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Article

Kramer Levin Naftalis & Frankel LLP | USA | 29 Jan 2020

USMCA: Implications for Biologics and Innovation

On Wednesday, President Donald Trump signed the United States-Mexico-Canada Agreement (USMCA) into law. The USMCA contains a number of key and

Article

Mintz | USA | 2 Nov 2018

ML Strategies Health Care Lame Duck Preview

With the opioid bill passed, the House on recess and the Senate having cut a deal to get out the door, we all begin to wonder: after the dust settles

Article

Bristows | USA, European Union | 29 Oct 2018

CLIP of the month: Does orphan drug pricing pose an antitrust problem?

In the USA, a rare or orphan disease is defined as affecting fewer than 200,000 people and more than 7,000 rare diseases have been identified to date

Article

Hogan Lovells | USA | 23 Oct 2018

CMS proposes requiring drug prices in TV ads

On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer

Article

Arent Fox LLP | USA | 5 Sep 2018

PhRMA Faces Setback - For Now - In Challenge to California’s New Drug Price Transparency Law

On August 28, 2018, the United States District Court for the Eastern District of California (the Court) dismissed with leave to amend the

Article

Cooley LLP | USA | 31 Aug 2018

Court Dismisses Lawsuit Challenging CA S.B. 17 But Gives Leave to Amend

This week a California judge dismissed a lawsuit filed in December 2017 by the Pharmaceutical Research and Manufacturers of America (PhRMA)

Article

Banner Witcoff | USA | 30 Aug 2018

Does Secret Prior Art Survive in the AIA? Twelve Interested Parties Weigh In

In May, a panel of the U.S. Court of Appeals for the Federal Circuit applied an on-sale bar under the America Invents Act (AIA) to Helsinn's U.S

Article

Mintz | USA | 12 Mar 2018

ML Strategies Health Care Preview Week of March 12th

This week, Congress returns to Washington with 11 days to finalize a government spending bill. House appropriators will be meeting throughout the week

Article

Gordon Rees Scully Mansukhani | USA | 25 Jan 2018

Will Massachusetts be able to negotiate Medicaid prescription drug prices?

In the absence of new federal policies to tame high price drugs, Massachusetts’ state Medicaid program is fighting for the power to negotiate

Article

Quarles & Brady LLP | USA | 13 Dec 2017

Trade Group Sues State of California to Block S.B. 17 Drug Pricing Bill

As an update to a recent Health Law Alert ("California Passes Two Drug Pricing Transparency Laws," 112017), we learned that on December 8, 2017

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