pharmaphorum

AUGUST 25, 2022

The double-headed antibody binds to CD3 on T cells and redirects them to BCMA-expressing myeloma cells, with the aim of stimulating an immune attack on the tumour, which remains incurable despite a slew of new therapies reaching the market in recent years.

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Pharmaceutical Technology

APRIL 5, 2023

More than a decade after the first patient was treated with a CAR-T therapy, six therapies relying on the same principles have been approved by the US Food and Drug Administration (FDA) and marketed to thousands of patients. More broadly however, several advancements are on the horizon for cell and gene therapies in 2023.

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FDA Immunization 59

pharmaphorum

DECEMBER 23, 2022

There’s been huge progress in treatments for blood cancer in recent years – but drawbacks of expensive CAR-T cell and injected antibody therapies have led drug developers to look at novel oral therapies as patient-friendly alternatives. CellCentric, a U.K-based

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pharmaphorum

APRIL 5, 2022

Immunocore now has approval on both side of the Atlantic for Kimmtrak – the first cancer therapeutic based on T cell receptor (TCR) technology – after getting a green light from the European Commission. It’s the first treatment for mUM in the EU, as well as the first BiTE drug to treat a solid tumour.

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Labelling Chemotherapy Immunization 52

pharmaphorum

JANUARY 11, 2021

While bluebird has conducted pioneering work in gene therapy for blood disorders and in cancer cell therapy, products have been delayed by issues with filing data for the FDA. The gene therapy firm will be focused on its most important therapies in beta-thalassemia, cerebral adrenoleukodystrophy and sickle cell disease in the US And Europe.

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FDA 60

Pharmaceutical Technology

DECEMBER 5, 2022

CB1 receptors are primarily expressed in the brain and central nervous system, whereas CB2 receptors are expressed in T-cells in the immune system. Collectively, cannabinoid receptors (CB1 and CB2) are currently the most popular targets in preclinical stage of development, with 391 drugs tagged in total.

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pharmaphorum

FEBRUARY 22, 2021

Last week, Bluebird said it was pausing its Zynteglo (betibeglogene autotemcel) programme in Europe after a phase 1/2 trial in patients with sickle cell disease (SCD) – another red blood cell disorder – turned up two cases of blood cancers, one of acute myeloid leukaemia (AML) and another of myelodysplastic syndrome (MDS).

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Immunization 52

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

European Pharmaceutical Review

AUGUST 24, 2022

2 The role of the antibody is to deliver the payload to a specific site such as a cancer cell. Functionality of ADCs is dependent on being internalised together with the target into the endosomal/lysosomal compartment, where the cytotoxin is released by controllable chemistry leading to the death of the cancer cell. References.

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pharmaphorum

JANUARY 5, 2021

Like PD-L1, TIGIT is thought to act as a molecular brake that stops T cells from attacking tumours, and tiragolumab is currently leading the pack among drugs targeting the immune checkpoint. The post Roche nabs breakthrough tag for TIGIT cancer immunotherapy appeared first on.

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Chemotherapy Immunization FDA Labelling 52

pharmaphorum

AUGUST 18, 2022

bluebird bio’s Zynteglo has become the first cell-based gene therapy to be approved in the US, getting the nod from the FDA as a treatment for patients with beta thalassaemia who require regular blood transfusions. bluebird has opted to launch it at a cost of $2.8 million, which compares to the $1.7

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pharmaphorum

MAY 17, 2021

There had been speculation that the FDA might approve Empaveli (pegcetacoplan) only as a backup option for patients who don’t see a sufficient benefit with Alexion’s Soliris (eculizumab) or Ultomiris (ravulizumab), but the regulator opted for a broad indication that included first-line treatment for PNH. billion and $1.1

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FDA Labelling Vaccines 52

The Checkup by Singlecare

JANUARY 25, 2023

When asked whether they were concerned about sunburn, photoaging (wrinkles or leathery skin), precancerous skin conditions, or skin cancer, 29% of those surveyed said they weren’t concerned about any of these things. SPF 30 means it would take you 30 times longer to sunburn than if you weren’t wearing sunscreen at all.

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Documentation Insurance FDA 52

The Checkup by Singlecare

JANUARY 23, 2024

Various factors can lead to a bump on the head, such as head trauma , infections, cysts , or abnormal cell growth, and although head bumps might cause some discomfort, they usually aren’t a cause for alarm. Benign skin growths Skin growths such as moles, skin tags, and seborrheic keratosis can appear as bumps on the head.

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pharmaphorum

NOVEMBER 16, 2022

This is the case for the new generation of treatments known as advanced therapies, which encompasses cell and gene therapies, as well as tissue engineering. Of the innovations that have happened recently in pharma drug development, it is cell and gene therapy that have received the most attention. However, with a price tag of €1.58

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pharmaphorum

DECEMBER 2, 2020

These plans were soon abandoned and Hospira has remained a key part of the core Pfizer organisation – but that didn’t put the idea of separate business units to rest completely. For all the latest Pfizer news follow pharmaphorum’s Pfizer tag. The post A history of Pfizer appeared first on.

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pharmaphorum

MARCH 27, 2022

Johnson & Johnson is in course for approval of its multiple myeloma CAR-T therapy Carvykti in the EU the next few weeks, after getting a green light from the EMA’s human medicines committee. The post CHMP backs J&J’s myeloma CAR-T therapy Carvykti appeared first on.

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Labelling Immunization FDA 94

pharmaphorum

AUGUST 26, 2022

Roctavian delivers a working copy of the Factor VIII gene into cells via an adeno-associated virus (AAV) vector, and offers a one-shot, potentially curative therapy for haemophilia A. For now, the list price hasn’t been set and will depend on discussions with reimbursement authorities, according to the biotech.

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FDA 111

Roots Analysis

AUGUST 28, 2022

Recent advances in multi-omics approaches, including genomics, transcriptomics, proteomics, metabolomics, cytometry and imaging, in combination with bioinformatics and biostatistics, have been translated into several popular bioanalytical platforms, such as next-generation sequencing (NGS), single-cell analysis, flow cytometry and mass spectrometry.

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European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. 1 Following in vitro production from T cells collected from a patient’s leukapheresis procedure, the CAR T cells are infused back into the patient’s blood, where they proliferate and expand.

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Adverse Reactions Immunization Medical Schools Chemotherapy 85