Pharmaceutical Technology

DECEMBER 16, 2022

This therapy is currently in Phase II development and is expected to launch in the US and 5EU in 2027 and 2028, respectively. GlobalData’s report also covers a third pipeline candidate, quinagolide, a dopamine receptor antagonist being developed by Ferring Pharmaceuticals.

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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?

Labelling 59

Labelling 59

FDA Law Blog: Biosimilars

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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Labelling 64

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).

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Immunity Immunization Vaccines Health and Personal Care Stores 40

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 Diabetes 74

pharmaphorum

AUGUST 16, 2021

The drug is part of Merck’s efforts to expand its oncology portfolio and reduce its reliance on big-selling cancer immunotherapy Keytruda (pembrolizumab), which is patent protected in the US and Europe until 2028.

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Labelling 98

Express Pharma

MAY 7, 2024

per cent per year until 2028 1. At the same time, the rising costs for filling, packaging and labelling medicines, added to the increased energy costs, could cause a fall in revenue for pharmaceutical manufacturers, which are under additional pressure because of fixed sales prices for drugs (i.e. in the EU).

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Packaging Pharmaceutical Manufacturing Labelling 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.

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Biosimilars Pharmaceutical Companies Pharmaceutical Companies Labelling 70

Safe Biologics

MAY 10, 2024

Without a change, the number of eligible drugs will increase to 15 in 2027 and 2028 and to 20 every year thereafter. CMS is currently working to set prices for 10 drugs, with the final prices set to be announced by Sept. 1 and go into effect in 2026.

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Biosimilars Drug Pricing Documentation Labelling 130

FDA Law Blog: Biosimilars

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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Labelling Documentation 52

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 Communication 52

Express Pharma

NOVEMBER 13, 2024

million by 2031, assuming the asset attains approval in 2028. Additionally, patients who completed PHOENYCS GO will continue to be assessed in a long-term open-label study, underscoring both companies’ commitment to understanding the sustained benefits and safety profile of dapirolizumab pegol.”

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Labelling Immunity Immunization 105

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.

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Pharmaceutical Companies Pharmaceutical Companies Labelling Communication 52