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Cancer Life Sciences Pharmaceutical Industry

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

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

Foley & Lardner LLP on

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...

Maynard Nexsen on

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

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

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

Foley & Lardner LLP

Cancer Drugs: Deals and Licensing for Antibody-Drug Conjugates

Foley & Lardner LLP on

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

Bennett Jones LLP

No Harm, No Class Action (Again): Ontario Superior Court Refuses to Certify Risk of Cancer Claim

Bennett Jones LLP on

In the recent decision of Palmer v Teva Canada Ltd., Justice Perell of the Ontario Superior Court dismissed the plaintiff's motion to certify a class action against manufacturers of the anti-hypertensive drug valsartan. The...more

Knobbe Martens

Cancer Drug Patent Not Dead Yet

Knobbe Martens on

(Mar. 31, 2022) Last Friday, ImmunoGen won an appeal at the Federal Circuit in ImmunoGen, Inc. v. Hirshfeld. The lawsuit is a civil action to order the granting of U.S. Application No. 14/509,809 (‘809), titled “Anti-FOLR...more

Console and Associates, P.C.

Medical Device Manufacturer B. Braun at the Center of Cancer Lawsuit Stemming from Ethylene Oxide Exposure

B. Braun, a Germany-based medical device manufacturer, is facing allegations that the company’s Allentown, PA facility exposed workers and nearby residents to dangerous levels of the chemical ethylene oxide. Ethylene oxide...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

Faegre Drinker Biddle & Reath LLP

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

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

Womble Bond Dickinson

The Analysis of Cell Free DNA in Urine for Cancer Diagnosis – A Prospective Alternative to Liquid Biopsy?

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A promising new technology may make the diagnosis of cancer and genetic mutation testing as easy as performing a urinalysis as part of an annual physical exam.  Cancer could be detected at its earliest stages, when treatment...more

Herbert Smith Freehills Kramer

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

Finding a New Way to Fight a Deceptive Disease

Womble Bond Dickinson on

Cancer is a horribly painful and debilitating illness, but would you ever call it “diabolical”? What about “conniving”? You might after you hear about the latest research out of Vanderbilt University showing that cancer cells...more

McDonnell Boehnen Hulbert & Berghoff LLP

Appendiceal Cancer Shows Age-related Somatic Gene Variants with Potential Diagnostic Relevance

Cancer of the appendix is a very rare form of cancer, having an incidence of 0.12 per 1,000,000 person-years (Siegel et al., 2020, Cancer statistics 2020 70:7-30).  Incidence is rising (by 232% from 2000-2016 in the U.S.)...more

Womble Bond Dickinson

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

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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

McDonnell Boehnen Hulbert & Berghoff LLP

USPTO News Briefs

In a notice published earlier this summer in the Federal Register (85 Fed. Reg. 41570), the U.S. Patent and Trademark Office announced that it was extending the Cancer Immunotherapy Pilot Program. ...more

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