Regulatory

With one approved biosimilar under its belt, and dozens more under review and in development, FDA’s biosimilar development program is moving “beyond the finish line”. But agency officials still have much to do to address critical issues related to product analysis and testing.

October 22, 2015.

In the midst of a leadership vacuum at the European Medicines Agency, Pharm Exec talks with the organization’s top medical officer, Hans-Georg Eichler, about its potentially game-changing drug approval program-one designed to balance safety requirements with faster patient access to the strong science now emerging from industry labs.

Managing the nomination of new FDA commissioner adds to packed agenda

Reflector outlines the current measures European countries are working or collaborating on to achieve a better understanding of pricing issues.

Nick Hicks looks at the challenges of devising a patient advocacy strategy amid the complex political, cultural and regulatory landscape of Russia and CIS.

In testifying before Congress last week on FDA regulation of long-awaited biosimilars, CDER director Janet Woodcock emphasized that evaluation of new therapies should be based on sound science. Jill Wechsler reports.

This week, the White House nominated Robert Califf to head FDA, long after he came to the agency in January 2015 as deputy commissioner for medical products and tobacco. But will he be confirmed, asks Jill Wechsler.

September 17, 2015.

Where is US payer formulary management heading-and what can the industry do to help influence its course?

On June 30, the Centers for Medicare and Medicaid Services (CMS) released the first full year of data under The Affordable Care Act’s transparency program, also known as Open Payments or the "Sunshine Act." This included approximately 11.4 million records totaling about $6.5 billion in payments made to 607,000 physicians and 1,121 teaching hospitals by 1,444 reporting entities during 2014. Combined with CMS’s September 2014 release of 2013 data for the period Aug. 1, 2013 through Dec.

Amarin ruling puts pressure on FDA to re-assess marketing rules

Three key questions dominate the agency’s Breakthrough Therapy Designation program since its 2012 launch.

Free speech ruling, social media flap, and "female Viagra" highlight busy month for agency.

As the U.S. Open Payments system improves operations and resolves discrepancies, the emergence of widely diverse and contradictory transparency programs in Europe and other nations raises new challenges for pharma, writes Jill Wechsler.

The latest organization to join the cost-effectiveness stampede is the National Comprehensive Cancer Network, which recently announced that it would add a new “tool” to its widely used guidelines that advise oncologists on cancer treatment strategies. Jill Wechsler reports.

The Reagan-Udall Foundation for the FDA (RUF) is overcoming initial roadblocks and gaining support from a range of public and private organizations, writes Jill Wechsler.

A non-antibiotic bactericidal treatment for humans was first proven effective in 1919. Ansis Helmanis asks why they are not commercially available in the United States.

France's bid to regain its influence reveals how far Europe is from fully achieving regulatory convergence, writes Reflector.

Manufacturers seek gradual rollout of more targeted FDA quality metrics program.

The case of Amgen v. Sandoz signals that preliminary injunctions will play major role in future patent disputes

FDA reform may get tangled up in user fee negotiations, budget debate

With biopharma companies increasingly accused of bankrupting the health care system with high prices, news that ICER has received a $5.2 million grant to expand its analyses of drug cost-effectiveness could be a game changer, writes Jill Wechsler.

For the second time in three years, the Supreme Court of the United States (SCOTUS) has weighed in on key aspects of the 2010 Obamacare law. Tom Norton reports.

Lisa Henderson discusses how role of social media in post-market adverse event reporting is finally being taken seriously by the FDA.

FDA has launched the process for reauthorizing the Prescription Drug User Fee Act (PDUFA), setting the stage for FDA to hear the views of patient, consumer and health professional representatives. Jill Wechsler reports.

The budget increase for NIH brought strong support from the biomedical research community and medical societies across the board.

All indications are that the July 2016 deadline for transition from Europe's eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) to the new Identification of Medicinal Products (IDMP) is not achievable. Sophie Daniels reports.

Despite recent advances, there continue to be significant issues that compromise the effective management of pulmonary arterial hypertension, writes Victoria Allan.

FDA wants pharma to be more selective in seeking special status for promising therapies