Life Sciences and Healthcare

FDA guidance recommends diversity in clinical trials for medical devices, but can’t require it

The FDA often stresses the importance of enrolling diverse patient populations in clinical trials conducted to support product applications — both in industry guidance documents and during interactions with product sponsors. In Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies, guidance released in September 2017, the FDA makes multiple […]

Modern tools to advance generic drug development and review

In news releases issued by the U.S. Food and Drug Administration (FDA), “firsts” always catch the eye. Because the majority of prescriptions in the U.S. are dispensed with generic medications, announcements of new “first generics” are especially noteworthy. These products are the first approval by the FDA that permits a manufacturer to market a generic […]

Life sciences licensing deals in the fourth quarter of 2017: updates and trends

During the fourth quarter of 2017, Cortellis Competitive Intelligence registered 1,107 new deals (excluding mergers & acquisitions) as part of its ongoing coverage of licensing activity in the life sciences sector compared to 1,043 in the third quarter and 1,035 in the fourth quarter of 2016.   High-value deals: worth $0.5 billion or more We […]

New blood pressure guidelines arrive: key takeaways for clinicians and patients

Towards the end of 2017, new guidelines on the appropriate range for blood pressure readings were released in a joint consensus between the American College of Cardiology and the American Heart Association. These guidelines recommend a decrease in the systolic and diastolic readings that constitute what a healthy blood pressure looks like and a re-categorization of elevated […]

Health technology assessment agencies play pivotal role in patient access to medicines

Timely recommendation for drug reimbursement by health technology assessment (HTA) agencies is critical to ensuring patient access to the medicines they need, a study by the Centre for Innovation in Regulatory Science (CIRS) has confirmed. As part of an ongoing effort to monitor regulatory and HTA performance, CIRS collected data on new active substances (NASs) […]

As biopharma innovation accelerates, partnering follows suit

Last year was a mixed bag for biopharma dealmaking, and not just by the numbers. Lofty valuations tamped down M&A, with buy-side companies also awaiting the outcome of U.S. tax reform. Oncology assets continued to rule, although first-in-class approvals actually showed a decline. And with orphan indications continuing to dominate drug development efforts, the biopharma […]

Steps taken to streamline regulatory processes in the Middle East

When the DIA’s Middle East Regulatory Conference convened in Kuwait late last year, an array of hot topics drew considerable discussion. The gathering, which brings together multiple stakeholders from multinational companies, local manufacturers and agents/distributors with representatives of health authorities from across the region, focused on verification/reliance procedures, lifecycle management, harmonization initiatives, pharmacovigilance, barcoding, serialization […]

Sublocade approval likely to be a game changer in the U.S. fight against opioid addiction

This article is a Clarivate Analytics Market Insight report, an ongoing series featuring expert reviews of hot topics in the pharma/biotech field, with analysis and discussion on the factors currently affecting the industry. Data leveraged for this analysis was gathered from Clarivate Analytics Cortellis. According to the latest National Survey on Drug Use and Health […]

Device Advice! The Value and Use of PRO Measures in Assessing Medical Devices

The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has issued its first report on patient reported outcomes (PRO) in premarket submissions and post market studies of medical devices . The report outlines the many steps that are being implemented by the FDA to meet the significant increase in PRO data […]