Life Sciences and Health Care - Global lawyers - Hogan Lovells

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Life Science and Health Care Horizon Guide

Aimmune Therapeutics on its groundbreaking approval by the FDA for PALFORZIA™, the first approved therapy for peanut allergy.

A drug company on strategies for obtaining orphan drug approval and working with scientific and regulatory groups to draft and submit designation request.

Persuading FDA to change a longstanding regulatory position on awarding exclusively to fixed-dose combination products, benefiting Gilead’s products in HIV and Hepatitis C fields.
Vayu Global Health Innovations in obtaining an EUA from FDA that allowed its bubble CPAP device to be distributed to hospitals to help alleviate the ventilator shortage associated with COVID-19.

IDx LLC to achieve De Novo reclassification from the FDA for the ground-breaking AI-based device IDx-DR, which autonomously analyzes images of the retina for signs of diabetic retinopathy.

Anthem, Inc. in more than 100 class action lawsuits that have been filed around the country related to their cyberattack.
Provider networks in multiple investigations of their clinical integration and joint negotiations with health plans by federal and/or state antitrust enforcers.
Zimmer Biomet and various European subsidiaries in relation to personal injury claims concerning metal-on-metal prosthetic hip replacements.
Eli Lilly in its European patent disputes concerning its oncology product, pemetrexed.
Novartis in a precedent case by obtaining an injunction using patent rights against a generic product before market entry in Russia.
Acting in multiple patent infringement and patent nullity proceedings related to patents for wound dressings.
Gilead Sciences on the technology license agreement with Xencor, Inc., developing engineered monoclonal antibodies for the treatment of cancer, autoimmune disease, asthma, and allergic diseases.
Pharmaceutical and biologics companies in connection with the numerous federal and state investigations of sales and marketing, pricing Medical rebate, FDCA promotional issues, and cGMP compliance.
Hospital transactions for Vanderbilt University, UW Health, UC Health, University of Minnesota, Saint Louis University, Georgetown University, University of Miami, the State University of New York and more.
MorphoSys on a global collaboration and license agreement with Incyte Corporation to further develop and commercialize tafasitamab, an anti-CD19 antibody currently in development to treat blood cancer.
Nanobiotix on commercial contracts, in particular on a strategic cooperation with MD Anderson Cancer Center for a large-scale, comprehensive clinical collaboration on NBTXR3.