News & Analysis as of

Life Sciences

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

FDA Issues Guidance on Use of Real-World Evidence for Medical Devices

by Arnall Golden Gregory LLP on

On August 31, 2017, the Food and Drug Aministration issued a final guidance titled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” In the guidance, which finalizes the agency’s July...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

FDA Approves First Cancer-Treatment Biosimilar -- Amgen's Mvasi

Earlier on September 14, 2017, the U.S. Food and Drug Administration approved Amgen's application to market Mvasi (bevacizumab-awwb), a biosimilar to Genentech's Avastin therapeutic antibody for the treatment of multiple...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

EIT Acquires Patent Portfolio For 3D Printed Spinal Fusion Cages

by Knobbe Martens on

On August 22, 2017, Emerging Implant Technologies GmbH (EIT) announced the acquisition of 22 patents and pending applications relating to 3D printed expandable spinal fusion cages based on living hinges from Dr. Morgan Lorio,...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

Business Litigation Report - August 2017

Supreme Court Highlights Importance of Statute-Specific Venue Rules - The Supreme Court upended nearly thirty years of practice when it ruled, in the TC Heartland LLC v. Kraft Foods Group Brands LLC U.S. , 137 S.Ct. 1514...more

California Environmental Law & Policy Update - September 2017 #2

by Allen Matkins on

Environmental and Policy Focus - Bill targeting Cadiz water transfer stalls in Senate committee - San Bernardino County Sun - Sep 1 - A bill designed to block the transfer of groundwater from the inland Southern...more

Keeping Pace in Clinical Research: The Common Rule Picks up Speed

by Dickinson Wright on

In recent years, the world of human subjects research has expanded not only with regard to the number of clinical research trials being conducted and the array of drugs and devices being tested, but also with respect to the...more

FDA Makes Gene Therapy Available for First Time in USA

by Snell & Wilmer on

Earlier this week, the FDA made gene therapy available for the first time in the United States. This decision, ushers in “a new approach to the treatment of cancer and other serious and life-threatening diseases” said the...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

Developments in Regenerative Medicine: FDA Announces Plans to Clarify Its Oversight of Cellular Therapy Products and Approves...

by Holland & Knight LLP on

FDA Commissioner Scott Gottlieb, on Aug. 28, 2017, announced steps the agency is taking to begin rolling out policies and guidance documents to clarify its oversight over regenerative medicine products. Dr. Gottlieb...more

A Dynamic Digital Health Sector Means More and Bigger Deals

The digital health sector is beginning to mature and investors are pouring more money into more deals, reports Rock Health in its survey of digital health investment in the first half of 2017. And, we might add, into bigger...more

2017 Mid-Year Technology and Life Sciences IPO Report

Wilson Sonsini Goodrich & Rosati’s 2017 Mid-Year Technology and Life Sciences IPO Report presents key data related to the pricing of 26 U.S.-based technology and life sciences issuers between January 1 and June 30, 2017. Just...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

General Data Protection Regulation: What It Means For US Healthcare/Life Science Companies (Part Three)

Even though the GDPR is a general regulation, some provisions are expressly addressing the specificities of the processing of personal data in the healthcare/life science sectors....more

General Data Protection Regulation: What It Means For US Healthcare/Life Science Companies (Part One)

The clock is ticking: on May 25, 2018, in less than a year from now, the General Data Protection Regulation (“the GDPR”) will apply in all Member States of the European Union (“EU”) and will replace the Directive 95/46/CE...more

General Data Protection Regulation: What It Means For US Healthcare/Life Science Companies (Part Two)

New General Features of the GDPR - Some of the GDPR general features may be of particular interest for companies in the healthcare/life science sectors....more

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