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.

Compounding 59

Compounding Labelling 59

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

Pharmaceutical Technology

OCTOBER 5, 2022

According to GlobalData’s analyst consensus forecast, Yescarta is expected to reach peak sales of $1.8bn in 2028, and Kymriah is expected to reach sales of $686m in the same year. Autologous CAR-T agents are now becoming the standard of care for patients in the third line and later settings, providing lucrative returns for these agents.

Chemotherapy 111

Chemotherapy Labelling 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).

Immunity 40

Immunity Immunization Vaccines Health and Personal Care Stores 40

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.

Labelling 62

Labelling 62

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.

Labelling 98

Labelling 98

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.

Biosimilars 130

Biosimilars Drug Pricing Documentation Labelling 130

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.

Biosimilars 71

Biosimilars Pharmaceutical Companies Pharmaceutical Companies Labelling 71

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

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