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
To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more
In Washington: The Senate Appropriations Committee on Tuesday released drafts of all 12 annual spending bills for 2021, setting up negotiations for a deal ahead of the Dec. 11 deadline to keep the government-funded. Bogged...more
In Washington: The Trump administration will pay Eli Lilly $375 million to supply 300,000 doses of its experimental antibody drug to treat COVID-19, the Department of Health and Human Services said Wednesday. If the Food and...more
In Washington: After halting coronavirus stimulus negotiations on Tuesday afternoon, President Donald Trump hours later signaled he would support specific coronavirus relief measures on stimulus checks, help for the...more
In Washington - The House of Representatives returns from recess this week to join the Senate colleagues for the final work period before they adjourn in mid-October for the November elections. The likelihood of a deal on...more
In Washington - Senate Majority Leader Mitch McConnell (R-KY) is planning to hold floor votes on unemployment benefits forcing Democrats to go on the record as coronavirus relief bill talks stall. Floor votes are a...more
This week, the FDA approved LYUMJEV (insulin lispro-aabc), a new insulin lispro product by Lilly. LYUMJEV is a formulation of insulin lispro, developed to speed the absorption of insulin into the blood stream and reduce A1C...more
On March 4, 2019, Eli Lilly announced that they will begin selling a lower-priced version of Humalog® (isulin lispro injection 100 units/mL) in the United States with a list price 50% lower than the current Humalog® list...more
The financial world has been busy—and generally not in a great way—since we’ve been gone. Luckily, we’re returning on something of a rare high note after a stronger-than-expected December jobs report and some reassurance...more
Case Name: Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., No. 2015-2067, 2017 U.S. App. LEXIS 555 (Fed. Cir. Jan. 12, 2017) (Circuit Judges Prost, Newman, and Dyk presiding; Opinion by Prost, C.J.) (Appeal from S.D....more
In Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., the Federal Circuit affirmed the district court decision finding infringement under Akamai of a two-step method of treatment when the prescribing information for the...more
Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2016: The FDA approved three biosimilar products in 2016, compared to only one in 2015 — Sandoz’s Zarxio®, a...more
Case Name: Eli Lilly & Co. v. Perrigo Co., Case No. 1:13-cv-00851-SEB-DKL (S.D. Ind. Aug. 22, 2016) - Drug Product and Patent(s)-in-Suit: Axiron® (testosterone metered transdermal solution); U.S. Patents Nos. 8,071,075...more
On December 11, 2015, the United States District Court for the Southern District of Indiana granted a motion to stay a Hatch-Waxman litigation pending the outcome of inter partes reviews (IPRs) on two of the patents-in-suit...more
The Hatch-Waxman Litigation and Life Sciences practice groups at Robins, Kaplan, Miller & Ciresi L.L.P. are pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the...more