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Cancer Life Sciences

Goodwin

CuraTeQ Biologics’ Trastuzumab biosimilar Receives Positive Opinion in Europe

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This week, CuraTeQ Biologics (a wholly owned step-down subsidiary of Aurobindo Pharma Limited) announced that its trastuzumab biosimilar, DAZUBLYS, has received a positive opinion from the European Medicines Agency Committee...more

Maynard Nexsen

Episode 230: Innovations in Cancer Treatment with Dr. Ray DuBois of MUSC Hollings Center

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Recorded at SCbio’s 2025 annual conference, Heather and Lauren welcome Dr. Ray DuBois, a physician and researcher who has dedicated his life to cancer research and patient-centered care. Dr. DuBois, Director of MUSC’s...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 225: Cancer Care Access & Treatments with Dr. Sengar of...

Maynard Nexsen on

Join hosts Heather, Lauren, and John as they sit down with Dr. Sengar, an accomplished oncologist from Alabama Cancer Care, a network committed to delivering quality cancer care to underserved communities. In this episode, we...more

K&L Gates LLP

FDA Revokes Authorization for the Use of Red Dye No. 3 in Food and Ingestible Drugs

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On 15 January 2025, the US Food and Drug Administration (FDA) announced that it will revoke the color additive authorization for use of FD&C Red No. 3 in food (including dietary supplements) and ingestible drugs. This ban...more

DLA Piper

FDA Bans Red Dye No. 3 Under the Delaney Clause

DLA Piper on

The US Food and Drug Administration (FDA) has revoked its authorization for the use of FD&C Red No. 3, also known as Red Dye No. 3. Issued on January 15, 2025, the ban will go into effect for food (including dietary...more

Searcy Denney Scarola Barnhart & Shipley

The Link Between Certain Medications and Cancer Risk

When you take a medication your doctor prescribes, the last thing you expect is for it to do more harm than good. But, unfortunately, medications are not always as safe as they should be. In fact, some medications have been...more

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

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed...

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Recorded at NC Life Sciences Organization’s Annual Meeting, Heather and Matthew welcome Ed Hernandez, who oversees drug product manufacturing at Eli Lilly, an international pharmaceutical company. Ed discusses how Eli Lilly...more

Nelson Mullins Riley & Scarborough LLP

IARC Releases Its Priority Evaluation List for 2025-2029

The International Agency for Research on Cancer (IARC) released its 2025-2029 Priority List for evaluation in April of this year, see Advisory Group Recommendations on Priorities for the IARC Monographs, The Lancet Oncology...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

Stikeman Elliott LLP

Palmer v. Teva Canada Ltd.: Court of Appeal Confirms No Compensation for Risk “In the Air”

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In Palmer v. Teva Canada Limited, the Ontario Court of Appeal upheld the lower court’s decision to deny certification of a proposed product liability class action seeking damages for the alleged increased risk of being...more

Polsinelli

Florida Legislative Session 2024: Health Care Highlights

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The Florida Regular Legislative Session began on January 9, 2024, and ended on March 8, 2024. Below is a summary of relevant health care laws that will be effective July 1, 2024, if they are approved by Governor DeSantis....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

White & Case LLP

Oncology dealmaking fuels biotech M&A

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Global spending on cancer medicines is set to reach US$375 billion by 2027, with innovation in drug discovery and development ramping up to meet rising demand. While the global biotech sector continues to grapple with...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

Axinn, Veltrop & Harkrider LLP

Natera and the Power of the Patent

At least since the Supreme Court’s eBay decision in 2006, a vocal contingent has been decrying the erosion of patent rights. The entry of a preliminary injunction in Natera, Inc. v. NeoGenomics Laboratories, Inc. that would...more

Davis Wright Tremaine LLP

Project W: The Price of Survival Should Not Be Pain and Suffering

Project W alumna Carole Spangler Vaughn has spent her entire career in the life sciences industry working on solutions to prevent and treat diseases. When Carole was diagnosed with breast cancer and underwent chemotherapy,...more

Foley & Lardner LLP

Cancer Moonshot Initiative Adds Precision Surgery Effort

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The White House recently announced the Precision Surgery Initiative (PSI) as a “first-of-its kind Advanced Research Projects Agency for Health (ARPA-H) program to develop novel technologies” to more precisely excise cancerous...more

Mintz - Health Care Viewpoints

OIG Issues Favorable Advisory Opinion on Gift Cards to Incentivize Patients to Return Samples for At-Home Colorectal Cancer...

The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued yet another favorable Advisory Opinion on the use of gift cards to motivate patients to receive medically necessary or...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 136: Dr. Amy Curtis, Radiation Oncologist, Gibbs Cancer...

Maynard Nexsen on

Coming to you from SCBIO’s 2023 annual conference, hosts Matthew and Heather welcome Radiation Oncologist Dr. Amy Curtis of the Gibbs Cancer Center & Research Institute. Our conversation highlights the institute’s...more

Goodwin

USPTO Launches the Cancer Moonshot Expedited Examination Pilot Program

Goodwin on

On February 1, 2023, the United States Patent & Trademark Office (USPTO) will begin accepting petitions to accelerate examination under the Cancer Moonshot Expedited Examination Pilot Program (the “Moonshot Program”). The...more

Ladas & Parry LLP

USPTO Announces Expedited Examination Pilot Program for Cancer Prevention Technologies

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In support of President Biden’s Cancer Moonshot program, the USPTO announced that it will expedite the examination of patent applications that pertain to technologies to prevent cancer and cancer mortality...more

Morgan Lewis

USPTO Introduces Cancer Moonshot Expedited Examination Pilot Program

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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

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