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ISoP New Board of Trustees Members Announced

Amparo de la Peña, Vice President of Pharmacometrics at Simulations Plus, will join Jeff Sachs, Pavan Vaddady and Hao Zhu as new board members for 2024

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Hao-zhu , Jennifer-pastore-monroy , Jill-fiedler-kelly , Eli-lilly , Jeff-sachs , Office-of-clinical-pharmacology , Exchange-commission , Simulations-plus-inc , Quantitative-clinical-pharmacology-at-daiichi-sankyo-inc , Nasdaq , Simulations-plus , Vice-president

ISoP New Board of Trustees Members Announced

ISoP New Board of Trustees Members Announced
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FDA Roundup: September 22, 2023

FDA Roundup: September 22, 2023
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FDA Roundup: September 22, 2023

/PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA issued...

Opportunities-for-future-research , Office-of-clinical-pharmacology , Office-of-women-health , Drug-administration , Radiological-health-international-harmonization-strategic-plan , Office-of-media-affairs , Formal-meetings-between , Accreditation-scheme , Conformity-assessment , Medical-device-user-fee-amendments , Drug-evaluation

FDA Roundup: September 22, 2023

FDA Roundup: September 22, 2023
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Office-of-media-affairs , Drug-administration , Office-of-clinical-pharmacology , Office-of-women-health , Radiological-health-international-harmonization-strategic-plan , Opportunities-for-future-research , Formal-meetings-between , Accreditation-scheme , Conformity-assessment , Medical-device-user-fee-amendments , Drug-evaluation

Assessments Of Drug Safety And Effectiveness Continue To Fail People With Obesity

Assessments Of Drug Safety And Effectiveness Continue To Fail People With Obesity
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Simulations Plus Hosts the 2022 Model-Informed Drug Development (MIDD+) Scientific Conference



Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, announced record-setting attendance and virtual

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Failure to Show a Reasonable Expectation of Success Dooms Obviousness Allegations | Haug Partners LLP

In Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.,1 the Federal Circuit affirmed the obviousness analysis performed by the Patent Trial and Appeal Board (“PTAB”), which...

Office-of-clinical-pharmacology , Drug-administration , New-drug-application , Clinical-pharmacology ,

The Virtues Of Claiming Precisely What The FDA Approved! - Intellectual Property

In Teva Pharms. USA, Inc. v. Corcept Therapeutics, Inc., No 21-1360 (Fed. Cir. Dec. 7, 2021), the Federal Circuit affirmed the Final Written Decision of the Patent Trial and Appeal Board ("the Board") holding Teva failed to show all the challenged claims in PGR2019-00048 would have been obvious.

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Federal Circuit Affirms PTAB Decision in Teva Pharms Case

In Teva Pharms. USA, Inc. v. Corcept Therapeutics Inc. No 21-1360, the Federal Circuit affirmed the Final Written Decision of the Patent Trial and Appeal Board the Board holding Teva failed to show all the challenged claims in PGR2019-00048 would have been obvious.

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