Regulatory

There’s renewed optimism in the biomedical research community that years of effort finally may begin to pay off for developing cutting-edge gene and cellular treatments for debilitating and life-threatening conditions. Jill Wechsler reports.

The Senate hearing to weigh the appointment of Robert Califf to be the next commissioner of FDA was a fairly friendly event, with mostly softball questions about policies and programs. Jill Wechsler reports.

November 18, 2015.

Large pharma companies have fallen “below legal and ethical standards” for making public information from the relevant clinical trials, according to a report from Bioethics International.

Building on our annual look at the industry's product pipeline, four key themes stand out that are driving the fast-changing environment for drug development.

The Generic Pharmaceutical Association has called for policy makers to take steps to promote the development of competitive generic therapies and of biosimilars.

The new interim report on the UK's Accelerated Access Review, which aims to speed up access to innovation in the NHS, is lacking in detail, writes Leela Barham.

After months of anticipation, pharma marketers continue to wait for FDA to update its policies governing sponsor communications involving unapproved drug uses. Jill Wechsler reports.

In Pharm Exec’s 2013 end-of-year supply chain roundup, we began with a three-word vision of the immediate future that left little room for ambiguity: “Serialization is coming.” With the impending laws regarding “track and trace” promising to alter the way pharmaceuticals are packaged and shipped, we outlined how global pharma was gearing up to deal with the effects of serialization, and how companies needed to review their own internal practices and those of their outsourcing partners, as the need for technology solutions for both sides of the outsourc

Some of the radical thinking on healthcare spending from a new EC specialist group offers robust food for thought, writes Reflector.

Doctors, advocates, politicians, and even the Feds have jumped on the price-gouging bandwagon. Jill Wechsler reports.

The answer is perhaps not that much, according to some biosimilar developers, as well as payers and health plans. Jill Wechsler reports.

Public outrage over more high-priced drugs is undermining support for provisions in the House-passed 21st Century Cures legislation that provide additional exclusivities for developing certain new therapies, writes Jill Wechsler.

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.

Carlos Angulo and Alexandra W. “Sasha” Miller argue that an increasingly common brand company tactic is threatening to undermine the entire FDA generic drug approval process.

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.