News & Analysis as of

Sandoz Was Disinvited to the Patent Dance: The Federal Circuit's First Interpretation of the BPCIA Will Have to Wait

Since the 1984 enactment of the Drug Price Competition and Patent Term Restoration Act, Hatch-Waxman litigation has dominated the sphere of life-sciences patent litigation. The battle between proprietary and generic...more

Post Wisely

Two FDA Guidelines Help Life Sciences Companies Solve Social Media Conundrums - Social media presents new challenges for life sciences companies. Companies that post about their products on space-constrained social...more

Celltrion Healthcare Co. v. Kennedy Trust for Rhematology Research (S.D.N.Y. 2014); Hospira Inc. v. Janssen Biotech Inc. (S.D.N.Y....

Earlier this month, Judge Paul Crotty, U.S. District Court Judge for the Southern District of New York handed down rulings in two separate cases related to the biosimilars law (the Biologics Price Competition and Innovation...more

NNI Publishes Progress Review of 2011 EHS Research Strategy

On June 25, 2014, the National Nanotechnology Initiative (NNI) posted Progress Review on the Coordinated Implementation of the National Nanotechnology Initiative 2011 Environmental, Health, and Safety Research Strategy, which...more

FDA Issues Final Nanotechnology Guidances and Draft Guidance for Comment

On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide "greater regulatory clarity for industry on the use of nanotechnology in...more

More of the Same: Recently Released FDA Social Media Guidance for the Life Sciences Industry

On June 17, 2014, the U.S. Food and Drug Administration ("FDA") continued to outline its expectations for pharmaceutical and medical device manufacturer use of social media platforms to promote manufacturers' products in two...more

FDA Plays Catch Up in the Digital Age

Part of JD Supra's series on innovation and the law. A look at how, as pharmaceutical manufacturers increasingly turn to social media to exchange information, laws and regulations that are decades old struggle to keep pace...more

D.C. Circuit Court of Appeals Upholds FDA Oversight of Autologous Stem Cell Therapeutics

A company that developed a stem cell-based therapy for treating diseases and conditions was found to be in violation of the federal Food, Drug, and Cosmetic Act for failing to seek approval for its product. Cellular and...more

February 2014: Life Sciences Litigation Update

Can the FDA Be Held Liable in a Private Lawsuit for Failure to Prevent Recent Drug Shortages? In Carik et al. v. United States Dep’t of Health & Human Servs. et al., CV 12-272, __ F. Supp. 2d __, 2013 WL 6189313 (D.D.C. Nov....more

Privacy And Data Security For Life Sciences And Health Care Companies

Pepper Hamilton Health Care-Life Sciences Webinar - The explosion of mobile technology and Web applications linking patients with doctors, pharmacies and medical devices is undergoing scrutiny by the FDA, FTC, HHS and...more

The Regulation of Follow-on Biologics

What is new in the world of follow-on biologics? Manthei: Congress enacted the Biologics Price Competition and Innovation Act of 2009 to provide an alternative to the submission of a Biologics License Application for...more

The Life Sciences Report - Fall 2013

In this issue: - How to Expedite Examination of a Patent Application - The FDA Releases Final Guidance for Mobile Medical Applications - Creating Value in the Medtech Industry Using a Gender Lens -...more

China Life Sciences Health Industry Client Briefing – May/June 2013 (July 12, 2013)

Pharmaceuticals, Medical Devices, Health Care & Life Sciences - .. Medical Devices Regulations and News - Provincial FDAs to Approve Certain Changes to Medical Device Registration Certificates – June 21,...more

Business Litigation Report -- April 2013

In This Issue: - Firm News: DoJ Star Healthcare Fraud Prosecutor Joins Washington, D.C. Office; and Quinn Emanuel Wins Top Honors at the Inaugural U.S. Benchmark Annual Awards - Main...more

Dechert Survey of Securities Fraud Class Actions Brought Against U.S. Life Sciences Companies

Publicly Traded Life Sciences Companies in the United States Remain an Increasingly Popular Target of Securities Fraud Class Action Lawsuits: The past year was particularly noteworthy with respect to the absolute and...more

Digital Health: Where is the Action for Entrepreneurs? [Video]

As CES 2013 draws to a close, Michael Esquivel, a partner in Fenwick’s Start-ups and Venture Capital Group, identifies where the action is for entrepreneurs and investors in digital health and healthcare IT. According to...more

China Life Sciences and Health Industry Client Briefing – November 2012 (December 13, 2012)

In This Issue: Priorities, Practical Tips and Lessons Learned from Reed Smith’s China Device Regulatory Briefing on December 4, 2012; Programs of Designated Drug Production to be Initiated: Five to 10 Pilot Varieties...more

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