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Health Antitrust & Trade Regulation

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

NDA/ANDA Holders Must Affirmatively Submit Data to FDA or Risk Losing Products’ Active Listing in The Orange Book

by Mintz Levin on

Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years. Among others tackling...more

Biosimilar Market Developments Continue Apace in 2018

It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation’s abbreviated marketing pathway for biosimilar products....more

Trump Administration: 2017 Recap and 2018 Outlook

On January 20, 2017, businessman Donald J. Trump was sworn in as the 45th President of the United States following a contentious and unconventional 2016 presidential election. Republicans also successfully maintained control...more

ICYMI: PrivSec’s Weekly News Picks

by Davis Wright Tremaine LLP on

Tech Republic reports that “the executive order may help bring internet to previously hard to reach areas, something several ISPs have been working towards.” “A more connected country”, author Olivia Krauth reports, “could...more

Antitrust enforcement priorities for 2018

by Bricker & Eckler LLP on

Health care antitrust in 2017 saw governmental agencies successfully pursue a number of enforcement actions. Examining these actions provides insight and guidance as to what might happen in antitrust enforcement in 2018 and...more

Healthcare Transactions: Year in Review

by Bass, Berry & Sims PLC on

On December 3, 2017, CVS Health Corp. (NYSE: CVS) announced it would purchase health insurer Aetna Inc. (NYSE: AET) for $67.5 billion, a transaction that would be one of the biggest healthcare mergers in the past decade. The...more

French Competition Authority Fines a Pharmaceutical Laboratory EUR 25 Million for Anti-Generic Practices

by McDermott Will & Emery on

On 20 December 2017, the French Competition Authority (the FCA) imposed a EUR 25 million fine on a pharmaceutical laboratory, for delaying entry onto the market of the generic version of Durogesic, and for hindering its...more

FDA Resets Enforcement Priorities for OTC Homeopathic Drugs

Happy New Year! And now on to your regular Consumer Product Matters programming… Another Federal agency with a consumer-protection mandate has taken a significant step to reset compliance expectations and enforcement...more

FDA Guidance on Decision Support Software: Implications for Industry

by Epstein Becker & Green on

On December 8, 2017, the U.S. Food and Drug Administration (“FDA”) issued draft guidance titled “Clinical and Patient Decision Support Software” (“CDS Guidance”). According to FDA Commissioner Scott Gottlieb, M.D., the CDS...more

Congress Responds to Proposed Health Care Mergers with Calls for Hearings and New Merger-Related Legislation

by Baker Donelson on

December saw the announcement of several significant proposed mergers in the health care industry, each of which has the potential to reshape the industry. These transactions include both vertical mergers between health care...more

Year in Review: The Top-Five U.S. Market Developments of 2017

by Goodwin on

Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017...more

Federal Circuit Rules BPCIA Preempts State Law

by Jones Day on

On December 14, 2017, the U.S. Court of Appeals for the Federal Circuit again interpreted the Biologics Price Competition and Innovation Act ("BPCIA"). In Amgen Inc. et al. v. Sandoz Inc., 15-cv-1499 (Fed. Cir. 2017), the...more

China FDA Solicits Comments on Conditional Approvals for New Drugs and Compassionate Use of Investigational Drugs

by Ropes & Gray LLP on

The China Food and Drug Administration (“CFDA”) recently proposed two draft circulars for public comments, namely (a) the Technical Guidelines for Conditional Approvals for Urgently Needed Drugs (“Draft Conditional Approvals...more

FTC Wins Provider Merger Challenge in District Court

by King & Spalding on

On December 13, 2017, a federal district court issued an order preliminarily enjoining the merger of North Dakota healthcare providers, Sanford Health, Sanford Bismarck, (Sanford) and Mid Dakota Clinic, P.C. (MDC). The order...more

Physician Certification Group Wins Dismissal of Antitrust Suit Brought By Physicians

by Mintz Levin on

A physician organization has failed to sufficiently plead that a physician certification group caused an unreasonable restraint of trade through its actions to promulgate its certification program. Last week, a district court...more

Federal Court Enjoins North Dakota Physician Practice Merger

by Holland & Knight LLP on

On December 15, 2017, United States Magistrate Judge Alice Senechal of the District of North Dakota entered an order preliminarily enjoining the merger between two large physicians practices in the Bismarck/Mandan market,...more

Digital Health: FDA Gives Nod to Multiple First-in-Class Devices

Digital health—the convergence of healthcare, devices, genomics (in some instances), and digital technology—is a fast-growing sector teeming with the promise to improve the health of millions of people. A key feature of...more

FDA Issues Draft Guidance on Orphan Drug Designation in Pediatric Subpopulations

by Latham & Watkins LLP on

New guidance intends to limit product sponsors’ exclusions from the requirement to study pharmaceuticals in pediatric patients. On December 20, 2017, the US Food and Drug Administration (FDA or Agency) issued draft...more

Why worry about gung-ho approvals for medical devices? FDA’s own record

The Food and Drug Administration has closed out the year by issuing a new white paper reaffirming the agency’s three-year-old warning to surgeons and women to avoid in general the use of a surgical device called a morcellator...more

Despite Presence of “Power Buyer,” FTC Obtains Preliminary Injunction of Proposed Physician Acquisition in North Dakota

by Mintz Levin on

While antitrust enforcement of hospital mergers is well-established, physician acquisitions have only recently and increasingly seen antitrust scrutiny. Last week, in a 69-page opinion, a federal district court granted the...more

Call Waiting? Challengers Continue to Await Ruling in Appeal of 2015 TCPA Order

We continue to await a ruling from the US Court of Appeals for the DC Circuit in the appeal of the Federal Communications Commission’s (FCC) July 2015 Omnibus Telephone Consumer Protection Act (TCPA) Declaratory Ruling and...more

FTC Granted Preliminary Injunction to Block Physician Practice Acquisition

On December 13, 2017 a magistrate judge in the U.S. District Court for the District of North Dakota granted a request of the Federal Trade Commission (FTC) and North Dakota Attorney General to preliminarily enjoin Sanford...more

FDA 2017 Year In Review: Therapeutic Products Energized by Cures Act, Bold Leadership

As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and highlight important legal, regulatory, and business developments. For...more

The Next Frontier in Hospital Mergers: Crossing Geographic Markets

With the Federal Trade Commission’s successful track record in challenging mergers of provider systems operating in the same geographic area, several hospitals are looking farther afield for merger partners. One recent...more

Sanford Health/Mid Dakota Clinic Healthcare Provider Merger Temporarily Blocked

by King & Spalding on

On Wednesday, December 13, 2017, a federal district court issued an order preliminarily enjoining the merger of North Dakota healthcare providers, Sanford Health, Sanford Bismarck, (together “Sanford”) and Mid Dakota Clinic,...more

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