Pharmaceutical Industry

News & Analysis as of

Seventh Circuit Knocks Out Claims Against Generic Manufacturer on Preemption Grounds

It is not often that we get the opportunity to discuss an opinion from a panel of judges including two former professors from our law school. Diane Wood is the Chief Judge of the 7th Circuit and taught us Civil Procedure at...more

Competition/antitrust law

Focus on the US - Cartel enforcement activity and stiffer criminal penalties against price fixing - The Department of Justice (DOJ) continues to investigate and seek criminal charges against worldwide cartels. This...more

Blog: Heath Provisions in President’s Budget Take Aim at Drug Prices and Opioid Abuse

Today, the President sent Congress the $4 trillion Fiscal Year 2017 Budget Proposal – his last while in office. While the Budget on the whole is dead on arrival in the Republican-controlled Congress, there are provisions...more

The US Biosimilars Pathway: Key Questions

In 2015, FDA issued a number of final guidance documents for biosimilars. But many fundamental questions remain unsettled and the industry awaits FDA’s guidance on labeling of biosimilars, the requirements for...more

Injunctive Relief Claims Lead to Defense Opportunities

It’s not all that common, but every now and then our opponents feel their oats and seek injunctive relief – usually against the continued marketing of an FDA-approved product. A state-law plaintiff seeking such injunctive...more

AbbVie Submits Citizen Petition on Interchangeable Biosimilars

AbbVie, Inc., a biopharmaceutical company, has submitted a citizen petition to the FDA regarding determinations of interchangeability under the BPCIA. An interchangeable biological product is biosimilar to a reference...more

Catching up on developments posted on the blog

Some quick updates on stories I have been following: SENTENCING FOR DEADLY PAIN-MEDS DOC: An Orange County, CA., physician has been sentenced to 30 years to life imprisonment. She was convicted of murder for her...more

Blood on the Tracks Hits No. 1 and the Lessons Learned from SciClone

On this week in 1975, Bob Dylan’s 15th studio album, Blood on the Tracks, reached the Number 1 album slot on the Billboard charts. This was in spite of no song rising above the 31st slot on the single charts. It came out in...more

Arizona Supreme Court Adopts Learned Intermediary Doctrine

The Arizona Supreme Court has issued an opinion adopting the learned intermediary doctrine in Arizona. The Supreme Court rejected the Arizona Court of Appeals’ earlier decision holding that the learned intermediary doctrine...more

The US Biosimilar Pathway: What’s Ahead

2015 was a landmark year for biosimilars. It began with the approval of the first US biosimilar, Sandoz’s Zarxio, in March 2015 under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Zarxio entered the US...more

CMS Finalizes Long-Awaited Covered Outpatient Drug Rule

The Centers for Medicare & Medicaid Services (“CMS”) recently issued a final rule implementing provisions of the Patient Protection and Affordable Care Act of 2010 (“ACA”) that pertain to Medicaid reimbursement for covered...more

California-Based Pharmaceutical Company Settles with SEC Regarding FCPA Offenses in China

On February 4, the SEC settled FCPA allegations with a California-based pharmaceutical company with a cease and desist order finding that the company violated the FCPA’s anti-bribery, books and records, and internal controls...more

SciClone Pharmaceuticals: A Textbook Case of FCPA Violations for Gifts, Meals, Entertainment and Travel

The Securities and Exchange Commission continues its steady march as the prominent FCPA enforcement agency against corporations.  The Justice Department has not brought any enforcement actions this year and continues to...more

Behind the Curtain: Shkreli was NOT the Big Story on the Hill Today

Congress’s complex relationship with prescription drugs was on display today in the House of Representatives. In the House Committee on Oversight and Government Reform (OGR), Martin Shkreli pleaded the 5th at a hearing...more

Final WHO Biosimilar Naming Proposal Resembles FDA Approach

On January 26, 2016, the World Health Organization (WHO) unveiled the final version of its proposal for a worldwide biosimilar naming convention. The WHO proposes to add a “biologic qualifier” (BQ) suffix, which consists of...more

Drug Manufacturer Discount Cards: Accept With Caution

Pharmaceutical manufacturer discount card usage by government program beneficiaries has been an active area for government action in recent years. In a September 2014 Special Advisory Bulletin, the U.S. Department of Health...more

FDA Regulatory and Compliance Monthly Recap — January 2016

OPDP enforcement reaches record low in 2015 as drugmakers face uncertainty in digital marketing - Enforcement by the OPDP has fallen notably since 2010. The decline has been attributed, in part, to the agency's slow...more

ICYMI: Biosimilars and FDA Regulatory Webinar

Our Biosimilar webinar series continued this month with Linda Bentley and Joanne Hawana’s Biosimilars FDA/Regulatory Overview presentation. Linda and Joanne discussed statutory provisions related to FDA’s authority to approve...more

Increased Scrutiny of Drug Pricing What Should Pharmaceutical Companies Know

As U.S. spending on pharmaceuticals continues to rise, reaching $373.9 billion in 2014, government scrutiny of drug pricing practices has increased in response. Early last year, the U.S. Department of Health and Human...more

The CMS Final Covered Outpatient Drug Rule Addresses Many Industry Concerns

The rule implementing the Medicaid Drug Rebate Program is less burdensome and costly than what was originally proposed. In 2010, the Affordable Care Act (ACA) directed the US Centers for Medicare and Medicaid Services...more

Delaware Supreme Court Holds That Expectation Damages Involving the Breach of an Obligation to Negotiate in Good Faith a License...

On December 23, 2015, the Delaware Supreme Court sitting en banc issued its second opinion in Siga Technologies Inc. v. PharmAthene, Inc. In its first decision, the Court reaffirmed its recent decision in Titan “that where...more

Life Sciences. Major Russian legislation changes for 2015

1. Entry into force of the set of amendments to the Federal Law on the Circulation of Medicines that were approved in December 2014 - Federal Law No. 429-FZ of December 22, 2014 on Amendments to the Federal Law on the...more

Record breaker: US M&A in 2015

As the dust settles from the explosion of US M&A activity in 2015, it is fitting to reflect on the forces that fueled the boom and consider what last year’s trends may tell us about the year ahead. The record year...more

Breaking News – Learned Intermediary Mandates Dismissal of 31 of 32 New Jersey Accutane Plaintiffs

The demise of the New Jersey Accutane litigation under the new mass tort judge continues apace. Today 31 more Accutane cases were dismissed for failure to establish warning causation under the learned intermediary rule. ...more

Healthcare Regulatory Diligence: “What Does it Mean to Financial Underwriting?”

It’s deal time! The 2016 JP Morgan Healthcare Conference has set the tone for another successful year for healthcare investing. A company’s financial health is a key factor in the underwriting process for any type of loan...more

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