Prescription Drugs

News & Analysis as of

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 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

10 Things You Need to Know About Health Care Bankruptcies in 2017

The coming year will likely continue to be a tumultuous year for health care providers, suppliers, and payers, as they adapt to meet new challenges and market forces, particularly in light of the open questions as to the...more

White Collar Crime Law Enforcement in a Trump Justice Department - 8 Predictions

After a conventional presidential campaign, determining the policy priorities and direction of the incoming administration with respect to the Justice Department’s white collar law enforcement responsibilities can be a...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

The World in US Courts: Orrick's Quarterly Review of Decisions Applying US Law to Global Business and Cross-Border Activities

Alien Tort Statute (ATS)/Torture Victims Protection Act (TVPA)/Anti-Terrorism Act (ATA) - District Court Dismisses ATS Claim Where Alleged Conduct in US Was Not Directly Linked to Injuries Claimed in Other Countries...more

Health Alert (Australia) November 21 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: New South Wales - 16 November 2016 - Page v Healthscope Operations Pty Ltd [2016] NSWSC 1608 - PRACTICE AND PROCEDURE...more

OIG Releases 2017 Work Plan

On November 10, 2016, the Office of Inspector General (“the OIG”) of the U.S. Department of Health and Human Services (“DHHS”) is charged with ensuring the integrity of more than 100 programs administered by DHHS, including...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

Florida Medical Marijuana Law Will Take Effect January 2017

Florida voters passed a new medical marijuana law, Amendment 2, on November 8, 2016. Florida joins 27 other states, the District of Columbia, Puerto Rico, and Guam in allowing public medical marijuana programs. The new law...more

Forest Labs. Holdings Ltd. v. Mylan Inc.

Case Name: Forest Labs. Holdings Ltd. v. Mylan Inc., No. 13–1602–SLR (Consolidated), 2016 U.S. Dist. LEXIS 89268 (D. Del. July 11, 2016) (Robinson, J.) - Drug Product and Patent(s)-in-Suit: Savella® (milnacipran...more

Bayer Pharma AG v. Watson Labs., Inc.

Case Name: Bayer Pharma AG v. Watson Labs., Inc., Case No. 12-1726-LPS, 2016 U.S. Dist. LEXIS 96267 (D. Del. July 18, 2016) - Drug Product and Patent(s)-in-Suit: Natazia® (estradiol valerate / dienogest); U.S. Patent No....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

Guest Post – Tis Better to Try and Fail, Then to Have Never Tried At All: Internal Corporate Policies Do Not Create a Heightened...

What follows is a guest post by Cara DeCataldo, a Reed Smith associate, who gamely stepped up to the plate to research one of a number of blogging topics that have been hanging fire for some time now. This topic is a type of...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

Tyco Healthcare Group LP v. Mutual Pharm. Co., Inc.

Case Name: Tyco Healthcare Group LP v. Mutual Pharm. Co., Inc., Civ. No. 07-cv-1299 (SRC)(CLW), 2016 U.S. Dist. LEXIS 95789 (D.N.J. July 22, 2016) (Chesler, J.) - Drug Product and Patent(s)-in-Suit: Restoril®...more

Don’t Underestimate the Statute of Limitations

As we hurtle into the holiday season, we are reminded that good things often come in small packages. That certainly was the case in a one-and-a-half-page opinion that the Ninth Circuit filed last week in a prescription...more

Torrent Pharmaceuticals Ltd. et al v. Daiichi Sankyo Co., Ltd., et al

Case Name: Torrent Pharmaceuticals Ltd. et al v. Daiichi Sankyo Co., Ltd., et al, Civ. No. 16-C-2988, 2016 U.S. Dist. LEXIS 96448 (N.D. Ill. July 25, 2016) (Pallmeyer, J.) - Drug Product and Patent(s)-in-Suit: Benicar®...more

Guest Post – The FDA’s Two-Day Meeting on Manufacturer Off-Label Communications

Today’s guest post is by Liz Minerd, a Reed Smith associate, who closely followed the online feed of the recent FDA meeting that the Agency called to discuss what changes would be appropriate in its off-label promotion...more

Mylan and Mabion Reach Agreement on Rituximab Biosimilar

According to a Mabion press release, Mylan recently reached a deal with Mabion, a Polish biotech firm, for the exclusive right to commercialize Mabion’s rituximab biosimilar candidate in EU countries and non-EU Balkan states....more

UCB, Inc. v. Accord Healthcare, Inc.

Case Name: UCB, Inc. v. Accord Healthcare, Inc., Civ. No. 13-1206-LPS (Consolidated), 2016 U.S. Dist. LEXIS 109362 (D. Del. Aug. 12, 2016) (Stark, J.) - Drug Product and Patent(s)-in-Suit: Vimpat® (lacosamide); U.S....more

Health Alert (Australia) November 7, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Victoria 2 November 2016 - Tan v Gibbons [2016] VSC 652 - The plaintiff in these proceedings, Dr Tan, sought judicial review...more

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