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News

Time’s up: New enforcement era for regenerative medicines begins June 1

On April 21, 2021, FDA’s Center for Biologics Evaluation and Research (CBER) Director Peter Marks M.D. confirmed that the grace period intended to provide developers of regenerative...

News

Ramping up the drug pricing debate: Dueling bills and paying for health care infrastructure

The U.S. House of Representatives is considering dueling proposals related to drug pricing under Medicaid and Medicare, including the reintroduced Republican-led H.R. 19, the “Lower...

Media Mention

GP-led Secondaries Report 2021 Private Equity International

In a recent report produced by Private Equity International, Ed Harris and Adam Brown comment on the expanding GP-led secondaries market, including restructurings, continuation funds and...

News

HHS Regulatory Sprint takes final shape, Part 2: AKS, Stark regulatory revisions for value-based care

Following on last October’s publication of two proposed rules, the Department of Health and Human Services (HHS) published on November 20 two final rules intended to “modernize...

News

Trump Administration revives rebate safe harbor rule in late effort to reform drug pricing

On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized its previously abandoned 2019 proposal to exclude certain rebates...

News

OIG signals “significant concerns” with company-sponsored speaker programs

On November 16, 2020, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG) issued a rare Special Fraud Alert – a type of guidance historically ...

Published Works

GP-led transactions are in good health Estates Gazette

In a recent article for Estates Gazette, Ed Harris, Sian Owles, Nicholas Holman, Adam Brown and Elliot Weston explore what GP-led transactions are, the common motivations for their...

News

OIG denies proposed manufacturer-sponsored copay support program for Medicare beneficiaries

On September 23, the HHS OIG published Advisory Opinion No. 20-05, advising that OIG found “highly suspect” a manufacturer’s proposal to create a copay subsidy program to...

Published Works

COVID-19 and fund secondaries – how should pension schemes position themselves? Investment & Pensions Europe

Partners Ed Harris, Jeremy Pickles, Faye Jarvis and Adam Brown co-wrote an Investment & Pensions Europe article which focusses on how pension funds can best position themselves to take...

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