Legal

Tapping Compliance Data to Drive Success

August 10, 2020

ByXavier Duburcq

How pharma leaders can convert data collected for compliance purposes from a cost center into a critical success factor.

Culture and Compliance: Building a Culture of Business Ethics

July 08, 2020

ByJohn F. Crowley|Patrik Florencio

Pharmaceutical Executive

Amid the limitations of traditional compliance programs that emphasize control measures, here are steps biopharma companies can implement in their own cultures to ensure they’re behaving and performing with integrity.

What You Need to Know about the Drug Supply Chain Security Act

March 18, 2020

ByRob Besse

It is vital to begin asking questions about your company’s DSCSA readiness and compliance, as well as that of your strategic partners, writes Rob Besse.

Attacks on Pharmaceutical Improvement Patents

August 21, 2019

ByRobert L. Stoll|Nick Colic

Pharmaceutical Executive

Is Congress harming pharmaceutical research by limiting enforcement of improvement patents?

Identity Crisis: Data Protection Roles for Life Sciences Companies

January 07, 2019

ByJames Clark

James Clark addresses one of the key questions data protection and compliance officers are asking following the implementation of the General Data Protection Regulation -"What role am I playing under the GDPR?"

Curing Big Pharma’s Litigation Spend Woes with Data-Driven Medicine

October 04, 2018

ByDaniel Gold

Daniel Gold looks at the benefits of centralising an organization's data in a core repository and adopting a comprehensive business intelligence strategy.

Beyond the Merits: Generic Company Defense Strategies

June 22, 2018

ByJosh Reisberg

Josh Reisberg outlines the foundation of a broad, overall defense strategy for generic companies embroiled in Hatch-Waxman patent infringement litigations.

New Challenge to IP Innovation

August 31, 2016

BySteve Maebius

For generic firms, Inter Partes Reviews (IPRs) are a cost-effective way to clear out FDA Orange Book-listed patents before or during litigation; for originator companies, they pose a threat to valuable patent portfolios. Steve Maebius reports.

Cuozzo v Lee: How Many Bites at the Apple are Enough?

August 05, 2016

ByTraci Medford-Rosow and Peter C. Richardson

Having lobbied hard to have Inter Partes Review proceedings (IPRs) enacted, the tech industry may now be regretting what it wished for, write Traci Medford-Rosow and Peter C. Richardson.

Pay for Delay?

October 01, 2013

Pharmaceutical Executive

Europe follows the United States with a harsh new spotlight on agreements that slow generic entry for medicines losing exclusivity.