years of BioWorld

BioWorld™ has built an enduring relationship with everyone in the drug development and medical technology sectors. As we celebrate our 30th anniversary, we reflect on how the publication has changed over the years to accommodate shifts in media consumption and industry needs.   BioWorld has built an enduring relationship with everyone in the drug development […]

2019 trends in regulatory approvals of new medicines

A study by the Centre for Innovation in Regulatory Science (CIRS) has identified trends in approvals of New Active Substances (NASs) by six major regulatory authorities1 , focusing on 2019 as well as the period from 2010 to 2019. In addition to tracking the number of approvals and the time to approval, the study also […]

COVID-19 Complicates Value-Based Care

Value-based care contracts are adding a layer of complexity for provider organizations impacted by COVID-19. As part of these contracts, provider organizations often assume financial risk for commercial, Medicaid, or Medicare patients, in addition to responsibility for meeting quality benchmarks. Potential impacts of the pandemic on provider organizations engaged in value-based care arrangements include: Cost […]

COVID-19 Brings Seismic Shifts to Future Healthcare Delivery

The coronavirus pandemic is rapidly reshaping the way patients access care and the strategy of healthcare providers treating those patients. The situation echoes other recent national seismic shifts —the Great Recession and Affordable Care Act—that drove changes like increased healthcare consolidation and value-based care. Patients, many reluctant to seek care at medical facilities or even […]

Applying regulatory flexibility in the age of COVID-19

A study by the Centre for Innovation in Regulatory Science has found that there are numerous regulatory routes that can be used to assess and authorise medical products during a public health emergency or pandemic. Although yet to be used extensively, these Emergency Use Pathways (EUPs) offer the regulatory flexibility needed to ensure that medical […]

Key Disruptors in The Multiple Myeloma Landscape: 2020 and Beyond

Accelerated innovation in drug design and development is providing diverse treatment options for cancer patients, including hematological malignancies, like multiple myeloma. However, innovation has complicated physicians’ therapy selection and decision making, including how best to sequence treatment across lines of therapy. Thereby contributing to an unmet need for indications like multiple myeloma, that are typically […]

Four NMEs Hope to Keep Up Momentum in the U.S. Migraine Market

For these new entrants, differentiation is evident but access is critical – and each faces market headwinds. 2018 marked a turning point in the U.S. migraine market with the launch of three anti-CGRP monoclonal antibodies (MAbs): Novartis/Amgen’s Aimovig, Teva’s Ajovy, and Eli Lilly’s Emgality. Not only did these products become the first migraine-specific drugs approved […]

Synergy Between AI and Digital Platforms for PBMs; Driving Value-Based Programs

Both CVS Health and Express Scripts have recently expanded value-based care programs aimed at improving patient outcomes and reducing the high costs for treatments associated with oncology and cardiovascular disease, respectively. PBMs and payers believe that with seamless access to patient data, new technology such as artificial intelligence and predictive analytics will be critical in […]

The COVID-19 pandemic: European regulators respond

The COVID-19 pandemic is spreading around the world with, as of this writing, more than one million cases globally and more than 500,000 cases in Europe alone. Here we summarize how The European Medicines Agency (EMA) as well as the European Commission (EC), the Heads of Medicines Agency (HMA) and the European Center for Disease […]

Combating COVID-19: Insights from the BIO Europe conference

The Cortellis team regularly attends industry conferences to provide summaries, updates and insights on what’s happening across the life sciences R&D landscape. Here we summarize select proceedings from the spring BIO Europe Conference.*  In the wake of the coronavirus COVID-19 (SARS-CoV-2) pandemic and a lockdown on worldwide travel, the 14th Annual BIO-Europe Spring Partnering meeting […]