Legal

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.

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

Op-Ed: The best way to capitalize on the potential revenue influx from enterprise-level drug adherence programs is to create room at the executive table for a Chief Adherence Officer.

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?"

There’s a need, now more than ever, to balance complex regulations, rising consumer demand and shifting market realities, writes Graham Francis.

Amid a still-difficult environment for enforcing cannabis-related patents, this article explores some of the types of patent protection available for cannabis-based therapies and inventions.

The role of insurance and risk management in protecting middle-market distributors from the growing opioid multi-district litigation (MDL).

Pharm Exec convenes an expert panel at CBI’s Pharmaceutical Compliance Congress to discuss new ways to navigate the many complexities when it comes to the crucial task of assessing business and risk in the life sciences.

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

This article examines the key ways the new tax bill will impact the pharmaceutical industry.

Milana Chamberlain and George Cameron ask: is it time for pharma to start using human rights language?

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.

The case of Amgen v. Sandoz signals that preliminary injunctions will play major role in future patent disputes

Determining a company’s acquisition/merger value requires an intensive due diligence process. Attorney Gregg Metzger discusses salesforce contracts which, especially for life science companies, cannot be overlooked.

The looming shift to cross-border compliance in Europe puts the spotlight on the evolving role of chief compliance officers.

Inter Partes Review can potentially offer a more economical and streamlined litigation strategy for pharma and biotech players, writes David Dalke.

Long before a deal is signed in ink, a company's compliance and legal team should be involved in the vetting process, writes Severin Wirz.

As the pacing picks up around dealmaking as the alternative to organic growth, Pharm Exec brings together experts from big Pharma and biotech to dissect the road ahead for M&A, licensing, and partnership activity.

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

As small biotech firms test the water in partnerships with Big Pharma, the best calling card is a well-framed strategy on intellectual property.

Caronia decision shows the staying power of Sorrell v. IMS Health.

Courts across the country are making it easier to prove that a drug is unsafe, warning label notwithstanding.

Compliance officers have risen into management's highest ranks, by choice in some organizations, and by government decree in others. Either way, their importance as a strategic partner can hardly be understated.

IP must adapt to new ways of extracting value from assets the industry never knew it had, writes William Looney.