News & Analysis as of

Actavis Amici Briefs Don’t Support Injunction

The expedited appeal to the Second Circuit pits New York State’s arguments for facilitating competition in a “molecule market” (a product market defined by the active ingredient of a prescription drug) against the brand name...more

Generic Drug Cos. Face Failure-To-Warn Claims In Calif.

On Jan. 20, 2015, the U.S. Supreme Court declined to hear an appeal involving failure-to-warn claims against generic pharmaceutical manufacturers. Teva Pharms. USA Inc. v. Super. Ct., No. 13-956 (U.S. Jan. 20, 2015). This...more

FDA Proposes Electronic Distribution of Prescribing Information

Drug manufacturers may no longer be required to distribute prescribing information on paper—with limited exceptions—and instead may have to distribute that same information electronically. The FDA recently issued a proposed...more

Product Liability Alert: Failure-To-Warn Suit Against Generic Drug Maker Proceeds Despite Argument of Federal Preemption

On January 20, 2015, the U.S Supreme Court denied cert in Teva v. Superior Court of California, Orange County, refusing to review a California state court ruling allowing patients to proceed with claims that Teva...more

FDA Clarifies Orphan Drug Exclusivity Policy Following Court Defeat

On the heels of a loss in federal court last fall, the FDA recently announced a clarification of its policy concerning orphan drug exclusivity. In short, despite a court ruling requiring the FDA to grant orphan drug...more

"Insights Conversations: Life Sciences"

A healthy market for M&A activity, particularly cross-border deals, and a strict regulatory environment are the big factors influencing the health and activities of life sciences companies. Skadden partners John T....more

A Step Forward in Approving Lower-Cost “Generic” Biologic Drugs

A federal advisory panel has helped clear the path for what may be the first biosimilar biologic drug ever approved in the United States. Interestingly, generics of traditional drugs have been available in the U.S. for...more

Generic Drug Manufacturers to Face Failure-to-Warn Claims in California

On January 20, 2015, the Supreme Court declined to hear an appeal involving failure-to-warn claims against generic pharmaceutical manufacturers. Teva Pharms. USA Inc. v. Super. Ct., No. 13-956, 2015 WL 231967 (U.S. Jan. 20,...more

Electronic Distribution of Prescribing Information for Prescription Drugs & Biologicals

The FDA published a proposed rule on December 18, 2014 that would require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or...more

FDA One Step Closer to New Direct-To-Consumer Television Ad Requirements

Last February, the Food and Drug Administration (FDA) asked for public feedback on a proposed research study related to prescription drug television advertisements. In a notice published in the Federal Register on January 13,...more

Blog: FDA Submits Notice for Collection of Information Regarding Direct-to-Consumer Advertisements

The Food and Drug Administration (FDA) recently submitted a proposed collection of information on disclosing risks in direct-to-consumer (DTC) prescription drug television (TV) advertisements to the Office of Management and...more

Guest Post: 41 New Drugs Approved in '14 -- A Random Spike or a Growing Trend of Drug Innovation?

By Cambria Alpha-Cobb* and Anthony D. Sabatelli** -- If innovation drives progress, then 2014 was the year of progress!  During the past year the U.S. Food and Drug Administration approved 41 new drugs.  That is 14 more than...more

ODAC Committee Votes to License Sandoz’s Zarxio®

As noted in our previous client alert, FDA Accepts First Biosimilar Application Filed under Section 351(k) of the Public Health Service Act, Sandoz Inc. (“Sandoz”) filed the first biosimilar application under the Biologics...more

FDA Regulatory Update: Forecasting FDA Regulation of Laboratory Developed Tests (LDTs) in 2015

2015 is proving to be a landmark year for FDA’s regulation of laboratory developed tests. As we have previously discussed (see our blog here), the U.S. Food and Drug Administration (FDA) has been expressing its intention to...more

FDA Regulatory and Compliance Monthly Recap - December 2014

FDA replaces pregnancy labeling system with a new standard in a bid to provide more clarity - The regulator is discarding its decades-old system to explain the risks of prescription drugs to women who are pregnant or...more

JPML Asked to Consolidate Benicar Lawsuits

Daiichi Sankyo, Inc. developed the prescription medication Benicar (Olmesartan Medoxomil) to treat high blood pressure. In April 2002, the U.S. Food and Drug Administration (FDA) approved Benicar. Since that time, it has...more

The Patent Office Clarifies the Ban on Patenting Naturally-Derived Drugs and Other Products

Since the very beginning of America’s revolutionary patent system, inventors in the life sciences have been granted patents for discovering and purifying natural products. It was taken as a given that a purified natural...more

Xarelto Suits Sent to Louisiana

Xarelto (rivaroxaban) is a new generation anticoagulant in a class of drugs known as direct thrombin inhibitors. It is a blood thinner used to reduce the risk of blood clots and strokes. Xarelto has also been marketed as...more

HHS Issues Notice of Proposed Rulemaking for Clinical Trials Registration and Results Submission to ClinicalTrials.gov

On November 19, 2014, the Department of Health and Human Services (HHS) published, for a 90-day public comment period, a Notice of Proposed Rulemaking (NPRM) for Clinical Trials Registration and Results Submission. The...more

Federal Circuit’s Sandoz v. Amgen Decision Forecloses Early Declaratory Judgment Suits by Biosimilars Applicants

On December 5, in the closely watched Sandoz v. Amgen case, the Federal Circuit held that a biosimilars applicant cannot use the Declaratory Judgment Act to challenge a reference product sponsor's patent prior to filing a...more

Federal Circuit Rules Against Patent Declaratory Judgment Actions Before Biosimilar Application Is Filed

On December 5, 2014, the Federal Circuit issued its opinion in Sandoz Inc. v. Amgen Inc. et al. In a unanimous panel opinion (Judges Dyk, Taranto and Chen), the Court held that clinical trials initiated to support a possible...more

Celltrion Healthcare Co. v. Kennedy Trust for Rhematology Research (S.D.N.Y. 2014); Hospira Inc. v. Janssen Biotech Inc. (S.D.N.Y....

Earlier this month, Judge Paul Crotty, U.S. District Court Judge for the Southern District of New York handed down rulings in two separate cases related to the biosimilars law (the Biologics Price Competition and Innovation...more

Court Allows “Product Hopping” Claims to Proceed in Suboxone Litigation Based on Allegations of Removal of Prior Formulation and...

We’ve previously discussed antitrust claims related to “product hopping”—allegations that pharmaceutical manufacturers have reformulated or otherwise altered their products to prevent automatic generic substitution. Earlier...more

What’s Next for the FDA’s Draft Social Media Guidances?

As many of our life sciences clients know, 2014 brought long-awaited draft guidance documents from the FDA regarding three social media-related topics of interest. The FDA provided its much-anticipated views on...more

FDA Regulatory and Compliance Monthly Recap – November 2014

In an unusual move, the FDA takes issue with the accuracy of Sciecure’s studies in a warning letter over sales promotion material for the company’s sleeping pill - In addition to criticizing the pharmaceutical company...more

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