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The Issue with Reissue: PTE Edition

FDA Law Blog: Biosimilars

Merck applied for a patent term extension on the reissued patent, claiming the start of the regulatory review period as April 2004 and termination at the approval of the BRIDION NDA in December 2015. With this long regulatory review period, the PTO granted the statutory-maximum five-year patent term extension.

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Analysis Life Sciences: What is the state of pharmaceutical quality in the U.S.? Call it murky

Agency IQ

What is the state of pharmaceutical quality in the U.S.? Call it murky A new report published by the FDA’s Office of Pharmaceutical Quality (OPQ) promises a look at the current “State of Pharmaceutical Quality.” Fill out the form to read the full article.

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Analyzing the impact of biosimilars on biologic drug manufacturing technologies

Drug Patent Watch

Biosimilars have been transforming the pharmaceutical landscape by offering cost-effective alternatives to biologic drugs. link] How Biosimilars are Shaking Up the Pharmaceutical Landscape. ” – Association for Accessible Medicines References Examining the impact of biosimilar-to-biosimilar transition on healthcare costs.

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Gilead Sciences Appoints Stacey Ma, PhD as Executive Vice President, Pharmaceutical Development and Manufacturing

The Pharma Data

(Nasdaq: GILD) announced today that Stacey Ma, PhD will join the company as Executive Vice President, Pharmaceutical Development and Manufacturing, and will become a member of the company’s senior leadership team, reporting to Chairman and Chief Executive Officer Daniel O’Day.

Science 52
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The role of STRIs in cancer

Drug Target Review

Previously, Dr Worland served as Chief Executive Officer of Anadys Pharmaceuticals, Inc., Prior to his appointment as Chief Executive Officer of Anadys Pharmaceuticals, Dr Worland served as its Chief Scientific Officer and President, Pharmaceuticals. Prior to Anadys Pharmaceuticals, Inc.,

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The Market for Image and Performance Enhancing Drugs (IPEDs)

Common Sense for Drug Policy Blog

2015 ), with raw powders imported from ‘producer’ countries like China, Egypt, Greece, Thailand, Turkey, and India (Antonopoulos and Hall 2016 ; Brennan et al. 2015 : 241) suggest that some suppliers are subject to a process of normalisation due to their IPED-using peers, and thus do not view themselves as ‘real dealers’.

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Analysis Life Sciences Thank You CDER’s Office of Pharmaceutical Quality to reorganize, citing need to address ‘pain points’

Agency IQ

BY ALEXANDER GAFFNEY, MS, RAC | NOV 9, 2023 6:35 PM CST Background on CDER’s Office of Pharmaceutical Quality (OPQ) CDER’s Office of Pharmaceutical Quality became operational in January 2015, making it a still relatively recent addition to the agency. Read our analysis of a recent meeting focused on KASA here. ]