News & Analysis as of

FDA Releases Biosimilar Naming Guidance

FDA just released a final Guidance for Industry, “Nonproprietary Naming of Biological Products.” The guidance provides that naming for originator biological products, related biological products, and biosimilars should...more

2016 Year In Review: Securities Litigation And Regulation

2016 was an active year in securities litigation. In the first half of 2016 alone, plaintiffs filed 119 new federal class action securities cases. It was also a busy year for SEC enforcement proceedings, with a record 868...more

FDA Issues Newest Guidance Regarding Biosimilar Application Process

On December 29, the U.S. Food and Drug Administration released its latest Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). ...more

Speculation of ANDA Product Launch Before FDA Approval Does Not Warrant Permanent Injunction

On December 28, 2016, Judge Stark of the District of Delaware, despite having previously found infringement, held that plaintiffs Bayer Pharma AG, Bayer Intellectual Property GmbH, and Bayer HealthCare Pharmaceuticals Inc....more

Beyond the Eleventh Hour: FDA Prepares to Finalize Intended Use Amendments Despite Midnight Rule Relief Act

On Monday, FDA issued a final rule to amend FDA’s established definitions of “intended use” for drugs and devices, the primary consideration in determining whether a product is regulated for a particular use and what...more

FDA Accepts aBLA for Mylan-Biocon’s Proposed Herceptin® Biosimilar

As we previously reported, in November Mylan and Biocon submitted an aBLA to the FDA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). Today, Mylan announced that the FDA has accepted its...more

Happy Holidays from FDA: The Agency Issues Four Enforcement Letters for Unlawful Promotion

The Food and Drug Administration recently issued holiday gifts, in the form of enforcement letters, to four pharmaceutical companies. The letters are reminders that FDA is not in a partying mood when it comes to unlawful...more

Federal District Court finds brand-name manufacturer’s alleged regulatory delay tactics a valid theory of attempted monopolization

In a recent decision denying the defendant’s motion to dismiss, Judge Mitchell Goldberg of the Eastern District of Pennsylvania allowed the manufacturer of a generic version of Suboxone to proceed upon an interesting theory...more

“Regulatory Causation” Roundup

Last week’s Westlaw search (that’s one way we find the cases we discuss in the Blog) brought a blast from the past – a case almost three years old showed up discussing – and rejecting – expert testimony about so-called...more

Human Drug Compounding: FDA Issues Four Guidance Documents

FDA had a busy holiday season, issuing two final guidance documents and two draft guidance documents for industry related to human drug compounding right before the start of the new year. These guidance documents cover...more

21st Century Cures: Food and Drug Administration (FDA) Drug Provisions

The 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment and facilitating innovation review and...more

The New FDA: Product Development, Pricing and Beyond - Part 2

What impact will the incoming Trump administration have on the 2017 health care and life sciences regulatory outlook? In this two-part podcast, The New HHS: Tom Price and Value-Based Health Care and The New FDA: Product...more

Biosimilars in Europe: 2016 Year in Review and What’s Ahead

Europe’s biosimilar market continues to develop, with biosimilars in new classes approved and pending in applications before the European Medicines Agency (EMA). 22 biosimilars are approved in eight different product classes...more

Confidentiality in BPCIA Cases

The Biologics Price Competition and Innovation Act (“BPCIA”) contemplates the exchange of highly sensitive information from the pre-suit “patent dance” (see, e.g., 42 U.S.C. 262 (l)(2)(A)) throughout litigation, bringing...more

SDNY Applies Preemption in Favor of Branded Drug

On January 3, 2017, we commenced the dreary process of taking down the Christmas decorations. The German nutcrackers slid back into their cartons. Stockings marched from the mantle into plastic storage containers. We picked...more

On the Heels of 21st Century Cures Enactment, FDA Finalizes Medical Device Accessories Guidance

On December 30, 2016, the Food and Drug Administration (FDA or the Agency) issued a final guidance document entitled Medical Device Accessories – Describing Accessories and Classification Pathways for New Accessory Types....more

FDA Issues New Guidance on Use of Clinical Pharmacology Studies to Show Biosimilarity

The FDA issued a new Guidance today, titled “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.” The Guidance is intended to “assist sponsors with the design and use of clinical...more

Year In Review: The Top-Five U.S. Market Developments of 2016

Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2016: The FDA approved three biosimilar products in 2016, compared to only one in 2015 — Sandoz’s Zarxio®, a...more

U.S. Senate committee rips drug makers for predatory price-gouging

Congress must stop Big Pharma predators from ripping off American consumers by acting like hedge funds, buying up decades-old, off-patent drugs and jacking up prices on long-standing “gold standard” prescription medications,...more

The Peaks – The Ten Best Prescription Drug/Medical Device Decisions of 2016

Today we’re going peak bagging – no, not to the Canadian Rockies or Patagonia (we leave that to Bexis) – for the high points in this year’s drug/medical device product liability jurisprudence. Last week, we visited the...more

FDA Guidance on Cybersecurity in Medical Devices

On December 28, 2016, the Food and Drug Administration (FDA) issued guidance on Postmarket Management of Cybersecurity in Medical Devices. The guidance clarified aspects of the reporting requirements under Part 806 (21 CFR...more

Year in Review: The Top-Five Legal Developments of 2016

Here are our picks for the top-five most significant legal developments in the world of biosimilars in 2016: ..Congress passed and President Obama signed the 21st Century Cures Act. Among other things, the Act modifies...more

When Time is Money

As the Biologics market is predicted to be a $250 billion market in the next few years, it is not surprising that parties embroiled in biosimilar litigation go to the mat. Both Apotex and Sandoz filed cert petitions this year...more

The First Amendment Does Not Protect All Off-Label Drug Promotion

FDA is considering making off-label promotion easier, consistent with recent case law. The drug and biologics industry is also proposing an ease up of FDA regulation, which would allow it to “responsibly” promote new drug...more

Cures Act Affirms Drug Companies’ Ability to Discuss Certain Information with Payors

Since congressional enactment a presidential signing of the Cures Act into law earlier this month, we have been blogging on discrete regulatory and clinical areas affected by its provisions. One small, but by no means...more

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