News & Analysis as of

Disclosure Requirements Biotechnology

Hogan Lovells

FDA’s creation of public database of 200 Complete Response letters raises questions

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The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies whose drug and biological...more

Morgan Lewis

SEC Focus on the Life Sciences Industry: What to Expect and How to Prepare

Morgan Lewis on

The life sciences sector remains a critical area of focus for the US Securities and Exchange Commission (SEC) under the current administration. Companies operating in the healthcare, pharmaceutical, biotechnology, and medical...more

Rothwell, Figg, Ernst & Manbeck, P.C.

3 Tips for Avoiding Having to File a Budapest Treaty Declaration When Prosecuting Patent Applications on Biological Materials

The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure is an international agreement to establish a uniform system for depositing microorganisms and other...more

Fenwick & West LLP

The Life Sciences IPO Market Is Off to a Solid Start in 2025

Fenwick & West LLP on

Various biotech companies have completed or launched their IPOs so far in 2025. As of early February, five sizeable life sciences companies have priced their IPOs and one has filed to go public soon. ...more

Fenwick & West LLP

Clinical Data FAQs: How to Prepare for Disclosure

Fenwick & West LLP on

When it comes to disclosing clinical trial data in the biotechnology arena, in particular for public biotech companies, timing is everything. Disclosures are not just about when to reveal the information, but also what is...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Key Inventorship Considerations in AI-assisted Drug Development

The utilization of artificial intelligence (“AI”) is becoming ubiquitous across a wide range of industry sectors. The biotech industry is no exception. AI-driven platforms have become increasingly useful to biotech...more

Foley Hoag LLP - Public Companies & the Law

Biotech Public Markets Finally Thawing(?): Two Massachusetts Biotechs file S-1s

In an encouraging sign that the equity capital markets may be improving for biotechnology companies, Bicara Therapeutics Inc. and Zenas Biopharma, Inc. filed S-1 registration statements yesterday, signaling their intention to...more

Fenwick & West LLP

Biotech Companies Continue to Make Progress on ESG

Fenwick & West LLP on

A Look at the Disclosure Practices of Small and Mid-Size Companies - In our report we continue to look at the progress that smaller public biotech companies have made in their reporting on environmental, social and...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 3, March 2023

Amazon Sued for Not Telling New York Store Customers about Tracking Biometrics - “Thanks to a 2021 law, New York is the only major American city to require businesses to post signs letting customers know they’re tracking...more

Fenwick & West LLP

The Evolution of ESG Disclosure for Biotech Companies

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Despite some recent criticisms of environmental, social and governance (ESG) initiatives and their proponents, demands for ESG information, including by large institutional investors and regulators, are expected to continue....more

Fenwick & West Life Sciences Group

Biotech Industry at Inflection Point with ESG Initiatives

Corporate social responsibility is not a new concept, but in recent years there has been an increased focus by investors and other stakeholders regarding how companies are addressing their environmental, social and governance...more

Goodwin

Hong Kong Stock Exchange Issues New Guidance for Listing Pre-Revenue Biotech Companies

Goodwin on

Since the introduction of a new listing regime on 30 April 2018 that enables the listing of pre-revenue Biotech Companies on the Main Board of the Hong Kong Stock Exchange (the “Exchange”), a total of 16 of these listings...more

Skadden, Arps, Slate, Meagher & Flom LLP

Guide for Annual Reporting on Fiscal Year 2019 for Companies Listed on the Hong Kong Stock Exchange

This update provides an overview of recent developments that will affect preparation of annual results and annual reports for companies listed on The Stock Exchange of Hong Kong Limited (HKEX). In particular, it covers...more

Hogan Lovells

A new year, a new disclosure: ICMJE requires registrations for clinical trials beginning in 2019 to include disclosure of data...

Hogan Lovells on

Clinical trials starting patient enrollment this year must include a "data sharing plan" in their trial registrations (such as on ClinicalTrials.gov), according to a policy published by the International Committee of Medical...more

Skadden, Arps, Slate, Meagher & Flom LLP

Capital Markets Alert – Public Market Advocacy Groups Release Guidance

On April 27, 2018, the Securities Industry and Financial Markets Association (SIFMA), the U.S. Chamber of Commerce and Nasdaq, along with certain technology and biotechnology groups, released a policy paper titled “Expanding...more

McDonnell Boehnen Hulbert & Berghoff LLP

BIO International Convention 2014 Preview - BIO and World-Wide Intellectual Property Protection

The 2014 BIO International Convention begins next week in San Diego. If you are planning on attending, you probably already know that the amount of information and opportunities available at BIO can be daunting. Therefore,...more

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