News & Analysis as of

Life Sciences Pharmaceutical Industry

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

A road map to Life Sciences M&A in Germany

by Hogan Lovells on

U.S.-based life sciences companies considering transactions in Europe may easily become over-whelmed with the complexity of Europe’s various jurisdictions....more

"Sunshine" in Belgium: New Statutory Transparency Requirements for Life Sciences Companies

by Allen & Overy LLP on

On 23 June 2017, the Belgian “Sunshine Act” entered into force, requiring life sciences companies to disclose relationships with healthcare actors based in Belgium. Companies in both the pharmaceutical and medical devices...more

FDA Commissioner Announces Stem Cell Enforcement Shift, Plans to Develop Comprehensive Regenerative Medicine Policies

In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 “on the FDA’s new policy steps and enforcement...more

What’s on the Menu for Private Equity Funds, Sovereign Wealth Funds, and Investment Managers

by Hogan Lovells on

In this hoganlovells.com interview, Hogan Lovells partner Michael Szlamkowicz talks about what types of transactions private equity funds, sovereign wealth funds, and investment managers are considering and why life sciences...more

August 2017: Life Sciences Litigation Update

Mylan Institutional LLC v. Aurobindo Pharma Ltd., No. 2017-1645, 2017 WL 2192945 (Fed. Cir. May 19, 2017). On May 19, 2017, the Federal Circuit issued a precedential opinion in Mylan Institutional LLC v. Aurobindo Pharma Ltd....more

EMA released reflexion paper clarifying information related to the selection of starting materials

by Hogan Lovells on

The European Medicines Agency (“EMA”) has released a reflexion paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances. The reflexion paper provides...more

A road map to Life Sciences M&A in Poland

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

Skipping The Patent Dance: U.S. Supreme Court In Amgen V Sandoz Makes It More Difficult For Patent Owners To Delay Marketing Of...

by Ladas & Parry LLP on

On June 12, 2017, in a unanimous decision authored by Justice Thomas in Amgen Inc. v. Sandoz Inc., the United States Supreme Court considered the complex statutory scheme that attempts to expedite resolution of patent...more

Sign, Sign, Everywhere A Sign: Don’t Overlook What FDA Says and Writes

by Arnall Golden Gregory LLP on

In the 1971 song, “Signs,” the Canadian rock band, Five Man Electrical Band sang, “Sign, Sign, Everywhere a Sign … Can’t You Read the Sign?” The lyric resonates with us periodically as we discuss with a client a response from...more

News from Abroad -- EPO Applies Doctrine of Plausibility to Small Molecule Pharmaceuticals

In Decision T 488/16, the Boards of Appeal of the European Patent Office (BoA) have revoked EP 1 169 038, which protected the blockbuster protein tyrosine kinase (PTK) inhibitor dasatinib (Sprycel®). The only request on file...more

IP is at the heart of life sciences innovation

by Hogan Lovells on

In recent years, technology and innovation has advanced at an unprecedented pace. Flying taxi drones, self-driving cars and 3D-printers immediately come to mind. However, exciting progress has been made in life sciences and...more

A Difficult Decision for EMA

by Hogan Lovells on

The bids to host the EMA are in! We have reviewed all of them and give you our personal impressions on what to expect. After the EMA has announced the development of a business continuity plan to deal with the workload...more

PTAB Life Sciences Report - August 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Celltrion, Inc. v. Biogen Inc. et al. PTAB Petition: IPR2017-01230; filed March 30,...more

Technology and Life Sciences IPO Survey - 2017 First Half

by Fenwick & West LLP on

This report analyzes key aspects of initial public offerings (IPOs) for technology and life sciences companies that went public in the first half of 2017. Downloading the full report will provide you access to a number of...more

Philadelphia Ranked Fifth In List Of U.S. Life Science Clusters

by Fox Rothschild LLP on

A study of interest for those in the Philadelphia region has recently been released. Rising two spots from last year, Philadelphia has been ranked fifth on the list of life science clusters in the United States recently...more

PTAB Life Sciences Report - July 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Myriad Genetics, Inc. v. Johns Hopkins University - PTAB Petition: IPR2017-01102; filed March...more

Supreme Court Decision Allows Faster Marketing of Biosimilars

On Monday, June 12, 2017, the United States Supreme Court in a unanimous decision held that manufacturers making biosimilars of biologic drugs did not have to wait until after gaining federal approval of the biosimilar to...more

Relocation of the European Medicines Agency – France shows EMA its smooth moves

by Hogan Lovells on

With Brexit under way, the European Medicines Agency is looking for a new home. France revealed itself as a serious contender when it considered offering not just one hosting place for the Agency, but five! Up until recently,...more

Electronic Drug Product Listing Errors Can Result in FDA Warning Letter

by Morgan Lewis on

FDA Warning Letters focus on inaccurate drug product listings. Over the last year, the US Food and Drug Administration (FDA or Agency) has increased its enforcement efforts concerning drug product listing requirements,...more

Outsourcing in the Pharmaceutical and Life Sciences Sectors – A UK Perspective

Pharmaceutical and Life Sciences companies operate in a demanding environment and face diverse challenges such as pricing pressure, increased regulatory requirements and mounting costs. With this backdrop, they have, starting...more

185 Results
|
View per page
Page: of 8
Cybersecurity

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.