News & Analysis as of

Biologics

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

Alston & Bird Healthcare Week in Review

by Alston & Bird on

On November 15, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017. The Biosimilar User Fee Amendments of 2017 (BsUFA II)...more

All-Or-Nothing Damages Strategy Leads To No Damages Despite Admission Of Patent Infringement

by Orrick - IP Landscape on

Promega Corp. v. Life Technologies Corp., Fed. Cir. (November 13, 2017) - The Federal Circuit affirmed a Wisconsin district court’s decision to overturn the $52 million award a jury awarded to Promega Corporation...more

All-or-Nothing Damages Strategy Leaves Promega with Nothing

The Federal Circuit’s recent decision in Promega Corp. v. Life Technologies Corp. is a cautionary tale that failure to present evidence of damages closely tied to each alternative basis of liability may result in a hollow...more

Q3 Earnings Round-up

by Goodwin on

Below are some highlights from third quarter earnings reports recently released by biologics and biosimilar companies....more

IPR Updates

by Goodwin on

The PTAB remains a busy venue for biologics patents. Here are some IPR updates from the weeks since our last IPR update...more

Second CAR-T Cell Therapy Approved by FDA

by Holland & Knight LLP on

Less than two months after approving the first gene therapy for use in the U.S., that of Novartis's Kymriah for treatment of pediatric patients with acute lymphoblastic leukemia (ALL), the FDA has approved a second...more

Is it a drug, device, biologic, or combination product? FDA issues final guidance on classification

by Hogan Lovells on

On September 26, 2017, the Food and Drug Administration (FDA) published a final guidance document providing further clarity on how FDA classifies a product as a drug, device, biological product, or a combination product,...more

Summary of FDA Guidance on Statistical Approaches to Evaluate Analytical Similarity

On September 21, 2017, the U.S. Food and Drug Administration released a nonbinding draft guidance for industry, Statistical Approaches to Evaluate Analytical Similarity, for comment purposes. This guidance is part of a series...more

FDA Launches New Tool For Accessing Drug Adverse Event Information

by Hogan Lovells on

FDA recently launched a public dashboard within the FDA’s Adverse Event Reporting System (FAERS) to improve access to data on adverse events related to drug and biological products. FDA Commissioner Scott Gottlieb, M.D....more

A Path Forward: Corporate Integrity Agreement Sheds Light on Manufacturer Interactions With Independent Charitable Foundations

by Hogan Lovells on

Manufacturers of pharmaceuticals and biologics have been closely watching the industry-wide investigation by the Boston U.S. Attorney's Office into manufacturer support of independent charitable foundations that assist...more

OIG Advisory Opinion 17-03 Approves Pharmaceutical Manufacturer's Product Spoilage/Replacement Program

by Baker Ober Health Law on

A pharmaceutical manufacturer proposing to offer customers – at no additional cost – replacements for certain spoiled products that can no longer be administered to patients (Replacement Program) has been granted approval by...more

Following Biosimilar Trial, Jury Awards Amgen $70 Million for Pfizer’s Pre-Approval Infringement of Now-Expired EPO Patent

In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in damages for Pfizer’s infringement of one of Amgen’s expired patents...more

Recent IPR Updates

by Goodwin on

The PTAB has been a busy place for biologics patents in the past few weeks. Here are some of the highlights...more

A road map to Life Sciences M&A in Russia

by Hogan Lovells on

U.S.-based life sciences companies considering transactions in Europe may easily become overwhelmed with the complexity of Europe’s various jurisdictions. In this series, members of our European Life Sciences Transactions...more

The Biosimilars Council Supports Sandoz’s Preemption Position in Federal Circuit Amicus Brief

by Goodwin on

Last week the Biosimilars Council submitted an amicus brief in the Federal Circuit remand proceedings for Amgen v. Sandoz, arguing that Amgen’s state-law claims for Sandoz’s failure to comply with the patent dance’s...more

Pharma and Biologic Disputes in Canada – New Regulations Take Effect September 21, 2017

by Bennett Jones LLP on

Pharma and biologics manufacturers will soon have big decisions to make regarding their pharmaceutical and biological product strategy in Canada. On September 6, 2017, the Governor General in Council, on recommendation of the...more

FDA Makes Gene Therapy Available for First Time in USA

by Snell & Wilmer on

Earlier this week, the FDA made gene therapy available for the first time in the United States. This decision, ushers in “a new approach to the treatment of cancer and other serious and life-threatening diseases” said the...more

A road map to Life Sciences M&A in Germany

by Hogan Lovells on

U.S.-based life sciences companies considering transactions in Europe may easily become over-whelmed with the complexity of Europe’s various jurisdictions....more

To the Spoiler Go the Spoils: OIG Approves Limited Product Replacement Program

by Hogan Lovells on

A perennial question for manufacturers of drugs and biologicals that require specialized handling, storage, or reconstitution is how to handle circumstances in which the product is spoiled, breaks, or otherwise becomes...more

EMA released reflexion paper clarifying information related to the selection of starting materials

by Hogan Lovells on

The European Medicines Agency (“EMA”) has released a reflexion paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances. The reflexion paper provides...more

Skipping The Patent Dance: U.S. Supreme Court In Amgen V Sandoz Makes It More Difficult For Patent Owners To Delay Marketing Of...

by Ladas & Parry LLP on

On June 12, 2017, in a unanimous decision authored by Justice Thomas in Amgen Inc. v. Sandoz Inc., the United States Supreme Court considered the complex statutory scheme that attempts to expedite resolution of patent...more

Federal Circuit Suggests Solution to Patent Owner’s Dilemma When Applicant for Biosimilar Product Refuses Discovery

by BakerHostetler on

In Amgen, Inc. v. Hospira, Inc., Appeal No. 2016-2179 (Fed. Cir. Aug. 10, 2017), the Federal Circuit suggested what an owner of a reference product suing an applicant for a biosimilar under the Biologics Price Competition and...more

Senate Passes Long-Awaited FDA User Fee Package

Following nearly two years of negotiations and hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User...more

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