Pharmaceutical Technology

NOVEMBER 13, 2022

The US Food and Drug Administration (FDA) has granted approval for AstraZeneca ’s Imfinzi (durvalumab) plus Imjudo (tremelimumab) and platinum-based chemotherapy to treat Stage IV (metastatic) non-small cell lung cancer (NSCLC) in adults.

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pharmaphorum

JULY 2, 2021

The decision comes after FDA advisors voted six to two in April that Keytruda (pembrolizumab) should not stay on the market as a treatment option for patients with PD-L1-expressing gastric or gastroesophageal junction (GEJ) adenocarcinoma in patients who have received two or more earlier lines of therapy.

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pharmaphorum

DECEMBER 1, 2021

BeyondSpring’s hopes of an early Christmas gift from the FDA were dashed today after the regulator said it was unable to approve the company’s lead drug plinabulin as a treatment for low white blood cell counts caused by cancer chemotherapy. of patients taking plinabulin plus pegfilgrastim and 13.6%

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Hospital Pharmacy Europe

AUGUST 23, 2023

A human CD40 agonistic antibody targeting CD40, mitazalimab kickstarts the cancer-immunity cycle by priming and activating tumour-specific T cells. Targeting CD40 with mitazalimab has the potential to augment responses to chemotherapy. The EMA orphan drug designation follows a similar approval by the FDA in May 2023.

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European Pharmaceutical Review

MAY 4, 2023

Amivantamab was the first bispecific monoclonal antibody (BsMAb) approved in the EU to treat advanced NSCLC with EGFR exon 20 insertion mutations post chemotherapy. Overall, the mechanisms of action for amivantamab include ligand blocking, receptor degradation, and immune cell-mediated activity.

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Pharmaceutical Technology

APRIL 26, 2023

The US Food and Drug Administration (FDA) has granted orphan drug designation to IN8bio’s INB-400 and INB-410 to treat a range of malignant gliomas, including newly diagnosed glioblastoma multiforme (GBM). This marks the first-ever designation for genetically modified gamma-delta T cell therapies.

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Pharmaceutical Technology

FEBRUARY 26, 2023

While the French MaaT Pharma has submitted further information to the FDA, its trial remains on hold. In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI. But the approval came through after an FDA Advisory Committee meeting. with placebo.

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pharmaphorum

MARCH 30, 2022

The SKYSCRAPER-02 showed that the combination of the two drugs given on top of chemotherapy was unable to improve progression-free survival versus Tecentriq (atezolizumab) plus chemo in extensive-stage SCLC – a notoriously hard-to-treat form of lung cancer.

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pharmaphorum

NOVEMBER 29, 2022

Amplifying and reinvigorating persistent T cell immunity has become a much-needed path to enhance anti-tumor efficacy. T cells are known to mediate anti-tumor immune responses. For that reason, they have become the key target of immune checkpoint therapies, like PD-(L)1 agents.

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European Pharmaceutical Review

OCTOBER 19, 2023

Granzyme B is an enzyme released by activated immune cells and using this as a in vivo imaging biomarker has great potential to monitor immune cell activation in a variety of inflammatory diseases, autoimmune diseases, cancer and infections. What do you envision the future of radiopharmaceuticals to be like?

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The Checkup by Singlecare

SEPTEMBER 12, 2023

The Shingrix vaccine triggers the immune system to respond to the varicella virus and suppress the outbreak of shingles,” says David Cutler , MD, a family medicine physician at Providence Saint John’s Health Center in Santa Monica, California. This is a typical immunization response as your body builds a defense against possible infection.

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Pharmaceutical Technology

MARCH 6, 2023

Patients in the US and EU with recurrent or metastatic nasopharyngeal carcinoma (NPC), a subtype of head and neck squamous cell carcinoma (HNSCC), are mostly treated with a combination of chemotherapy agents in the frontline setting, such as cisplatin + gemcitabine. months for the chemotherapy arm (hazard ratio [HR]: 0.52).

