Amgen, Sandoz argue biosimilar patent case to the Supreme Court

Amgen, Sandoz argue biosimilar patent case to the Supreme Court

Sandoz counsel argued that Amgen's position "wrongly delays the marketing of every biosimilar."

Senate committee launches investigation into opioid marketing

Senate committee launches investigation into opioid marketing

The committee is seeking information about the companies' sales and marketing strategies.

Veeva and QuintilesIMS tussle over customer reference data

Veeva and QuintilesIMS tussle over customer reference data

Veeva is countersuing QuintilesIMS in the wake of allegations that Veeva mishandled its proprietary data.

Industry groups petition the FDA over off-label rule

Industry groups petition the FDA over off-label rule

PhRMA, BIO, and the Medical Information Working Group filed a citizen petition over a final rule they say raises risks for drugmakers.

FDA guidance seeks to clarify pharma comms with payers

FDA guidance seeks to clarify pharma comms with payers

But it may also increase the reporting burden for drugmakers.

In draft guidance, the FDA defines appropriate off-label comms as being 'consistent' with the label

In draft guidance, the FDA defines appropriate off-label comms as being 'consistent' with the label

The regulator is providing examples of appropriate off-label communications.

The FDA targeted DTC, video, unapproved drug promotion in 2016

The FDA targeted DTC, video, unapproved drug promotion in 2016

The agency issued 11 enforcement letters last year.

The FDA to study whether people can recognize misleading drug ads

The FDA to study whether people can recognize misleading drug ads

The agency has faced questions about how it regulates off-label communications.

The FDA issues untitled letters to Sanofi and Celgene over distracting ads

The FDA issues untitled letters to Sanofi and Celgene over distracting ads

Regulators said the ads distract viewers from superimposed safety information.

The FDA extends deadline for off-label input

The FDA extends deadline for off-label input

The previous deadline was January 9.

Five things for pharma marketers to know: Wednesday, December 14, 2016

Five things for pharma marketers to know: Wednesday, December 14, 2016

Obama signs 21st Century Cures Act into law; the FDA approved 19 new drugs in 2016; Sanofi in talks to acquire Actelion

Senate passes Cures Act, which opens door to use of real-world evidence

Senate passes Cures Act, which opens door to use of real-world evidence

The bill now heads to President Obama's desk. He is expected to sign the sweeping piece of legislation.

House passes 21st Century Cures Act that would allow some off-label sharing

House passes 21st Century Cures Act that would allow some off-label sharing

The bill includes two provisions that would address drugmakers' calls for clarity on sharing off-label information with payers and regulators.

Pharma pushes to share off-label info with payers at FDA hearing

Pharma pushes to share off-label info with payers at FDA hearing

Insurers and pharmacy benefit managers already have a sophisticated understanding of clinical data, the industry argued.

5 questions raised at the FDA's off-label hearing

5 questions raised at the FDA's off-label hearing

The FDA asked questions about the risks and benefits of allowing off-label communications.