Jill Wechsler, Pharm Exec’s Washington Correspondent

April 21, 2016.

April 12, 2016.

More than a year after approving its first biosimilar, FDA has authorized a second therapy in this category.

The courts, pharma, and policymakers push FDA to rethink communications policy.

Doctors and oncologists agree with pharma companies in opposing the latest proposal from the CMS to revise how it pays for drugs administered in doctors’ offices.

March 10, 2016.

Clinical trials are challenging because pain is subjective, making it hard to define objective endpoints or to compare one drug to another.

March 03, 2016.

Various factors have altered the landscape for exchange of information on drugs and medical products, but the FDA has not kept pace in updating its rules governing what marketers can say about their therapies, writes Jill Wechsler.

March 02, 2016.

February 26, 2016.

After eight years in development, FDA is looking to expand its Sentinel system to play a more visible role in assessing medical product efficacy, as well as safety.

February 18, 2016.

February 11, 2016.

February 12, 2016.

There was scant praise from the medical community for the eighth and final budget plan from the Obama administration.

Vaccine R&D has grown exponentially in recent years, spurred by ethical and medical needs to combat lethal infectious outbreaks and increased funding from public and private agencies and organizations.

Can the feds negotiate Medicare Part D prices? Jill Wechsler reports.

Valeant and Turing's fuzzy explanations of pricing practices to the House Oversight and Government Reform Committee cast a shadow over the broader industry, writes Jill Wechsler.

Jill Wechsler reports on how FDA is trying to finding a balance between clinical trials large enough to assess all relevant populations and small enough to include deep data on each patient.

January 05, 2016.

January 06, 2016.

The last few months have been tough for pharmaceutical companies, and the political environment in Washington isn’t likely to improve in the coming year, writes Jill Wechsler.

OND Director John Jenkins would like to see sponsors invest in more “me-better” drugs-as opposed to “me-too” medicines-to expand treatment options for patients and to boost competition among manufacturers.

The continuing attack on industry pricing and marketing jeopardizes coverage, R&D.

Jill Wechsler on why the FDA program that encourages biopharma companies to develop new treatments for rare and neglected diseases has been in the spotlight recently.

The continuing campaign to ratchet down prescription drug prices has generated considerable talk about how compounders could provide less costly, alternative therapies. Jill Wechsler reports.

Drug pricing backlash threatens regulatory reform, R&D advances

December 02, 2015.

November 30, 2015.