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Life Sciences › Cancer › Clinical Trials

Foley & Lardner LLP

Cancer Drugs: Antibody-Drug Conjugate Litigation

Foley & Lardner LLP on

Antibody-drug conjugates (ADCs) are typically composed of a monoclonal antibody attached to a cytotoxic drug via a chemical linker. The antibody is able to identify biomarkers on and attach to cancer cells, allowing targeted...more

Manatt, Phelps & Phillips, LLP

TRIALS AND TRIBULATIONS: How to Remove Barriers Blocking Cancer Patients From Clinical Trials and Advance the Next Generation of...

Manatt, Phelps & Phillips, LLP on

EXECUTIVE SUMMARY - Clinical trials are a lifesaving option for many cancer patients. But too many patients face barriers preventing access to this critical treatment. Everyone suffers when patients cannot access...more

Morgan Lewis

USPTO Introduces Cancer Moonshot Expedited Examination Pilot Program

Morgan Lewis on

The Cancer Moonshot Expedited Examination Pilot Program (the new Pilot) will accord special status (earlier examination) to patent applications directed to technologies to prevent cancer and cancer mortality. The new Pilot...more

Faegre Drinker Biddle & Reath LLP

Southern District of Texas Holds Learned Intermediary Doctrine Applies to Clinical Trials

Faegre Drinker Biddle & Reath LLP on

Does the learned intermediary doctrine apply in the context of a clinical trial? According to the Southern District of Texas, it does. The case in question is Butler et al. v. Juno Therapeutics, Inc., a tragic case...more

Smart & Biggar

Rx IP Update - June 2019

Smart & Biggar on

National Pharmacare Update: Publication of the final report of the Advisory Council - On June 12, 2019, the Minister of Health tabled the final report, A Prescription for Canada: Achieving Pharmacare for All, from the...more

Wilson Sonsini Goodrich & Rosati

Companies with New Cancer Drug Candidates Should Plan Now for August 2020

Wilson Sonsini Goodrich & Rosati on

Requirement for a Pediatric Clinical Investigation - Starting on August 18, 2020, any drug company submitting an original application for a first-to-be approved or licensed cancer drug that: - is indicated for an adult...more

Wilson Sonsini Goodrich & Rosati

FDA Launches Expanded Access Experimental Cancer Drug Project

Wilson Sonsini Goodrich & Rosati on

In the U.S., patient access to investigational cancer drugs—outside of clinical trials licensed by the U.S. Food and Drug Administration (FDA)—has historically proven insurmountable for most patients for at least the...more

Skadden, Arps, Slate, Meagher & Flom LLP

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

Skadden, Arps, Slate, Meagher & Flom LLP on

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

Knobbe Martens

Myriad Genetics Announces an Assay that Identifies Patients for Olaparib Treatment

Knobbe Martens on

Salt Lake City-based Myriad Genetics, Inc. announced that its BRACAnalysis CDx® test accurately identifies patients with ovarian cancer for a second-line treatment with olaparib. The announcement came as a result of a...more

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