Biotechnology

News & Analysis as of

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

TSCA/FIFRA/IRIS/NTP/TRI - EPA Promulgates Final TSCA Reporting And Recordkeeping Rule For Nanoscale Materials: After over a decade of effort, the U.S. Environmental Protection Agency (EPA) issued on January 12, 2017, a...more

Top 5 Patent Red Flags in Life Sciences Due Diligence

Since IP represents 75 to 90% of the value of life science transactions, due diligence is a critical component of the valuation process....more

EMA hosts workshop on adaptive pathways

On 8 December 2016, the European Medicines Agency (“EMA”) organised a workshop in collaboration with the European Commission to gather the views and proposals from stakeholders on the adaptive pathways approach. The aim...more

White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Biotechnology

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and...more

The Life Sciences Report - Winter 2017

Consumer Digital Health: Market Shift Is Leading to New Opportunities - The newest wave of consumer digital health investment focuses on applications encouraging consumers to change health-related behaviors, shifting...more

Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2017

Predictions and Outlook for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 2017 - 2016 was full of surprises, two of which will drive much of the agenda for OCSPP during 2017. First, Congress...more

White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Biotechnology

On January 4, 2016, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017 Update). The Update to the Coordinated Framework provides a comprehensive...more

Don’t Miss These 2017 J.P. Morgan Healthcare Conference Events in San Francisco

If your work involves life sciences dealmaking, you know it’s the time of year to start firming up your plans for the week of the J.P. Morgan Healthcare Conference. In the last 10 years, the second week of January in San...more

Who Owns IP Rights in the Age of Artificial Intelligence?

AI raises issues that go to the very foundations of intellectual property law, including the economic incentive to encourage certain activities, and the “moral rights” associating with according credit to authors....more

Biotech Patent Dispute Between Academics That Is Far From Academic

On December 6, 2016, the parties to the complex and soon-to-be departed world of patent interferences orally argued their positions on motions in what has been described as the “biotech trial of the century” and as “the...more

EPO Stays Proceedings Over Patentability Of Plants And Animals

While the U.S. is still sorting out “natural products” jurisprudence under 35 USC § 101, the European Patent Office (EPO) is wrestling with the patentability of plants and animals, and has announced an immediate stay on all...more

The 21st Century Cures Act

Signed into law by President Obama on December 13, 2016, the 21st Century Cures Act (Act) was overwhelmingly supported in both houses of Congress and comprises a dizzying array of provisions aimed to improve and modernize...more

Not Just a Formality? USPTO Sequence Rules May Impact Existing Biotech Portfolios

Patent applications containing nucleic acid or protein sequences are required to include an electronic sequence listing using a required format and standard symbols. The United States Patent and Trademark Office (USPTO), in...more

21st Century Cures: Modernizing Public and Private Research

The 21st Century Cures Act, signed into law by President Obama on December 13, encourages biomedical research investment and facilitates innovation review and approval processes. Through National Institutes of Health (NIH)...more

21st Century Cures Act’s Effect on Pharmaceutical and Biotechnology Industries

The 21st Century Cures Act contains significant new mandates for both the FDA and NIH that affect the pharmaceutical and biotechnology industries and are intended to advance drug research, discovery, approval, and promotion...more

The Passage of the 21st Century Cures Act by Congress will produce Sweeping Changes to the Biotech, Medical Device,...

The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more

Lessons Learned from AIA Invalidity Proceedings in the Bio/Pharma Space

September 16, 2016, marked the fourth anniversary of the effective date for the invalidity proceedings before the Patent Trial and Appeal Board (PTAB or Board) created by the America Invents Act (AIA). These new AIA...more

Food for Thought: Ninth Circuit Rejects GMO and Pesticide Bans in Three Hawaii Counties Because State and Federal Laws Preempt the...

Alika Atay et al v. County of Maui, et al, No. 15-16466 (9th Cir., Nov. 18, 2016) - Hawai’i Papaya Indus. Assn., et al v. County of Hawaii, No. 14-17538 (9th Circ., Nov. 18, 2016) - Robert Ito Farm, Inc., et al. v. County...more

Highlights from McDermott’s 2016 Pharmaceutical/Medtech Dealmaking Symposium

On October 25, 2016, McDermott Will & Emery held its fifth annual Pharmaceutical/Medtech Dealmaking Symposium in Cambridge, Massachusetts. The day consisted of a series of thought-provoking panels with leading dealmakers in...more

Myriad Genetics Announces an Assay that Identifies Patients for Olaparib Treatment

Salt Lake City-based Myriad Genetics, Inc. announced that its BRACAnalysis CDx® test accurately identifies patients with ovarian cancer for a second-line treatment with olaparib. The announcement came as a result of a...more

The PTAB Review - November 2016

New Testimonial Evidence with Preliminary Responses: Panacea or Placebo? Just over three years ago, during a keynote speech at the AIPLA annual meeting, the Patent Trial and Appeal Board (PTAB) was criticized as a...more

Intellectual Property Bulletin - Fall 2016

Mean Girls v. The Right of Publicity: Lessons Learned From the Lohan and Gravano Lawsuits - On September 1, 2016, a New York appellate court ended two closely watched right of publicity lawsuits brought by Lindsay...more

Biotechnology Innovation Organization's Amicus Brief for In re Aqua Products, Inc.

On Friday, December 9, 2016, the Federal Circuit will hear oral arguments en banc in the In re Aqua Products, Inc. case to consider two questions related to the PTAB's treatment of Motions to Amend in IPR proceedings. ...more

IBioIC Announces Recipients Of £3 Million In Funding For Synthetic Biology Projects

On October 17, 2016, the Industrial Biotechnology Innovation Centre (IBioIC) announced over £3 million in investments over six synthetic biology projects. IBioIC was founded by Ingenza Ltd, GlaxoSmithKline plc (GSK), and...more

Investing in Cuban Health Care Biotech Industries

The Obama Administration made significant new regulatory changes to allow certain investment opportunities in the Cuban health care and biotech industries. While many barriers remain, US firms in the health care industry...more

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