News & Analysis as of

Patents Patient Protection and Affordable Care Act (PPACA)

Troutman Pepper

Building on Successful Judicial Assignment Reform in Texas

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More than 16 months ago, the two ranking members of the Senate Judiciary Committee asked Chief Justice John Roberts to direct the Judicial Conference of the United States to study forum shopping in patent litigation,...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Biosimilar Approval Recap – 2021

The U.S. Food and Drug Administration approved four biosimilar drugs in 2021 under the provisions of the Biologics Price Competition and Innovation Act (BPCIA, codified at 42 U.S.C. § 262) as part of the Affordable Care Act...more

Goodwin

Legal Developments to Keep an Eye Out for in 2020

Goodwin on

Here are our picks of some legal developments to keep an eye out for in the new year: Federal Circuit Decisions on Bevacizumab and Trastuzumab Preliminary Injunctions: Appeals are pending on the District of Delaware’s...more

BakerHostetler

Capitol Hill Healthcare Update

BakerHostetler on

Highlights this week include a lame duck update on year-end health bills and tax provisions; lawmakers reacting to a federal judge ruling the Affordable Care Act is unconstitutional; Sen. Hatch seeks to update Hatch-Waxman;...more

Holland & Knight LLP

Tax Reform Changes to Healthcare

Holland & Knight LLP on

Following a final vote in the U.S. House of Representatives on Wednesday morning, Dec. 20, 2017, Congress sent the Tax Cuts and Jobs Act (H.R. 1) to President Donald Trump's desk. In addition to extensive revisions to the tax...more

Patterson Belknap Webb & Tyler LLP

100 Days Plus Under Trump: What They Mean for Biologics

President Donald J. Trump has now been in office for just over one hundred days. Observers have been quick to mark this milestone and assess the new administration’s performance, especially on headline-grabbing issues like...more

Troutman Pepper

Post-Grant Challenges in Life Sciences: A Midyear Assessment

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The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

Polsinelli

Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute

Polsinelli on

The U.S. Food and Drug Administration rejected Amgen Inc.’s request that biosimilars makers be forced to share their applications and manufacturing processes with competitors, exacerbating the company’s recent defeat in...more

Carlton Fields

Expect Focus - Regulators Are Watching: New Products, New Opportunities, New Risks - Volume III, Summer 2014

Carlton Fields on

In This Issue: - IN THE SPOTLIGHT ..Standard CGL Policy Form Adds Data Breach Coverage Exclusion - LIFE INSURANCE ..Class Claims Against Lincoln National Barred in Section 419 Action – Again ...more

Troutman Pepper

Telemedicine and Mobile Health Innovations Amid Increasing Regulatory Oversight

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The growing mobile health market is rapidly transforming health care delivery. More than 80 percent of physicians use mobile technology to provide patient care, and more than 25 percent of commercially insured patients use...more

Mintz - Health Care Viewpoints

Health Care Update - July 2014

In This Issue: - E&C continues to push for bipartisan efforts to improve drug pipeline - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Health Care News ...more

Knobbe Martens

Biosimilars Webinar - July 23, 2013

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On Tuesday, July 23, Knobbe Martens hosted a live webinar event covering "Preparing for Biosimilars: Key Points for Participating in the U.S. Regulatory Framework." Partners Eli Loots, Carol Pitzel Cruz, and Sheila Swaroop...more

McDonnell Boehnen Hulbert & Berghoff LLP

WLF Submits Comments on Abbott's Citizen Petition on Biosimilars

Last April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act...more

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