Biotechnology

News & Analysis as of

USDA Declares “Do-Over” on Overhaul of Biotechnology Regulations

The U.S. Department of Agriculture’s (“USDA”) Animal and Plant Health Information Service (“APHIS”) is renewing efforts to amend or replace its existing rules governing plant-based biotechnology, while highlighting possible...more

In Case You Missed It: Launch Links - Week of January 31, 2016

Some interesting links we found across the web this week: The State of Venture Capital - How much VC money is out there, and where is it coming from? Click through to the full presentation for a detailed...more

Dates And Locations Of "Modernizing The Regulatory System For Biotechnology Products" Meetings Announced

On February 1, 2016, the dates and locations for the last two public engagement sessions discussing the "Modernizing the Regulatory System for Biotechnology Products" memorandum were announced. The first meeting occurred on...more

OSTP Announces Second and Third Public Engagement Sessions for Modernizing the Regulatory System for Biotechnology Products

On February 1, 2016, the White House Office of Science and Technology Policy (OSTP) announced the dates and locations for the second and third public engagement sessions that will discuss the July 2, 2015, memorandum entitled...more

European Life Sciences Review: Issue 1

Welcome to the first issue of our EU Life Sciences Review . It is produced by our life sciences lawyers in London, Brussels, Frankfurt, Moscow, and Paris and covers some of the most critical developments in the pharmaceutical...more

Record breaker: US M&A in 2015

As the dust settles from the explosion of US M&A activity in 2015, it is fitting to reflect on the forces that fueled the boom and consider what last year’s trends may tell us about the year ahead. The record year...more

Hands Tied: Patenting Diagnostic Inventions Remain a Difficult Task

What does the Federal Circuit really think about the Supreme Court’s recent § 101 jurisprudence? The denial of the petition for rehearing en banc in Ariosa Diagnostics v. Sequenom in November of 2015 answers that question....more

FDA Approves First Genetically Modified Food-Producing Animal

On November 19, 2015, the United States Food and Drug Administration (FDA) approved a new animal drug application (NADA) that authorizes the marketing of the AquAdvantage Salmon, a genetically modified Atlantic salmon. In...more

Securities Class Action Suits Increased in 2015

Last year there were more class action suits filed compared to the prior year. The actions were brought largely against companies traded on the two major exchanges in the biotech and healthcare sectors, according to a recent...more

Elevance Announces Successful Second Generation Olefin Metathesis Scale Up

On January 19, 2016, Elevance Renewable Sciences Inc. (Elevance), a Biobased and Renewable Products Advocacy Group (BRAG®) member, announced the successful scale-up of a second-generation biorefinery technology of the...more

Biofuel, Corn, And Sorghum Farmers Challenge Lowered RFS Volumes

On January 8, 2016, seven biofuel and agriculture groups requested the U.S. Court of Appeals for the D.C. Circuit to review the Renewable Fuel Standards (RFS) for 2014, 2015, and 2016. The Petition was filed by Biotechnology...more

Guest Post -- Jackson Laboratory Hosts Microbiome Symposium Related to Cancer and Immunology

Editor's note: This is the fourth article in a series on advancements in microbiome research and development. Early last month, the Jackson Laboratory for Genomic Medicine in Farmington, CT held its second annual...more

PTAB Declares Interference for Groundbreaking Gene-Editing Technology

Earlier this week, the Patent Trial and Appeal Board (PTAB) set the stage for what is expected to be an epic battle over who owns the intellectual property rights to “the biggest biotech discovery of the century.” On January...more

[Event] Do Not Enter: Privacy & Security for Life Sciences Companies - Regulatory Roundtable Immersion Series - Session #7 - Jan....

Cooley's Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant...more

Healthcare & Life Sciences Private Equity Deal Tracker: Scholar Rock Secures $36 Million in Funding

Scholar Rock, based in Cambridge, Mass., is a biotechnology company focused on developing drugs that selectively target supracellular activation of growth factors in the disease microenvironment. The company’s initial drug...more

November 2015 IPO Market Review

The November IPO market produced a dozen IPOs with gross proceeds of $1.30 billion. The month’s tally brings the total number of IPOs over the first 11 months of 2015 to 150 with total gross proceeds of $24.63...more

BIO CEO: IPR System Threatens Medical Innovation

In an article published earlier this fall on Medium, Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood urges Congress to modify the inter partes review (IPR) system, which he argues has "turn[ed] the...more

Advisory Committee On Biotechnology And 21st Century Agriculture To Meet

On November 19, 2015, the USDA published Notice of the Advisory Committee on Biotechnology and 21st Century Agriculture (AC21) Meeting in the Federal Register. The meeting will review the purpose, history, operational...more

FDA Seems Ready to Weigh In on “Natural” Food Labeling

In 1960, Judge Friendly famously began an opinion by asking, “What is chicken?” Today, the question is, “What is ‘natural’?” Courts today are filled with cases claiming that foods labeled as “natural” are misleading...more

FDA Issues Final Food Biotechnology Labeling Guidelines for Plant Foods; Discourages “GMO Free” Claims

On November 19, 2015, FDA issued its final guidance for industry concerning the requirements for voluntarily indicating whether food products have or have not been derived from genetically engineered plants. The final...more

TSCA: New Requirements for Submitting Section 5 Notices Take Effect in January 2016

The U.S. Environmental Protection Agency (EPA) recently reminded stakeholders that new requirements for submitting Toxic Substances Control Act (TSCA) Section 5 notices and support documents will take effect on January 19,...more

Life lines: Life sciences M&A and the rise of personalised medicine

The second report in our Deal Dimensions series, written in collaboration with Mergermarket and launched today, reveals that 94 per cent of life sciences companies are planning an acquisition in the next year, with more than...more

Healthcare & Life Sciences Private Equity Deal Tracker: Atreca Secures $56 Million in Funding

Atreca has announced it has secured $56 million in series A funding. Atreca, based in Redwood City, California, is a privately held biotechnology company developing therapeutics drawn from human immune responses,...more

FDA Requests Comment on Term “Natural” in Food Labeling

On November 10, 2015, the FDA announced that it will be soliciting public comments on the use of the term “natural” in food labeling. The comment period will open on November 12, 2015 and is expected to close on February 10,...more

Farewell the ten sequences rule. The new MPEP disposes of the old §803.04 rule.

The latest MPEP revisions make a variety of changes. Most of the attention has focused on changes to examination procedures for 35 U.S.C. §101, for the obvious reason that this is an aspect of the law that has been in...more

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