Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
340B Drug Pricing Program Compliance
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
[Podcast] Food for Thought and Thoughts on Food: What to Expect in 2023
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 116: Michael Carlin, Manager, Engage HCP by TrialCard
Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion
PODCAST: Williams Mullen's Benefits Companion - New Prescription Drug and Health Coverage Reporting Requirements
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Key Considerations for Reshoring U.S. Drug Manufacturing
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under the Hood
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
When the Federal Circuit resurrected Amarin’s “skinny label” infringement claims against Hikma last month, it offered some important lessons for drug developers. The precedential decision helps clarify the kinds of...more
As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more
Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated report to the White House Competition Counsel regarding a...more
Foreign-made drugs, nutritional supplements and medical devices imported into the United States with false or misleading labeling or designed to look like an established competing product in violation of the Lanham Act could...more
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
Focus I: International black market trade - Among the industries that suffer most from black and grey market activities, the pharmaceutical sector sadly holds one of the top positions. The World Health Organization (WHO)...more
Alien Tort Statute (ATS)/Torture Victims Protection Act (TVPA)/Anti-Terrorism Act (ATA) - District Court Dismisses ATS Claim Where Alleged Conduct in US Was Not Directly Linked to Injuries Claimed in Other Countries - ...more
Over seven years ago, the Federal Circuit delivered a mixed ruling against Pfizer in litigation against Teva) relating to the pain medication Celebrex® (celocoxib) (where "celocoxib" is...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Novartis Vaccines and Diagnostics, Inc. et al. v. Pfizer, Inc. 2:15-cv-01283; filed February 18, 2015 in the District...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Janssen Pharmaceuticals Inc. et al. v. Alkem Laboratories Limited 1:13-cv-09227; filed December 26, 2013 in the Northern...more
In Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit reversed the district’s holding of no Lunesta® patent infringement that was based on a certification submitted to the court, and found...more
When assessing the validity of a patent, you cannot ignore the dependent claims. That was the main takeaway from the recent Federal Circuit case, Research Foundation of State University of New York v. Mylan Pharmaceuticals...more
In Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., the Federal Circuit invalidated a number of claims directed to a polymer defined by its “molecular weight” because the term was ambiguous, and Applicants’ conflicting...more
“Reverse Payment” Settlements Face Greater Antitrust Scrutiny Following U.S. Supreme Court Ruling in FTC v. Actavis: Federal Trade Commission v. Actavis, Inc. - Resolving a split among the U.S. Courts of Appeals, the...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Cornerstone Therapeutics Inc. et al. v. Exela Pharma Sciences LLC et al. 1:13-cv-01275; filed July 24, 2013 in the...more
The Supreme Court on Monday declined to grant certiorari in Momenta Pharmaceuticals v. Amphastar Pharmaceuticals, a case involving a split in authority that has arisen among Federal Circuit judges regarding the scope of the...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Alza Corp. et al. v. Par Pharmaceutical Inc. et al. 1:13-cv-01104; filed June 19, 2013 in the District Court of Delaware...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Takeda Pharmaceutical Co. et al. v. Impax Laboratories, Inc. 3:13-cv-02416; filed May 29, 2013 in the Northern District...more
In Dey, L.P. v. Sunovion Pharmaceuticals, Inc., the Federal Circuit vacated the district court’s grant of summary judgment in favor of Sunovion, and remanded for further consideration of whether Sunovion’s clinical trial...more
Enactment of the Leahy-Smith America Invents Act in 2011 focused the patenting community on the changes of U.S. patent law from "first to invent" under the 1952 Patent Act to "first inventor to file" under the AIA as the...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Eisai R&D Management Co., Ltd. v. Rea - 1:13-cv-00548; filed May 2, 2013 in the Eastern District of Virginia: ...more
In This Issue: Novartis Pharmaceuticals Corp. et al. v. Noven Pharmaceuticals Inc. et al.; Purdue Pharmaceutical Products L.P. et al. v. Dr. Reddy's Laboratories, Inc. et al.; Taro Pharmaceuticals North America, Inc....more