Regulatory

Excitement over more new treatments for cancer and rare diseases is offset by cringing over prices.

Value frameworks are now "sexy". In the US, no fewer than five have emerged since around 2015. Leela Barham discusses how the value assessment landscape is evolving.

The UK's proposed Accelerated Access Review is being dogged by delay and disappointment, writes Leela Barham.

The Association of the British Pharmaceutical Industry has sought permission for a Judicial Review of the National Institute for Health and Care Excellence’s unpopular changes to tackle drug affordability.

The FDA's Mary Ann Slack outlines how the Agency is working to adopt electronic practices by initiating efforts to simplify the submission process for new drug and generic drug applications.

With the US Institute for Clinical and Economic Review (ICER) looking like it is here to stay, Leela Barham considers how its value framework is evolving.

In the second of her articles on US value assessment, Leela Barham reviews the emergence of multiple frameworks and looks at their potential impact.

To gain better alignment of coverage and risk, evidence-based arguments are critical during the underwriting process.

Three messages that resonated from this year’s annual meeting of the Drug Information Association.

The FDA ruling that exempts biosimilar makers from waiting an extra six months after approval to distribute a new product should help overcome delays in future biosimilar sales, writes Jill Wechsler.

Last week’s EFPIA and EU Health Council annual conferences highlighted the growing divisions-and resentments-between industry and governments on drug pricing. Reflector reports.

Congressional measures lack the support to move forward, writes Jill Wechsler.

A look at evidence and value in a time of social and policy change.

In the 21st Century Cures Act, Congress excluded from FDA regulation certain clinical decision support, or CDS, software.

Analysts who spoke with Pharm Exec expect the online retail giant to enter the pharma space within the next two years.

The Center for Biologics Evaluation and Research is gearing up to facilitate the development and approval of regenerative medicine advanced therapies (RMAT), as defined by the 21st Century Cures Act.

The Senate confirms Scott Gottlieb as FDA commissioner. User fee reauthorizations, a hiring freeze, and the opioid epidemic are a few of the issues awaiting the agency's new leader.

There will be 13 full-time positions dedicated to creating and providing guidance in the emerging subject area.

The agency hopes to better use global resources and avoid duplicate inspections of foreign facilities.

Effectively addressing prior authorization challenges as part of a company’s core sales and marketing tactics can yield tangible and substantial benefits, writes Dan Rubin.

If pharma companies want to hold their own in the current climate, they must embrace rather than resist market change, writes Peter Muller.

Nine months on from the 2016 EFPIA Disclosure Code deadline - requiring all member companies across Europe to publish their data concerning their transfer-of-value transactions to HCPs - EFPIA's Andrew Powrie-Smith offered an update on media and industry responses.

Pilot study affirms the value of a standards-based solution for prescription drug traceability-and the need to start now to meet compliance deadlines for the Drug Supply Chain Security Act.

Curing cancer is not an impossibility anymore. Essential to any effort to achieve this will be the policies coming from President Trump’s administration, writes James Nathanielsz.