European Pharmaceutical Review

SEPTEMBER 7, 2023

Current limitations of CAR-T therapies could potentially be overcome through new advances in the production of T-cell progenitors, suggests Dr Olivier Negre, Chief Scientific Officer of Smart Immune. The post Bioprocessing & Bioproduction In-Depth Focus 2023 appeared first on European Pharmaceutical Review.

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Immunization 98

STAT

APRIL 10, 2024

These include oxytocin, which is used during childbirth; Rho(D) immune globulin, which helps some women during pregnancy; standard-of-care chemotherapy, pain and sedation medicines; and ADHD pills. Unresolved shortages have, in fact, been hovering above 300 for more than a year as numerous basic and life-saving medicines are in short supply.

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Chemotherapy Immunization 142

Pharmacy Times

OCTOBER 28, 2022

Modifications related to final product verifications, immunizations, and remote work loom on the horizon for 2023.

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Immunization 132

The Checkup by Singlecare

NOVEMBER 26, 2024

Vitamin D Vitamin D coupons Most people think of vitamin D as the sunshine vitamin without realizing how big of an impact it has on our immune system. Low levels of vitamin D have been linked to poor immune function and fatigue, which can inhibit your recovery from COVID, says Simpson. Who should avoid vitamins for post-COVID fatigue?

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pharmaphorum

MAY 27, 2021

If all goes well, CTP-543 could be ready for filing in early 2023, but even so it looks set to reach the AA market well behind Eli Lilly, which reported positive phase 3 results with its JAK 1/2 inhibitor Olumiant (baricitinib) earlier this year. In severe cases it can lead to loss of all head and body hair.

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FDA Immunization 105

The Thyroid Pharmacist

DECEMBER 16, 2022

I am excited to share that I finished my fourth book (also known as my first book as a mommy) in April of 2022, and it will be released in April 2023! We are hoping to feel more settled in 2023. This is a great option for those looking to support immune health, hormone balance, and metabolic health.

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STAT

JUNE 26, 2024

In a related move, the Advisory Committee on Immunization Practices opted not to make a recommendation yet on use of GSK’s Arexvy vaccine in adults 50 to 59, saying the committee didn’t have enough data with which to make such a recommendation. Read the rest…

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Vaccines Insurance Coverage Insurance Immunization 134

STAT

OCTOBER 2, 2023

and Europe are ramping up their campaigns urging eligible people to get another vaccine round against Covid and flu, promoting the immunizations as people’s best way to protect themselves and reduce pressure on health systems during what is expected to be another tough winter. LONDON — Health officials in the U.K.

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Vaccines Immunization 129

PharmaShots

MARCH 24, 2023

PTC Therapeutics’ Upstaza (eladocagene exuparvovec) Receives NICE Recommendation for the Treatment of AADC Deficiency Date: Mar 24, 2023 | Tags: PTC Therapeutics, Upstaza, eladocagene exuparvovec, AADC Deficiency, Regulatory, NICE Onconova Therapeutics Entered into a Research Collaboration with Pangea Biomed to Identify Biomarkers for Cancer (..)

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European Pharmaceutical Review

JUNE 27, 2023

AC Immune SA has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy vaccine candidate for Alzheimer’s disease. The anti-Abeta therapy “specifically targets the most toxic forms of Abeta” according to Dr Andrea Pfeifer, CEO of AC Immune SA.

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Vaccines Immunization FDA 105

pharmaphorum

JANUARY 27, 2023

Affimed is using bispecific antibodies to activate the innate immune system of cancer patients to create longer-lasting and more effective results. Hoess describes the company’s clinical programmes, including an ADC for Hodgkin’s lymphoma and a novel cell therapy approach. The post JP Morgan 2023 – Adi Hoess appeared first on.

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Immunization 59

The Checkup by Singlecare

SEPTEMBER 22, 2023

But young children, older adults, and individuals with weakened immune systems are at high risk of severe, potentially life-threatening RSV illness. Infants have a high risk because their airways may be small enough to close up when inflamed and their immune systems aren’t yet fully developed.

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Vaccines Immunization Insurance FDA 105

Pharmacy Times

JANUARY 5, 2024

Adalimumab-aqvh (Yusimry; Coherus Biosciences) entered the market in July 2023, following approval by the FDA in December 2021.

