News & Analysis as of

New HHS clinical trials registry regulations set to go into effect in January 2017: top points in one chart

Nearly a decade after Congress directed significant expansion of the national clinical trials database, www.ClinicalTrials.gov, the US Department of Health and Human Services (HHS) has issued final implementing regulations...more

First Circuit Affirms Tough Standard for Alleging Securities Fraud; Revives One Claim Against Local Drug Maker

On November 28, 2016, the First Circuit upheld the dismissal of all but one of the class action securities fraud claims against Cambridge, MA drug company, ARIAD Pharmaceuticals, Inc., reaffirming the exacting pleading...more

FDA Issues Interim Response to AbbVie’s Citizen Petition on Interchangeability

About 12 months ago, AbbVie filed a Citizen Petition asking the FDA to take certain steps to tighten and clarify its procedures for making interchangeability determinations. Earlier this year, both Sandoz and GPhA urged the...more

FDA Regulatory and Compliance Monthly Recap — November 2016

OPDP issues fifth untitled letter of the year to Supernus for misrepresenting Oxtellar XR in KOL video - In its fifth untitled letter in 2016, the OPDP raised concerns about a Spanish KOL video suggesting Supernus’...more

MoFo IP Newsletter - November 2016

FDA (Finally!) Issues New Regulations to Clarify Pharmaceutical Patent Litigation: How to Use Patent “Use Codes” - October 6, 2016, the FDA issued a final rule implementing certain provisions of the Medicare...more

FDA Holds Hearing on Off-Label Communications

After several high-profile defeats in both district and circuit courts involving the off-label promotion of regulated products and the First Amendment, the U.S. Food and Drug Administration (FDA) is now engaged in a...more

Pharmaceutical Product Liability Class Action Filed Relating to Olmetec Drug

Earlier this month a proposed class action was filed in Montreal by the Consumer Law Group alleging that Merck, Shering-Plough and Daiichi Sankyo (the Defendants) provided inadequate warnings about the drugs Olmetec and...more

Regulatory News Roundup

The following are some noteworthy news stories on the regulatory front: ..The FDA shared best practices for biosimilar development. ..The EMA okayed a combination of insulin glargine and lixisenatide for treatment...more

Sandoz: Etanercept biosimilar switch has no impact on safety and efficacy

Novartis announced on Friday that the EGALITY study, analyzing the clinical safety and efficacy of Sandoz’s etanercept biosimilar, was published in the British Journal of Dermatology. The 52-week EGALITY study involved...more

FDA Indefinitely Delays Action on Regulating Laboratory Developed Tests

On November 18, 2016, the Food and Drug Administration (FDA) notified industry groups that it no longer plans to finalize its draft guidance on laboratory developed tests (LDTs). FDA stated that it intends to work with the...more

FTC Addresses Homeopathic Drug Advertising

The Federal Trade Commission (“FTC”) recently released an enforcement policy statement regarding marketing claims for products in the over-the-counter (“OTC”) homeopathic drug market. Long permitted to fly under the FTC’s...more

Boehringer Ingelheim Pharma GMBH & Co. KG v. FDA

Case Name: Boehringer Ingelheim Pharma GMBH & Co. KG v. FDA, Civ. No. 15-656 (CKK), 2016 U.S. Dist. LEXIS 86952 (D.D.C. July 6, 2016) (Kollar-Kotelly, J.) - Drug Product and Patent(s)-in-Suit: Pradaxa® (dabigatran...more

Basics of the BPCIA

The FDA broadly defines biologics as medical products derived from living sources (human, animal, plant, or microorganism) intended to treat or prevent diseases. Biologics thus include such varied vehicles of medical...more

FDA CDER Identifies Nanotechnology as Area of Interest for Site Visit Training Program for OPQ Staff

The Food and Drug Administration (FDA) published a Federal Register notice on November 16, 2016, announcing the 2017 Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) Staff Experiential...more

Five Important Themes to Watch in the Reform of FDA’s Off-Label Communications Policy

As we’ve previously reported, FDA has recently been forced to reexamine its legal position and enforcement policies related to drug and device manufacturers’ off-label communications. Although the Agency has for years...more

Regulators Highlight Differing International Biosimilar Regulations; Interchangeability Guidance May Slip to 2017

Bloomberg BNA reported that a panel of regulators at the DIA 2016 Biosimilar Conference in Washington highlighted the differences among biosimilar regulations internationally and the ongoing changes as countries revise their...more

GlaxoSmithKline LLC v. Teva Pharms. USA, Inc.

Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., Civ. No. 14-878-LPS-CJB, 2016 U.S. Dist. LEXIS 94438 (D. Del. July 20, 2016) (Burke, M.J.) - Drug Product and Patent(s)-in-Suit: Coreg® (carvedilol); U.S....more

Super Moon Harkens Low Tide for Hatch-Waxman Patent Disputes

This week, the U.S. Supreme Court denied a petition for writ of certiorari in a case that will give pharmaceutical companies pause when considering whether to settle patent challenges under Hatch-Waxman. The Supreme Court’s...more

FDA Hosts Public Meeting on Off-Label Communications

The US Food and Drug Administration (FDA) recently held a two-day public meeting on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (off-label communications), which offered...more

FDA Holds Public Hearing on Manufacturer Communication of Scientific and Medical Information

On November 9 and 10, 2016, FDA held a public hearing to obtain input on manufacturer communications involving unapproved uses of approved or cleared medical products (i.e., “off-label” uses). The hearing was moderated by...more

Horizon Pharma Ireland Ltd. v. Actavis Labs., UT, Inc.

Case Name: Horizon Pharma Ireland Ltd. v. Actavis Labs., UT, Inc., Civ. No. 14-7992 (NLH/AMD), 2016 U.S. Dist. LEXIS 109068 (D.N.J. Aug. 17, 2016) (Hillman, J.) - Drug Product and Patent(s)-in-Suit: Pennsaid® (diclofenac...more

Ninth Circuit Smells a Rat and Reinstates Claim That Pharmaceutical Company Failed to Disclose Cancers in Animal Testing

The Ninth Circuit recently revived a securities class action against Arena Pharmaceuticals, issuing a decision with important guidance to pharmaceutical companies speaking publicly about future prospects for FDA approval of...more

Eli Lilly & Co. v. Perrigo Co.

Case Name: Eli Lilly & Co. v. Perrigo Co., Case No. 1:13-cv-00851-SEB-DKL (S.D. Ind. Aug. 22, 2016) - Drug Product and Patent(s)-in-Suit: Axiron® (testosterone metered transdermal solution); U.S. Patents Nos. 8,071,075...more

Vanda Pharm. Inc. v. Roxane Labs., Inc.

Case Name: Vanda Pharm. Inc. v. Roxane Labs., Inc., Civ. No. 14-757-GMS (Consolidated), 2016 U.S. Dist. LEXIS 113521 (D. Del. Aug. 25, 2016) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Fanapt® (iloperidone); U.S....more

Sanofi v. Glenmark Pharms. Inc.

Case Name: Sanofi v. Glenmark Pharms. Inc., Civ. No. 14-264-RGA (Consolidated), 2016 U.S. Dist. LEXIS 116950 (D. Del. August 31, 2016) (Andrews, J.) - Drug Product and Patent(s)-in-Suit: Multaq® (dronedarone); U.S....more

759 Results
|
View per page
Page: of 31
JD Supra Readers' Choice 2016 Awards

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×