News & Analysis as of

Pharmaceutical Industry Life Sciences

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

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

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

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

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

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

PTAB Life Sciences Report - October 2017

About the PTAB Life Sciences Report:  Each month we will report on developments at the PTAB involving life sciences patents. Sun Pharmaceuticals Industries, Ltd. v. Novartis AG - PTAB Petition: IPR2017-01929; filed...more

EMA senior officer: pharmaceutical companies encouraged to prepare for Brexit

by Hogan Lovells on

Agnès Saint-Raymond, MD, Head of International Affairs at the European Medicines Agency (“EMA”), recently urged pharmaceutical companies to be “proactive” in preparing for Brexit, as there is still uncertainty around a...more

Product Liability Update: October 2017

by Foley Hoag LLP on

Massachusetts Federal Court In Multi-District Litigation Holds Under Six States’ Laws That Manufacturer Of Brand-Name Pharmaceutical Is Not Liable For Injuries Caused By Generic Equivalents Whose Manufacturers Were Required...more

Five Takeaways From Fenwick’s Sixth Annual Digital Health Investor Summit

Fenwick’s Sixth Annual Digital Health Investor Summit started on an upbeat note with Rock Health’s Megan Zweig sharing the venture fund’s mid-year funding report. After the uncertainty brought by the 2016 presidential...more

The commission assessment – a decision-making aid for EMA's relocation?

by Hogan Lovells on

Last week, a staff retention survey was published, according to which certain contestants in the race for hosting the EMA were less liked by the EMA staff. And now the decision-making progress is going forward....more

A road map to life sciences M&A in Spain

by Hogan Lovells on

U.S.-based life sciences companies considering transactions in Europe may easily become overwhelmed with the complexity of Europe’s various jurisdictions. In this series, members of our European Life Sciences Transactions...more

Following Biosimilar Trial, Jury Awards Amgen $70 Million for Pfizer’s Pre-Approval Infringement of Now-Expired EPO Patent

In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in damages for Pfizer’s infringement of one of Amgen’s expired patents...more

Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate...

by Hogan Lovells on

On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning...more

A road map to Life Sciences M&A in Russia

by Hogan Lovells on

U.S.-based life sciences companies considering transactions in Europe may easily become overwhelmed with the complexity of Europe’s various jurisdictions. In this series, members of our European Life Sciences Transactions...more

The life sciences industry under the antitrust spotlight in China: two practical points

by Hogan Lovells on

The simple fact is that the Chinese antitrust regulators are determined to up their enforcement activities in the life sciences industry. Almost immediately after drug pricing was liberalised in 2015, an antitrust enforcement...more

EMA Launches New Submission Form Facilitating Submission Of Post-Authorisation Data

by Hogan Lovells on

The European Medicines Agency (“EMA”) has issued a new submission form in order to help marketing authorisation holders to submit the post-approval data that is generated to satisfy post-authorisation measures related to...more

Gilead to Acquire Kite Pharma for $11.9 Billion

by Knobbe Martens on

Gilead Sciences, Inc. recently announced an agreement to acquire Kite Pharma, Inc. for $11.9 billion. According to the announcement, Kite Pharma focuses on cell therapy treatment for cancer, which involves the genetic...more

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