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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

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

Hogan Lovells on

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?

Hogan Lovells on

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

Womble Bond Dickinson

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

Womble Bond Dickinson on

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

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

Hogan Lovells on

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

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

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

Knobbe Martens on

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

Butler Snow LLP on

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

McDonnell Boehnen Hulbert & Berghoff LLP

Utah Judge Denies Myriad's Preliminary Injunction Motion

In a 106-page opinion, U.S. District Court Judge Robert J. Shelby on Monday denied Myriad Genetics motion for preliminary injunction in Myriad Genetics v. Ambry Genetics. Characteristic of its aggressive defense of its...more

McDonnell Boehnen Hulbert & Berghoff LLP

Top Three Stories of 2013

Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories. For 2013, we identified fourteen stories that were covered on Patent Docs last year...more

McDonnell Boehnen Hulbert & Berghoff LLP

Top Stories of 2013: #7 to #10

Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories. For 2013, we identified fourteen stories that were covered on Patent Docs last year...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report -- December 08, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Astrazeneca AB et al. v. Aurobindo Pharma Ltd. et al. 3:13-cv-07298; filed December 3, 2013 in the District Court of New...more

McDonnell Boehnen Hulbert & Berghoff LLP

Where Do We Stand?

Some of our commenters have asked (with greater or lesser degrees of stridency) that we "take a position" on claims like the Myriad method claims at issue in the lawsuits brought against Ambry Genetics, Gene-by-Gene, and...more

McDonnell Boehnen Hulbert & Berghoff LLP

Authors of Genome Medicine Article Form Genetic Testing Company

In a paper published in March in the journal Genome Medicine, Dr. Jeffrey Rosenfeld of the University of Medicine & Dentistry of New Jersey and Dr. Christopher Mason of Cornell University contended that due to the...more

Morrison & Foerster LLP

A victory for generics suppliers

In late June the Supreme Court issued its ruling in the much-anticipated Mutual Pharms. Co. v. Bartlett, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). As we...more

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