Industry news

Rules of the PAP road not always clear, even to seasoned travelers

Marie Powers / BioWorld

As a veteran health care journalist, I appreciate the need for biopharmas to recoup R&D costs and to operate profitably, so it’s hardly surprising to me when newly approved drugs are priced at a premium. But I’m also a consumer and a caregiver. In the context of those roles, the convoluted prescription drug supply chain with its multitude of handoffs seems purposely designed to obscure the true cost of branded drugs and, in turn, the true value of patient assistance programs (PAPs).

The Evolution of Regulatory Operations

Michael Gordon / PharmExec.com

Two decades of growth and evolution have put regulatory operations (reg ops) on the map as a pivotal entity in global life sciences companies, leading cross-functional collaboration to deliver R&D’s primary output – product data – to R&D’s pivotal customer (health authorities globally) while keeping up with an ever expanding set of complex regulations to support patient benefit and commercial goals.

Content Marketing’s Data Fail: Information Without Insight?

Ben Locwin / PharmExec.com

A recent conference on content marketing encapsulated what has been a growing problem in efforts to glean insights from today’s swell of healthcare information: An astounding number of statistics were presented with no context, along with infographics with much more focus on the visuals and little picture elements, and no scrutiny on the totality of erroneous and misrepresented data.

25 October 2016

Epic Sciences to Contribute to Cancer Moonshot Blood Profiling Atlas

Epic Sciences in collaboration with other industry, academic, and government partners will contribute to the Blood Profiling Atlas pilot of the Cancer Moonshot Initiative championed by Vice President Biden and the White House. The Blood Profiling Atlas seeks to create an open database of results from liquid biopsy tests to accelerate the development of safe and effective blood profiling diagnostics for patient benefit.

UK aims to cut four years from drug development process

PharmaPhorum

The government has published its long-awaited Accelerated Access Review, a report that aims to cut up to four years from the process that gets a drug from the lab to use on England’s National Health Service.

The Importance of Stakeholder Research in Rare Disease Drug Development

Fierce Biotech

The approval of novel orphan drug designations continues to grow, while many existing rare disease therapies are receiving approval for expanded indications. With this increase and broadening class of products, including some that target the same mutation or molecular defect, sponsors face new and significant market access challenges in securing reimbursement.

US and Europe Collaborate on Patient Treatments

In an Oct. 18, 2016 FDAVoice blog post, Jonathan C. Goldsmith, MD, associate director of FDA’s Rare Diseases Program in the Center for Drug Evaluation and Research’s (CDER) Office of New Drugs, and Sandra Kweder, MD, deputy director of FDA’s Europe office and liaison to the European Medicines Agency (EMA), expressed their excitement over FDA’s collaboration with EMA to advance treatments for rare diseases and engage with patients.

Patients covered by government programs need not apply

Mari Serebrov / BioWorld

When Mylan NV tried to put out the public outcry over its latest hike in the Epipen price by expanding its patient assistance programs (PAPs), U.S. lawmakers weren't impressed. "PAPs seem like a playbook all [drug] companies are using instead of coming down on the price," Rep. Elijah Cummings (D-Md.) responded last month to Mylan CEO Heather Bresch's testimony before the House Oversight and Government Reform Committee about the Epipen price increases. 

Patient assistance programs keep growing and changing to meet demand

Michael Fitzhugh / BioWorld

The rise of a complex and lucrative specialty drug market in the U.S. has created not only new opportunities for drugmakers, but also new challenges. With a significant portion of care shifting from in-patient to out-patient settings and insurers tightening the reins on specialty drug coverage, drugmakers have turned to patient assistance programs (PAPs) to help them succeed.

PAPs valuable but increasingly ensnared in drug pricing predicament

Marie Powers / BioWorld

Millions of U.S. consumers hear and read those words every day in direct-to-consumer (DTC) ads from the London-based pharma and similar verbiage from its cohorts. Copay assistance, discounted pricing and free medications for those who qualify are hallmarks of the biopharma industry's ubiquitous patient assistance programs (PAPs), which also encompass services such as insurance reimbursement support, counseling, genetic testing, health care classes and certain devices.