The Pharma Data

JUNE 24, 2021

Professor of Oncology at the University of Utah School of Medicine, Senior Director for Clinical Research Innovation at Huntsman Cancer Institute and member of the TALAPRO-3 steering committee. Source link:[link].

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PPD

JUNE 20, 2023

Prior analyses indicate that recessions can affect drug demand for myriad reasons, including lower utilization of patented biologics and branded drugs, as well as an uptick in utilization of biosimilars and generics. Does your CRO look after your most valuable resources?

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The Pharma Data

MAY 6, 2021

ENVI calls on the Commission to “revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the EU.”. . To EMA, Rasi’s work with CTC is a conflict of interest, leading it to impose conditions. .

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Agency IQ

MARCH 1, 2024

For example, statutorily, the prescription drug user fee program (PDUFA) has a statutory cap of total carryover for operating reserves of 14 weeks, while the biosimilar user fee program (BsUFA) had a goal of bringing the carryover balance down to “no greater than 21 weeks of operating reserves” by the end of the 2022 fiscal year.

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FDA Law Blog: Biosimilars

JANUARY 1, 2024

Finally, FDA said in a Warning Letter that a Clinical Investigator, Anish S. Swedish company Sonesta Medical AB was accused of several violations of medical device design requirements, failure to exercise appropriate control over contractors, and failure to adequately review complaints and determine whether MDRs needed to be filed with FDA.

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The Pharma Data

OCTOBER 27, 2020

During the clinical development stage, Molecular Partners will provide clinical supply. The companies will work together to scale-up manufacturing capacity, in collaboration with Sandoz, the generics and biosimilar Novartis division, to provide worldwide supply. ” Collaboration Terms and Share Subscription.

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Agency IQ

OCTOBER 27, 2023

Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)

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The Pharma Data

SEPTEMBER 10, 2020

Investigator-Sponsored Studies and Clinical Research Collaborations. . Today, we have an industry-leading portfolio of 23 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma. Grivas P. . Pfizer Inc.:

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The Pharma Data

OCTOBER 29, 2020

on clinical trial costs, throughout all study phases, across both regions. “We We are very excited about this model that seamlessly incorporates two of the most compelling and complementary international clinical research hubs for our biotech clients from early to late phase studies,” said Yvonne Lungershausen, CEO of Avance Clinical.

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FDA Law Blog: Biosimilars

APRIL 8, 2024

We recently summarized another GAO report which described challenges FDA continues to face with clinical research inspections. The White Paper acknowledges that “there is little to no flexible manufacturing capacity” and notes that FDA’s shortage response can include “exercising temporary regulatory discretion to increase supply.”

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Agency IQ

MARCH 1, 2024

There are also some product-specific bioequivalence guidelines open for comment, along with concept papers proposing the development of materials on the topics of biosimilar development and non-inferiority comparisons in clinical trials.

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FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

Implications for Future of Clinical Research R3 represents an important evolution in GCP, shifting away from a prescriptive model toward a more flexible, risk-based approach.

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