NY Times

APRIL 20, 2021

The European Union’s drug regulator said that the Johnson and Johnson vaccine should carry a warning of potential risk for rare blood clots on the label, but did not recommend stopping the vaccine, saying the benefits of the vaccine outweighed the risks.

Labelling 53

Labelling Vaccines Immunization Immunity 53

pharmaphorum

JULY 13, 2021

The change to the vaccine’s emergency use authorisation (EUA) label comes after around 100 cases of Guillain-Barré were detected in recipients after 12.8 J&J requested the change to the label, which was confirmed in a letter to its Janssen Biotech subsidiary from the FDA yesterday.

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Vaccines Labelling Immunity Immunization 98

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

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

JANUARY 26, 2022

“Every year in the US, hundreds of people are diagnosed with metastatic uveal melanoma who, until now, had no approved treatment options,” said Immunocore chief executive Bahija Jallal.

Chemotherapy 124

Chemotherapy Labelling Immunity Immunization 124

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

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

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.

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Vaccines Labelling Immunity Immunization 105

Pharmaceutical Business Review

NOVEMBER 27, 2024

The label extension application is supported by positive Phase III data from adolescent trials reported in May this year. In the US and Canada, the application also includes two-year antibody persistence data, demonstrating that 97% of subjects maintained their immune response after 24 months.

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Vaccines Labelling Immunity Immunization 52

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.

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Labelling Immunity Immunization 98

European Pharmaceutical Review

NOVEMBER 11, 2022

The Phase III randomised, open-label, active-controlled superiority trial studied 352 adults in an initial two-week screening period, followed by randomisation of 2:1 to 400mg livtencity TM twice per day (n=235) or conventional antiviral therapies (n=117) for up to eight weeks.

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

pharmaphorum

MAY 30, 2022

One concern for public health experts is that with vaccination against the similar smallpox virus ending more than 40 years ago, there is little immunity in global populations to help curb the spread of infections.

Vaccines 105

Vaccines Labelling Immunity Immunization 105

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

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.

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Immunity Immunization Vaccines Communication 97

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

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.

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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

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

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

Big Molecule Watch

FEBRUARY 17, 2025

IXCHIQ is a single-dose, live-attenuated vaccine indicated for active immunization against the chikungunya virus, and represents the first (and currently only) chikungunya vaccine. However, Valneva has submitted label extensions to the FDA, the European Medicines Agency, and Health Canada seeking extension to adolescents aged 12 to 17 years.

Vaccines 45

Vaccines Immunity Immunization Labelling 45

pharmaphorum

AUGUST 25, 2021

The 15-valent conjugate vaccine was at least as effective as Pfizer’s 13-valent Prevnar 13 in the study, which involved infants up to 15 months old, and will form the basis of regulatory filing to extend the label for Vaxneuvance later this year, according to Merck.

Vaccines 105

Vaccines Labelling Immunity Immunization 105

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).

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Dosage Labelling Immunity Immunization 69