Immunity and Labelling - Pharmacist Digest

FDA declines Eli Lilly’s bowel disease drug over manufacturing issues

Pharmafile

APRIL 14, 2023

However, concerns weren’t expressed over the clinical data package, safety or label for the medicine. Mirikizumab was hoped to become a new drug treatment for ulcerative colitis (UC), a condition where abnormal reactions in the immune system cause inflammation in the inner lining of the colon. read more

Packaging

Packaging Labelling Immunity Immunization

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

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

Merck acquires Prometheus Biosciences

Express Pharma

APRIL 17, 2023

Prometheus is a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialisation of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases.

Immunity

Immunity Immunization Research Laboratories 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

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

Chugai Pharmaceutical submits NDA for crovalimab to Japan’s MHLW

Pharmaceutical Technology

JUNE 15, 2023

Chugai Pharmaceutical has submitted a new drug application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for crovalimab to treat paroxysmal nocturnal haemoglobinuria (PNH), a rare blood disorder in which parts of the immune system attack and damage red blood cells and platelets.

Labelling

EU probes low platelet safety issue with COVID-19 shots

pharmaphorum

MARCH 12, 2021

The experts have also recommended a safety update on the label of Oxford University/AstraZeneca’s COVID-19 vaccine, which has been linked to anaphylactic reactions, in what has turned out to be a concerning week for vaccine safety.

Vaccines

Myasthenia Gravis

RX Note

MARCH 3, 2024

In most cases, the immune system targets the acetylcholine (ACh) receptor (less commonly the muscle-specific tyrosine kinase MuSK). Introduction Myasthenia gravis is an autoimmune disease that attacks the connections between nerves and muscles, resulting in weakness in skeletal muscles (e.g.

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

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

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

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

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

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

EC approves AstraZeneca’s Ultomiris to treat NMOSD

Pharmaceutical Technology

MAY 11, 2023

It inhibits the C5 protein in the terminal complement cascade, part of the body’s immune system. The regulatory approval was based on the data obtained from the multicentre, open-label CHAMPION-NMOSD Phase III trial, which assessed the efficacy and safety of Ultomiris in NMOSD adult patients.

Labelling

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

Immunocore gets EU nod for TCR cancer therapy Kimmtrak

pharmaphorum

APRIL 5, 2022

Kimmtrak (tebentafusp) has been cleared to for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM), mirroring its label in the US. GlobalData analyst Dr Sakis Palioras said in a recent research not that Kimmtrak’s 5.7 ” Image by Pexels from Pixabay .

Labelling

Labelling Chemotherapy Immunity Immunization

US FDA approves Takeda’s HyQvia to treat PI in children

Pharmaceutical Technology

APRIL 12, 2023

The US Food and Drug Administration (FDA) has approved Takeda ’s supplemental Biologics Licence Application (sBLA) to expand the use of its HyQvia subcutaneous immune globulin (ScIG) for the treatment of primary immunodeficiency (PI) in children aged between two and 16 years.

Labelling

Developing a new treatment paradigm for chronic kidney disease

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

Diabetes Labelling Immunity Immunization

Developing a new treatment paradigm for IgAN

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

Diabetes Labelling Immunity Immunization

ImaginAb licenses CD8 ImmunoPET tracer to Leucid Bio

Pharmaceutical Technology

APRIL 13, 2023

CD8 ImmunoPET (89Zr crefmirlimab berdoxam) is an 89Zr-labeled mini body, designed to bind to CD8 receptors on human T cells for non-invasive, quantitative PET imaging. “This agreement with Leucid Bio is an opportunity for ImaginAb to continue expanding our partnerships, and showcases the increasing adoption of our CD8 ImmunoPET technology.”

Labelling

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

China’s NMPA approves AstraZeneca’s Soliris to treat gMG

Pharmaceutical Technology

JUNE 14, 2023

It inhibits the C5 protein in the terminal complement cascade, part of the body’s immune system. The therapy’s tolerability and safety profile were found to be consistent throughout the primary treatment period, as well as the open-label extension.

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

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

First oral treatment approved for post-transplant refractory cytomegalovirus

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

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 Compounding

Getting Quality Supplements

The Thyroid Pharmacist

NOVEMBER 29, 2023

This is because I had learned about various adulterants found in supplements, how some supplement manufacturers don’t actually put the products that are on the label in the bottle, or that the dosages listed on the label may be completely different from what’s in the products. We have 290 expiring in April 2025.)

Health and Personal Care Stores

Health and Personal Care Stores Immunity Immunization Labelling

US FDA accepts Regeneron’s pozelimab BLA for priority review

Pharmaceutical Technology

FEBRUARY 21, 2023

Currently, there are no approved treatments for CHAPLE, a life-threatening hereditary immune disease caused by an overactivation of the complement system. The investigational, fully human monoclonal antibody, Pozelimab has been designed to block the complement factor C5 activity. The regulatory body is expected to decide on 20 August.

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

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 awards full approval to Paxlovid amidst hazy coverage plans

Pharmaceutical Technology

MAY 26, 2023

The label is specified for the treatment of “mild-to-moderate Covid-19 in adults who are at high risk for progression to severe COVID-19, including hospitalisation or death.” This decision makes Paxlovid the first oral antiviral pill, and the fourth drug approved overall, to treat Covid-19 in adults.

Labelling

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

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

BMS scores first approval for psoriasis therapy Sotyktu

pharmaphorum

SEPTEMBER 11, 2022

Analysts at Mizuho have suggested that competition from BMS’ drug could trim Otezla’s 2025 sales from $3 billion to $2 billion, although Amgen is attempting to defend its product by expanded the label of the drug to include mild psoriasis.

Labelling

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

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

Immunocore claims first-ever FDA approval for TCR cancer therapy

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

Chemotherapy Labelling Immunity Immunization

Health Canada to review Arcutis’ roflumilast cream NDS for plaque psoriasis

Pharmaceutical Technology

JULY 12, 2022

A validated target in dermatology, PDE4 is an enzyme that induces overactive immune responses. The NDS submission by Arcutis is based on positive findings from the company’s pivotal Phase III programme and two long-term open-label clinical trials. Health Canada has provided a target action date of 30 April next year.

Labelling

As cases rise, WHO says monkeypox risk is “moderate”

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

ASH: Argenx cues up a second use for efgartigimod

pharmaphorum

DECEMBER 12, 2022

Dutch biotech Argenx is on course to add another rare disease indication to the label of its FcRn blocker Vyvgart – primary immune thrombocytopenia (ITP) – thanks to new data reported at the ASH annual meeting.

Immunity