News & Analysis as of

Biotechnology › New Guidance

Morgan Lewis

FDA Regulatory Uncertainty Calls for Strategic Decision-Making by Drug Developers

Morgan Lewis on

The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the...more

Procopio, Cory, Hargreaves & Savitch LLP

USPTO Provides Guidance in Light of Amgen v. Sanofi

Procopio, Cory, Hargreaves & Savitch LLP on

The U.S. Supreme Court’s May 2023 decision in Amgen, Inc. v. Sanofi (Amgen) sent shock waves through the patent world, particularly in the chemical and biotech segments, due to its invalidation of Amgen patents based on a...more

Foley & Lardner LLP

Navigating the AI Frontier: Legal and Operational Insights Into Generative AI

Foley & Lardner LLP on

In our ever-changing technological environment, artificial intelligence (AI) is beginning to exert its influence on numerous sectors, revolutionizing our approach to work. As businesses and organizations worldwide adopt...more

Jones Day

New Guidance: Inside Information Disclosure by Listed Biotech Companies in Belgium

Jones Day on

The Development: Belgium's financial regulator, the Financial Services and Markets Authority ("FSMA"), published a recent opinion on "Considerations and good practices with respect to inside information disclosures by listed...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

American Conference Institute (ACI)

[Virtual Event] 18th Advanced Summit on Life Sciences Patents - August 5th - 6th, 9:00 am EDT

American Conference Institute (ACI) on

Perfect Your Patent Prosecution Strategies and Master the Patent Application Process in the U.S and Around the World. ACI’s 18th Global Summit on Life Sciences Patents virtual conference this August will provide practical...more

Skadden, Arps, Slate, Meagher & Flom LLP

Capital Markets Alert – Public Market Advocacy Groups Release Guidance

Skadden, Arps, Slate, Meagher & Flom LLP on

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

Hogan Lovells

FDA Issues New Guidance Documents on Regenerative Medicine but Delays Enforcement

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative cell-based therapies. ...more

8 Results
 / 
View per page
Page: of 1

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