News & Analysis as of

Life Sciences

FDA Issues Fourth and Final Software as a Medical Device Clinical Evaluation Guidance

by McDermott Will & Emery on

The FDA recently released “Software as a Medical Device (SAMD): Clinical Evaluation,” a final guidance document that aims to establish a common understanding of clinical evaluation and principles for demonstrating the safety,...more

FDA Issues Guidance on Digital Health

by Stinson Leonard Street on

The Food and Drug Administration (FDA) issued two guidance documents last week clarifying its approach to certain health-related software in response to the addition of Section 520(o) to the Food, Drug and Cosmetic Act, which...more

Life Sciences Quarterly (Q4 2017): The Use of Social Media and Mobile Applications

by Ropes & Gray LLP on

What are the legal implications of using social media and mobile applications in clinical trials and the recent developments impacting research fraud investigations? In this recap of our fourth quarter presentation, which...more

District Courts Split over Proper Patent Venue for Hatch-Waxman Act Litigation

by Morgan Lewis on

There have been two interpretations of the “acts of infringement” language in the patent venue statute regarding ANDA submissions in Hatch-Waxman litigation....more

A Dialogue With Corporate Counsel: Skadden’s Seventh Annual Pharmaceutical and Medical Device Seminar

Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more

Canada releases proposed amendments to Regulations governing patented medicines pricing

by Smart & Biggar on

On December 2, 2017 Canada’s Governor-in-Council published proposed Regulations Amending the Patented Medicines Regulations (“the proposed Regulations”). The 75-day consultation period ends February 15, 2018. The proposed...more

Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Inc. (D. Del. 2017)

Last month, in Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Inc., District Judge Richard G. Andrews of the U.S. District Court for the District of Delaware denied a motion to dismiss filed by...more

The U.S. Congress intends to make a comprehensive revision of the foreign investment review

by Morrison & Foerster LLP on

On November 8, bipartisan lawmakers in both houses of the United States and the United Democrats proposed a new act aiming to make major revisions to the current review of the laws applicable to the U.S. Foreign Investment...more

Canada Provides More Guidance On Patent Eligibility Of Diagnostic Method Claims

by Foley & Lardner LLP on

While the patent eligibility of diagnostic method claims remains questionable in the United States, the Canadian Intellectual Property Office has issued updated guidance on the types of diagnostic method claims that can–and...more

UK Government Announces Life Sciences Sector Deal

by Hogan Lovells on

The UK government has published a White Paper setting out its new Industrial Strategy and, as part of that strategy, has agreed a Sector Deal with the UK life sciences sector. ...more

FDA Releases Stem Cell Guidance Documents

by Foley & Lardner LLP on

Therapies that use autologous or allogeneic stem cells are examples of early personalized therapies. Removing cells from a patient and reintroducing them to the same or a matched patient, for example, as done in bone marrow...more

FDA Creates Streamlined Review Pathway for Certain NGS-Based Tumor Profiling Tests

by McDermott Will & Emery on

On November 15, 2017, the FDA announced the clearance of a tumor profiling test under a novel, streamlined FDA premarket review pathway for certain next generation sequencing (NGS)-based tumor profiling tests. The creation of...more

Ninth Circuit Improperly Lowers Admissibility Bar for Expert Causation Testimony

by Foley Hoag LLP on

In Wendell v. GlaxoSmithKline LLC, the U.S. Court of Appeals for the Ninth Circuit reversed a trial court order that excluded expert testimony concerning the cause of a profoundly rare and deadly disease. The decision...more

UK publishes paper on Brexit and medicines regulation

by Hogan Lovells on

On the same day as the European Council voted to move the European Medicines Agency (EMA) from London to Amsterdam, the UK Parliament issued a briefing paper on Brexit and medicines regulation. ...more

EMAmsterdam: Hogan Lovells welcomes its new neighbour

by Hogan Lovells on

By Hein van den Bos, Ruth Franken and Silvia Gardini After months of discussion, a final vote has been cast on the European Medicines Agency (EMA)'s new home post-Brexit. And it's right around the corner from us, here in...more

European Medicines Agency heads for Amsterdam

by Allen & Overy LLP on

Today the 27 member states of the European Union have decided on Amsterdam as the new home of the European Medicines Agency. The decision came after three rounds of voting, with Amsterdam eventually emerging the winner after...more

Unknown Problem Plus Nonobvious Solution Cannot Render Patent for Sublingual Formulation of Asenapine Obvious

by McDermott Will & Emery on

The District Court for the District of Delaware found Forest Labs’ patent for sublingual or buccal compositions of asenapine and methods of using such compositions to treat mental disorders, including schizophrenia and mania,...more

PTAB Life Sciences Report - November 2017 #2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Sawai USA, Inc. v. Astellas Pharma Inc. PTAB Petition: IPR2018-00079; filed October 16,...more

Rare Grant of Request for Rehearing in Biologics-related IPR

by Morgan Lewis on

Reconsideration leads to a reversal of course regarding a key claim limitation. On October 26, 2017, in Hospira, Inc. v. Genentech, Inc., the Patent Trial and Appeal Board (PTAB) granted Hospira’s request for rehearing and...more

Italian Regions cannot recommend against use of costly medicines – says highest administrative court

by Allen & Overy LLP on

A recent decision by the Italian Council of State (CS) comes as welcome news for the innovative pharmaceutical industry as it sets important boundaries to the initiatives that regional authorities can take in the attempt to...more

PTAB Life Sciences Report - November 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Pfizer Inc. v. Biogen, Inc and Genentech, Inc. PTAB Petition: IPR2017-02126; filed October 6,...more

Bioquark Seeks to Reverse Brain Death

Last year, two biotech companies announced that they had received institutional review board (IRB) approval for a study focused on the clinical intervention of brain death in humans. The study, entitled "Non-randomized,...more

Pharma Distributors Trade Association Sued for Conspiracy to Exclude Competition for its Track and Trace Software

On October 23, 2017, a company that developed software to track and trace pharmaceuticals filed a complaint against a pharmaceutical distributors trade association that currently dominates the market for such software,...more

PTAB Life Sciences Report - October 2017 #2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Complete Genomics, Inc. v. Illumina Cambridge Ltd. - PTAB Petition: IPR2017-02172; filed...more

USPTO and EPO Examiners Discuss Key Considerations for Filing Effective Precision Medicine and Bioinformatics Applications in the...

At a symposium and webinar presented by Fenwick & West and Mewburn Ellis, we asked U.S. Patent and Trademark Office and European Patent Office examiners to provide perspective on the preparation and prosecution of patent...more

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