News & Analysis as of

Biotechnology

How Pharma, Biotech and Medical Device Companies Can Protect Against Product Liability Lawsuits

by Mark Mansour on

Among the many concerns manufacturers of therapeutics face is that of product liability lawsuits. While it is difficult to entirely eliminate the risk, there are steps companies can take to minimize it. Here are a few...more

Is there a legislative fix for biotech patents?

by Morrison & Foerster LLP on

By some accounts, we have entered a golden age for innovation in personalised medicine. Through scientific advancements in the study of genetic coding and molecular analysis, it is now possible to screen an individual for...more

Compliance Deadline for New ClinicalTrials.gov Regulations is Tuesday April 18 2017

by Hogan Lovells on

On 21 September 2016, the Department of Health and Human Services (HHS) published a final rule that clarified and expanded the requirements for clinical trial registration and results submission on the ClinicalTrials.gov...more

Wrap-Up of Federal and State Chemical Regulatory Developments, April 2017

by Bergeson & Campbell, P.C. on

TSCA/FIFRA - EPA Denies TSCA Section 21 TBBPA Petition: On March 17, 2017, the U.S. Environmental Protection Agency (EPA) denied a Toxic Substances Control Act (TSCA) Section 21 petition submitted by, among others,...more

AkzoNobel Launches Tool To Monitor Biobased Materials In Products

by Bergeson & Campbell, P.C. on

On March 31, 2017, AkzoNobel, a member of BRAG, announced the launch of an online tool that uses e-certification to monitor the biobased content of products. Companies that sign up to use the online platform will be able to...more

Politics, Medicine and Progress

by Mark Mansour on

Biotechnology companies are making daily breakthroughs in understanding genetic and biomolecular causes of disease, and are committed to developing the next generation of medicines to transform patient care. It has been...more

Don’t Miss The Biobased and Renewable Chemicals Conference, May 10-11, 2017, In Wilmington, Delaware

The 2017 Biobased and Renewable Chemicals Conference, which has been organized by the Delaware Sustainable Chemistry Alliance (DESCA) and supported by the American Chemical Society (ACS) Green Chemistry Institute, is a...more

Boom Predicted in Biodegradable Stent Market

Stents, which are typically inserted into a blood vessel in order to expand the vessel to prevent or alleviate a blockage, have traditionally been made from metal mesh and remained in the body permanently (or until later...more

Guidebook: Cybersecurity in the Pharma, Biotech, and Medical Devices Industries

by Foley & Lardner LLP on

As a life sciences or medical device company, it is mission critical to protect lab books, drug and clinical test data, product formulas and production processes that underlie your patents, trade secrets and know-how from...more

A Chinese healthcare boom

by Hogan Lovells on

Presenting a tremendous potential for growth fueled by domestic demographic and economic forces, China's healthcare industry has attracted notable PE investments in recent years. And with some commentators projecting that...more

Nominations Open For Annual Rosalind Franklin Award

by Bergeson & Campbell, P.C. on

On March 8, 2017, the Biotechnology Industry Organization (BIO), a member of the Biobased and Renewable Products Advocacy Group (BRAG®), announced that nominations for the fourth annual Rosalind Franklin Award for Leadership...more

European Parliament Plenary Votes Strengthen Biobased Economy

by Bergeson & Campbell, P.C. on

On March 14, 2017, European Bioplastics (EUBP) welcomed the outcome of the European Parliament’s plenary vote on the waste legislation proposal in which the Members of Parliament recognized the contributions of bioplastics to...more

National Academies Report Finds Future Biotechnology Products May Overwhelm Agencies

by Bergeson & Campbell, P.C. on

On March 9, 2017, the National Academies of Sciences, Engineering, and Medicine (National Academies) published a report entitled Preparing for Future Products of Biotechnology, prepared by the Committee on Future...more

Publish or Perish? The Balance Between Public Disclosure and IP Protection in Scientific Research

by JD Supra Perspectives on

Public disclosures can destroy intellectual property rights related to the work. Scientists and their attorneys need to strike a delicate balance between competing interests. ...more

Wrap-Up of Federal and State Chemical Regulatory Developments, March 2017

by Bergeson & Campbell, P.C. on

TSCA/FIFRA/NTP - Lynn L. Bergeson, Charles M. Auer, and Carla Hutton, “Practitioner Insights: A Review and Analysis of TSCA Reform Provisions Pertinent to Manufacturers and Processors of Nanoscale Materials,” Bloomberg...more

NAS Issues Report on Preparing for Future Products of Biotechnology

by Bergeson & Campbell, P.C. on

On March 9, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) announced the release (pre-publication version) of a new report: Preparing for Future Products of Biotechnology. Pursuant to the White...more

Myths & Misconceptions of Biotech Securities Claims: An Analysis of Motion to Dismiss Results (2005-2016)

There is a common life cycle for Directors and Officers Liability for a publicly-traded biotechnology company bringing its first drug or device to the market. In the early stages, whether pre-clinical or Phase 1, there is...more

DOE Publishes Report On Biorefinery Optimization Workshop

by Bergeson & Campbell, P.C. on

On February 27, 2017, the U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced the publication of the Biorefinery Optimization Workshop Summary Report. The report provides an overview of the...more

Preparing Biotech Patent Applications - Ten Strategies for Success

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

AkzoNobel Joins Partnership To Develop Wood To Chemicals Biorefinery

On February 9, 2017, Avantium announced a partnership with AkzoNobel (a member of the Biobased and Renewable Products Advocacy Group (BRAG®)), Chemport Europe, RWE Generation, and Staatsbosbeheer to develop a reference plant...more

Relocation of the EU Medicines Agency - The Netherlands: Tulips & EMA, a Gouda combination

by Hogan Lovells on

The EMA is looking for a new home. According to the Dutch Minister of Foreign Affairs and the Minister of Health, Welfare and Sports' formal bid, this home is where the heart of the Netherlands is. It might not have the food,...more

USDA Extends Comment Period On Biobased Product Categories For Federal Procurement

by Bergeson & Campbell, P.C. on

On February 21, 2017, USDA announced in the Federal Register that the comment period for the Designation of Product Categories for Federal Procurement proposed rule had been extended. The proposed rule aims to amend the...more

Supreme Court Limits Foreign Reach of the U.S. Patent Act

The supply from the United States of a single component of an invention, for assembly of the invention abroad, is not patent infringement under Section 271(f)(1) of the Patent Act. This is according to a unanimous ruling this...more

Advanced Bioeconomy Leadership Conference March 1-3, 2017, Washington D.C.

by Bergeson & Campbell, P.C. on

The Advanced Bioeconomy Leadership Conference 2017 (ABLC 2017) will be held March 1 - 3, 2017, at the Mayflower Hotel in Washington, D.C. ABLC is the gathering point for top leaders in the Advanced Bioeconomy -- bringing...more

Illinois State Senators Introduce Legislation To Boost Biobased Economy

by Bergeson & Campbell, P.C. on

On February 9, 2017, Illinois State Senators Andy Manar and Chapin Rose introduced legislation aimed at growing Illinois’ biobased economy by providing incentives under the Renewable Chemical Production Tax Credit Program...more

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