pharmaphorum

AUGUST 25, 2022

Johnson & Johnson has its first worldwide regulatory approval – in the EU – for Tecvayli, one of two much-anticipated bispecific antibodies the drugmaker has developed for patients with multiple myeloma. Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA.

FDA 98

FDA Immunization 98

pharmaphorum

JULY 25, 2022

Tecvayli (teclistamab) is an off-the-shelf bispecific antibody targeting both BCMA and CD3 which is also under review at the FDA and if approved will slot into J&J’s myeloma therapy portfolio alongside Darzalex (daratumumab) – an antibody directed at CD38 – and BCMA-targeted CAR-T therapy Carvykti (ciltacabtagene autoleucel).

FDA 52

FDA 52

Pharmaceutical Technology

MAY 2, 2023

IO agents include the classes of immune checkpoint modulators, cell therapies, bispecific antibodies, oncolytic viruses, therapeutic vaccines, and cytokines. Marketed bispecific antibodies are largely bispecific T-cell engagers (BiTEs), which work by directing T-cells to antigen-expressing tumour cells.

Immunization 52

Immunization Vaccines 52

Pharmaceutical Technology

NOVEMBER 9, 2022

million price tag. Both factor VIII prophylactics and Roche’s bispecific antibody Hemlibra that are used for haemophilia A patients are expensive, and so a gene therapy could save money, says Dr. David Rind, chief medical officer (CMO) of ICER. The post Can gene therapies for haemophilia defend their high price tags?

FDA 111

FDA 111

pharmaphorum

MARCH 27, 2022

The KarMMa trial of Abecma involved a similar patient group – treated with at least three lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody such as J&J’s Darzalex (daratumumab) – with an overall response rate of 72% and 28% complete responses.

Labelling 96

Labelling Immunization FDA 96

Roots Analysis

SEPTEMBER 13, 2023

Conjugation is the process of formation of a single, stable hybrid, wherein one of the entities is a molecule, such as protein, antibody, peptide and small molecule. Bioconjugation is a subset of conjugation where one of the entity is a biomolecule, such as protein or an antibody.

Labelling 40

Labelling 40