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Life Sciences Cancer Food and Drug Administration (FDA)

Foley & Lardner LLP

Antibody Drug Conjugates Keep Growing: What You Need to Know

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What Are ADCs and Why Are They Growing? Over the past few years economic headwinds have resulted in fewer deals, with companies and private equity firms alike reassessing where to spend money. But one portion of the...more

Sheppard Mullin Richter & Hampton LLP

Krazati Untitled Letter: A Cautionary Tale for CFL Promotion of Accelerated Approval Drugs

On August 1, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to Mirati Therapeutics Inc., a Bristol Myers Squibb Co. (Mirati), relating to promotional...more

Foley & Lardner LLP

Cancer Drugs: Antibody-Drug Conjugate Litigation

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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

Foley & Lardner LLP

Cancer Drugs: Deals and Licensing for Antibody-Drug Conjugates

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Antibody-drug conjugates (ADCs) are a promising class of cancer treatments with an accelerating number of U.S. Food and Drug Administration (FDA) approvals and rapidly growing market size, as discussed in previous articles in...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 2, March 2024

HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: February 2024

The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more

Knobbe Martens

Alpha Tau Receives FDA Breakthrough Device Designation for Alpha DaRT Treatment of GBM

Knobbe Martens on

Alpha Tau Medical Ltd. (“Alpha Tau”) is a medical technology start-up focused on the research, development, and commercialization of its Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) treatment for solid cancerous...more

Kramer Levin Naftalis & Frankel LLP

Recent Updates on CAR T-Cell Therapy: FDA Approvals and Patent Litigation

On Feb. 5, 2021, the Food and Drug Administration (FDA) granted approval for a new CAR T-cell therapy, Breyanzi® (lisocabtagene maraleucel), to Juno Therapeutics, a subsidiary of Bristol-Myers Squibb (BMS). Breyanzi® is...more

Smart & Biggar

First year of Project Orbis leads to 38 approvals of cancer therapies, including 8 by Health Canada

Smart & Biggar on

Update: In the Mid-year update: Health products approved in 2021, Health Canada reported the approval of two additional cancer drugs in collaboration with Project Orbis partners between January and June 2021 – Retevmo...more

Womble Bond Dickinson

Cancer Vaccines: The Fourth Pillar of Anti-Cancer Therapy?

Womble Bond Dickinson on

Innovative technologies are being deployed to address the Western world’s major killer: cancer. Traditionally, cancer treatment has included surgery, chemotherapy, and radiation, but recently, the development of targeted...more

Womble Bond Dickinson

FDA Approves the Gardasil 9 Human Papillomavirus (HPV) Vaccine for Prevention of Head and Neck Cancer

Womble Bond Dickinson on

After a decade or more of research suggesting that the HPV vaccine could be effective in protecting against certain types of head and neck cancer, the FDA has finally given approval for this application of Gardasil 9, the...more

Kramer Levin Naftalis & Frankel LLP

CAR T-Cell Therapy Takes Off and Brings on Patent Litigation

CAR T-Cell therapy, a new biologic therapy, is taking off. As companies continue to develop this new and promising therapy, patent litigation inevitably follows.  ...more

Smart & Biggar

Rx IP Update - June 2019

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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

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

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

Patterson Belknap Webb & Tyler LLP

FDA Authorizes First Direct-to-Consumer Test for BRCA Gene Mutations

On March 6, 2018, the U.S. Food and Drug Administration (“FDA”) authorized, with special controls, the first direct-to-consumer test to detect the presence of genetic mutations in the BRCA1 and BRCA2 genes (“BRCA genes”). ...more

Snell & Wilmer

FDA Makes Gene Therapy Available for First Time in USA

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Earlier this week, the FDA made gene therapy available for the first time in the United States. This decision, ushers in “a new approach to the treatment of cancer and other serious and life-threatening diseases” said 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

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

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