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.

Hogan Lovells Publications

Good Manufacturing Practice and the global supply chain

Supply chain oversight: what to expect from —and how to prepare for— an increasingly global supply chain and heightened FDA scrutiny

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Hogan Lovells Publications

Influencer promo guide: Best practices for drug and device firms

All companies must be mindful of compliance with Federal Trade Commission (FTC) guidelines for influencers and marketers, which require, among other things, that ads and endorsements be...

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Hogan Lovells Publications

China adds 30 drugs to its "urgently needed" list Pharmaceutical and Biotechnology Alert

Faster review periods and waiver of requirement for Chinese clinical trials are intended to encourage marketing applications

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Sponsorships and Speaking Engagements

ACI's FDA Boot Camp (New York)

Scott Kaplan presented on the topic "Understanding FDA Enforcement and Authority and Actions" at the 33rd American Conference Institute's (ACI) FDA Boot Camp in New York.

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Webinar

CBD and the changing regulatory landscape for hemp-derived products

Please join us on Tuesday, February 26 for a webinar on the regulatory landscape for hemp-derived products, including cannabidiol, or CBD.

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