News & Analysis as of

Pharmaceutical Industry Food and Drug Administration (FDA) European Union

Goodwin

Antitrust and Competition Life Sciences Quarterly Update Q2 2024

Goodwin on

To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more

Goodwin

STADA and Alvotech Announce Launch of UZPROVO® in Europe

Goodwin on

​​​​​​​On July 22, 2024, STADA Arzeimittel AG (“STADA”) and Alvotech announced the launch of ustekinumab biosimilar AVT04 under the name UZPROVO® across a majority of European countries. UZPROVO®, the first approved...more

WilmerHale

The Interplay Key Decisions at the Intersection of Antitrust and Life Sciences - June 2024

WilmerHale on

Court Orders Delisting of Patents from Orange Book and Denies Motion to Dismiss Antitrust Counterclaims for Improper Orange Book Listings. On June 10, Judge Stanley Chesler of the District of New Jersey entered judgment on...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 2, March 2024

HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more

Sheppard Mullin Richter & Hampton LLP

Recent Healthcare-Related Artificial Intelligence Developments

AI is here to stay. The development and use of artificial intelligence (“AI”) is rapidly growing in the healthcare landscape with no signs of slowing down. From a governmental perspective, many federal agencies are embracing...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Gardner Law

[Hybrid Event] MASTERING TOMORROW'S HEALTHCARE TECH: A CUTTING-EDGE APPROACH TO REGULATORY, COMPLIANCE, AND PRIVACY DEMANDS -...

Gardner Law on

FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

MoFo Life Sciences

The EU’S New Proposal For Plants Developed Using New Genomic Techniques: How Does It Compare To U.S. Regulation?

MoFo Life Sciences on

After much anticipation, the EU Commission’s proposal for a regulation on plants developed using New Genomic Techniques (NGTs) is now under consideration. For an overview of the EU proposal, please see MoFo’s recent post....more

Goodwin

Year in Review: Top Biosimilars-Related Regulatory Developments of 2022

Goodwin on

As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...more

Faegre Drinker Biddle & Reath LLP

5 Major Drug and Device Developments of 2022

As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more

Venable LLP

Senator Mike Lee Introduces the Biosimilar Red Tape Elimination Act to Eliminate Switching Study Requirement for Biosimilar...

Venable LLP on

On November 17, 2022, Senator Mike Lee (R-UT) introduced the “Biosimilar Red Tape Elimination Act” to increase biosimilar competition and reduce patient costs by prohibiting the FDA from requiring switching studies to approve...more

Venable LLP

Biosimilars Approved in the EU are Considered Interchangeable

Venable LLP on

​​​​​​​On September 19, 2022, the European Medicines Agency (EMA) and the Heads of Medicines’ Agencies (HMA) issued a joint statement explaining their scientific rationale for determining that biosimilars approved in the EU...more

Goodwin

EMA Reports on Pilot Program on Tailored Scientific Advice for Biosimilar Development

Goodwin on

On September 30, 2021, the European Medicines Agency (EMA) released a report entitled “Tailored Scientific Advice for Biosimilar Development,” describing results from its pilot program in which biosimilar applicants were...more

MoFo Life Sciences

Vaccine Production And State Intervention In The U.S.

MoFo Life Sciences on

During the COVID-19 pandemic, governments across the globe have become increasingly involved in the private sector. State-owned enterprises have long been common in Asia, but the pandemic has increased their prominence in...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, March 2021 # 12

Hogan Lovells on

In Washington: President Biden on Tuesday began what is expected to be a weeks-long sales pitch to tout the new coronavirus relief package. Biden visited Smith Flooring in Chester, Pennsylvania, a small business that received...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time....more

Morgan Lewis

Life Sciences International Review | August 2020

Morgan Lewis on

Welcome to the August 2020 issue of our Life Sciences International Review. This issue covers new developments within Asia, Europe, and the United States in intellectual property, regulatory, pricing, and international trade,...more

McDermott Will & Emery

Fast Track for COVID-19 Drug and Vaccine Approval in the United States and Europe

McDermott Will & Emery on

The Coronavirus (COVID-19) pandemic poses an acute health risk to the population. One key to successfully combating COVID-19 lies in clinical research. Currently, almost all major research-based pharmaceutical companies, many...more

Hogan Lovells

COVID-19: Daily Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time. ...more

Hogan Lovells

COVID-19: Daily Report for Life Sciences and Health Care Companies

Hogan Lovells on

The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time. ...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

Hogan Lovells on

We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

53 Results
 / 
View per page
Page: of 3

"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:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide