Area of focus

Pharmaceuticals and Biotechnology

From counseling innovators on product lifecycle management to handling risk and regulatory compliance, we’ve got you covered. Many of us have been on the other side of the table as regulators. We use that experience with FDA, EMA, and other key agencies to help you anticipate and respond to agency actions.

Our...

Representative experience

Representing TESARO in its US$101m Series B financing, its IPO, all of its follow-on equity financings, and its US$165m notes financing.

Representing Medigene AG in US$1bn+ deal with bluebird bio to establish a strategic T cell receptor alliance in cancer immunotherapy.

Representing Sanofi in its US$2.2bn global collaboration with Regeneron Pharmaceuticals to develop novel antibody-based immuno-oncology treatments.

Advising Pfizer on its immuno-oncology research collaboration with Western Oncolytics to investigate novel oncolytic virus technology.

Advising Novartis in US$665m acquisition of Selexys Pharmaceuticals and with its landmark portfolio transformation transactions with GSK and Eli Lilly.

Helping multiple pharmaceutical and biotechnology companies develop product approval strategies.

Convinced FDA to give 5-year exclusivity to fixed dose combination products that include a new chemical entity and a previously approved active ingredient.

Assisting pharmal manufacturers with drug price reporting and other regulatory and compliance obligations under Medicaid, Medicare, and 340B Drug Pricing programs.

Advising a research-based pharmaceutical company with respect to a government demand for price reductions under its federal contracts with the U.S. DVA.

Representing a leading Japanese innovator pharmaceutical firm in numerous Hatch-Waxman actions in relation to generic versions of its product.

DepoMed in patent suit and IPRs against Endo Pharmaceuticals relating to Opana® ER; PTAB upheld Depomed’s patents on controlled release gastric retentive technology.

Representing Merck Sharp & Dohme in HatchWaxman actions against Hospira and Sandoz in relation to Merck’s antibiotic drug, Invanz®.

Serving as national product liability counsel for Bristol-Myers Squibb in a mass tort involving allegations that Abilify causes compulsion gambling.

Representing a global pharmaceutical company on multijurisdictional personal injury litigation and coordinating the client’s defense in more than 27 countries.

Serving as lead national counsel for the world’s largest biotechnology company.

Representing a global pharmaceutical company on several claims arising out of clinical trials in China.

Representing a biotechnology manufacturer in investigation of multiple whistleblower allegations that the company promoted a surgical implant for off-label use.

Conducted internal investigations at global pharmaceutical companies into allegations of money laundering, international corruption, and fraudulent practices related to asset transfers in multiple countries.

Hogan Lovells Publications

Online sale of pharmaceuticals in Russia remains prohibited and lawmakers are yet to pass the bill allowing online sales

Russian law currently prohibits the online sale of pharmaceuticals and requires that pharmaceuticals must be sold only in stationary pharmacies operated by a person holding a pharmaceutical ...

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Blog Post

Will FDA be forced to implement a drug importation program?

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.”...

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Sponsorships and Speaking Engagements

Introduction to Drug, Biologics, and Biosimilars Law and Regulation

Scott Kaplan will be presenting the segment titled "Regulation of Manufacturing" at the Food and Drug Law Institute's Introduction to Drug, Biologics, and Biosimilars Law and Regulation...

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Blog Post

FDA launches temporary “TRIP” program to help HCT/P sponsors gain regulatory clarity

Acting Food and Drug Administration (FDA) Commissioner Ned Sharpless, M.D. recently announced that FDA is implementing a temporary program called the Tissue Reference Group Rapid...

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Blog Post

FDA issues benefit-risk framework for assessing opioid drug applications, announces public meeting

Agency seeks input on “comparative advantage” requirement for new opioids

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