News & Analysis as of

Biologics

You Can’t Put That Tissue There: FDA Clarifies Important HCT/P Regulatory Criteria

by Arnall Golden Gregory LLP on

One of the first warning letters of 2018 was issued to a manufacturer of a human cell, tissue, and cellular and tissue-based product (HCT/P) that the Food and Drug Administration said was regulated as a drug, and as a...more

American College of Rheumatology White Paper Encourages Use of Biosimilars

by Goodwin on

Last week, the American College of Rheumatology (ACR) published a new white paper “encourag[ing] providers to incorporate [biosimilars] into the treatment plans of patients with rheumatic diseases where appropriate.” The...more

Congress Makes Key Changes to Medicare Physician Payment Programs as Part of Short-Term Government Funding Bill

• Congress amended current law to prevent CMS from applying the “MIPS” payment adjustment to separately billed items like drugs and biologics, which will drastically reduce the total amount of payment adjustments to clinical...more

Biosimilars 2017 Year in Review

by Fish & Richardson on

Since the passage of the Biologics Price Competition and Innovation Act (BPCIA), 2017 has been the most active year yet for drug manufacturers. Fish attorneys Tasha Francis, Jenny Shmuel, and Brianna Chamberlin addressed the...more

Rx IP Update - January 2018

by Smart & Biggar on

Apotex granted damages from contract research organization for delayed FDA approval of two products - Appeal of summary dismissal under PMNOC Regulations: dismissal order stayed...more

When a 20 year patent term just isn't enough: Market and data exclusivity

by FPA Patent Attorneys on

In our first article in this series we considered patent term extension regimes in key jurisdictions as a means for extending the 20 year patent term. This next article considers market and data exclusivity provisions, which...more

Blog: New Jersey Adopts Regulations Targeting Gifts and Payments from Pharmaceutical Manufacturers to Prescribers

by Cooley LLP on

Regulations adopted by the New Jersey Attorney General Division of Consumer Affairs titled LIMITATIONS ON AND OBLIGATIONS ASSOCIATED WITH PRESCRIBER ACCEPTANCE OF COMPENSATION FROM PHARMACEUTICAL MANUFACTURERS became...more

Medicare 340B Drug Payment Policy Survives Legal Challenge; Hospitals Say, It's Not Over

by Baker Ober Health Law on

A federal court has handed CMS an initial legal victory enabling drastic cuts in Medicare Part B payment to take effect for separately payable drugs and biologicals purchased by hospitals under the 340B Drug Discount Program...more

New Jersey Issues Rules to Chill Drug Manufacturer Payments to Prescribers

by Hogan Lovells on

The New Jersey Attorney General plans to finalize new limits on payments and other benefits that New Jersey licensed prescribers may accept from pharmaceutical manufacturers, although the expected final rule is less...more

Update on Biosimilar Testing: Cinfa, Mylan/Biocon, Sandoz

by Goodwin on

Below is a roundup of several recently published comparative studies between biosimilars and reference biologics. In a study presented at the American Society of Hematology’s 59th Annual meeting, the authors concluded that...more

State Law Cannot Circumvent Congress’s Scheme for Biologics

In Amgen v. Sandoz, No. 2015-1499, the Federal Circuit affirmed the Northern District of California’s decision that Sandoz had not waived its preemption defense and that the Biologics Price Competition and Innovation Act of...more

Comment Deadline Approaches for CMS’s Proposed Changes to Medicare Advantage and Part D Programs for CY 2019 – Part 2: Beneficiary...

by Epstein Becker & Green on

On November 28, 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan,...more

FDA Approves the First Gene Therapy to Treat an Inherited Disease

On December 19, 2017, FDA approved the gene therapy Luxturna (voretigene neparvovec-rzyl), developed by Spark Therapeutics, to treat children and adults with biallelic REP65 mutation-associated retinal dystrophy, an inherited...more

Biosimilars: Strategic Considerations for 2018

by Polsinelli on

2017 was an eventful year for biosimilars in the U.S. As the number of biosimilar filings increased, important legal and regulatory decisions changed the strategic landscape of the biosimilars market for both innovators and...more

FDA Provides Guidance on Classifying Medical Products

The Food and Drug Administration (FDA) recently issued final guidance on the classification of medical products. FDA, Final Guidance for Industry and FDA Staff, Classification of Products as Drugs and Devices and Additional...more

American College of Rheumatology Identifies Six Factors for Future FDA Biosimilar Oversight

by Goodwin on

In response to an FDA request for comments regarding existing requirements for biologics and biosimilars, the American College of Rheumatology (ACR) submitted a letter identifying six “minimum components of review and...more

2017 Biosimilar Approvals in Europe

The European biosimilar market has expanded at record pace in 2017.  The EMA approved marketing of sixteen biosimilar products referencing seven different innovator biologic products.  For five of the innovator products –...more

FDA 2017 Year in Review: Therapeutic Products, Part 2

Yesterday we started off our year-end series of blog posts with the first part of a review of FDA’s actions for 2017 in the therapeutic products space. Part 1 recapped Commissioner Gottlieb’s initiative to tackle drug...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

Federal Circuit Rules that BPCIA Preempts State Law Biosimilars Claims

In an opinion issued on December 14, 2017, the United States Court of Appeals for the Federal Circuit held that the 2010 Biologics Price Competition and Innovation Act (“BPCIA”) preempts the use of state law to penalize...more

US Biosimilar Approvals Soar in 2017

Marketing approval for US biosimilars has taken off in 2017. FDA has approved five biosimilar products this year, increasing the number of approved biosimilars from four to nine. In addition to new biosimilars of AbbVie’s...more

[Webinar] Anticipating When the FDA Will Treat Your Product as a Drug-Device Combination - January 17th, 11:00am CT

by Robins Kaplan LLP on

Wednesday, January 17, 2018, 11:00 A.M. CST -- The FDA considers a product a drug-device if it includes at least two of the following: a drug component, device component, or a biologic component. The FDA does not classify as...more

Sandoz Announces Phase I Data For Its Pegfilgrastim Biosimilar

by Goodwin on

On December 8, 2017, Sandoz, a division of Novartis, announced data purportedly showing that its pegfilgrastim biosimilar candidate matches the reference biologic, Neulasta® in terms of pharmacokinetics, pharmacodynamics,...more

Federal Circuit Clarifies Probative Value of Patent Dance Statements

by Jones Day on

The Situation: The Biologics Price Competition and Innovation Act was considered in a November 2017 decision by the United States Court of Appeals for the Federal Circuit. The Result: The court found that the commercial...more

CMS Releases Major MA/Part D Proposed Rule

by Hogan Lovells on

CMS released the first major MA/Part D rulemaking in several years, proposing a number of significant changes to the Part D program, including required pass-through of pharmaceutical company rebates to lower patient...more

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