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Partnerships Food and Drug Administration (FDA)

Wilson Sonsini Goodrich & Rosati

[Event] Biotech Summit 2024 - October 9th - 10th, Boston, MA

Wilson Sonsini’s inaugural Biotech Summit will address topics of critical importance to Biotech and Biopharmaceutical companies, including early and late-stage venture financing, partnering strategies, current and future AI...more

Benesch

Dental/DSO Intelligence Monthly Report: June/July 2024

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A study at the University of Illinois Chicago College of Dentistry developed a chatbot using information reviewed by faculty members to answer questions about clinical procedures. Cortino Sukotjo, DDS, PhD, a professor of...more

Benesch

Dental/DSO Intelligence Monthly Report: February 2024

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Conceived and founded by 16 doctors, EPIC4 is a unique entity—a Specialty Partnership Organization where dental specialists can maximize potential at all stages of their life and practice. Forming EPIC4 was something of an...more

Fenwick & West LLP

Reflections on the J.P. Morgan Healthcare Conference: Key Themes for 2024

Fenwick & West LLP on

The Fenwick life sciences team recently returned from the 2024 JP Morgan Healthcare conference. As we reflect back on the week, there were several key themes and trends that we expect will continue to resonate and evolve over...more

Wilson Sonsini Goodrich & Rosati

[Ongoing Program] 2023 Medical Device Digital Health Conference - June 16th, San Francisco, CA

Wilson Sonsini’s 30th Annual Medical Device Digital Health Conference will address topics of critical importance to medical device and digital health companies today, including key healthcare regulatory considerations, the...more

Wilson Sonsini Goodrich & Rosati

[Ongoing Program] MDC 2023 Reception & Dinner Women’s Networking Event & Program - June 15th, Menlo Park, CA

Wilson Sonsini’s 30th Annual Medical Device Digital Health Conference will address topics of critical importance to medical device and digital health companies today, including key healthcare regulatory considerations, the...more

Benesch

3D Printing Half-Year Report - Q2 2021

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Is 3D printing the next litigation frontier? Litigation over 3D printing will become increasingly more prevalent as the technology becomes less expensive to build due to rising demand, some lawyers say. A federal court in...more

Goodwin

Ranibizumab Biosimilar Program Updates

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This week, three development programs announced updates to their ranibizumab biosimilars. Ranibizumab is the active ingredient in Genentech’s LUCENTIS, which is indicated for retinal vascular disorders, including neovascular...more

McDermott Will & Emery

Hospital and Health System Innovation Summit: Lessons Learned: Diligence, Detours and Data, Oh My

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Industry leaders shared first-hand lessons learned from their work on recent innovation related projects. We covered a range of case studies, highlighting lessons learned around mission alignment, conflicts of interest,...more

McDermott Will & Emery

Three Tips for Tackling Risk in Digital Health

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Digital health companies face a complicated regulatory landscape. While the opportunities for innovation and dynamic partnerships are abundant, so are the potential compliance pitfalls. In 2018 and in 2019, several digital...more

Foley & Lardner LLP

FDA Approves Companion Dx for PD-1 Inhibitor

Foley & Lardner LLP on

According to the American Cancer Society (“ACS”), lung cancer (both small cell and non-small cell) is the second most common cancer in both men and women (not counting skin cancer). About 14% of all new cancers are lung...more

Goodwin

Celltrion/Teva and Amgen/Allergan Announce FDA Submissions for Proposed Biosimilars of Herceptin®

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Yesterday, two groups announced the submission of applications seeking FDA approval of biosimilars of Herceptin® (trastuzumab), which is indicated for the treatment of HER2-positive early breast cancer, adjuvant breast...more

Goodwin

FDA accepts Celltrion/Teva BLA for biosimilar of Rituxan®

Goodwin on

Celltrion and Teva announced today that the FDA has accepted for standard review their BLA for CT-P10 and that regulatory action is expected in the first quarter of 2018. CT-P10 is a proposed biosimilar to Rituxan®...more

McDermott Will & Emery

IRS Office of Chief Counsel Treated Collaboration Arrangement as Partnership

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In a newly released Chief Counsel Advice, the Internal Revenue Service (IRS) Office of Chief Counsel treated a collaboration arrangement relating to the development and commercialization of a drug as a deemed partnership for...more

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