European Pharmaceutical Review

JUNE 16, 2023

The first and only CD20xCD3 T-cell engaging bispecific antibody ( BsAb ) for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) that is given for a defined period of time has been approved by the US Food and Drug Administration (FDA). How does Genentech’s bispecific antibody for DLBCL work? What did the trial data show?

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STAT

NOVEMBER 29, 2023

But experts quickly cautioned that risk of this complication is probably minuscule compared to the known risk of secondary cancers from other cancer therapies like chemotherapy and radiation. I think this is why we’re all surprised.   Continue to STAT+ to read the full story…

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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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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 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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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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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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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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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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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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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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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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pharmaphorum

SEPTEMBER 13, 2022

Crucially, he observed a connection between certain tumours and inflammation, noting that neoplastic tissues were often covered with leukocytes of the immune system. 1942 – Chemotherapy moves from trenches to treatment . 1942 – Chemotherapy moves from trenches to treatment . 1907 – The magic bullet of immunotherapy.

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European Pharmaceutical Review

APRIL 10, 2024

The recent FDA approvals of two microbiome products in the US, in November 2022 and April 2023, 1-2 represent a significant milestone, maturing the industry and paving the way for advancement and regulatory clearance of additional microbiome products in broader indications. Notably, from one donor to another, significant variations exist.

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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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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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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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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

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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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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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

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

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

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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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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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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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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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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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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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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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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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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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

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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European Pharmaceutical Review

MAY 23, 2024

Last month, CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) was the first BCMA-targeted CAR-T cell therapy to be approved for second-line treatment of multiple myeloma by the US Food and Drug Administration (FDA). CAR T Cells: Engineering Immune Cells to Treat Cancer [Internet]. 2 Why does CARVYKTI have potential in multiple myeloma?

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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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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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