Medical Device Legal News with Sam Bernstein: Episode 18
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Podcast: Unpacking FDA's Final Clinical Decision Support Guidance - Diagnosing Health Care
Podcast: Post-Dobbs - Considerations for Clinical Trials and Research - Diagnosing Health Care
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
JONES DAY PRESENTS® Digital Health and Clinical Research: Understanding Regulatory Regimes
JONES DAY PRESENTS® The Impact of Digital Health on Research and Clinical Trials
Nota Bene Episode 75: Clinical Trial Disclosures on the World Map with TrialScope Chief Strategy Officer Thomas Wicks
Podcast: Non-binding Guidance: SEC Disclosure Issues for Life Sciences Companies
Life Sciences Quarterly (Q3 2019): SEC Enforcement and Class Actions Regarding FDA Communications
Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry
Life Sciences Quarterly (Q4 2017): The Use of Social Media and Mobile Applications
The US Court of Appeals for the Federal Circuit affirmed the grant of a preliminary injunction (PI) in the biopharmaceutical space, concluding that the plaintiff satisfied the requirements for injunctive relief, including...more
In its June 10, 2020, opinion in Nguyen v. Endologix, the U.S. Court of Appeals for the Ninth Circuit applied the plausibility standard to a plaintiff’s securities fraud claims and affirmed the district court’s dismissal,...more
This month, the Court of Justice of the European Union (CJEU) addressed a case of particular interest for pharmaceutical companies that are in the process of developing a new product. Regulatory and commercial considerations...more
Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019....more
Reasonably Continuous Diligence Is Not Negated If an Inventor Works On Improvements or Evaluates Alternatives to the Claimed Invention - In ATI Technologies ULC v. IANCU, Appeal Nos. 2016-2222, -2406, -2608, the Federal...more
Federal Circuit Summaries - Before Newman, Dyk, and Chen. Appeal from the Patent Trial and Appeal Board. Summary: An injury-in-fact is required to establish Article III standing for judicial review of agency action,...more
The recent New York Court of Appeals decision in Stega v. New York Downtown Hospital provides strong support for defamation claims arising out of witness testimony in investigations and quasi-judicial hearings....more
An Update on Vanessa’s Law - This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act...more
On January 30, 2015, the United States Court of Appeals for the District of Columbia issued an opinion in a case regarding the Federal Trade Commission’s (FTC) challenge to the advertisements of POM Wonderful’s (“POM”)...more
On Jan. 30, 2015, the U.S. Court of Appeals for the D.C. Circuit affirmed the FTC’s ruling that POM Wonderful made false and misleading advertising claims that its pomegranate juice products were effective in fighting various...more