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pharmaphorum

NOVEMBER 29, 2022

Tecentriq is a monoclonal antibody designed to bind with PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blockings its interactions with both PD-1 and B7.1 Patients given the Tecentriq plus chemotherapy combination survived a median of 16 months after treatment, compared with 13.4

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pharmaphorum

DECEMBER 21, 2020

Trodelvy (sacituzumab govitecan) is a first-in-class TROP2 antibody-drug conjugate drug that was granted accelerated approval by the FDA in April for adults with metastatic triple-negative breast cancer (TNBC), who have received at least two previous therapies for metastatic disease. months in patients treated with chemotherapy.

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European Pharmaceutical Review

DECEMBER 28, 2023

Finally, Andreas looks at the prospects for antibodies that target the innate immune system in treating both haematological malignancies and solid tumours. As a result, when the patient’s lymphoma relapses after treatment with chemotherapy, BV and CPIs, there are no effective treatment alternatives for these patients.

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pharmaphorum

NOVEMBER 23, 2020

ADC Therapeutics could claim its first product approval in the US next May, after the FDA started a priority review of lead drug Lonca for diffuse large B-cell lymphoma (DLBCL), an aggressive form of non-Hodgkin’s lymphoma. The post FDA sets May date for verdict on ADC’s lymphoma drug Lonca appeared first on.

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pharmaphorum

MAY 24, 2021

While there are plenty of EGFR-targeting drugs on the market for NSCLC, Rybrevant is the first to be FDA-approved for patients with exon 20 mutations, and also represents Janssen’s first lung cancer therapy. It is in trials as both a first-line and second-line therapy after chemotherapy for tis type of cancer.

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pharmaphorum

JANUARY 5, 2021

Roche’s closely-watched combination of two checkpoint inhibitors – TIGIT-targeting tiragolumab and PD-L1 drug Tecentriq – has claimed breakthrough status from the FDA. Roche’s drug is already FDA-approved as a monotherapy and in combination with Avastin (bevacizumab) and chemotherapy for previously-untreated NSCLC with high PD-L1 expression.

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pharmaphorum

JANUARY 26, 2023

The cancer is particularly challenging for immunotherapy, as it tends to have fewer mutations than other cancers, presenting fewer targets for immune cells, and tends to be immunologically ‘cold’, with few immune cells infiltrating the tumour. It remains ongoing with updated results due in the coming months.

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The Checkup by Singlecare

OCTOBER 24, 2024

As an immune checkpoint inhibitor, pembrolizumab prevents cancer cells from blocking the immune system’s ability to kill off cancer cells. The FDA has conditionally approved the use of gilvetmab in dogs with stage 2 or stage 3 melanoma or stage 1, stage 2, or stage 3 mast cell tumors. What is Keytruda used for in dogs?

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pharmaphorum

JANUARY 20, 2021

Sweden’s Sobi has secured EU approval for Doptelet in primary chronic immune thrombocytopenia (ITP), an indication that the company expects to accelerate sales of the drug. ITP affects around 100 people per million worldwide. Sobi’s drug will have to compete with various drugs including Novartis’ Promacta (eltrombopag) – which made $1.2

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Hospital Pharmacy Europe

AUGUST 23, 2023

This follows a similar approval by the FDA in May 2023. Mitazalimab is a human CD40 agonistic antibody targeting CD40 and which kickstarts the cancer-immunity cycle by priming and activating tumour-specific T cells. Targeting CD40 with MM has the potential to augment responses to chemotherapy.

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pharmaphorum

JANUARY 26, 2022

The FDA has placed a partial clinical fold on clinical trials of Gilead Sciences’ magrolimab, the centre piece of its $4.9 Other research suggests it my also play downgrade immune responses by cell-killing T cells as well as dendritic cells, which are involved in antibody responses, making it a compelling target for drug developers.

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Pharmaceutical Technology

AUGUST 16, 2022

months compared with patients treated with standard-of-care chemotherapy. The accelerated US Food and Drug Administration (FDA) approval of Enhertu for HER2-mutant NSCLC was based on the findings of the Phase II DESTINY-Lung02 trial, which demonstrated an impressive 57.7%

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The Checkup by Singlecare

OCTOBER 8, 2024

Ozempic (semaglutide) is a weekly prescription medication that is approved by the Food and Drug Administration (FDA) to help control blood glucose levels in people with Type 2 diabetes. It is also sometimes prescribed off-label (for a non-FDA-approved use) for weight loss.

