Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
The Classification of Gasoline & Gasoline Fumes as a Carcinogen: Considerations for Corporate Executives & Attorneys
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 237: Tackling Cancer with Cellular Immunotherapy with Dr. Leonardo Ferreira of Torpedo Bio
Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 235: Revolutionizing Cancer Care with Eric Perrault of Kiyatec
Episode 230: Innovations in Cancer Treatment with Dr. Ray DuBois of MUSC Hollings Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 225: Cancer Care Access & Treatments with Dr. Sengar of Alabama Cancer Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed Hernandez of Eli Lilly
Meeting Cancer Reporting Requirements
Podcast - Counsel That Cares - The Value of Value-Based Cancer Care
Episode 150 - Jane Pine Wood, Senior Vice President & Chief Legal Officer, BioReference
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 136: Dr. Amy Curtis, Radiation Oncologist, Gibbs Cancer Center & Research Institute
The Rare Air of Elevation Oncology: Raising Nearly $200M in 2 Years, with CEO Shawn Leland
Federal Appeals Court Hears Arguments on CAR T-Cell Therapy Patent Dispute
Ming-Wei Chen and Fanheng Zhou, the scientists behind RephImmune, join hosts Lynnsey and Matthew to discuss how their biotech startup is developing a next-generation cell therapy platform designed to overcome the limitations...more
Recorded at SCbio’s 2025 annual conference, Heather and Lauren welcome Eric Perrault, the CEO of Kiyatec, which focuses on functional precision oncology. Eric discusses their exciting process, which aims to predict how...more
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
On March 19, 2025, Shanghai Henlius Biotech announced that the FDA has granted Orphan Drug Designation for HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer. HLX22 binds to HER2 extracellular...more
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
Antibody Drug Conjugates (ADCs) are a class of small molecule drugs (also known as a payload) and an antibody conjugated together by a chemical linker. ADCs are designed to target specific cells, such as cancer cells, while...more
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
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
Report on Research Compliance 19, no. 4 (April, 2022) - A six-year review of the institutional review board (IRB) at National Jewish Health (NJH) of Denver has been resolved, with the organization outsourcing the...more
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
Report on Research Compliance 17, no. 5 (May 2020) - Study sponsors should be making additional efforts to enroll older individuals in cancer trials, incorporating such strategies in study design and recruitment methods,...more
Is BELVIQ adding to patient cancer risks? In February of 2020, an announcement was made that the weight loss drug lorcaserin (sold under brand names BELVIQ and BELVIQ XR) would be voluntarily withdrawn from the market in...more
On October 29, 2019, the Federal Court issued its final decision under the pre-amended Patented Medicines (Notice of Compliance) Regulations: Janssen Inc v Apotex Inc, 2019 FC 1355. Justice Phelan granted Janssen’s...more
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
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
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
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
What is Quality Anyways?: James Hinton, the CEO of Baylor Scott and White, got a good laugh from the audience when he said that he was proud to be one of the five or six hundred hospitals in the nation’s top 100 hospitals....more
On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved Janssen Therapeutics’ Erleada (apalutamide), a non-steroidal antiandrogen for the treatment of castration-resistant non-metastatic prostate cancer....more
Fast track for orphan diseases and rare forms of cancers - By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd November2017, the Ministry of Health enacted new...more
Novocure recently announced final results from a phase III EF-14 clinical trial of its Optune device for treatment of newly diagnosed glioblastoma (GBM)....more
Myriad Genetics recently announced clinical results showing that its BRACAnalysis CDx® test was able to identify patients with HER2-negative metastatic breast cancer who had improved response with Lynparza (olaparib),...more
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
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
The United States Patent and Trademark Office “USPTO” is launching the “Patents 4 Patients” initiative, which will provide an accelerated review for methods of cancer treatments. Effective on June 29, 2016 the new “Cancer...more