Pharmaceutical Industry

News & Analysis as of

In re: Nexium: Ranbaxy’s Motion for a Mistrial to Be Argued Today

Today, the Nexium district court will hear arguments on the Ranbaxy defendants’ motion for a mistrial. As we have previously reported, In re: Nexium is the first pay-for-delay case to go to trial since the Supreme Court’s...more

What’s Next for In re: Nexium: Defendants’ Motions for Directed Verdicts Likely to Turn on Sufficiency of Expert Testimony

As we previously reported, the In re: Nexium trial is the first pay-for-delay trial in the wake of the Supreme Court’s Federal Trade Commission v. Actavis decision. But if the Nexium defendants have it their way, plaintiffs’...more

Public Outcry Over Generic Price Hikes Spurs Criminal Investigations

Drug manufacturers Impax Laboratories and Lannett Company have come under public scrutiny and, more recently, criminal investigation for their recent generic drug price increases. The companies disclosed in recent SEC filings...more

EP Committee Study on Legislative Areas of the TTIP Addresses Nanomaterials

The European Parliament (EP) Committee on Environment, Public Health, and Food Safety (ENVI) has posted a study entitled ENVI Relevant Legislative Areas of the EU-US Trade and Investment Partnership Negotiations (TTIP). The...more

FDA Publishes Second Draft Guidance for Further Clarification of Drug Supply Chain Security Act

Earlier this year, the U.S. Food and Drug Administration (FDA) requested information and commentary for the implementation of the Drug Supply Chain Security Act (DSCSA) that in part "establishes a Federal system for tracing...more

The New Promotional Rules: “There Are No New Promotional Rules”

There is resounding evidence that physicians and patients rely on the Internet—including social medial platforms—to research and communicate health information. FDA, however, has been slow to adapt even though the potential...more

BIO IPCC Panel Discusses Impact of Myriad-Mayo Guidance

Yesterday, we reported on a session of the Biotechnology Industry Organization (BIO) Intellectual Property Counsel's Committee fall conference, which took place earlier this week in Nashville, TN, in which the U.S. Patent and...more

CMS Finalizes Proposal to Remove Continuing Medical Education Exclusion from Sunshine Act Regulations

On October 31, 2014, the Centers for Medicare & Medicaid Services (CMS) issued its final Medicare physician fee schedule rule for CY 2015 (the Final Rule), which also includes certain changes to the Sunshine Regulations. ...more

SEC Charges Former Pharmaceutical Executive and Close Friend With Insider Trading

The Securities and Exchange Commission recently charged a former pharmaceutical company executive and his longtime friend with insider trading, alleging that the friend generated more than $1 million in illicit profits by...more

DOJ Investigation into Generic Pharmaceutical Pricing Signals Potential Criminal Exposure

The United States Department of Justice Antitrust Division (DOJ) recently served two U.S.-based generic pharmaceutical manufacturers with criminal grand jury subpoenas. It is reported that the subpoenas request all...more

A CEE Change Is Coming

Earlier this month, U.S. Customs and Border Protection (Customs) announced that it plans to expand its first three Centers of Excellence and Expertise (CEEs) over the next 12 months to cover their entire industries. Included...more

Lex Machina Looks at ANDA Cases

Lex Machina, a commercial venture spinning out of the "quantitative statistics" trend in patent scholarship popularized by Mark Lemley, Kimberly Moore, David Schwartz, and others, has released a Report on ANDA litigation that...more

White Collar Watch - October 2014

In This Issue: - Government demonstrates willingness to enforce Affordable Care Act provision that could cost providers millions of dollars - Words can come back to haunt you: Boilerplate pleading could lead...more

Beginning to Close the POM Circle? – POM Wonderful and Drug Advertising: JHP Pharmaceuticals

Earlier this year, in POM Wonderful LLC v. Coca-Cola Co.,[1] the Supreme Court examined the interaction between the Lanham Act’s prohibition against false advertising and the FDCA’s prohibition against food, drug and...more

CME Payments Largely Remain Excluded From Sunshine Act Reporting

The Centers for Medicare & Medicaid Services (“CMS”) has finalized changes to a number of reporting requirements under the regulations implementing the Physician Payments Sunshine Act (“Final Rule”). When CMS proposed...more

Nexium District Court Takes Pioneering Approach to Preliminary Jury Charge

How does a court explain the complicated area of law at the intersection of patent settlements and antitrust law to a group of lay-jurors in the wake of Actavis? The district court’s approach to preliminary jury instructions...more

Mobile Health Apps are in a Boom Phase – Why is it so Hard for Pharmaceutical Companies to Find Users?

Mobile medical and health applications have been in a boom phase for the past few years, but despite this trend, one group of entities has had trouble breaking into the mobile medical app sphere, pharmaceutical (i.e., pharma)...more

The Era of Generic Biologic Drugs Has Officially Begun: An Update on U.S. Biosimilars  [Video]

Paul A. Calvo, Ph.D., director at the intellectual property law firm Sterne, Kessler, Goldstein & Fox, P.L.L.C., discusses the success of generic biologic manufacturers at the FDA and in the courts as the era of generic...more

Pharmaceutical manufacturers beware: HHS OIG issues warning about copay coupon programs

The Office of Inspector General of the Department of Health and Human Services recently issued a warning to pharmaceutical manufacturers, reminding them that copay coupons used for drugs purchased through federal healthcare...more

Red Notice Newsletter - October 2014

Welcome to the October 2014 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. - This month on the anticorruption front, a Texas company agrees to pay more than $5 million to settle allegations...more

Patent Owners: Better Address All Obviousness Arguments Raised by Petitioner

Pharmatech Solutions, Inc. v. LifeScan Scotland Ltd. - In a final written decision addressing an obviousness challenge, the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB, the Board) found the...more

Court Report - October 2014 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. AstraZeneca Pharmaceuticals LP et al. v. Pharmadax USA, Inc. et al. 8:14-cv-01710; filed October 23, 2014 in the Central...more

Dr. Reddy’s Laboratories Settles on Eve of Trial – Agrees to Cooperate with Plaintiffs

Much has happened since our last post on the Nexium “pay for delay” class action lawsuit. Jury selection began in the District of Massachusetts on Monday, October 20, 2014. The day prior, one of the generic drug makers, Dr....more

Blog: Litigation Round-Up: Some Recent Drug & Device Settlements, Investigations, Inquiries

Settlements - Pharmaceutical company Organon Inc. agreed to pay $31 million to settle federal and state allegations that it underpaid Medicaid drug rebates, provided kickbacks to nursing home pharmacy companies,...more

SEC – USAO Charge Trader In Analyst Insider Trading Case

Earlier this month the SEC brought an insider trading case against Zachary Zwerko, a financial analyst at a pharmaceutical company identified only as Pharma Co. SEC v. Zwerko, Civil Action No. CV 8181 (S.D.N.Y. Filed Oct. 10,...more

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