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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FDA Chemotherapy Immunization 52

pharmaphorum

JANUARY 26, 2022

Immunocore has secured a piece of biotech industry history, becoming the first company to get an FDA approval for a cancer therapeutic based on T cell receptor (TCR) technology. The post Immunocore claims first-ever FDA approval for TCR cancer therapy appeared first on.

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FDA Chemotherapy Labelling Immunization 107

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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FDA Chemotherapy Immunization 52

pharmaphorum

DECEMBER 30, 2021

Johnson & Johnson’s much-touted crop of bispecific antibodies for cancer generated its first commercial product in May, and the drugmaker has now filed for FDA approval of a second candidate. “We look forward to working with the FDA in their review of our teclistamab submission.”

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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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FDA Chemotherapy Immunization 52

pharmaphorum

AUGUST 22, 2021

Bristol-Myers Squibb has scored a win in its drive to get Opdivo into earlier lines of cancer therapy, getting FDA approval for the drug for post-surgical treatment of invasive bladder cancer. ” The post BMS gets FDA nod for Opdivo as first adjuvant bladder cancer therapy appeared first on.

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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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Chemotherapy FDA Labelling Immunization 52

European Pharmaceutical Review

SEPTEMBER 25, 2023

The humanised IgG4 anti-PD-1 antibody is indicated for unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy. The treatment is currently under review by the US FDA and the European Medicines Agency (EMA) for advanced or metastatic ESCC after prior chemotherapy.

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Chemotherapy FDA Immunization 87

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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Chemotherapy Immunization Hospitals FDA 98

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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Chemotherapy FDA Immunization 52

pharmaphorum

SEPTEMBER 25, 2020

Leap Therapeutics will get a swift FDA review for its lead drug DKN-01 for a form of gastric and gastroesophageal junction (G/GEJ) cancer after being awarded fast-track status by the regulator. In animal models, neutralising DKK1 has been shown to activate an innate immune response against malignant cells.

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FDA Immunization Chemotherapy Hospitals 54

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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Immunization Chemotherapy Medical Schools FDA 84

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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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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Chemotherapy FDA Immunization Hospitals 52

pharmaphorum

OCTOBER 22, 2021

The European Commission has given a green light to Opdivo (nivolumab) with chemotherapy for previously-untreated patients with HER2-negative oesophageal, gastric and gastroesophageal junction (GEJ) cancer whose tumours express the PDL-1 biomarker with a score of five or more. months compared to 11.4 months, respectively.

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Chemotherapy Immunization FDA 91

pharmaphorum

DECEMBER 18, 2020

MacroGenics’ HER2-targeted breast cancer drug Margenza has been approved by the FDA, challenging several recently approved drugs with a narrow efficacy edge over Roche’s Herceptin in data gathered so far in advanced disease. The median progression-free survival (PFS) of patients treated with Margenza and chemotherapy was 5.8

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Chemotherapy FDA Immunization 52

pharmaphorum

SEPTEMBER 6, 2022

The Nijmegen, Netherlands-based biotech was founded in 2018 to develop therapies designed to change the balance of protein expression within the tumour ‘microenvironment’, which can defend cancers against the immune system, and is increasingly becoming a source of new targets in oncology. The Series A round includes €3.6

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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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Chemotherapy Immunization FDA 58

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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FDA Chemotherapy Immunization 52

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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FDA Adverse Reactions Chemotherapy Immunization 40

pharmaphorum

OCTOBER 14, 2021

The FDA has approved Merck’s Keytruda as a first-line therapy for advanced cervical cancer. Keytruda (pembrolizumab) can be used in combination with chemotherapy, with or without bevacizumab, to treat patients with persistent, recurrent or metastatic cervical cancer where the tumour expresses a certain level of PD-L1.

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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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Vaccines Immunization Pharmacy Program Director Chemotherapy 105

pharmaphorum

JULY 1, 2022

Just weeks after Bristol-Myers Squibb claimed an FDA green light for Opdivo as a neoadjuvant therapy for non-small cell lung cancer, AstraZeneca is looking to encroach on its territory. The post AZ takes aim at BMS’ lead in neoadjuvant NSCLC appeared first on.

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Chemotherapy FDA Immunization 52

STAT

MARCH 6, 2023

Still, when doctors told her last year that the cancer was growing despite two operations, radiation therapy, and a fifth regimen of chemotherapy, the retired business-meeting facilitator decided to do something unorthodox: spend $83,000 out of pocket on an unproven experimental cancer vaccine.

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European Pharmaceutical Review

JUNE 27, 2023

Of note, the US Food and Drug Administration (FDA) and ANSM (French regulatory authorities) have established themselves as early leaders to develop guidelines. Since these fresh FDA approvals for microbiome-based therapies, regulatory pathways are becoming clearer and opening new perspectives for companies.

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Chemotherapy Immunization FDA Vaccines 97

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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Chemotherapy Immunization FDA Labelling 52

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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Chemotherapy Immunization FDA 52

pharmaphorum

NOVEMBER 20, 2020

months for patients in the control group, who received standard second-line chemotherapy. The green light made it the first and only targeted, chemo-free regimen licensed in Europe specifically for patients with BRAF V600E-positive mCRC, and came shortly after the combination was approved by the FDA for the same indication.

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Chemotherapy Immunization FDA 52

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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FDA Chemotherapy Immunization Hospitals 40

European Pharmaceutical Review

FEBRUARY 15, 2023

Only one late-onset immune-related adverse event (AE) occurred, 16 months post-treatment. Neoadjuvant nivolumab in combination with chemotherapy was approved by the US Food and Drug Administration (FDA) in March 2022 for lung cancer. Neoadjuvant nivolumab did not lead to surgical delays.

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Chemotherapy Immunization FDA 85

pharmaphorum

DECEMBER 10, 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 combination earned a breakthrough designation from the FDA earlier this year.

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Chemotherapy FDA Immunization 71

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

OCTOBER 4, 2020

However it requires high-dose chemotherapy to destroy the bone marrow, and that poses significant risks to patients in its own right, and can also lead to graft-versus-host disease, a potentially life-threatening complication in which the bone marrow donor’s immune cells attack the recipient’s cells and tissues.

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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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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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Chemotherapy Immunization FDA 59

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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Chemotherapy Immunization Hospitals FDA 40

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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