pharmaphorum

MAY 10, 2021

An update on the Janssen jab at the PRAC’s latest meeting concluded that the benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects, but its labelling will be updated to recommended increased vigilance in people with thrombocytopenia and a recent history of blood clots.

Vaccines 122

Vaccines Labelling Immunity Immunization 122

European Pharmaceutical Review

FEBRUARY 13, 2023

This is like antigens which can trigger an immune response and act as a vaccine. Firstly, using liquid chromatography and mass spectrometry, they carry out a systematic comparison of different fragments of a mRNA molecule to be tested with a similarly fragmented reference mRNA labelled with a stable carbon isotope.

Immunity 105

Immunity Immunization Labelling Vaccines 105

Pharmaceutical Technology

JANUARY 23, 2023

The management of SLE and LN consists largely of treatment options that are based on highly efficacious steroids or immune-suppressive therapy with an undesirable safety profile, which includes accrued organ damage, infections and cancer. in 2018 across the 7MM despite being an off-label therapy for lupus.

Labelling 111

Labelling Immunity Immunization 111

pharmaphorum

FEBRUARY 9, 2022

Using a vaccine to utilise the patient’s own immune system to fight cancer is particularly attractive because of the targeted approach made possible by this technology. While therapeutic cancer vaccines are able to help the body identify particular proteins expressed by cancer cells and then to instigate an immune response.

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Vaccines Immunity Immunization Labelling 134

Pharmaceutical Technology

JULY 29, 2022

The open-label, three-cohort, multicentre trial analysed intravesical BCG, N-803 combination in BCG-unresponsive high-grade NMIBC patients. This is a compelling example of the power of inducing trained innate immune memory to potentially provide long-term, durable effects against serious, life-threatening diseases.”.

Labelling 105

Labelling Immunity Immunization Vaccines 105

European Pharmaceutical Review

SEPTEMBER 22, 2022

The removal of HIV DNA from the cellular genome is essential to effecting a cure; the virus takes up long-term residence in tissue reservoirs, where it hides, evading the immune system and escaping antiretroviral therapy. As a result, HIV can persist in tissue reservoirs for years.

Labelling 145

Labelling Immunity Immunization 145

Express Pharma

FEBRUARY 21, 2024

There are multiple Phase III studies for the ADC in frontline NSCLC in combination with immune checkpoint inhibitors such as Merck’s Keytruda (pembrolizumab) or AstraZeneca’s Imfinzi (durvalumab). There’s a parallel BLA for DS-1062 in HR+ and HER2-breast cancer that is pending approval.

Chemotherapy 111

Chemotherapy Labelling Immunity Immunization 111

pharmaphorum

AUGUST 4, 2021

At the moment, the condition can only be managed using powerful corticosteroid drugs, which suppress the immune system but can have serious side effects if used long-term. Olumiant has also been in the spotlight for safety, and has warnings on its label for infections, malignancies and blood clots.

Labelling 107

Labelling Immunity Immunization 107

PharmaShots

MAY 11, 2023

Ariceum's expertise in radiochemistry & labeling technology will be useful to UCB in enhancing its capacity & discovery of highly distinctive products for immune-related diseases Ariceum will use a special library to screen against oncology targets of interest.

Immunity 40

Immunity Immunization Labelling 40

pharmaphorum

JUNE 11, 2021

takeover of Bioverativ in 2018, is designed to block the complement pathway of the immune response, which becomes activated in CAD. At the moment CAD is managed using off-label therapies, including rituximab and corticosteroid drugs. Sutimlimab, which Sanofi acquired via its $11.6

Immunity 96

Immunity Immunization Labelling 96

FDA Law Blog: Biosimilars

APRIL 30, 2023

Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. Importantly, because FDA has sovereign immunity from damages claims, sponsors trapped in S. That bill is S.

Immunity 59

Immunity Immunization Biosimilars Labelling 59

pharmaphorum

JULY 9, 2021

According to the EMA’s pharmacovigilance risk assessment committee (PRAC), labelling for Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax should be updated to reflect “very rare cases” of myocarditis and pericarditis with the shots. . ‘No evidence’ Zynteglo causes blood cancer.

Vaccines 105

Vaccines Labelling Immunity Immunization 105

pharmaphorum

JANUARY 7, 2022

NI006 is an antibody that binds to the misfolded forms of the transthyretin protein that form the fibrils, and cause them to be cleared away by immune cells like macrophages. Ionis’ drug has however been held back by a limited label and some safety concerns and Ionis recently sold North American rights to the drug to Sobi.

