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Regulatory Oversight Trump Administration Pharmaceutical Industry

Venable LLP

CBER Director Resigns from FDA, Commissioner Makary’s Recent Remarks on FDA Staffing Cuts, CBER Hiring Data, and Additional...

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Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency’s structure and stakeholder interactions. ...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – May 2020 #12

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In Washington: Sen. Debbie Stabenow (D-MI) and Senate Minority Leader Chuck Schumer (D-NY) will be launching a messaging campaign on “the cost of Republican inaction during the COVID-19 crisis.”  Schumer said President...more

Robins Kaplan LLP

Financial Daily Dose 12.10.2019 | Top Story: Remembering Influential Former Fed Chair Paul Volcker

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Some remembrances upon the passing of influential former Fed Chair Paul Volcker, a force in American economic policy for nearly 60 years who led “the Federal Reserve’s brute-force campaign to subdue inflation in the late...more

Robins Kaplan LLP

Financial Daily Dose 10.6.2019 | Top Story: Drug Distributors and Maker in Talks for Multi-billion-dollar Opioid Litigation...

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A group of three major drug distributors—McKesson, AmerisourceBergen, and Cardinal Health—are in the midst of talks with representatives of state and local governments who have brought more than 2000 opioid-related lawsuits...more

Troutman Pepper Locke

HHS to Require Manufacturers to Disclose Drug Pricing in Television Advertisements

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U.S. health officials have taken the first concrete step toward implementing the vision set out in the “American Patients First” blueprint published by President Trump and Health and Human Services (HHS) Secretary Alex Azar...more

Hogan Lovells

Likely FDA Impact of the Government Shutdown: Regulatory Submission Reviews, Inspections, and Research Projects

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The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019.  Unfortunately, FDA is one of the agencies with at least some...more

Hogan Lovells

CMS proposes requiring drug prices in TV ads

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On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or...more

Robins Kaplan LLP

Your Daily Dose of Financial News

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To no one’s surprise, the Fed followed through with its months of promises and raised its benchmark interest rate by 25 basis points yesterday. The FOMC also indicated that it’s planning to raise rates again in December....more

Verrill

"Right to Try" Comes to the Federal Stage: What Stakeholders Should Do Now

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On May 30, 2018, surrounded by patients directly impacted by tragic and intractable diseases, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017...more

Akerman LLP - Health Law Rx

Derailing the Gravy Train – Trump Unveils Plan to Reduce Drug Prices

Throughout his presidential campaign, President Trump championed the need to allow the government to negotiate drug prices on behalf of the Medicare program. However, that third rail for pharmaceutical companies was not...more

Hogan Lovells

Administration presents plans to lower drug prices

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On May 11, 2018, President Trump and Department of Health and Human Services (HHS) Secretary Alex Azar delivered highly anticipated speeches regarding the administration's plan to reduce drug prices. ...more

Robins Kaplan LLP

Your Daily Dose of Financial News

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There’s falling from grace, and then there’s Elizabeth Holmes. Once compared glowingly to Steve Jobs, Holmes’ well-documented Theranos ills (including exaggerated and faked blood-test results) have landed her with SEC...more

Hogan Lovells

New Legislation Increases Access to Medical Products for Military Applications

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Yesterday, the President signed new legislation that gives the Department of Defense (DoD) new opportunities to advocate to FDA for expedited development, review, and Emergency Use Authorization (EUA) for medical products...more

Hogan Lovells

USTR Requests Input on Impact of Trade Agreements on Government Procurement

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On August 21, 2017, the Department of Commerce (Commerce) and the Office of the United States Trade Representative (USTR) issued a request for public comment on the impact of government procurement provisions of U.S. trade...more

Patterson Belknap Webb & Tyler LLP

100 Days Plus Under Trump: What They Mean for Biologics

President Donald J. Trump has now been in office for just over one hundred days. Observers have been quick to mark this milestone and assess the new administration’s performance, especially on headline-grabbing issues like...more

Hogan Lovells

Antitrust, Competition and Economic Regulation Quarterly Newsletter - Winter 2017

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FTC takes another look at merger remedies - On 3 February 2017, the U.S. Federal Trade Commission (“FTC”) released its Merger Remedies Study, which analyzed the success of merger remedies imposed by the FTC from 2006 to...more

Robins Kaplan LLP

Your Daily Dose of Financial News

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And we thought Brexit was something. Buckle up. It’s going to be a wild market ride... Whoa....more

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