Latest

House Committee Approves 21st Century Cures Legislation

May 21, 2015: House Energy and Commerce Committee approves the landmark 21st Century Cures Act reform bill.

Gilead Honored at Pharm Exec Brand of the Year Event

The company picked up the Pharm Exec Brand of the Year award last week at the iPharma event in New York.

New & Noteworthy

Regulatory Dark Horse? EU Directive on Cross-Border Patients’ Rights

Reflector looks at the revitalized European Union directive on patients’ rights in cross-border healthcare.

Refuting R&D Tax Credit Myths

Why executives should make the US R&D tax credit part of their planning discussions.

What Does the UK's "New" Government Mean for the Industry?

Following the Conservatives surprise majority win in the UK election, Leela Barham asks what does it mean for pharma?

Multiethnic Marketing: The Billion-Dollar Upside

Tapping into the fast-growing and lucrative “multicultural” segment requires new and more aggressive approaches to brand planning and consumer engagement, writes Steve Millerman.

From the Editor

From Care to Cure

This year's Pharm Exec Brand of the Year is a huge game-changers, but the big-picture impact will come down to pricing, distribution, and the broader goal of making sure that those patients who need the cure, get the cure, writes William Looney.

The New Health: Navigating with Nash

Learnings gleaned from our annual EAB meeting, hosted this year by Dr. David Nash, Dean of the Thomas Jefferson University School of Population Health.

Is There Gold in the DNA Selfie?

Pharma jumps on board personal genomics train—at least for test drive—but will journey ultimately help transform treatment or stall out as just another fad?

Europe

NICE Proposes Office of Market Access

NICE's proposed Innovation Office emerges with a new name. Leela Barham reports.

Regulatory Dark Horse? EU Directive on Cross-Border Patients’ Rights

Reflector looks at the revitalized European Union directive on patients’ rights in cross-border healthcare.

New European Guidelines Tackle Controversial HTA Components

EUnetHTA has developed guidelines to help “set a general framework for EUnetHTA on how to conduct economic evaluations”, arguably HTA's most controversial element. Leela Barham reports.

Global

Regulatory Dark Horse? EU Directive on Cross-Border Patients’ Rights

Reflector looks at the revitalized European Union directive on patients’ rights in cross-border healthcare.

Sunshine Over Europe: Event Sheds Light on Disclosure

Sunshine was a strong feature of this week's CBI’s Global Transparency Reporting Congress in London, in more ways than one.

The Goods and Services Tax: A Bane or a Boon for Indian Pharma?

Dr. Anuj Gupta explains the potential implications of the GST— or the goods and services tax — on Indian pharma.

PEspeaks

Manufacturers Continue to Fight Over Biosimilar Naming

After hearing “strong views” on the issue, FDA is expected to release biosimilar-naming guidance later this year.

FDA's Califf Seeks New “Ecosystem” for Clinical Trials

Current clinical trials are regarded as “too slow, too expensive, not reliable, and not designed to answer the important questions,” according to FDA’s new deputy commissioner for medical products &tobacco, Robert Califf.

NICE Proposes Office of Market Access

NICE's proposed Innovation Office emerges with a new name. Leela Barham reports.

Regulatory Dark Horse? EU Directive on Cross-Border Patients’ Rights

Reflector looks at the revitalized European Union directive on patients’ rights in cross-border healthcare.

News Update

House Committee Approves 21st Century Cures Legislation

May 21, 2015: House Energy and Commerce Committee approves the landmark 21st Century Cures Act reform bill.

Regulatory

Manufacturers Continue to Fight Over Biosimilar Naming

After hearing “strong views” on the issue, FDA is expected to release biosimilar-naming guidance later this year.

New European Guidelines Tackle Controversial HTA Components

EUnetHTA has developed guidelines to help “set a general framework for EUnetHTA on how to conduct economic evaluations”, arguably HTA's most controversial element. Leela Barham reports.

Pharma Gains Marketing Flexibility, Loses Exclusivities in Revised “Cures” Proposal

The revised Cures proposal makes it easier for pharma to distribute journal articles and medical textbooks to physicians, but it also drops provisions that provided added exclusivity for certain new therapies.

Sales & Marketing

"There's a Cure for That..."

Cures and therapies with curative intent are here in hepatitis C and are imminent in other serious diseases. So what does this mean for pharma stakeholders, from suppliers to patients, asks Mike Rutstein.

Opposites Attract: Pairing R&D and Commercial Teams

Meike Wenzel and Clifford Hall examine a new concept for early commercialization planning to facilitate good cross-functional working practice.

Data is Now the Key to Marketing

Neil Gleghorn, looks at the upsurge of technology and metric-driven marketing operations in the strictly regulated pharmaceutical industries.

R&D

Refuting R&D Tax Credit Myths

Why executives should make the US R&D tax credit part of their planning discussions.

Pharmacies — A New Patient Education Opportunity

Kenneth Getz of the Tufts Center for the Study of Drug Development looks at leveraging pharmacists as a channel to raise clinical research literacy among patient communities.

Strategy

Capturing the Cloud: A Conversation with Veeva Systems Matt Wallach

Pharm Exec talks to Matt Wallach, President of upstart start-up, Veeva Systems

Opposites Attract: Pairing R&D and Commercial Teams

Meike Wenzel and Clifford Hall examine a new concept for early commercialization planning to facilitate good cross-functional working practice.

Is Procurement Living Up to the Challenge?

Mike Straw offers four key changes to address the "lack of love" for pharmaceutical procurement functions.