Immunity, Immunization and Labelling

Off-label Use

RX Note

JULY 29, 2023

In fact, off-label drug uses can become widely entrenched in clinical practice and become predominant treatments for a given clinical condition. In a study published in JAMA Internal Medicine , off-label use lacking strong scientific evidence had a higher adverse drug event rate compared with on-label use.

Labelling

Labelling Dosage Immunity Immunization

Cancer vaccines: providing the edge in oncology

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.

Vaccines

Vaccines Immunity Immunization Labelling

New Legislation Would Cut Off Access To The Courts And Immunize FDA Actions From Timely Judicial Review

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

Immunity Immunization Biosimilars Labelling

Analytical platform could advance mRNA medicine QC

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

Immunity Immunization Labelling Vaccines

UCB Entered into a Research Collaboration with Ariceum Therapeutics to Discover New Modalities for Immune-related Diseases and Cancer

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

EMA panel probes heart inflammation with Pfizer/BioNTech COVID vaccine

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

EU gives narrower label to Apellis, Sobi’s PNH drug

pharmaphorum

DECEMBER 15, 2021

Apellis Pharma and partner Sobi have won EU approval for their paroxysmal nocturnal haemoglobinuria (PNH) drug pegcetacoplan in Europe, with a more restricted label than in the US. The post EU gives narrower label to Apellis, Sobi’s PNH drug appeared first on.

Labelling

FDA accepts to review ImmunityBio’s BLA for bladder cancer treatment

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

Labelling Immunity Immunization Vaccines

First patient dosed with HIV gene therapy

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

Daiichi Sankyo poised to add another ADC blockbuster with datopotamab deruxtecan for non-squamous NSCLC: GlobalData

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

Chemotherapy Labelling Immunity Immunization

EHA21: Sanofi builds case for rare disease drug sutimlimab after FDA rejection

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

FDA adds warning of rare neurological side effect to J&J COVID jab

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.

Vaccines

Paving the way for anti-Abeta active immunotherapy

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

Immunity Immunization Vaccines Communication

E.U. Regulator Argues to Continue J&J Vaccine With a Warning Label

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

Labelling Vaccines Immunity Immunization

Ultomiris recommended for approval in EU for neuromyelitis optica spectrum disorder

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

BMS Sotyktu approves for the Treatment of Moderate-to-Severe Plaque Psoriasis

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.”

Adverse Reactions

Adverse Reactions Immunity Immunization Labelling

Current and future players in the lupus market

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

Lilly has a bad hair day as Pfizer rival hits the mark in alopecia

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

Low Dose Naltrexone and Hashimoto’s

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

Compounding

Compounding Immunity Immunization Compounding Pharmacies

AstraZeneca goes bigger in amyloidosis with Neurimmune deal

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.

Labelling

BioNTech, InstaDeep showcase early warning system for COVID variants

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

Vaccines Immunity Immunization Labelling

Opdivo set to take on Keytruda in adjuvant melanoma

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

Janssen files its first CAR-T therapy cilta-cel in Europe

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

Boehringer’s spesolimab data raises hope for serious skin disease

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.

Labelling

EC approves Regeneron’s immunotherapy for cervical cancer

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

Adverse Reactions Chemotherapy Immunity Immunization

Roche’s Actemra cuts chances of COVID-19 ventilator use in phase 3 trial

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.

Labelling

Labelling Immunity Immunization Hospitals

EMA finds possible link between mRNA COVID jabs and myocarditis

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

Phase III trial shows tislelizumab improves outcomes for liver cancer patients

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

FDA clears Kyverna’s IND for scleroderma therapy

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

Moderna’s mRNA vaccine along with Keytruda obtains PRIME designation

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

CHMP backs J&J’s myeloma CAR-T therapy Carvykti

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

MSD and Nectin to collaborate on clinical trial for KEYTRUDA® combination

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

Late-stage ulcerative colitis pipeline continues to innovate

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

Immunity Immunization Documentation Labelling

Regeneron tests COVID-19 antibody therapy in UK’s RECOVERY trial

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

Hospitals Labelling Immunity Immunization

Sun Pharma agrees deal to buy alopecia player Concert

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

US FDA grants approval for AstraZeneca’s combination liver cancer therapy

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

Dosage Labelling Immunity Immunization

Cullinan Oncology signs licence deal with Harbour BioMed

Pharmaceutical Technology

FEBRUARY 14, 2023

Cullinan Oncology has signed an exclusive licence with Harbour BioMed for clinical-stage B7H4 x 4-1BB bispecific immune activator HBM7008’s (CLN-418) development and marketing in the US. HBM7008 has been developed from HBICE, a next-generation heavy chain-only antibody (HCAb)-based multi-specific antibody discovery platform.

Immunity

A Comprehensive Guide to Vitamins

FADIC

OCTOBER 20, 2023

Vitamin A Role of Vitamin A : Vitamin A has many vital functions in your body: It strengthens your immune system. It helps your muscles move and supports your immune system. ‌ Vitamin E Role of Vitamin E : Vitamin E supports your immune system and prevents blood clots. It’s essential for your vision.

Immunity

Immunity Immunization Dosage Patient Counseling

What Are Biopharmaceuticals?

Pharma Packaging Solutions

JUNE 30, 2023

Whole blood, organ and tissue transplants, breast milk, antibodies for passive immunity, fecal microbiota, human reproductive cells, and stem-cell therapy are all examples of this type of biologic. We offer a variety of packaging services, including vial and ampule labeling, pharmaceutical kit assembly, and more.

Packaging

Packaging Immunity Immunization Vaccines

Avenge Bio secures FDA orphan drug designation for mesothelioma therapy

Pharmaceutical Technology

JUNE 16, 2023

The first-in-human, single-arm, open-label, dose-escalation and expansion trial aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumour activity of AVB-001 given intraperitoneally to people living with high-grade serous adenocarcinoma in the ovary, primary peritoneum or fallopian tube.

Immunity

US FDA grants RMAT designation for Kyverna’s KYV-101

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