STAT

OCTOBER 24, 2024

Among the basic and life-saving medicines for which shortages continue to be problematic are Rho(D) immune globulin, pain and sedation medications, and ADHD pills. By 2021, nearly 2,000 volunteers had answered the call to test an experimental Alzheimer’s drug known as BAN2401.

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Immunity Immunization Drug Pricing Drug Development 262

pharmaphorum

DECEMBER 4, 2020

The 4 th Antigen Specific Immune Tolerance Digital Summit (ASIT) brings together industry representatives from the fields of autoimmunity, allergy, immuno-oncology and transplantation to tackle the complexities behind autoimmune disorders head on. The post 4th Antigen Specific Immune Tolerance Summit appeared first on.

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Immunity Immunization Medical Schools Drug Development 52

pharmaphorum

FEBRUARY 24, 2021

2021 will be the year when big market access changes – including the far wider use of health economic evaluation – are implemented in Spain. In the latest of a suite of features looking at the biggest markets in Europe, Leela Barham takes stock of what 2021 could bring for market access in Spain. Higher biosimilar savings.

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Biosimilars Immunity Immunization 100

pharmaphorum

MARCH 4, 2021

Instead of large phase 3 trials, the MHRA will require studies showing immune responses for tweaked versions of previously approved vaccines, in line with similar guidance issued by the FDA late last month. The post Budget 2021: Sunak focuses on vaccine development to restart economy appeared first on.

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Vaccines Immunity Immunization 105

pharmaphorum

FEBRUARY 25, 2021

A nasal delivery method will also produce an immune response at the point where the virus enters the body. Altimmune’s AdCOVID is an adenovirus-vector vaccine designed to stimulate a broad immune response including both antibody and T-cell responses in the nasal cavity and respiratory tract, the point of entry for the virus.

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Vaccines Immunity Immunization 111

Express Pharma

NOVEMBER 21, 2024

Zai Lab obtained exclusive rights in January 2021 to develop and commercialise efgartigimod in Greater China* from argenx. Additionally, it is approved in the EU for gMG and in Japan for gMG and primary immune thrombocytopenia (ITP) under brand names Vyvgart and Vyvdura.

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Immunity Immunization 96

Drug Patent Watch

DECEMBER 9, 2024

Additionally, the immunogenicity of biosimilars, which is the ability of the drug to trigger an immune response, can be highly variable and impact the safety and efficacy of the drug. 2021, November 2). link] Lawless, L. 2016, November 11). Overcoming Challenges in the Emerging Biosimilar Landscape. link] Kurki, P., link] Algorics.

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Biosimilars Immunity Immunization 91

pharmaphorum

OCTOBER 17, 2022

When James P Allison and Tasuku Honjo were awarded the Nobel Prize for Medicine in 2018 for their discovery of cancer therapy through inhibition of negative immune regulation, it shone a light on decades of research into recruiting the immune system to fight cancer. That’s what makes them such a tricky detective mystery!

Immunity 115

Immunity Immunization Drug Development 115

pharmaphorum

NOVEMBER 15, 2021

Plus 2 add on workshops: • Elucidating the anti-tumor immunity of other immune checkpoint inhibitors in oncology. Ensure your research team secures its place at the forefront of the immune checkpoint inhibitor space by putting this event on the calendar for 2021. The post TIGIT Therapies 2021 appeared first on.

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Medical Schools Immunity Immunization Hospitals 52

Express Pharma

APRIL 7, 2023

The findings, published in the journal Environmental Health Perspectives , provide further evidence on the adverse effects of air pollution on the immune system. The team analysed data from 927 participants aged 40 to 65 years, who answered questionnaires and gave blood samples in the summer of 2020 and in the spring of 2021.

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Vaccines Immunity Immunization Diabetes 110

Pharmaceutical Technology

NOVEMBER 14, 2022

Such developments, including a 2021 approval of AstraZeneca’s Saphnelo (anifrolumab) , prompted The Lancet Rheumatology to posit that 2022 could be a “banner year” for the condition. In lupus, the body’s immune system starts to attack its own cells. MSCs and CAR-Ts for lupus.

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Immunity Immunization 144

Express Pharma

AUGUST 23, 2023

The study was performed to understand whether the immunity gained after vaccination or a prior infection was less effective or “leaky” in situations where people are exposed to high levels of the virus.

