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12 Oct 2021, 6:35 am by Natalie DiFelice
She has worked on many pharmaceutical products liability cases and acted as defense counsel for Merrell Dow Pharmaceuticals, Inc. [read post]
12 Oct 2021, 6:35 am by Natalie DiFelice
She has worked on many pharmaceutical products liability cases and acted as defense counsel for Merrell Dow Pharmaceuticals, Inc. [read post]
11 Oct 2021, 7:59 pm by Cynthia Marcotte Stamer
Federal government contractors and grant recipients should tighten cyber security policies, practices and internal controls to mitigate their exposure to civil False Claims Act claims by the Department of Justice (“DOJ”) under a new DOJ Civil Cyber-Fraud Initiative announced by DOJ last week. [read post]
5 Oct 2021, 6:36 am by Dennis Crouch
If so, please identify the changes and their associated impacts. 8. [read post]
1 Oct 2021, 9:19 am by Cynthia Marcotte Stamer
Given the potential of enforcement based on current or past practices or events and the likely need for candid discussion of issues and concerns associated with past and present noncompliance risks, HIPAA Covered Entities, PHR Vendors and others dealing with health apps or connected devices also should consider engaging legal counsel familiar with the various rules to help guide this evaluation within the scope of attorney-client privilege. [read post]
23 Sep 2021, 2:10 am by Rose Hughes
The US Courts of Appeal of the Federal Circuit (CAFC) found in Belcher Pharmaceuticals v Hospira, Inc that a formulation patent was unenforceable in view of inequitable conduct, in the form of contradictory submissions to the patent office and the regulatory agency (FDA) by the patentee. [read post]
18 Sep 2021, 8:45 pm by Patent Docs
The program will consist of two panels: • Panel I -- Current Topics in the Federal Circuit’s Law of Written Description and Enablement -- John Josef Molenda of Steptoe & Johnson LLP will moderate a panel consisting of Larry Coury of Regeneron Pharmaceuticals, Inc.; Henry Hadad of Bristol-Myers Squibb; Joshua Rosenkranz of Orrick, Herrington & Sutcliffe LLP; and John Whealan of The George Washington... [read post]
16 Sep 2021, 12:57 pm by Simmons Hanly Conroy
” The New York State trial is expected to continue into October with remaining defendants Allergan Finance (a subsidiary of AbbVie Inc.), Teva Pharmaceutical Industries Ltd. and Anda, Inc. [read post]
In undoubtedly one of the most important decisions of the year so far, on 24 August 2021, the English Court of Appeal handed down its judgment in FibroGen v Akebia (FibroGen Inc v Akebia Therapeutics Inc [2021] EWCA Civ 1279), partially allowing FibroGen’s appeal, and so finding one of the ‘Family A’ patents, EP 823, valid and infringed. [read post]
3 Sep 2021, 3:30 am by John Jenkins
Here’s an excerpt with a hair-raising tale from a small cap issuer about just how much Robinhood’s promo cost it: One company pushing back is Florida-based drugmaker Catalyst Pharmaceuticals Inc., which says Robinhood’s program cost it more than $200,000 last year and could be even more expensive this year. [read post]
30 Aug 2021, 10:13 am by Rebecca Tushnet
” Does the greater regulation of pharmaceuticals mean that Pom Wonderfulapplies differently to them than to food and beverage labels? [read post]
20 Aug 2021, 12:15 pm by Tom Lamb
In April 2013 a so-called “Dear Doctor” letter was sent out in Canada by Novartis Pharmaceuticals Canada Inc. warning about some serious side effects associated with Tasigna and a drug label change with new information concerning those leukemia drug Tasigna side effects. [read post]
16 Aug 2021, 6:32 am by Robert Kraft
” From the news release of the American Association for Justice.The post States Announce $26 Billion Settlement to Resolve Opioid Lawsuits first appeared on Kraft Elder Law. [read post]
10 Aug 2021, 6:20 am by Robert Kraft
” Additionally, “Pharmacy operators Walgreens Boots Alliance Inc, CVS Health Corp, Rite Aid Corp, and Walmart Inc agreed to settle with the counties for a combined $26 million. [read post]
9 Aug 2021, 4:00 am by Administrator
Co-blogger Mark Mancini has already posted on the Federal Court of Appeal’s recent decision in Alexion Pharmaceuticals Inc v Canada (Attorney General), 2021 FCA 157. [read post]
5 Aug 2021, 12:12 pm by Lawrence B. Ebert
(collectively, GSK) sued Teva Pharmaceuticals USA, Inc. in the United States District Court for the District of Delaware for infringement of claims of GSK’s Reissue Patent No. [read post]