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Robinson+Cole Data Privacy + Security Insider

Privacy Tip #385 – 23andMe Sends Letter to Data Breach Victims that Suing Over Breach is Futile

We previously alerted readers to the fact that the most recent data compromise of 23andMe exposed data related to Ashkenazi Jews and individuals of Chinese descent. It is reported by Ars Technica, citing TechCrunch, that...more

Manatt, Phelps & Phillips, LLP

Accessing Cell and Gene Therapies: Insights on Coverage, Reimbursement and Emerging Models

Editor’s Note: In a new white paper, summarized below, Manatt Health discusses emerging reimbursement models for cell and gene therapies. The paper provides an overview of current Medicaid, Medicare and commercial coverage,...more

Nelson Mullins Riley & Scarborough LLP

The Promise of Brain-Delivered Gene Therapy

Gene therapy aims to treat the underlying genetic cause of a disease rather than only the symptoms. It involves the delivery of properly functioning DNA into a patient’s genetic material to correct an underlying genetic...more

Hogan Lovells

Gene therapy development in Europe brings layers of liability risks

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The investments in Advanced Medicinal Products (ATMPs) that use gene therapy, somatic cell therapy, and engineered tissues for preventing, treating, or curing human diseases probably represent the biggest innovation in the...more

Hogan Lovells

China's draft implementation rules on human genetic resources: potential changes on HGR Supervision?

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The Ministry of Science and Technology of China has finally issued the draft of Implementation Rules for the Regulations of Human Genetic Resources Administration for public comments on March 21, 2022, which gives more...more

Robinson+Cole Data Privacy + Security Insider

Privacy Tip #314 – Got a Genetic Testing Kit for Christmas? Read this Before you Send In That Swab

I have written about genetic testing kits before, but this subject matter is worth repeating. I find that people don’t always understand the consequences when sending a swab to a genetic testing company.  Consumer Reports...more

Spilman Thomas & Battle, PLLC

What was Fascinating in 2021 for Biotech

2021 was a fascinating year in biotech, especially for legal issues. Of course, 2021, as the second year of a global pandemic, must be viewed in context with 2020....more

Spilman Thomas & Battle, PLLC

The Story of Henrietta Lacks and the Biotechnology Company Accused of Selling Her Cells for Profit

Two articles (Newsweek and Fierce Biotech) describe the new lawsuit by the Henrietta Lacks Estate surrounding the HeLa cell line. The claim is "unjust enrichment," a difficult claim to win, but one that seems to fit this...more

McDonnell Boehnen Hulbert & Berghoff LLP

Science Does Not Support the Latest COVID Hysteria

In a time of a global pandemic, with antivaxxer and anti-science sentiments running rife, and when combinations of fear, distrust, and paranoia are rampant, it is easy for important results from basic science to become fodder...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

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

Haug Partners LLP

Vaccine Design Will Likely Determine the Success of Each COVID-19 Vaccine

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This article provides a basic overview of the immune system and how its successful engagement is necessary to produce a commercial vaccine, with a specific focus on the SARS-CoV-2 virus that causes the COVID-19 disease and...more

McDonnell Boehnen Hulbert & Berghoff LLP

Inherited Neanderthal Gene Encodes Genetic Risk for COVID-19

Svante Pääbo created the science of detecting Neanderthal DNA in archeological samples (and living humans) almost single-handedly (see Neanderthal Man: In Search of Lost Genomes).  So it will come as little surprise to many...more

Hogan Lovells

California Governor vetoes bill to establish the Genetic Information Privacy Act

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California’s “Genetic Information Privacy Act” (SB 980), vetoed on September 25, 2020 by Governor Gavin Newsom, would have established obligations for direct-to-consumer (“DTC”) genetic testing companies and others that...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

[IP Hot Topics Podcast] Innovation Conversations: Walter Isaacson, Part 1 (Transcripts)

Welcome to Innovation Conversations, a special series of Sterne Kessler's IP Hot Topics podcast. I'm your series host, Trey Powers, a Director in Sterne Kessler's biotech and litigation practice groups. Joining me as a cohost...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

[IP Hot Topics Podcast] Innovation Conversations: Walter Isaacson, Part 1

In this inaugural edition of the IP Hot Topics podcast, we kick off our Innovation Conversations series. We’re joined by renowned author, analyst, journalist, historian and Tulane University professor Walter Isaacson....more

McDonnell Boehnen Hulbert & Berghoff LLP

Chromosomal Rearrangements Associated with Chemotherapeutic Drug Resistance

Chemotherapeutic drug resistance is one reason cancer remains an unsolved clinical problem despite the efforts ever since President Nixon declared his "War on Cancer" in 1971.  Cancer cells, due in part to the genetic...more

Robins Kaplan LLP

Section 101 Love in the Time of COVID-19, with Apologies to Gabriel García Márquez

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It is a good bet that everyone has a heightened appreciation for diagnostic technology right now. The countries that have fared reasonably well during the ongoing pandemic are those with meticulous testing regimens. After...more

Robinson+Cole Data Privacy + Security Insider

Consumer-Facing DNA Testing Company Suffers Data Breach

Last week, Veritas Genetics, a consumer-facing DNA testing company, suffered a security breach affecting customer information in its database. Veritas offers whole-genome sequencing to consumers for $599. The security...more

Orrick, Herrington & Sutcliffe LLP

Profiles in Innovation: Twist Bioscience’s Co-Founder Navigates Company from Start-up to Public Company

As a pioneer in DNA synthesis with several patents to her name, Dr. Emily Leproust could have enjoyed a distinguished career without ever leaving the lab. Instead she founded (and just took public) a company that promises to...more

Epstein Becker & Green

New Gene Therapy Guidances Signal Anticipated Growth of Product Submissions by FDA

Recognizing that gene therapy products are now a “therapeutic reality” for some patients, the U.S. Food and Drug Administration (“FDA”) recently unveiled six draft guidance documents intended to foster the development of...more

Knobbe Martens

FDA Commissioner Plans to Create a Fast Track Approval Pathway for Certain Gene Therapies

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During a speech on May 22, 2018 at the Alliance for Regenerative Medicine's Annual Board Meeting, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that the FDA plans to alert companies that “certain...more

Butler Snow LLP

Genomics and Genetics – Helping to Remove Inferences and Possible Litigation Bias

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It is no secret that every lawsuit attributing the development of disease to an alleged exposure to a toxic substance requires early consideration of alternate causes. One powerful tool being used more frequently to do this...more

Knobbe Martens

Preparing Biotech Patent Applications - Ten Strategies for Success

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Obtaining issued patents in the biotechnology space can be a challenge. Here is a list of ten patent strategies we recommend for biotechnology innovators to increase their odds of obtaining valuable intellectual property...more

Fenwick & West LLP

Bad Science Makes Bad Patent Law—No Science Makes It Worse (Part II)

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In Part I, I explained some general criteria for laws of nature, considering the prototypes of Newton's laws and Einstein's E=mc2. Now I'll turn to whether there are laws of nature in biology. Biological generalizations,...more

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