World of DTC Marketing
APRIL 12, 2021
A blood-thinning agent, heparin, had been adulterated due to the product license holder (Baxter) procuring a toxic substance that had been illegally substituted for the genuine registered material. The adulterated product was found to have caused nine patient deaths and 574 serious adverse events (SAEs).
Pharmaceutical Technology
JULY 15, 2022
California’s budget documents give few details about the tender process, but state that CalRx will spend $50 million to partner with a contract manufacturer to develop biosimilar insulin products in vial and pen form. This CMO will be responsible for product roll-out and distribution. In-house manufacturing the norm.
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Camargo
OCTOBER 14, 2021
The expanded use of the INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs (INTERACT) meeting : INTERACT meetings are intended to facilitate IND-enabling efforts where a sponsor is facing a novel, challenging issue that might delay the progress of the product towards entry into the clinic in the absence of this early FDA input.
FDA Law Blog
MARCH 5, 2023
Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. As part of its Generic Drug User Fee Amendments of 2022 (“GDUFA III”) Commitment, FDA agreed to expedited development of PSGs.
FDA Law Blog
AUGUST 17, 2023
FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. §
Camargo
DECEMBER 9, 2020
Camargo is currently involved with no less than three product applications that are stalled because the FDA is requiring inspections before the application can be approved (assuming a satisfactory outcome). Biopharma and manufacturing company Alkermes was recently able to participate in a remote document review for its ALKS 3831 product.
Pharmaceutical Technology
NOVEMBER 21, 2022
Meanwhile, another recently released MHLW report confirmed that 696 essential drugs from 94 companies were identified as unprofitable due to increasing costs of manufacturing and packaging and the depreciation of the Japanese yen.
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