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Labelling Immunity Immunization 116

LifeProNow

APRIL 3, 2023

Notes NMOSD NMOSD is a rare disease in which the immune system is inappropriately activated to target healthy tissues and cells in the CNS. CHAMPION-NMOSD CHAMPION-NMOSD is a global Phase III , open-label, multicentre trial evaluating the safety and efficacy of Ultomiris in adults with NMOSD.

Immunity 130

Immunity Immunization Labelling 130

LifeProNow

MARCH 28, 2023

Psoriasis is a widely prevalent, chronic, systemic immune-mediated disease that impacts approximately 14 million people in Europe. The results are particularly meaningful for dermatologists and patients who have been waiting for a more effective and convenient oral therapy to help manage this serious, chronic, immune-mediated disease.”

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Adverse Reactions Immunity Immunization Labelling 130

pharmaphorum

SEPTEMBER 16, 2022

. “Treating with Opdivo in earlier stages of cancer, when the immune system may be more responsive, has the potential to help prevent recurrence – a critical goal of improving patient outcomes,” she said in a statement.

Labelling 98

Labelling Immunity Immunization 98

pharmaphorum

DECEMBER 24, 2021

Biologic drugs used to treat plaque psoriasis are used off-label in GPP, but there’s little data on their effectiveness. In some cases the consequences are fatal, and at the moment there are no approved therapies in the US or Europe for GPP flares.

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Labelling Immunity Immunization 103

pharmaphorum

SEPTEMBER 18, 2020

But the findings of the latest phase 3 study, EMPACTA, could change that after Roche said it plans to share results with the FDA and other regulators to get its label expanded on the basis of the latest results. The study did not identify any new safety signals for Actemra/RoActemra.

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Labelling Immunity Immunization Hospitals 97

European Pharmaceutical Review

AUGUST 16, 2022

The RATIONALE 301 Phase III randomised, open-label study included more than 600 patients in the US, Europe and Asia. receptors on macrophages, helping the body’s immune cells to detect and fight tumours. The primary endpoint of non-inferiority of overall survival (OS) between the two groups of patients was met, BeiGene said.

Labelling 98

Labelling Immunity Immunization 98

Pharmaceutical Technology

APRIL 6, 2023

The PRIME scheme designation was granted by the EMA based on positive results obtained from the ongoing Phase IIb randomised, open-label KEYNOTE-942/mRNA-4157-P201 trial that enrolled 157 patients with stage III/IV melanoma. The Keytruda immunotherapy increases the body’s immune system ability to help identify and destroy tumour cells.

Vaccines 98

Vaccines Labelling Immunity Immunization 98

pharmaphorum

MARCH 27, 2022

Carvykti – developed by J&J with China’s Legend Biotech – was approved on the back of a single arm, open-label, clinical trial in 113 patients – CARTITUDE-1 – which showed an overall response rate of 84%, with signs of the cancer disappearing altogether in 69% of recipients.

Labelling 98

Labelling Immunity Immunization 98

European Pharmaceutical Review

SEPTEMBER 22, 2023

The vaccination of patients with AN1792 led to the activation of their immune systems, which started producing endogenous anti-Abeta antibodies. Therefore, active immunotherapy to trigger the immune system to produce sustained levels of endogenous antibodies has now become far more attractive.

Immunity 97

Immunity Immunization Vaccines Communication 97

pharmaphorum

JANUARY 13, 2022

The algorithm looks at the structure of the SARS-CoV-2 spike protein used to gain entry to host cells, looking for changes that could enable the virus to evade immunity, as well as other features that could affect the ‘fitness’ of the virus – its ability to reproduce and transmit between people.

Vaccines 97

Vaccines Immunity Immunization Labelling 97

pharmaphorum

APRIL 30, 2021

BMS and bluebird had been hoping for a label allowing third-line use. “Despite advances in the treatment of multiple myeloma, there remains a high unmet need, especially for patients whose disease continues to progress,” said Peter Lebowitz, head of oncology R&D at Janssen.

Immunity 82

Immunity Immunization Labelling 82

pharmaphorum

SEPTEMBER 16, 2020

The phase 3 open-label trial will test the cocktail in patients hospitalised with COVID-19 and will compare the effects of adding the antibody cocktail REGN-COV2 to the usual standard-of-care versus standard-of-care on its own.

