European Pharmaceutical Review

AUGUST 24, 2022

ANTIBODY-DRUG conjugates (ADCs) are therapeutic molecules designed as highly targeted medicines with the promise of changing the way we treat cancer and other diseases. An ADC combines the specificity of an antibody and the potent power of an anti?cancer cancer agent or disease-relevant toxin.

Compounding 83

Compounding Pharmaceutical Companies Pharmaceutical Companies 83

Pharmaceutical Technology

FEBRUARY 22, 2023

The patent battle between Amgen and Sanofi over their cholesterol-lowering antibodies has divided big pharma in the past months. Both drugs are monoclonal antibodies that inhibit the protein PCSK9. Both drugs come with a high price tag. To an extent, the challenge here lies in the nature of antibodies, says Contreras.

FDA 104

FDA 104

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

pharmaphorum

JANUARY 5, 2022

The FDA thinks an antibody-drug conjugate (ADC) developed by AbbVie could set new standards in treatment for certain patients with lung cancer, awarding the drug breakthrough status. The post FDA gives AbbVie’s c-Met lung cancer ADC a breakthrough tag appeared first on.

FDA 111

FDA Chemotherapy 111

pharmaphorum

DECEMBER 23, 2021

Daiichi Sankyo has been granted breakthrough status by the FDA for patritumab deruxtecan, a HER3-targeted antibody-drug conjugate (ADC) in clinical trials for lung cancer. The post FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag appeared first on.

FDA 72

FDA Chemotherapy 72

pharmaphorum

MARCH 23, 2022

Argenx only recently scored FDA approval for its intravenous anti-neonatal FC receptor (FcRn) antibody Vyvgart for generalised myasthenia gravis (gMG), but is already looking to defend its franchise with a new subcutaneous version of the drug. After 29 days’ treatment IgG levels were reduced by 66.4% in the IV arm.

FDA 52

FDA 52

European Pharmaceutical Review

MARCH 1, 2023

Producing biologics by isolating proteins Biologics like antibodies and other protein-based drugs are produced by living cells such as yeast in large bioreactors. The authors explained that these are commonly used for tagging proteins for study or attaching protein drugs to drug-delivering nanoparticles.

Vaccines 94

Vaccines 94

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

APRIL 27, 2022

The coveted status has been awarded to the HER2-targeting antibody-drug conjugate (ADC) on the back of the DESTINY-Breast04 trial results, unveiled in February, which involved patients with HER2-low, unresectable and/or metastatic breast cancer previously treated with one to two prior lines of chemotherapy. .”

Chemotherapy 59

Chemotherapy FDA 59

pharmaphorum

APRIL 20, 2021

The cost-effectiveness agency has said that anti-CD20 antibody Kesimpta (ofatumumab) can be prescribed via the NHS in England and Wales as a treatment for adults with RMS with active disease, as either a first-line therapy or after alternative drugs have been tried.

Hospitals 111

Hospitals Documentation 111

pharmaphorum

DECEMBER 12, 2022

Vyvgart is already approved to treat generalised myasthenia gravis, getting a green light for that indication from the FDA a year ago, and launched with a $225,000 per annum price tag in competition with rival gMG drugs like AstraZeneca/Alexion’s C5 inhibitor Soliris (eculizumab).

Immunization 52

Immunization Labelling FDA 52

pharmaphorum

JANUARY 18, 2022

The hope is that they will harness and re-programme natural cellular mechanisms to selectively remove the disease driving proteins from human tissues, working by boosting interactions – gluing – between therapeutically relevant proteins and the machinery used by cells to naturally tag and destroy proteins.

Immunization 52

Immunization 52

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. Oral therapy data presented at ASH. CellCentric, a U.K-based

Immunization 52

Immunization Hospitals Vaccines 52

pharmaphorum

OCTOBER 29, 2021

Gilead’s Trop-2 targeting antibody-drug conjugate Trodelvy (sacituzumab govitecan) will be paired with Merck’s PD-1 inhibitor Keytruda (pembrolizumab) in a new phase 3 trial in previously-untreated subjects with locally advanced or metastatic TNBC. While its headline revenue of $7.4

Chemotherapy 52

Chemotherapy FDA 52

Pharmaceutical Technology

MAY 15, 2023

Adeno-associated virus vectors, alcohol dehydrogenase compositions, and antibody serum stabilisers are some of the accelerating innovation areas, where adoption has been steadily increasing. Among maturing innovation areas are anti-influenza antibody compositions and anti-interleukin-1, which are now well established in the industry.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Immunization Vaccines 52

The Checkup by Singlecare

JANUARY 15, 2023

Aduhelm is a monoclonal antibody that targets amyloid beta, the protein which piles up in the brain and seems to be at the root of the disease. Aduhelm carries a hefty price tag, and it is not appropriate for any other form of dementia, such as dementia with Lewy bodies and vascular dementia. Compare donepezil alternatives.

Dosage 52

Dosage FDA Insurance 52

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 98

Labelling Immunization FDA 98

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

pharmaphorum

AUGUST 26, 2022

The US biotech claimed conditional marketing approval from the European Commission for Roctavian (valoctocogene roxaparvovec) as a treatment for adults with severe haemophilia A, who don’t have a history of developing the antibodies that inhibit the activity of blood-clotting protein Factor VIII. million spread over five years.

FDA 111

FDA 111

European Pharmaceutical Review

NOVEMBER 10, 2022

Complex medicines offer diverse therapeutic modalities, including RNA therapeutics and antibody-drug conjugates (ADCs). Based on fluorescently labelled antibodies and drugs, the technology offers an array of benefits to drug discovery, from characterising complex cell models of disease to understanding the molecular mechanism of drug action.

Labelling 97

Labelling Compounding 97

pharmaphorum

DECEMBER 2, 2020

The New York-based firm has requested approval for the combination of its anti-CD20 antibody ublituximab and umralisib, an oral drug that inhibits PI3K-delta and CK-1 epsilon. US biotech TG Therapeutics has begun a rolling filing with the FDA for its combination therapy for chronic lymphocytic leukaemia, in a challenge to Roche.

FDA 52

FDA Chemotherapy 52

European Pharmaceutical Review

DECEMBER 27, 2023

Additionally, it was not recommended to use low-dose steroids or allow early administration of tocilizumab, a monoclonal antibody targeting the interleukin-6 (IL-6), in order to reduce and prevent severe CRS. This is in addition to its considerable price tag.

Adverse Reactions 84

Adverse Reactions Immunization Medical Schools Chemotherapy 84