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Pharmaceutical Technology

JULY 8, 2022

Moreover, a deeper understanding of immune evasion by cancer cells may provide novel sensitization strategies to further enhance the clinical response of BiTEs. . The confirmatory Phase III TOWER trial demonstrated superior overall survival in R/R B-ALL patients with Blincyto versus conventional chemotherapy (7.7 months vs. 4.0

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PharmaShots

MAY 12, 2023

Sanofi Reports P-IIIb Trial (HARMONIE) Results of Nirsevimab for the Prevention of Hospitalizations due to RSV-Related LRTD Date: May 12, 2023 | Tags: Sanofi, Nirsevimab, RSV-Related LRTD, Clinical Trial, P-IIIb, HARMONIE Trial G1 Therapeutics Presents Preliminary Results from P-II Trial of Trilaciclib for Triple-Negative Breast Cancer at ESMO 2023 (..)

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pharmaphorum

OCTOBER 4, 2021

Xencor has previously partnered with MorphoSys and Incyte to test plamotamab in combination with their CD19-targeted antibody Monjuvi (tafasitamab) – plus Bristol-Myers Squibb’s Revlimid (lenalidomide) – as a chemotherapy-free strategy for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), an aggressive type of NHL.

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Pharmaceutical Technology

MAY 31, 2023

In January 2021, the US Food and Drug Administration (FDA) granted SNIPR001 a fast track designation. Several CRISPR-based gene therapies are in development , with one for sickle cell disease and transfusion-dependent beta thalassemia (TDT), being examined by the FDA for an approval.

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European Pharmaceutical Review

DECEMBER 27, 2023

Bridging therapy has been shown to correlate with an inferior response to CAR T-cell therapy due to both progression of the chemotherapy-refractory malignant disease during the manufacturing period and increased toxicity. Car-t “The living drugs”, immune checkpoint inhibitors, and precision medicine: A new era of cancer therapy.

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Pharmaceutical Technology

FEBRUARY 24, 2023

Amivantamab is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

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The Checkup by Singlecare

NOVEMBER 21, 2024

Botanical drugs According to the Michigan State University Center for Research on Ingredient Safety, botanical drugs are regulated by the FDA in the same way as prescription and over-the-counter drugs. This means the FDA reviews botanical medications for safety and efficacy before being approved. Its drug interaction risk is low.

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BuzzRx

JUNE 9, 2020

Some of these products are taken to treat specific symptoms, while others are taken as part of preventive health care practices because they are believed to prevent illness, boost immunity, aid weight loss , or supplement nutrition from dietary intake.

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The Checkup by Singlecare

DECEMBER 13, 2023

Antihistamines work by blocking the effects of histamine , a chemical released by your body’s immune system. Antiemetics may also reduce radiation-associated or chemotherapy-induced nausea resulting from cancer treatment. Kaopectate tablet and liquid suspension Bismuth subsalicylate is FDA-approved for treating nausea and vomiting.

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The Checkup by Singlecare

AUGUST 11, 2023

These medications all tell immune system cells to produce more anti-inflammatory mediators and less inflammatory products. For instance, biologic agents, such as Enbrel and Humira, may have FDA indications for only a few of the uses of methylprednisolone. While it has many uses, Trexall also has its share of adverse effects.

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Roots Analysis

OCTOBER 4, 2023

They are designed to recognize and bind to two specific molecules, such as a tumor cell and an immune cell, or two different parts of the same molecule. During the research, I noticed a significant increase in the number of FDA approvals for bispecific antibodies in recent years.

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PharmaShots

FEBRUARY 13, 2023

In SM, activated mast cells release histamine and other proteins that promote allergic reactions, inflammation, and other immune responses, and people living with the disease. Traditional therapies have included multi-kinase inhibitors, chemotherapy, and symptom-directed treatments.

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