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Vaccines Documentation Immunity Immunization 98

European Pharmaceutical Review

JULY 13, 2023

The field of immunotherapy is constantly evolving with the ultimate goal to develop new treatments that help the body’s immune system fight cancer. Immune cells, such as T cells and natural killer (NK) cells, have the inherent ability to combat diseases, including cancer, but are often inhibited by the body’s own suppressive mechanisms.

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Immunity Immunization Hospitals 98

European Pharmaceutical Review

NOVEMBER 1, 2023

In its decision to recommend the authorisation, the EMA’s human medicines committee (CHMP) assessed laboratory data showing that the adapted vaccine is able to trigger an adequate immune response against XBB.1.5. 5, it was able to trigger a strong immune response against this strain. The most common side effects with Nuvaxovid XBB.1.5

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Vaccines Immunity Immunization 105

BioPharma Dive

OCTOBER 10, 2024

The offering will fund testing of a potential rival to Amgen’s Tezspire and is already the sixth for an immune drug developer this year, the most since 2021.

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Immunity Immunization Drug Development 69

European Pharmaceutical Review

AUGUST 2, 2023

This is an additional ingredient designed to trigger a stronger immune response. The vaccine demonstrated a strong immune response in the trial. In a clinical trial, this vaccine was shown to faciliate a strong immune response against the Omicron BA.1 1 variant, in addition to the original 2020 strain.

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Vaccines Immunity Immunization 98

European Pharmaceutical Review

NOVEMBER 25, 2022

Certain RNA methyltransferases regulate RNA sensing and innate immune activation and represent novel immune-regulatory targets. In addition, STC-15 has shown efficacy in leukaemia models via mechanisms including inhibition of leukaemia stem cell function. .”

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Immunity Immunization 98

pharmaphorum

JUNE 1, 2021

Patients will also receive a dose of tacrolimus, an immune-suppressing drug, to guard against any immune reaction to the transplanted cells. — Novo Nordisk (@novonordisk) June 1, 2021. PRESS : Heartseed and Novo Nordisk enter into global collaboration and licence agreement for stem cell-based therapy for heart failure.

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Immunity Immunization Diabetes 138

pharmaphorum

SEPTEMBER 27, 2022

The principal is much the same as in checkpoint inhibitor treatment: preventing the cancer cells from evading detection by the body’s immune system and highlighting them for destruction by T cells. The ability for cancer cells to create this suppressive tumour microenvironment (TME) allows them to avoid detection by the immune system.

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Vaccines Immunity Immunization 97

Express Pharma

OCTOBER 16, 2024

Ophelia Chan, Business Fundamentals Senior Analyst at GlobalData, comments, “The COVID-19 pandemic highlighted the key advantages of mRNA technology in vaccine development, including rapid production, precise immune targeting, and streamlined manufacturing- factors that drove the success of mRNA-based COVID-19 vaccines.”

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Vaccines Immunity Immunization Diabetes 104

BioPharma Dive

OCTOBER 10, 2024

The offering will fund testing of a potential rival to Amgen’s Tezpire and is already the sixth for an immune drug developer this year, the most since 2021.

Immunity 64

Immunity Immunization Drug Development 64

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. And in December 2021, we saw FDA apply those factors in responding to a citizen petition (Docket No.

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Immunity Immunization Biosimilars Labelling 59

pharmaphorum

DECEMBER 4, 2020

Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter of 2021. VLA15 has demonstrated a promising immune response and safety data in pre-clinical and clinical studies so far.

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Vaccines Immunity Immunization 119

European Pharmaceutical Review

JULY 12, 2022

By binding to both CD19, an antigen expressed on B-cells, and to the CD3 receptor on T-cells, TNB-486 activates and recruits T-cells to CD19-expressing tumours where they can elicit an immune response. “By

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Immunity Immunization Chemotherapy 98

Pharmaceutical Technology

JUNE 12, 2023

Addiction affects an estimated three million US citizens and claimed over 100,000 lives in 2021 alone. CB1 is predominantly found in the central and peripheral nervous system, whereas CB2 is primarily located in immune cells. As drug targets, these receptors have demonstrated therapeutic value against different pain varieties.

