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Bar associations generally operate under the delegated authority of the state’s highest court. [read post]
23 Apr 2024, 1:58 am by Dan Cooper and Kristof Van Quathem
On April 22, 2024, the European Federation of Pharmaceutical Industries and Associations (“EFPIA”) issued a statement on the application of the AI Act in the medicinal product lifecycle. [read post]
20 Apr 2024, 9:03 pm by Sydney Ross Singer
The pharmaceuticals of interest belong to a wide variety of drug classes. [read post]
16 Apr 2024, 8:42 am by Holman
While the generic challenger prevailed with respect to the IBS-D patents, the district court found the patents directed toward the use of rifaximin to treat HE to be infringed and not invalid, and ordered that the effective date of a final approval of Norwich’s ANDA should not precede October 2029, which is the latest expiration date associated with the HE patents. [read post]
14 Apr 2024, 7:56 pm by Sabrina I. Pacifici
In some cases, generic manufacturers lose money on the drugs, disincentivizing other players in the pharmaceutical industry from stepping in to bolster fragile supply chains. [read post]
13 Apr 2024, 3:33 pm by admin
Of course, for the one “suggested” association for appetite suppressant use among women, the results were even more fragile. [read post]
9 Apr 2024, 2:56 pm by Brian Clark
General tax principles typically require that expenses associated with creating assets having useful lives lasting longer than the current tax year are capitalized. [read post]
8 Apr 2024, 9:47 am by Dennis Crouch
  Prior antipsychotic drugs have been associated with significant weight gain. [read post]
6 Apr 2024, 8:49 pm by Patent Docs
This year's conference co-chairs include Andrei Iancu (Partner, Sullivan & Cromwell LLP and former Director of the USPTO), Brian Malkin (Associate General Counsel, Teva Pharmaceuticals), and Mira Mulvaney (Assistant General Patent Counsel, IP Litigation, Eli Lilly & Company). [read post]
3 Apr 2024, 9:05 pm by renholding
To limit damages to the inflation dissipated by corrective disclosures, as required by Dura Pharmaceuticals v. [read post]
3 Apr 2024, 7:18 am by Bob Ambrogi
” TRĒ is officially launching its product tday at the annual conference of the Legal Marketing Association in San Diego. [read post]
2 Apr 2024, 9:50 am by Jonathan H. Adler
As Michael Dorf notes in this post, there are cases in which the maker of a brand-name pharmaceutical challenged the approval of a generic, but this avenue will not always be available. [read post]
1 Apr 2024, 10:58 am by Dennis Crouch
  Overall, this is a bad case for pharmaceutical formulary patents. [read post]
29 Mar 2024, 5:21 am by Rose Hughes
The drug substance is protected by a composition of matter patent and associated SPCs until 2029. [read post]
27 Mar 2024, 5:40 pm by Vincent Joralemon
Prioritizing “On-Label” Prescriptions Right now, few insurers cover off-label ketamine therapy (i.e., using generic ketamine, which is only approved as an anesthetic). [read post]
26 Mar 2024, 3:35 pm by Mark Walsh
(Katie Barlow) In the bar section, Kristen Waggoner, the president and general counsel of Alliance Defending Freedom, the organization representing the anti-abortion doctors and medical associations that challenged FDA’s actions on mifepristone. [read post]
26 Mar 2024, 12:12 pm by Amy Howe
Solicitor General Elizabeth Prelogar argues on behalf of the FDA. [read post]
25 Mar 2024, 12:39 pm by Amy Howe
The drug at the center of the case is known by the generic name mifepristone. [read post]