News & Analysis as of

Pharmaceutical Industry Food and Drug Administration (FDA) Medical Reimbursement

Manatt, Phelps & Phillips, LLP

Accessing Cell and Gene Therapies : Insights on Coverage, Reimbursement and Emerging Models

Over the past five years, cell and gene therapies have increasingly moved from the R&D pipeline to the health care setting, putting lifesaving treatments for certain cancers and genetic diseases within patients’ reach. Over...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In Tuesday's Report: FDA revokes...more

McDermott Will & Emery

[Ongoing Program] HPE New York 2020 - Part 3 - October 21st, 12:00 pm - 1:30 pm EDT

McDermott Will & Emery on

Maintain Connections with Healthcare Leaders. Stay Current on Market Trends. Look Ahead to 2021 and Beyond. Join us virtually for McDermott's signature HPE New York conference. We'll bring together preeminent healthcare...more

McDermott Will & Emery

[Ongoing Program] HPE New York 2020 - Part 2 - October 14th, 12:00 pm - 1:30 pm EDT

McDermott Will & Emery on

Maintain Connections with Healthcare Leaders. Stay Current on Market Trends. Look Ahead to 2021 and Beyond. Join us virtually for McDermott's signature HPE New York conference. We'll bring together preeminent healthcare...more

McDermott Will & Emery

[Ongoing Program] HPE New York 2020 - Part 1 - October 7th, 12:00 pm - 1:30 pm EDT

McDermott Will & Emery on

Maintain Connections with Healthcare Leaders. Stay Current on Market Trends. Look Ahead to 2021 and Beyond. Join us virtually for McDermott's signature HPE New York conference. We'll bring together preeminent healthcare...more

McDermott Will & Emery

[Ongoing Program] HPE New York 2020 - October 29th, 10:00 am - 1:30 pm EDT

McDermott Will & Emery on

HPE New York brings together preeminent healthcare private equity executives and investment bankers and unmatched keynote speakers to your remote workspace in a cutting-edge format – unlike any other conference this fall. ...more

Baker Donelson

OIG Okays Assistance Arrangement Offered to Drug Patients in Advisory Opinion 20-02

Baker Donelson on

In Advisory Opinion 20-02, the Office of Inspector General (OIG) approved certain lodging and travel assistance offered by a pharmaceutical manufacturer to patients being administered a drug manufactured by the pharmaceutical...more

Manatt, Phelps & Phillips, LLP

Evolving Pharmaceutical Benefit Trends and Medicaid Managed Care’s Role

Editor’s Note: State Medicaid programs continue to balance serving eligible beneficiaries and controlling costs. In an environment sharply focused on the cost of drugs, it is increasingly critical to understand the Medicaid...more

Hogan Lovells

Regulatory Insights for Life Sciences and Health Care Investments: Drug Pricing and Reimbursement

Hogan Lovells on

Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars....more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

BakerHostetler

Never Fear Regulatory Violations – Focus on Conditions to Payment

BakerHostetler on

The U.S. Court of Appeals for the Fourth Circuit recently upheld the dismissal of a False Claims Act (FCA) suit against Omnicare, Inc., in which the relator alleged that certain drugs repackaged by Omnicare’s subsidiary were...more

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