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Immunity Immunization Drug Development 143

pharmaphorum

SEPTEMBER 4, 2020

The French pharma in April joined forces with the UK’s GSK to produce the vaccine, with Sanofi contributing an antigen that produces the immune reaction. They are also scaling up manufacturing of the antigen and adjuvant, aiming to produce up to a billion doses in 2021.

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Vaccines Immunity Immunization 106

pharmaphorum

MAY 10, 2021

Happy to announce that @EU_Commission has just approved a contract for guaranteed 900 million doses (+900 million options) with @BioNTech_Group @Pfizer for 2021-2023. — Ursula von der Leyen (@vonderleyen) May 8, 2021. Other contracts and other vaccine technologies will follow.

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Vaccines Labelling Immunity Immunization 122

Pharmaceutical Technology

APRIL 14, 2023

This will suppress the effector characteristics in multiple immune cell subsets. In 2021, Tiziana Life Sciences and FHI Clinical signed an agreement to conduct a Phase II proof-of-concept clinical trial of intranasal foralumab in severe Covid-19 patients hospitalised with pulmonary inflammation in Brazil.

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Immunity Immunization 98

pharmaphorum

OCTOBER 12, 2020

SMi Group is delighted to announce the return of the successful 3D Cell Culture Conference for its 5th consecutive year, taking place on 10th and 11th February 2021 as a virtual conference with online access only. Focus Day: 9 February 2021. Conference: 10th – 11th February 2021. Workshop B – 13.30 – 17.30

Immunity 52

Immunity Immunization Drug Development 52

European Pharmaceutical Review

FEBRUARY 6, 2023

David Hallett, PhD, Chief Scientific Officer at Exscientia explained: “PKC theta is an attractive immune modulating drug target; however, it has been challenging for the field to design a small molecule with the required potency as well as selectivity against other closely related kinases.”

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Compounding Immunity Immunization 98

European Pharmaceutical Review

NOVEMBER 18, 2022

The document showed that in 2021, approximately 16 billion vaccine doses, worth $141 billion, were supplied across 47 vaccines and 94 manufacturers. Achieving Immunization Agenda 2030 goals. WHO is calling for much-needed changes to the global vaccine market to save lives, prevent disease and prepare for future crises.”

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Vaccines Immunity Immunization Documentation 98

pharmaphorum

JANUARY 26, 2022

At the moment the only other BiTE to reach the US market is Amgen’s CD19-targeting Blincyto (blinatumomab), which has been approved for various types of leukaemia and made $340 million in sales in the first nine months of 2021.

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Chemotherapy Labelling Immunity Immunization 124

European Pharmaceutical Review

MAY 4, 2023

Overall, the mechanisms of action for amivantamab include ligand blocking, receptor degradation, and immune cell-mediated activity. 4 BsMAb amivantamab was designed to enhance adherence of tumour cells to macrophages and natural killer cells, to improve immune-cell mediated killing of cancer cells. Cancer Ther. 2020; 19(10): 2044–56.

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Immunity Immunization Chemotherapy 98

pharmaphorum

JANUARY 26, 2021

However, the company did caution that its predictions for 2021 were based on an understanding that prescription drugs sales in hospitals would start to return to normal in the second half of the year. That’s enabling us to manage the clinical trial impact.”. Some products have been affected, however.

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Hospitals Immunity Immunization 111

pharmaphorum

APRIL 26, 2022

PubMed cites 1,822 pieces of research relating to the microbiome in 2011, which grew to 25,153 published in 2021. As more research has been conducted, closer and unexpected links have been found between the microbiome of the gut, as one example, and other areas of the body, such as brain health and the immune system.

Immunity 115

Immunity Immunization Diabetes Drug Development 115

pharmaphorum

NOVEMBER 25, 2021

— Tom Peacock (@PeacockFlu) November 23, 2021. “There is no evidence it [was] more transmissible, virulent or better at evading immune recognition than other SARS-CoV-2 lineages,” commented Balloux. He also said that while case numbers are still very low, B.1.1.529 before becoming extinct.

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Vaccines Immunity Immunization 116

European Pharmaceutical Review

AUGUST 16, 2022

receptors on macrophages, helping the body’s immune cells to detect and fight tumours. In January 2021, BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialise BeiGene’s tislelizumab in North America, Europe, and Japan. The BLA is still under review.

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Labelling Immunity Immunization 98