News & Analysis as of

Pharmaceutical Industry

Supreme Court Order Indicates Interest in Reviewing Campie, the False Claims Act Outlier of the Ninth Circuit

In an order issued on April 16, 2018, the U.S. Supreme Court invited the Solicitor General to file a brief “expressing the views of the United States” concerning the 2017 decision of the U.S. Court of Appeals for the Ninth...more

AGG Food and Drug Newsletter - April 2018

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Head of FDA Calls on Doctors, Internet-Service Providers To Join Opioid Fight

Painkillers Prescribed Haphazardly While Online Sales Soar - One of the reasons the nation’s opioid crisis has spun out of control could be the fact that doctors are not trained universally in the field of pain management....more

Your Daily Dose of Financial News

by Robins Kaplan LLP on

It was a busy Thursday in the big pharma world, with drugmaker Shire rejecting a $60 billion takeover offer from Japan’s Takeda, while US rival Allergan disclosed that it was considering a bid of its own for Shire....more

The State AG Report Weekly Update April 2018 #3

by Cozen O'Connor on

2018 AG Elections- Republican Gentner Drummond Announces Bid for Oklahoma Attorney General- Republican Gentner Drummond has declared his candidacy for Oklahoma AG in 2018. ...more

National Right to Try Act Passes U.S. House

by Thompson Coburn LLP on

The concept of a “Right to Try” has been spreading through the U.S. over the last four years, beginning with the first passing of such laws in Colorado in 2014. Most recently, President Trump has echoed support for a federal...more

Federal Court Dismisses CFAA Claims Against Former Executive, Allows CFAA and DTSA Claims Against Competitor in Pharmaceuticals...

by Seyfarth Shaw LLP on

A recent decision from the Eastern District of Pennsylvania reinforces the importance of the timing of purported misconduct in alleged violations of the Computer Fraud and Abuse Act (CFAA) and Defend Trade Secrets Act (DTSA)....more

New Jury Imposes Disproportionate Punitive Award In AbbVie Retrial

Only three months after AbbVie obtained a retrial of a case in which a jury had imposed $150 million in punitive damages without awarding any compensatory damages, a new jury awarded the same plaintiff $200,000 in...more

FDA Weighs In on When Pregnant Patients Should be Included in Clinical Trials

by Hogan Lovells on

In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies evaluating drugs and therapeutic biological products in some circumstances and...more

Seeking to reduce premarket burdens, FDA proposes to expand Abbreviated 510(k) Pathway for certain devices

by Hogan Lovells on

Building on recent efforts to streamline premarket review of medical devices, on April 12, 2018, the Food and Drug Administration (FDA) issued a draft guidance seeking to expand use of the historically underutilized...more

Drop in Warning Letters for Medical Devices Raises Interesting Questions About the Industry

In 2017, FDA issued only 44 Warning Letters to medical device establishments. Of those, 11 were related to pre-market issues, which include investigational device exemption violations or lack of approval or clearance. Only 33...more

(Don’t) Take the Long Way Home: FDA Issues Draft Guidance on Expansion of the Abbreviated 510(k) Program

by Arnall Golden Gregory LLP on

The Food and Drug Administration channeled, in the other direction, the 1979 Supertramp song, “Take the Long Way Home,” after it issued a draft guidance entitled, “Expansion of the Abbreviated 510(k) Program: Demonstrating...more

Filing Review is About More Than Checking the Boxes; or Is It?

by Arnall Golden Gregory LLP on

Things sometimes change fast. Our original article described one company’s recent announcement that the Food and Drug Administration refused to file its new drug application as a reminder that the agency’s filing review may...more

Mylan Partners with Fujifilm Kyowa Kirin Biologics

by Goodwin on

Last week, Fujifilm Kyowa Kirin Biologics (FKB) and Mylan announced that they will partner with one another to commercialize in Europe FKB327, a biosimilar of adalimumab developed by FKB. As we previously reported, the...more

Federal Circuit Finds Personalized Medicine Invention Subject Matter Eligible

by Dorsey & Whitney LLP on

The Federal Circuit recently held claims for a personalized medicine treatment were patent eligible and valid. The claims at issue were directed toward administering specific dosages of a drug in the presence or absence of a...more

Court Dismisses FTC Antitrust Lawsuit Alleging That Shire ViroPharma Inc. Abused Government Processes to Delay Generic Competitors

by Arnall Golden Gregory LLP on

In recent years, the Federal Trade Commission (FTC) has brought a series of cases involving drug manufacturers allegedly seeking to delay competition from generic drug companies. See, e.g., F.T.C. v. Actavis, Inc., 570 U.S....more

Fresh From the Bench: Latest Federal Circuit Court Cases

In an ANDA applicant’s appeal from a bench trial judgment of validity and infringement, the Court affirmed the district court’s judgment on all counts. The case presented unusual procedural circumstances in a Hatch-Waxman...more

China Announces New Initiatives to Level the Playing Field for Innovative and Generic Drugs

by Ropes & Gray LLP on

China’s Government will launch several incentives to enhance accessibility of innovative drugs, especially imported oncology drugs. The State Council, China’s cabinet, has decided not to apply any tariff on imported drugs,...more

Outlook for OTC drug regulation

by Hogan Lovells on

Significant change is on the horizon for the over-the-counter (OTC) drug industry. OTC drug sales have grown from about US$3 billion in 1972 to over US$34 billion today, with over 300,000 products marketed. Please see...more

Big Pharma Feels the Pain of Opioid Litigation

by Sands Anderson PC on

Few would dispute that the opioid epidemic is of crisis proportion. In 2016, there were more than 63,600 drug overdose deaths in the United States from opioid pain medicines, including hydrocodone (Vicodin & Lortab),...more

Health Plans and Pharmacy Benefit Managers – Past and Future

Historically, health plans and pharmacy benefit managers (“PBMs”) have been uncomfortable neighbors. Plans provide drug coverage, but contract out the provision of such drugs to independent PBMs. PBMs in turn earn market...more

Report Details Uneven Implementation of the New Drug Tracing Law

Last month, the Department of Health and Human Services’ Office of Inspector General (OIG) released its latest report on compliance with the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post, the DSCSA...more

Hatch-Waxman goes to Taiwan

In December 2017, the Taiwan Pharmaceutical Affairs Act has been amended to harmonize generic approval process with prevailing international norms. The amended Act is expected to come into effect in late 2018 or early 2019....more

Top Developments in Hatch-Waxman Litigation for April 2018

by Morrison & Foerster LLP on

This month, we highlight several significant cases including Celgene Corp. v. Hetero Labs Ltd. and Regeneron Pharmaceuticals, Inc. v. Merus N.V. as well as new legislation proposed in both houses of Congress with respect to...more

USPTO Says Overlapping Range In Prior Art Insufficient to Invalidate Method of Treatment Patent

by Dechert LLP on

Pharmaceutical patents frequently claim treatment methods that utilize a range of amounts or concentrations for the active ingredient or excipients included in the formulation. Given the prevalence of such patents, there is...more

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