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.


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

Regulatory Insights for Life Sciences and Health Care Investments: Drug Pricing and Reimbursement

Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars.

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Blog Post

The new Belgian Biobank legislation will apply on 1 November 2018: are you ready?

The new Belgian Royal Act of 9 January 2018 on Biobanks will apply on 1 November 2018. The Royal Act implements Article 22 of the Belgian Law of 19 December 2008 on the procurement and use...

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Hogan Lovells Publications

FDA schedules public hearing on solutions to drug shortages Pharmaceuticals and Biotechnology Alert

The U.S. Food and Drug Administration (FDA) has announced it will hold a public meeting on November 27 in Washington, D.C. to give stakeholders – including health care providers,...

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Hogan Lovells Publications

Crackdown coming? Draft guidance suggests FDA is looking more closely at clinical trial disclosures Pharmaceuticals and Biotechnology Alert

On Friday, September 21, the Food and Drug Administration (FDA) published a draft guidance titled "Civil Money Penalties Relating to the Data Bank."

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Hogan Lovells Publications

FDA finalizes two guidances clarifying DSCSA enforcement exemptions and issues product identifier Q&A Pharmaceutical and Biotechnology alert

Yesterday, the U.S. Food and Drug Administration (FDA) finalized two important Drug Supply Chain Security Act (DSCSA)-related guidances that aim to help pharmaceutical trading partners...

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Sponsorships and Speaking Engagements

2018 340B Coalition Summer Conference

Chris Schott was a panelist for the "Pharmaceutical Manufacturers" breakout session on 9 July and a co-host of the "Ask the Experts Breakfast for Pharmaceutical Manufacturers" on 10 July at ...

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