Area of focus

Pharmaceutical 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.

Blog Post

EMA proposes new pharmacovigilance practices for the paediatric population

The European Medicines Agency (“EMA”) has proposed a new draft guideline document on good pharmacovigilance practices concerning medicinal products used by the paediatric...

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Blog Post

EMA's revised guideline on manufacture of the finished dosage form

The European Medicines Agency (EMA) has adopted a new guideline on manufacture of the finished dosage form of medicinal products for human use (“the new Guideline”).

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Blog Post

EMA released new procedural guide for Multinational Assessment Teams

The European Medicines Agency (“EMA”) has released a procedural guideline for rapporteurs and coordinators participating in Multinational Assessment Teams (“MNAT”).

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Blog Post

EMA further supports Small and medium-sized enterprises (SMEs) with a new Action Plan

The European Medicines Agency (“EMA”) has sought to support Small and Medium-sized Enterprises (SMEs). As part of this effort, the EMA has launched a new Action Plan to address...

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The European Commission opens a public consultation concerning EU legislation on Blood and, Tissues and Cells

The European Commission has opened an online stakeholders’ consultation for the evaluation of the European (“EU”) legislation regarding blood and, tissues and cells. The...

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EMA prepares plan to face Brexit

European Medicines Agency (EMA) has released a business continuity plan dealing with the potential implications of Brexit. EMA, which is currently established in London, will be required to ...

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