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A PSA on PSGs: PSG Meetings Are Now Available

FDA Law Blog

Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. FDA may deny a PSG if the applicant’s bioequivalence testing started after the PSG publication.

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Quality by design with a focus on biosimilars

Pharmaceutical Technology

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.

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The drug industry continues to dare regulation

World of DTC Marketing

Pfizer and Merck have chosen to designate a select few generic manufacturers to produce cheaper versions of their drugs through the Medicines Patent Pool (MPP). Experts across the board are predicting demand for antiviral drugs will rapidly outpace supply. At this point, one must wonder why the U.S. About those copay cards.

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In the News: October Regulatory and Development Updates

Camargo

In November 2017, Foundation Medicine received approval for FoundationOne CDx , a genomic profiling test for solid state tumors, which paved the way for partnerships with pharma companies’ therapeutics. In 2019, Foundation Medicine and Bayer Healthcare Pharmaceuticals, Inc. for patients with NTRK fusion cancer across all solid tumors.

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Pioneering access to complex generic products 

Drug Discovery World

Claire D’Abreau-Hayling, Chief Scientific Officer at Sandoz, examines how generic products can relieve industry pressure and improve access to essential medicines. Off-patent medicines today account for about 80% of global prescriptions at an estimated 20% of the total cost.

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Headache for Zosano as FDA turns down migraine patch

pharmaphorum

Zosano Pharma has been hit by an FDA rejection of its marketing application for migraine drug Qtrypta, asking for new bioequivalence data. Qtrypta is Zosano’s lead product candidate, but the company is also working on a follow-up in phase 2/3 for cluster headache.

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Jailed pharma exec fined £47m and banned from industry

pharmaphorum

The case was brought by the US Federal Trade Commission (FTC) and US states New York, California, Illinois, North Carolina, Ohio, Pennsylvania and Virginia, for Shkreli’s actions that blocked any competition with its key medicine to preserve monopoly profits.