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Biotechnology Genetic Testing

Epstein Becker & Green

Sponsored Genetic Testing Programs: Compliance Considerations Following DOJ False Claims Act Settlement

Epstein Becker & Green on

Manufacturer-sponsored genetic testing programs provide several benefits to patients, including expanding access to genetic testing, providing opportunities for patients to participate in research, empowering patients to make...more

Troutman Pepper

California AG Reaches Settlement With Biotech Company Over Marketing of Its Genetic Testing

Troutman Pepper on

On September 25, California Attorney General (AG) Rob Bonta announced a settlement with Biora Therapeutics, Inc. (Biora) regarding misleading claims the company made concerning the cost of its genetic testing services. Under...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Gene Therapy Approvals Gain Steam in 2023: Treatments Offer New Hopes for Rare Diseases

After decades of intense scientific research into developing gene editing technologies, and more than a few setbacks, the field has produced a number of success stories in recent years, demonstrating that regulatory agencies...more

Morgan Lewis

How China’s Detailed Human Genetic Resources Rules May Impact Multinational Life Science Companies

Morgan Lewis on

China’s Ministry of Science and Technology (MOST) officially announced on June 1, 2023 the release of the “Detailed Implementation Rules for the Management Regulations of Human Genetic Resources” (the Detailed HGR Rules)....more

Morrison & Foerster LLP

China Eyes New Export Controls for Life Sciences Technologies

China is considering new export restrictions on advanced technologies, including, in particular, in the life sciences sectors. In late December 2022, China’s Ministry of Commerce (“MOFCOM”) issued the proposed amendment to...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

McDonnell Boehnen Hulbert & Berghoff LLP

The Further Elucidation of Domestic Dog Ancestry

An international cadre of scientists* from almost 70 institutions worldwide recently reported their findings in the scientific journal Nature that the domesticated dog (Canis familiaris) arose from two populations of...more

Hogan Lovells

Legal confusion on essentially derived varieties must be cleared up for the sake of innovation - Green light to gene-editing...

Hogan Lovells on

As gene editing techniques come to the fore in the UK and elsewhere, industry increasingly needs clarity on the breeder's exception to plant variety rights. Originally published on IAM media.com on May 2022....more

Manatt, Phelps & Phillips, LLP

Delivering Breakthrough Treatments Affordably

Editor’s Note: In a recent webinar, Manatt Health’s Anthony Fiori, Senior Managing Director, and Alex Dworkowitz, Partner, hosted a panel of innovative thought leaders—including Dr. Sanjiv Shah, Chief Medical Officer of...more

Quarles & Brady LLP

California Governor Signs the Genetic Information Privacy Act

Quarles & Brady LLP on

On October 6, 2021, California Governor Gavin Newsom signed into law the Genetic Information Privacy Act (GIPA). This follows Governor Newsom’s veto of an earlier version of the bill almost exactly one year ago. ...more

McDonnell Boehnen Hulbert & Berghoff LLP

Peach Genome Dissected to Provide Insights into Ecological Influences

The humble peach has been the inspiration for pies, album titles, independent movies, and a fictional woman's baseball team, but is also an important food species, yielding 24.5 million tons globally in 2018.  Like all plant...more

McDonnell Boehnen Hulbert & Berghoff LLP

Dire Wolf DNA Shows Distinct New World Lineage

The dire wolf (Canis dirus), prototype of the various wolves that were important members of the House Stark family of characters in Game of Thrones, was found uniquely in North America until its extinction in the late...more

McDonnell Boehnen Hulbert & Berghoff LLP

Molecular Mechanism for (In)Famous Warburg Effect in Cancer Elucidated

Cancer, the "Emperor of All Maladies" as it has been termed, has been studied for millennia.  President Nixon's "War on Cancer" resulted in slow but steady progress, aided by the biotechnology revolution, the development of...more

McDonnell Boehnen Hulbert & Berghoff LLP

Epigenetic Changes Implicated in Age-related Diminution in Vision and Its Possible Reversal

The Fountain of Youth -- an enduring aspiration, particularly as the ravages of age reduce human faculties prior to leading inexorably to death.  Reduction in sight is the human faculty that can have the greatest effect on...more

McDonnell Boehnen Hulbert & Berghoff LLP

Neanderthal-specific Variants in Sodium Ion Channel Gene Associated with Sensitivity to Pain in Modern Humans

Over the past decade, genetic archeology has revealed two branches of the human family tree, one known since the 19th Century (the Neanderthals) and the other more recently discovered (the Denisovans, an Asian relative of the...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

Womble Bond Dickinson

Privacy Risks Of Recreational DNA Testing: States Take Action

Womble Bond Dickinson on

Last week the California legislature passed an important first step in protecting the American public from itself. The Genetic Information Privacy Act (GIPA) helps fill a gap in U.S. healthcare privacy that most people don’t...more

McDonnell Boehnen Hulbert & Berghoff LLP

Genetic Lesion Segregation Found in Chemically Induced Tumors in Mice

Genetic instability has long been recognized as a hallmark of oncogenesis and tumor progression. The phenomenon was first identified cytogenetically, most famously by the Philadelphia chromosome in chronic myelogenous...more

McDonnell Boehnen Hulbert & Berghoff LLP

Genetic Diversity and Relationships of Living and Extinct Lions

Lions (Panthera leo) once were a widely distributed group of terrestrial mammals, ranging during the Pleistocene (from about 2,580,000 to 11,700 years ago) in Eurasia, Africa, and North America, with species that included the...more

Fenwick & West Life Sciences Group

Biotech & Life Sciences Trends to Consider Following JPM 2020: M&A, Venture Capital and More

The annual gathering of life sciences executives and investors in San Francisco that many now call “JPM Week” recently concluded, marking the J.P. Morgan Healthcare Conference’s 38th year....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

McDonnell Boehnen Hulbert & Berghoff LLP

Avocado Genome Elucidated

The avocado, having gained popularity (at least in the U.S.) as a convenient (and delicious) vehicle for consuming otherwise not particularly healthful corn chips, has more recently been hailed as a "superfood" when consumed...more

Patterson Belknap Webb & Tyler LLP

FDA Authorizes First Direct-to-Consumer Test for BRCA Gene Mutations

On March 6, 2018, the U.S. Food and Drug Administration (“FDA”) authorized, with special controls, the first direct-to-consumer test to detect the presence of genetic mutations in the BRCA1 and BRCA2 genes (“BRCA genes”). ...more

McDonnell Boehnen Hulbert & Berghoff LLP

Sequenom Petitions for Certiorari

Sequenom filed its anticipated petition for certiorari today for Supreme Court review of the Federal Circuit's decision in Ariosa v. Sequenom. The petition advises the Court that it "should take this opportunity to provide...more

Foley & Lardner LLP

Three Pressing Challenges for Personalized Medicine

Foley & Lardner LLP on

Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

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