Regulatory

The House Energy & Commerce (E&C) Committee unanimously approved the 21st Century Cures legislation last week, but the debate is slated to continue for several months, if not longer. Jill Wechsler reports.

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

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.

The House Energy and Commerce Committee gave unanimous approval to the landmark 21st Century Cures Act reform bill on May 21, 2015.

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.

Insurers and payers demand lower prices-along with quality and innovation.

Edging through the complex terrain that is health technology assessment in Europe

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.

Demands from patient advocacy groups for broader subgroup representation in clinical trials has generated a new drug trial transparency initiative at the Center for Drug Evaluation and Research (CDER).

The industry continues to puzzle over FDA's proposed regulation of mobile medical apps (MMAs), writes Jill Wechsler.

Rampant concerns about the affordability of, and access to, new life-saving therapies is widening the debate over how much society should pay for new biomedical discoveries, writes Jill Wechsler.

The need for proactive pharmacovigilance is being increasingly acknowledged by all companies, regardless of their size and product mix, writes Dr. Chitra Lele.

Although the strategic hurdles of biosimilars market entry are not new, the task of imitating substantially more complex molecular entities offers up a host of new operational questions for pharma.

At the request of FDA, US Marshals seize unapproved prescription drugs from Florida distributor.

FDA extends ANDA rule comment period to June 8, 2015 after requests for more time.

FDA is under pressure to moderate oversight of pharma advertising and promotion.

FDA commissioner Margaret Hamburg has received praise and plaudits as she exits the Food and Drug Administration this week after six years on the job.

New legislation and changes in policy at FDA are leading to better control of the API supply chain.

Although the strategic hurdles of biosimilars market entry are not new, the task of imitating substantially more complex molecular entities offers up a host of new operational questions for pharma.

“It is not the strongest of the species that survives, nor the most intelligent that survives. It is the one that is most responsive to change.” In today’s healthcare market, Darwin's words have never been more relevant, writes Brad Ansley.

A controversial FDA proposal to alter the process for making changes to approved drug labels has drawn opposition and support in equal measure, writes Jill Wechsler.

Albert Wertheimer, PhD, MBA, Professor of Pharmaceutical Economics at Temple University and a member of Pharm Exec's Editorial Advisory Board, shows how the simple matter of a drug shortage is not a simple matter at all.

Jamie Gault outlines the key differentiators between each of FDA's programs to facilitate and expedite drug development and review of new drugs.

Congress, Obama offer strategies to reduce regulatory roadblocks to new breakthroughs.

The Securities and Exchange Commission (SEC) is focusing more on the accuracy and timeliness of biopharma company financial filings, particularly those related to regulatory actions involving FDA, writes Jill Wechsler.

Rohit Sood outlines five critical factors for companies entering this blossoming market.

The approval of the first biosimilar for market in the U.S. highlights the importance of further clarification from FDA on key policies related to the development and prescribing of highly similar biologics for patients, writes Jill Wechsler.

Mark Gross offers a case study in using structured product labeling (SPL) to reduce time to market.

Thanks to Shire's star drug Vyvanse, if you don't know much about binge-eating disorder, you soon will, writes Marylyn Donahue.

Drug shortages are declining, but they’re still a serious concern for regulatory authorities, policy makers and biopharma manufacturers, writes Jill Wechsler.