Pharmaceutical Technology

SEPTEMBER 2, 2022

The product labels do not help either; the FDA has approved all such agents for use at the fifth line of therapy or later, while the EMA has adopted the stance of fourth line of therapy or later use for these agents (Figure 1). Should CAR-T cells, or antibodies be used first? Does Blenrep have an efficacy advantage over Tecvayli?

FDA 59

FDA Labelling 59

Roots Analysis

NOVEMBER 27, 2023

The expansion project is anticipated to create approximately 500 new jobs once completed around 2028, adding to the existing workforce of nearly 2,000 individuals at the Chartres site. With this additional EUR 2.1

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Labelling 40

Pharmaceutical Technology

JUNE 16, 2023

Merck ( MSD ) has announced updated results with Keytruda (pembrolizumab) in the Phase III Keynote-811 trial, which opens up the possibility of changing the checkpoint inhibitor’s label in HER2-positive gastric or GEJ adenocarcinoma so it’s based on the tumour’s PD-L1 biomarker status. It showed promising event-free survival (EFS) of 62.4%

Chemotherapy 52

Chemotherapy Labelling FDA Communication 52

The FDA Law Blog

OCTOBER 6, 2023

Labs must also begin complying with device labeling requirements (21 C.F.R. Stage 2 (two years after issuance of the final rule) : Register with FDA as a device establishment and list LDTs performed, pursuant to 21 C.F.R. Part 801) and investigational device exemption requirements (21 C.F.R.

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FDA Labelling 64

Pharmaceutical Technology

DECEMBER 22, 2022

The new joint procedure will launch in Q1 2025 for oncology medicines and other advanced therapy medicinal products and extend to orphan drugs in 2028. However, he did point out that the joint assessment could be a useful way of narrowing down typically broad EMA label content to specific patient populations.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Labelling Communication 52

pharmaphorum

JANUARY 12, 2021

It says Farxiga will reach peak sales of $9 billion in 2028, with Jardiance forecast to reach $4.6 The post Boehringer, Lilly’s Jardiance ties to match AZ’s Farxiga with heart failure label appeared first on. billion, assuming a launch for HFrEF this year.

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Labelling FDA 77

The FDA Law Blog

DECEMBER 3, 2023

CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028. The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. Final Guidance at 2. of the total expenditures for all Part D drugs in 2021.

Labelling 105

Labelling Compounding Payment Processing Vaccines 105

pharmaphorum

JANUARY 14, 2021

Whilst the details of China’s economic recovery have been disputed, one forecaster, the Centre for Economics and Business Research, has predicted that China will now overtake the US as the world’s leading economy in 2028, five years earlier than was previously forecast. About the author.

Pharmaceutical Companies 72

Pharmaceutical Companies Pharmaceutical Companies Labelling 72

STAT

MARCH 26, 2025

From cancer warning labels to soda taxes , progressive states like California and New York have long led the way on legislation meant to improve public health. You’re reading The MAHA Diagnosis , a STAT series that examines the major elements of the Make America Healthy Again movement led by Robert F. Kennedy Jr.

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Labelling FDA 111

PharmaShots

JUNE 1, 2023

We are conducting an open-label, dose-escalation, phase I/II study PDC-LUNG-101 assessing the safety, tolerability, immunogenicity, and the preliminary clinical activity of therapeutic cancer vaccine PDC*lung, associated or not with anti-PD1 treatment in patients with non-small-cell lung cancer (NSCLC).

Immunization 40

Immunization Vaccines Health and Personal Care Stores Labelling 40

The FDA Law Blog

JANUARY 2, 2025

Under the proposed rule, any raw whole fruits and vegetables could be labeled healthy no matter the level of added sugars, sodium, or saturated fat. Therefore, manufacturers must maintain records for foods bearing a healthy claim unless it is clear from the foods mandatory labeling information.

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FDA Labelling Documentation 52