Pharmaceutical Industry

News & Analysis as of

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

Corruption and Foreign Government Institutions

The FCPA can create a very one-sided view of corruption. The bribe payer is punished and most times the recipient is not. The Justice Department has used creative approaches to ensnare recipients as in the Direct Partners...more

Cumberland Pharms., Inc., v. Mylan Institutional LLC

Case Name: Cumberland Pharms., Inc., v. Mylan Institutional LLC, Civ. No. 12-C-3846, 2015 U.S. Dist. LEXIS 134495 (N.D. Ill. Oct. 2, 2015) (Pallmeyer, J.)... Drug Product and Patent(s)-in-Suit: Acetadote®...more

The Challenge of Non-Interference

To understand the policy challenge created by repeal of the non-interference clause, consider this simple example. Acme Drug Company brings a drug to the market as a single source innovator. Essentially, they are without...more

Otsuka Pharm. Co., Ltd. v. Zydus Pharms. USA,

Case Name: Otsuka Pharm. Co., Ltd. v. Zydus Pharms. USA, C.A. Nos. 14-3168 (JBS/KMW),14-4671 (JBS/KMW),14-5878 (JBS/KMW),14-6398 (JBS/KMW),14-7252 (JBS/KMW), 2015 U.S. Dist. LEXIS 138853 (D.N.J. Oct. 13, 2015) (Simandle,...more

Representatives Send Letter to HHS and NIH Seeking Response to Pharmaceutical Costs

In a letter sent earlier this month to Secretary Sylvia Mathews Burwell of the U.S. Department of Health & Human Services and Director Francis S. Collins of the National Institutes of Health, fifty members of the U.S. House...more

As Urged by PhRMA and BIO, Supreme Court Agrees to Review Claim Construction Standard Used in Patent Office Trials

Pharmaceutical companies have reason to be pleased with the Supreme Court’s recent decision to grant a petition for a writ of certiorari in Cuozzo Speed Technologies, LLC v. Michelle K. Lee, Under Secretary of Commerce for...more

Final ACA Medicaid Drug Pricing Rule Published: Changes to 5i, Bundling, RCP and Other Provisions Leave a Lot for Manufacturers to...

On Thursday, January 21, the Centers for Medicare & Medicaid Services (CMS or “the Agency”) published its long-awaited final rule with comment period implementing the Medicaid pricing and reimbursement provisions of the...more

Cubist Pharms., Inc. v. Hospira, Inc.

Case Name: Cubist Pharms., Inc. v. Hospira, Inc., 2015-1197, 2015-1204, 2015-1259, 2015 U.S. App. LEXIS 19662 (Fed. Cir. Nov. 12, 2015) (Circuit Judges Wallach, Bryson, and Hughes presiding; Opinion by Bryson, J.) (Appeal...more

Blog: Final Medicaid Drug Rebate Program AMP Rule: Some Technical Highlights

We reported yesterday that the Centers for Medicare & Medicaid Services (CMS) Final Average Manufacturer Price (AMP) Rule (the “Final Rule”) was released and will be published in the Federal Register next week. If you are...more

McDermott EU Competition Annual Review 2015

McDermott has published an EU Competition Annual Review for 2015. This 87 page booklet will help General Counsel and their teams focus on the most essential EU competition updates for 2015. Beyond being used to understand...more

Breaking News – High Wattage Reasoning – Arizona Adopts Learned Intermediary

We’ve been following Watts v. Medicis Pharmaceutical Corp. ever since the Arizona Court of Appeals issued its bizarre ruling that the learned intermediary doctrine (“LID”), which has been adopted in almost every state, was...more

"Financial Relationships Likely to Be a Focus in Life Sciences Enforcement and Litigation"

For more than a decade, the Department of Justice (DOJ) has zealously pursued enforcement actions against the health care industry. Given the continued growth in government spending on health care and the billions of dollars...more

More on Patent Settlements Including Litigation at the European Courts

Last week I posted on the European Commission’s (EC) latest report into patent settlement agreements between originator and generic companies in the European Union (EU). The EC says each time it produces these reports that...more

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