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Pharmaceutical Industry › Clinical Trials › Trump Administration

Hogan Lovells

2025 Horizons Life Sciences and Health Care

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In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more

Bradley Arant Boult Cummings LLP

Makary Says Psychedelics Are Maybe Okay, M’Kay?

Bradley Arant Boult Cummings LLP on

Drugs are bad, m’kay. But what if they’re not? Psilocybin continues to be in the limelight for its potential medicinal uses, including most particularly its potential to combat the nation’s growing mental health crisis. Last...more

DLA Piper

Trump Administration’s DEI Executive Order and the Impact on FDA’s DAP Draft Guidance: Top Points

DLA Piper on

For more than a decade, the Food and Drug Administration (FDA) has made diversity in clinical trials a focus, including by issuing guidance, convening public-private workshops, and completing data analyses in an effort to...more

Hogan Lovells

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

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In Washington: Today, the House will meet for a pro forma session and the Senate will resume consideration of John Badalamenti to be United States District Judge for the Middle District of Florida.  The full House will be...more

Wilson Sonsini Goodrich & Rosati

CMS Makes CAR T-Cell Cancer Therapy Available to Medicare Beneficiaries Nationwide

Wilson Sonsini Goodrich & Rosati on

Autologous chimeric antigen receptor (CAR) T-cells—which are “living drugs”—are promising, emerging therapeutics in immuno-oncology. One example of these “living drugs” is Kymriah (tisagenlecleucel). The drug, a CD-19...more

Sunstein LLP

July 2018 IP Update: The Right to Try Act: A New Avenue for Use of Experimental Drugs

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On May 30, President Trump signed the Right to Try Act. The Act authorizes the use of experimental drugs without pre-approval or oversight by the Food and Drug Administration. Both the patient and the drug must meet certain...more

Knobbe Martens

Right to Try Act Gives Terminal Patients Opportunity to Try Early Therapies

Knobbe Martens on

Often those with terminal illnesses wish to try new experimental therapies. Now they can if they are willing to accept the risks. On May 30, 2018, President Trump signed into law the Right to Try Act. The Act allows eligible...more

Holland & Knight LLP

Right to Try Law Enacted by Congress: Implementation Unclear

Holland & Knight LLP on

On May 30, 2018, President Trump signed the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2018. The bill allows the provision of certain unapproved, investigational drugs to patients...more

Holland & Knight LLP

FDA Announces Modernization of Drug Review Process and Operations

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On June 4, 2018, the Food and Drug Administration (FDA) announced a major restructuring in its Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER). OND currently includes six offices with 19...more

Verrill

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

Verrill on

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

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