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Life Sciences Genetic Materials Biotechnology

Hogan Lovells

U.S. BIOSECURE Act: Key considerations for global cell, tissue, and gene therapy stakeholders

Hogan Lovells on

Efforts to curtail U.S. reliance on biotechnology companies in the People’s Republic of China (PRC) and prevent certain data of U.S. persons from being provided to the Chinese Communist Party (CCP) have come to the fore this...more

Akin Gump Strauss Hauer & Feld LLP

US Seeks Comments on Text for WIPO Genetic Resources Treaty

Summary - Last year the World Intellectual Property Organization (WIPO), under a threat of a vote, accelerated negotiations on an international legal instrument related to intellectual property (IP) and genetic resources...more

Goodwin

Recent FDA Initiatives to Support Development of Individualized Cell and Gene Therapies and Rare Disease Therapies

Goodwin on

​​​​​​​Last month, FDA issued a Request for Information (RFI) in the Federal Register seeking information and comments from interested stakeholders regarding “critical scientific challenges and opportunities to advance the...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene...

Maynard Nexsen on

Recorded at NC Life Sciences Organization’s Annual Meeting, our hosts Heather and Lauren are joined by Emily Chee, the US General Manager of Novartis Gene Therapies, a biotech company specializing in gene therapies for rare...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

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

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, Issue 23, 2022

Complex, Customized CRISPR Combo Could Help Patients Cure Their Own Cancer - “In a small phase 1 clinical trial run by PACT Pharma, researchers edited the genes of 16 patients’ immune cells to work against their cancer,...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

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

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

McDonnell Boehnen Hulbert & Berghoff LLP

Ticked Tabby Cats and Their Genetic Bases Elucidated

The domestic cat has been the subject of much study, recently involving its genetic structure, genomic DNA sequence, and comparisons with other felines.  The first such study was published in 2014, when an international...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

McDonnell Boehnen Hulbert & Berghoff LLP

Further and More Detailed Study of Domestic Cat Genome

The advent of technology making feasible elucidation of whole genomic sequencing over the past 30 years has led to reports of many if not most important or interesting animal genomes (including the most celebrated results 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

Morgan Lewis - As Prescribed

FDA Finalizes Guidance on Gene Therapy Orphan Sameness, but Questions Remain

While it may feel like FDA’s attention has been focused on COVID-19 for nearly two years, as we have written about in a previous blog post, FDA is looking to the future, and particularly, one that signals exciting prospects...more

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

Prime Medicine Emerges with $315 Million to Develop Next Generation Gene Editing Platform

On July 13, 2021, Prime Medicine, a Massachusetts biotech company developing next generation gene editing technology, emerged from stealth mode with $315 million in financing. The financing includes a $115 million Series A...more

McDonnell Boehnen Hulbert & Berghoff LLP

Nautilus pompilius Genome Determined

Cephalopods are fascinating creatures, and their primary living representative -- the octopus -- has recently been the subject of the Academy Award winning documentary "My Octopus Teacher."  They are clearly intelligent (as...more

McDonnell Boehnen Hulbert & Berghoff LLP

Great Dane Genome Reveals Involvement of Retrotransposition in Canine Diversity

The domestic dog (Canis lupus familiaris) has been the subject of many genetic studies, particularly since the dawning of the age of Whole Genome Sequencing in the late 20th Century.  These studies have elucidated some...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

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

Giraffe Genome Reveals Relevant Adaptations

The giraffe is the tallest extant terrestrial animal, and its iconic long neck (6 feet) provides advantages for foraging for food and detecting predators on the veldt over long distances. As a consequence, however, the...more

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