Author Info for Fenwick & West Life Sciences Group

Pinar Bailey Ph.D.

Digital Health Companies May Find a Faster Path to Market Under the FDA's Digital Health Plan

It looks like the FDA is moving forward—and swiftly—with the digital health plan articulated in FDA Commissioner Scott Gottlieb's June blog post, previously outlined in this post. Closely tracking the commissioner’s post, the…more

21st Century Cures Initiative, Digital Health, Federal Pilot Programs, Food and Drug Administration (FDA), Medical Devices

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Ran Ben-Tzur

Going Public Report: IPOs, SPACs and Direct Listings Facing Headwinds in 2022 After Record Year - 2021 Milestones and 2022 Outlook

Following a record-breaking year for IPOs and other going-public transactions in 2021, the beginning of 2022 has presented a challenging environment. That’s largely a result of volatile market conditions due to the ongoing…more

Capital Markets, Direct Listing, Environmental Social & Governance (ESG), Initial Public Offering (IPO), Investment Opportunities

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Michael Esquivel

In 2024, the Digital Health Revolution Continues

Digital health is showing signs of life despite financial markets that seem determined to bring some of 2023’s volatility into the new year. Stocks are up and down, and bond yields are climbing. Inflation is proving stubborn,…more

Capital Markets, Digital Health, Health Information Technologies, Healthcare, Initial Public Offering (IPO)

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James Evans

Going Public Report: IPOs, SPACs and Direct Listings Facing Headwinds in 2022 After Record Year - 2021 Milestones and 2022 Outlook

Following a record-breaking year for IPOs and other going-public transactions in 2021, the beginning of 2022 has presented a challenging environment. That’s largely a result of volatile market conditions due to the ongoing…more

Capital Markets, Direct Listing, Environmental Social & Governance (ESG), Initial Public Offering (IPO), Investment Opportunities

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Julia Forbess

Biotech Industry at Inflection Point with ESG Initiatives

Corporate social responsibility is not a new concept, but in recent years there has been an increased focus by investors and other stakeholders regarding how companies are addressing their environmental, social and governance…more

Biotechnology, Corporate Governance, Corporate Social Responsibility, Disclosure Requirements, Environmental Social & Governance (ESG)

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Robert Freedman

Going Public Report: IPOs, SPACs and Direct Listings Facing Headwinds in 2022 After Record Year - 2021 Milestones and 2022 Outlook

Following a record-breaking year for IPOs and other going-public transactions in 2021, the beginning of 2022 has presented a challenging environment. That’s largely a result of volatile market conditions due to the ongoing…more

Capital Markets, Direct Listing, Environmental Social & Governance (ESG), Initial Public Offering (IPO), Investment Opportunities

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Stephen Graham

Investment in eHealth: 2014, and what the future holds

Digital health, a category that was virtually nonexistent five years ago, has exploded in recent years and shows the potential to remake the way healthcare is delivered worldwide. Rock Health, the digital health incubator,…more

Digital Health, Emerging Technology Companies, Healthcare, Venture Funding

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Ron Llewellyn

Biotech Industry at Inflection Point with ESG Initiatives

Corporate social responsibility is not a new concept, but in recent years there has been an increased focus by investors and other stakeholders regarding how companies are addressing their environmental, social and governance…more

Biotechnology, Corporate Governance, Corporate Social Responsibility, Disclosure Requirements, Environmental Social & Governance (ESG)

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Melanie Mayer Ph.D.

Biosimilars: Supreme Court Grants Certiorari in Amgen v. Sandoz

On Friday, January 13, the Supreme Court granted certiorari in Amgen v. Sandoz (Nos. 15-1039 & 15-1195). The Supreme Court originally deferred its decision on the parties’ certiorari petitions in order to consider the Solicitor…more

Amgen, Biologics, Biosimilars, BPCIA, Certiorari

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Amanda Rose

Going Public Report: IPOs, SPACs and Direct Listings Facing Headwinds in 2022 After Record Year - 2021 Milestones and 2022 Outlook

Following a record-breaking year for IPOs and other going-public transactions in 2021, the beginning of 2022 has presented a challenging environment. That’s largely a result of volatile market conditions due to the ongoing…more

Capital Markets, Direct Listing, Environmental Social & Governance (ESG), Initial Public Offering (IPO), Investment Opportunities

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Matthew Rossiter

Strategies For Navigating The Life Sciences Capital Crunch

The need for innovation in healthcare has arguably never been greater. Originally Published in Navigating The Capital Crunch - April 15, 2013…more

Capital Markets, Financing, Healthcare, Life Sciences, Venture Capital

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David Tellekson

Federal Circuit: A Biosimilar Applicant Must Provide Notice of Intent to Market a Biosimilar Product, No Exceptions

On July 5, 2016, in Amgen v. Apotex (No. 2016-1308), the Federal Circuit again held that a biosimilar applicant must provide its biologic competitor with 180 days’ notice of intent to commercially market a biosimilar product…more

Amgen, Apotex, Biosimilars, BPCIA, Food and Drug Administration (FDA)

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Jennifer Yoo

A Complex Regulatory Landscape Emerges for Telemedicine

Every year, Rock Health surveys the digital health landscape, noting the changing trends related to adoption by providers, patients and payers of these innovative new technologies…more

Controlled Substances, Data Protection, Digital Health, Health Care Providers, Health Insurance Portability and Accountability Act (HIPAA)

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Fenwick & West Life Sciences Group

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