Regulatory

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

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.

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.

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.

The ongoing battle over drug reimbursement and pricing has raised questions about whether the pharmaceutical industry can continue to rely on high U.S. revenues to fund biopharmaceutical R&D.

The US drug regulatory system fails to address the country’s most urgent medical needs with the resources appropriate for the task. But change is possible, say Christopher-Paul Milne and Kenneth I. Kaitin.

President Obama has unveiled his $215m “Precision Medicine Initiative” to support the future biomedical research, while calling for a reduction in exclusivity on brand biologics from 12 to 7 years and a curb on "evergreen” patents on certain biologics. Jill Wechsler reports.

FDA officials have been busy rolling out advisories for pharma marketers, and there’s no let-up in sight, writes Jill Wechsler.

The small biotech space-credited with ending the drought in new FDA drug approvals in recent years-takes center stage at this year's J.P. Morgan Investors Conference.

An expert CPhI Worldwide panel has identified "the good, the bad, and the ugly" in its forecast for the pharmaceutical industry for 2015.

The "discussion draft" for legislation to speed "21st Century Cures" to patients emerged very quietly on Capitol Hill this week. Jill Wechsler reports.

FDA's Office of Hematology and Oncology Products (OHOP) is testing a treamlined review process that could be much faster and less costly for certain therapies. Jill Wechsler reports.

Several vaccine candidates are moving into larger clinical trials, supported by government and industry efforts to address manufacturing and research challenges. Jill Wechsler reports.

Brussels correspondent Reflector asks, what attitude will the new EC for competition, Margrethe Vestager, adopt to the pharmaceutical industry?

I offered up a prediction: that the future of the biopharmaceutical business depended on how managers fared on five key measures of performance.

Pharm Exec’s annual report highlights the key scientific, commercial, and reputational trends shaping the industry in the year ahead.