Life Sciences and Healthcare

Identifying risks in drug discovery

It is estimated that for every eight active substances entering Phase I clinical trials, only one product is approved and marketed.[1] The low success rate for clinical trials is largely driven by poor efficacy in humans and adverse events leading to the discontinuation of a drug development research program.[2] Findings related to the inherent properties […]

Which Exchanges Will UnitedHealth Enter in 2021?

On May 12, 2020, UnitedHealthcare announced that it filed to offer individual health plans in Maryland for 2021, and more announcements should be forthcoming UnitedHealth Group generated a buzz in its 2020 first quarter earnings call by revealing intentions to reenter health insurance exchanges in 2021. The insurer has a short history of offering plans […]

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 […]

The European MDR: Impetus, Impacts, And Current Status

In May 2017, the European Medical Devices Regulation (MDR), approved by the European Council and European Parliament earlier that year, came into force, setting the stage for its application. Initially set as May 26, 2020, the MDR DoA was postponed one year in April 2020 in response to the COVID-19 pandemic. The regulation was introduced […]

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 […]

Drug repurposing for rare disease treatment leads to reduced risk

Director of the Drug Discovery Platform of Parc Científic Barcelona, Jordi Quintana and his team secured funding to investigate a rare disease, amyloidosis. They set out to study a subset of the disease called familial amyloid polyneuropathy. Because of the rare nature of the disease and the limited patient base, traditional drug discovery and development […]

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 […]