Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
Specify the Steps of Information Manipulation or Lose under § 101 - In Mobile Acuity Ltd. v. Blippar Ltd. Appeal No. 22-2216, the Federal Circuit held that patent claims that merely recite result-orientated, functional...more
The Federal Circuit once again had an opportunity to opine on the extent of behavior by a generic drugmaker who opts to accept a "section viii carve-out" in its FDA approval (resulting in a so-called "skinny label) on...more
Reliably Determining Reasonable Royalty Rates from Lump Sum Licenses - In Ecofactor, Inc. V. Google LLC, Appeal No. 23-1101, The Federal Circuit held that license agreements containing a lump sum payment “based on” a royalty...more
The Federal Circuit reversed a decision from the District of Delaware dismissing a case for failing to plead induced infringement because the totality of the evidence raised fact questions that could not be resolved on a...more
Among recent trends in consumer product false advertising class actions has been the rise in cases alleging false advertising for products touting ingredients as “all natural” or “100% natural.” These lawsuits often point to...more
Although it's not often that I read a decision by the U.S. Court of Federal Claims, it appears that Vanda may be opening a new front in the brand/generic battle by surviving a motion to dismiss in a case it brought under the...more
Hosted by American Conference Institute, the 28th Annual Conference on Drug & Medical Device Litigation returns for another exciting year with curated programming and networking opportunities with 400+ industry...more
The Ninth Circuit Court of Appeals recently issued three noteworthy decisions holding that courts may consider information on the back or side of consumer product labels to clarify any ambiguous language on the front labels...more
I. Introduction - No pharmaceutical antitrust decision has had more impact than the Supreme Court’s 2013 decision in Federal Trade Commission v. Actavis, a decision which officially defined the term “reverse payment...more
A district court in Utah recently dismissed claims brought against a biotechnology company and its officers under Section 10(b) of the Securities Exchange Act and Rule 10b-5 adopted thereunder. The order in Richfield v....more
This past week, the internet lit up over whether it was okay for President Biden and the First Lady to order the same dish at the Red Hen. In this issue, we invite you to read the February highlights on clean labeling false...more
Welcome to Three Point Shot, a newsletter brought to you by the Sports Law Group at Proskauer. Three Point Shot brings you the latest in sports law-related news and provides you with links to related materials. In this double...more
Recent FDA guidance for determining and declaring the protein grams in a serving has helped muscle a class action out of federal court. FDA’s guidance clarifies that protein nutrient content claims under 21 CFR 101.9(c)(7)...more
Since the Supreme Court’s decision in TC Heartland (137 S. Ct. 1514 (2017)), the venue statute for patent cases, 28 U.S.C. § 1400(b), has been interpreted to mean that venue is proper only where the defendant “resides” or...more
Our Case of the Week this week is a re-write of our Case of the Week on October 5, 2020. The case involves a drug that could be used for multiple therapeutic purposes. A patent covered use of the product for a specific...more
In the first ruling of its kind nationwide, a federal court in Texas has upheld a hospital’s policy requiring employees to be vaccinated against COVID-19 as a condition of continued employment... ...more
The March 2021 issue of Sterne Kessler's MarkIt to Market® newsletter discusses fair use cases for photographs and three recent developments in the cannabis space. We also highlight recent accolades earned by Sterne Kessler's...more
People love their pets. The American Pet Products Association reported that pet owners spent $95.7 billion on their pets in 2019 and estimated the 2020 spend will be $99 billion. Combine the love for pets with cannabidiol...more
California Federal Court Denies Motion to Dismiss Securities Class Action Arising from Uber’s IPO; S.D.N.Y. Dismisses Ponzi Scheme Action Against HSBC Hong Kong for Lack of Personal Jurisdiction; Delaware Court of Chancery...more
Many of us think of coffee as a morning essential, however, there has been a long running debate between California regulators, courts, business, and consumer advocates regarding whether coffee must have a Proposition 65...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Releases Guidance on Intentional Adulteration - The U.S. Food and Drug Administration (FDA) has released the third and final installment of its draft guidance on intentional...more
Welcome to our first Product Lines issue of 2020. Product Lines is our quarterly e-newsletter that focuses on toxic torts and product liability issues. For this edition, we are reporting on several important and timely...more
BECAUSE DELAWARE WAS AN IMPROPER VENUE FOR DEFENDANT MYLAN, AND DEFENDANT 3M DEMONSTRATED THAT VARIOUS FACTORS WEIGHED IN FAVOR OF A TRANSFER, THE CASE WAS TRANSFERRED TO THE NORTHERN DISTRICT OF WEST VIRGINIA. Case...more
On January 27, 2020, Judge Richard G. Seeborg of the United States District Court for the Northern District of California granted a motion to dismiss a putative securities class action asserting claims under Sections 10(b)...more
Massachusetts state and federal courts issued a number of important product liability decisions in 2019. The Product Liability practice group at Nutter recently reviewed these cases. Highlighted below are some of the key...more