Hospitals 98

Hospitals Labelling Immunity Immunization 98

pharmaphorum

JANUARY 19, 2023

Alopecia areata is an autoimmune disease in which the immune system attacks the body’s hair follicles, causing hair to fall out, predominantly on the scalp, but also sometimes affecting other areas of the body like eyebrows, eyelashes, and facial hair. . The $11.50

Labelling 98

Labelling Immunity Immunization 98

Pharmaceutical Business Review

OCTOBER 12, 2023

The multicentre, open-label study will evaluate the autologous fully human anti-cd19 chimeric antigen receptor (CAR) T cell therapy KYV-101 in adult scleroderma patients. Kyverna Therapeutics CEO Peter Maag said: “We are keen to initiate our KYSA-5 trial in this new patient population and generate data to support our KYV-101 design goals.

Immunity 52

Immunity Immunization Labelling 52

Pharmaceutical Technology

NOVEMBER 23, 2022

Based on the open-label, multicentre, international Phase III EMPOWER-Cervical 1 clinical trial findings, the regulatory agency granted approval in advanced cervical cancer. Additionally, 21% of subjects who received Libtayo had immune-mediated adverse reactions. No new safety signals linked to Libtayo were reported in the trial.

Adverse Reactions 52

Adverse Reactions Chemotherapy Immunity Immunization 52

Pharmaceutical Technology

OCTOBER 25, 2022

Based on positive data from the open-label, international, randomised, multicentre Phase III HIMALAYA clinical trial, the regulatory agency granted the approval. The dosage and schedule of the combination treatment is named the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab).

Dosage 69

Dosage Labelling Immunity Immunization 69

The Thyroid Pharmacist

JUNE 30, 2023

However, low doses of this medication (hence, low dose naltrexone or LDN), have been found to modulate the immune system and have shown promise in improving cases of autoimmune disease. These include Crohn’s, MS, and Hashimoto’s, as well as other immune system-related conditions such as cancer and HIV/AIDS. Doses of 1.5-4.5

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Compounding Immunity Immunization Compounding Pharmacies 98

Pharmaceutical Technology

JULY 28, 2022

While the exact cause of UC remains unknown, it is often associated with immune system malfunction. One potential benefit of cobitolimod’s unique route of administration is that local administration via rectal enema has the potential to limit systemic absorption and the immune-related side effects that plague some marketed agents.

Immunity 98

Immunity Immunization Documentation Labelling 98

Pharmaceutical Business Review

JULY 16, 2024

Kyverna CEO Peter Maag said: “We are eager to begin generating data from our sponsored trial to advance the knowledge on a potential immunological reset of the patient’s immune system. “We KYV-101 is advancing through clinical development with trials in two main areas of autoimmune disease: rheumatology and neurology.

Labelling 59

Labelling Immunity Immunization 59

LifeProNow

APRIL 19, 2023

This process may include undergoing therapies such as radiation or chemotherapy, both of which may weaken an individual’s immune system. Generally, before receiving this kind of transplant, the patient will undergo a course of treatments to remove their own stem cells and prepare the body for the new stem cells.

Adverse Reactions 130

Adverse Reactions Chemotherapy Labelling Immunity 130

European Pharmaceutical Review

MARCH 14, 2024

This leads to the formation of immune complexes that deposit in the glomerulus and result in haematuria, proteinuria, and decline in kidney function. Furthermore, participants who switched from placebo to atacicept in the open-label extension had similar results at 72 weeks as those initially randomised to atacicept in the first 36 weeks.

Diabetes 98

Diabetes Labelling Immunity Immunization 98

European Pharmaceutical Review

MARCH 14, 2024

This leads to the formation of immune complexes that deposit in the glomerulus and result in haematuria, proteinuria, and decline in kidney function. Furthermore, participants who switched from placebo to atacicept in the open-label extension had similar results at 72 weeks as those initially randomised to atacicept in the first 36 weeks.

Diabetes 98

Diabetes Labelling Immunity Immunization 98

pharmaphorum

JUNE 7, 2021

Kymriah (tisagenlecleucel) was approved for relapsed/refractory ALL in 2017, but its label covers use in children and young adults aged up to 25, who account for the bulk of cases of the blood cancer. Around a quarter of patients treated with Tecartus had a severe immune reaction, and there were two deaths in the trial.

Labelling 105

Labelling Immunity Immunization 105

European Pharmaceutical Review

FEBRUARY 7, 2023

PVR blockade by NTX1088 is the first and only therapeutic approach aiming at restoring the antitumor immune activity of DNAM1 (CD226). The Phase I , open label clinical trial was initiated in November 2022. KEYTRUDA is MSD’s anti-PD1 therapy, in patients with locally advanced and metastatic solid tumours.

Immunity 52

Immunity Immunization Labelling 52