Opinion &amp; analysis

Roche’s External Control Arms Show What Real-World Evidence Can Look Like In Practice

Roche is leading the charge in the emerging field of using real-world evidence (RWE) with its recent acquisition of Flatiron Health, Inc. and Flatiron’s electronic health records database. Take a closer look at the use of RWE in actual practice in this illuminating article from Pink Sheet.

June 14, 2018

Novartis CEO Explains Delay In Telling US FDA About Zolgensma Data Fraud: We Wanted To Understand It First

Novartis AG tried to squash any murmurings that it had a disreputable intent in not disclosing the data fraud it knew about before approval of its gene therapy Zolgensma, saying the company wanted a full understanding of the issue first before bringing it to the attention of regulators. In a recent conference call with analysts, Novartis execs were bombarded with questions about their “prescribed process” of internal investigation, and when exactly they knew about the fraud. Find out how the pharma giant is handling such close scrutiny, how they are dealing with the AveXis scientists involved in the “data inaccuracies,” and the recent EMA decision to downgrade Zolgensma’s accelerated assessment.

August 2, 2019

Big Pharma CEOs Get Ready To Testify: Preparing For A No-Win Situation

Leading pharmaceutical executives called to testify before a Senate Finance Committee hearing on drug prices were likely the first of many to be summoned. It’s a no-win situation, but preparation can help. Find out why changing the subject can be a smart tactic. Discover how some senators may try to lure execs into inadvertently lying–and learn how to avoid it.

May 13, 2019

Novartis’ Zolgensma Had Manipulated Data In Application, US FDA Says

The gene therapy Zolgensma will remain on the market, but Novartis and subsidiary AveXis Inc. may face civil or criminal action after revelations by the FDA that data used for approval had been manipulated. In fact, the drug giant knew about the problem months before Zolgensma was approved and said nothing. Learn what happened, why the FDA still asserts confidence in its approval of Zolgensma, and what these events could mean to Novartis and the gene therapy industry moving forward.

August 3, 2019

Pharma’s New R&D Models: Federating Innovation

As ROI across R&D investments in big phama declines, companies look for new and innovative ways to access and nurture innovation via partnerships and through the use of new data types. In the process, the business models, products, and role of big pharma in healthcare is changing.

June 20, 2018

Office Of New Drugs Reorg Is Bigger Than Expected: US FDA Adds 11 Review Divisions

Changes are coming to the structure of the FDA’s Center for Drug Evaluation and Research division the Office of New Drugs. This long-planned reorganization is still in the nascent stages, but expected to bring a more modern approach that, along with IT improvements and other streamlined processes, will make drug reviews more efficient.

June 4, 2018

Ranbaxy Brothers Arrested, Downward Spiral Intensifies

With the Singh brothers of Ranbaxy being arrested over allegations of financial fraud, Scrip looks at the history of issues at the company and how things appear headed even further downhill with Daiichi Sankyo also separately pursuing enforcement of damages against the brothers.

September 2, 2019

Real-World Evidence Takes Courage: A Conversation With IQVIA’s Nancy Dreyer

The 21st Century Cures Act’s call for the use of real-world evidence (RWE) is slowly moving toward reality. But hurdles abound, warns IQVIA’s Nancy Dreyer. For instance, the FDA–which is behind the EMA in this area–appears split. Privacy concerns and lack of interoperability hinder progress. Learn why this sometimes-muddied distinction between randomized clinical trial data and RWE is so important, and find out RWE’s role in label expansions.

February 11, 2019

European Commission Highlights Medtech Notified Bodies Giving It Cause For Concern

With higher standards and new, demanding regulations for EU notified bodies, six notified bodies have been called into question by the European Commission. All are listed with warnings on the Commission’s Nando database. Some of those six offer testing in other medtech directives, and in those other directives, they remain competent.

August 2, 2019

CMS Actively Looking For New Reimbursement Pathway For Innovative Devices

The US Centers for Medicare and Medicaid Services (CMS) say they are seeking to improve medical devices reimbursement procedures as the device industry looks for a policy to help breakthrough devices receive temporary and automatic Medicare and Medicaid coverage. Read more here.

September 28, 2018

ASCO 2018: Optimism As Industry Resets And Looks To What Is Next

The tone of the 2018 ASCO annual meeting was one of regrouping, resolve, and refinement that may have left investors apathetic, but signaled a commitment to getting it right going forward to those in pharma. Examine the key takeaways from ASCO 2018.

June 4, 2018

EMA To Re-Prioritize Tasks To Cope With ‘Higher Than Expected’ Staff Losses

Although original estimates put staff losses at the European Medicines Agency at about 19% due to the EMA’s relocation from London to Amsterdam, the EMA reports that these losses may actually be much higher, forcing the agency to take a hard look at its most pressing priorities moving forward.

June 8, 2018

What Should You Be Earning? Salary Benchmarks And Hiring Trends In Regulatory Affairs

Tap into the findings of the latest Regulatory Affairs Professionals Society Overall Compensation & Scope of Practice Survey, a comprehensive study of the salaries, hiring trends, and other noteworthy data for regulatory professionals in 64 countries around the globe.

October 12, 2018