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Health Science, Computers & Technology 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

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

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 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On December 8, 2017, the U.S. Food and Drug Administration (“FDA”) issued draft guidance titled “Clinical and Patient Decision Support Software” (“CDS Guidance”).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

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

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

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

Pfizer Accuses J&J of Anticompetitive Business Practices over Remicade Biosimilar

by Knobbe Martens on

In a recent development with the ongoing complex litigation involving Janssen Biotech’s arthritis biologic medicine Remicade (infliximab) and Celltrion’s biosimilar, Celltrion’s partner Pfizer has filed a suit against...more

FDA Commissioner Announces Plans to Streamline Approval Process for Headline-Grabbing Products

by Dorsey & Whitney LLP on

Last week, Dr. Scott Gottlieb, Commissioner of the FDA, touched on two issues that have frequented headlines in the past two years. First, in remarks made on November 28, 2017, Commissioner Gottlieb expanded on plans to...more

Pharma Distributors Trade Association Sued for Conspiracy to Exclude Competition for its Track and Trace Software

On October 23, 2017, a company that developed software to track and trace pharmaceuticals filed a complaint against a pharmaceutical distributors trade association that currently dominates the market for such software,...more

FDA Releases Biosimilars Educational Materials

by Goodwin on

On October 23, 2017, FDA announced the release of new educational materials to help health care professionals understand what biosimilars are and how they are approved. The materials include four fact sheets and graphics that...more

Health Update - October 2017

A New Look at Digital Health Business Models - Editor’s Note: The Commonwealth Fund is developing an innovative digital health advisor (DHA)—an integrated suite of digital services that would provide consumers with health...more

China FDA’s Pharmaceutical Regulations Ready for Public Comments

by Ropes & Gray LLP on

The China Food and Drug Administration (CFDA) published its proposed amendment of the Drug Administration Law (DAL) and the Drug Registration Rules (DRR) for public comments. This Alert summarizes the key changes....more

U.S. watchdogs tally $1.5 billion cost for one type of defective medical device

Big medical device makers, like Big Pharma, have complained Big medical device makers, like Big Pharma, have complained relentlessly that Uncle Sam hamstrings them with red tape and bureaucracy that slows or prevents...more

Shanghai Tightens Industry Interactions with HCPs

by Ropes & Gray LLP on

In August 2017, multiple departments of Shanghai government, led by Shanghai’s Health and Family Planning Commission (“Shanghai HFPC”), jointly issued a series of administrative rules (collectively, “Recent Shanghai Rules”)...more

Building a Health App? Part 4: Avoiding an FTC Enforcement Action

The market for apps designed to improve health and wellness or even to diagnose and treat medical conditions continues to grow. Last week, the U.S. Food and Drug Administration (“FDA”) approved a new smartphone-based “carbon...more

Federal Trade Commission Announces Workshop on Competition in the Prescription Drug Market

On November 8, 2017, the Federal Trade Commission (FTC) will hold a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.” Acting FTC Chairman Maureen K. Ohlhausen and...more

THE LATEST: Integra Forced to Divest Neurosurgical Tools to Gain FTC Clearance

by McDermott Will & Emery on

WHAT HAPPENED - On February 14, 2017, Integra agreed to purchase Johnson & Johnson’s Codman neurosurgery business (excluding Codman’s neurovascular and drug deliver businesses) for $1.045 billion.... ...more

Pfizer and Flynn Pharma fined €101 million for charging the UK health service excessive prices for Phenytoin sodium capsules, an...

by Dechert LLP on

The UK Competition and Markets Authority (“CMA”) recently published its infringement decision of 7 December 2016 that imposed a fine on Pfizer and Flynn Pharma (“Flynn”) for abusing their respective dominant positions by...more

Coming soon from FDA? Streamlined safety information in prescription drug television ads

by DLA Piper on

Most people are by now familiar with prescription drug TV ads that provide lengthy (and often confusing) laundry-list descriptions of numerous potential safety risks (seemingly regardless of the severity or likelihood of the...more

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