The Pharma Data

JUNE 18, 2021

“The CLL14 trial results observed after four years of follow-up with treatment of venetoclax plus obinutuzumab show that these patients can experience long-lasting responses without disease progression, years after stopping treatment,” said Mohamed Zaki , M.D., NORTH CHICAGO, Ill. months; hazard ratio [HR] 0.33 [95% CI 0.25-0.45]);

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Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

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Agency IQ

JULY 13, 2023

Three of the major health effects associated with asbestos exposure are (1) lung cancer; (2) mesothelioma, a rare cancer found in the lining of the lung, chest, abdomen, and heart; and (3) asbestosis, a serious long-term non-cancer disease of the lungs. However, the majority of this ban was overturned by Corrosion Proof Fittings v.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Science Regulations Production 40

Codon

JULY 27, 2023

CNGA3-achromatopsia is a hereditary disease that causes people to see in shades of gray. They’re talking about a patient who has a rare genetic disease. These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. ” Gene-edited poplar tree stems appear red. From Sulis D.B.

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Codon

JULY 27, 2023

CNGA3-achromatopsia is a hereditary disease that causes people to see in shades of gray. They’re talking about a patient who has a rare genetic disease. These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. ” Gene-edited poplar tree stems appear red. From Sulis D.B.

Therapies 52

Therapies RNA DNA Engineering 52

Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. Of those 53, seven are new to the Agenda, having never before been included in prior agendas.

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The Pharma Data

JUNE 18, 2021

Undetectable minimal residual disease (uMRD) was achieved in 77% of patients in peripheral blood and 60% of patients in bone marrow. 2,3 CLL is predominately a disease of the elderly, with a median age at diagnosis of 70 years and is more common among men than women.

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Agency IQ

MARCH 7, 2024

BY LAURA DIANGELO, MPH | MAR 6, 2024 5:54 PM CST Fiscal year 2024 appropriations bills On March 3, 2024, House and Senate appropriators released a package of final fiscal year (FY) 2024 appropriations bills. AgencyIQ has the highlights. As POLITICO reported , this generally represents a 5.2% This is already raising some red flags.

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The Pharma Data

JUNE 18, 2021

The study met its primary endpoint of superior progression-free survival (PFS) as assessed by an independent review committee (IRC) with a HR 0.216 (95% CI, 0.131-0.357; p < 0.0001), demonstrating a reduction in the risk of disease progression or death for I+V of approximately 78% compared to C+O. . About the GLOW Study.

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Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

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Agency IQ

APRIL 12, 2024

The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation This week, the European Parliament voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. Directive 2001/83/EC and Regulation (EC) No 726/2004.

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The Pharma Data

MAY 13, 2021

Then these hormones can’t regulate your metabolism like they should…. While in a 2014 study published in the journal Biological Trace Elements Research…. Which is a finding that’s backed up by another 2014 human study…. Along with the amount of estrogen-regulating DIM that he added as well. So what’s the fix here?

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Production Packaging Doctors Research 52

Agency IQ

JUNE 16, 2023

FDA set to unveil new rule on Laboratory Developed Tests this August Following challenges getting a diagnostics reform package through Congress, known as the VALID Act, the FDA has just announced that it plans to release a proposed rule in August 2023 that would change the way that the agency effectively regulates laboratory developed tests (LDTs).

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