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Immunization FDA 65

The Checkup by Singlecare

DECEMBER 13, 2023

While there’s no sore throat “diet” per se, eating to support your immunity is essential—before, during, and after an illness. A well-balanced diet rich in fruits and vegetables helps keep your immune system strong, which can help prevent you from catching a cold or flu. What food is good for a sore throat?

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European Pharmaceutical Review

MARCH 26, 2024

Moderna’s next-generation COVID-19 vaccine mRNA-1283 demonstrated a higher immune response against SARS-CoV-2, interim results from the company’s Phase III trial show. Further details In October 2023, Moderna shared that the regulatory approval for the combination mRNA-1083 vaccine for adults 50 years and older was targeted for next year.

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Vaccines Immunization 110

PharmaShots

APRIL 7, 2023

TG Therapeutics Receives EMA’s CHMP Positive Opinion of Briumvi (ublituximab-xiiy) for the Treatment of Relapsing Forms of Multiple Sclerosis Date: Apr 3, 2023 | Tags: TG Therapeutics, Briumvi, Ublituximab-xiiy, Multiple Sclerosis, Regulatory, EMA, CHMP BMS Receives EMA’s CHMP Positive Opinion of Breyanzi (lisocabtagene maraleucel) for (..)

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FDA Immunization 53

PQA

DECEMBER 21, 2023

As we near the end of 2023, it’s a great time to reflect on our accomplishments this year. PQA’s New Look: PQA unveiled our refreshed brand at the 2023 PQA Annual Meeting. In 2023, we updated our CE program to provide more flexibility for busy professionals with courses that are 2-3 hours.

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Immunization 59

Pharmafile

APRIL 18, 2023

CET/4:00 p.m. read more

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Immunization Vaccines 40

European Pharmaceutical Review

NOVEMBER 25, 2022

Certain RNA methyltransferases regulate RNA sensing and innate immune activation and represent novel immune-regulatory targets. We anticipate presenting results from our Phase I study in 2023.” In addition, STC-15 has shown efficacy in leukaemia models via mechanisms including inhibition of leukaemia stem cell function.

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Immunization 98

Pharmaceutical Technology

APRIL 17, 2023

Prometheus Biosciences uses precision medicine to discover, develop and commercialise new therapeutic and companion diagnostic products to treat immune-mediated diseases. The company intends to advance the mAb into Phase III trials for UC and CD in 2023. TL1A is implicated in intestinal inflammation and fibrosis.

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Immunization 105

Pharmaceutical Technology

NOVEMBER 14, 2022

In lupus, the body’s immune system starts to attack its own cells. Saphnelo is also being studied in a Phase III trial in lupus nephritis, where a person’s immune system targets the kidneys, eventually leading to kidney failure. Several other investigational therapies are expected to have material updates in 2023.

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Immunization FDA 144

European Pharmaceutical Review

JANUARY 11, 2024

The biologic targets the p40 protein, which has key roles in treating immune-mediated diseases like Crohn’s disease, psoriasis as well as psoriatic arthritis, Alvotech highlighted. Uzpruvo is produced in Sp2/0 cells via perfusion, in the same way that the reference product Stelara is.

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Immunization 115

Pharmaceutical Technology

APRIL 14, 2023

This will suppress the effector characteristics in multiple immune cell subsets. After refining our clinical protocols, we need to discuss this approach with the FDA and plan to file an IND in 4Q 2023.” The effect was observed in patients with Covid-19 and multiple sclerosis, and also in healthy participants.

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Immunization FDA 98

PharmaShots

MARCH 23, 2023

Both companies will coordinate the clinical development across global regions Biohaven obtains global rights (Ex-China) for the development of BHV-8000, a highly selective, brain-penetrant, dual TYK2/JAK1 inhibitor to treat brain disorders Biohaven continues to advance BHV-8000 (previously TLL-041) licensed from Highlightll into a P-I study in 2023.

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Immunization 56

Drug Store News

JANUARY 31, 2024

CareALERTS was developed to increase immunization rates among adults and seniors, and in 2023 it successfully increased companion pneumococcal immunizations by 28% among participating pharmacies.

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Immunization 59

European Pharmaceutical Review

NOVEMBER 3, 2023

This decreases the activity of parts of the immune system that are involved in the inflammation of hair follicles that causes hair loss in people with alopecia areata.

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Immunization FDA 104

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. References 1. Garrido P et al.

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Immunization Chemotherapy FDA 98

NF2 BioSolutions

JUNE 2, 2023

And now in 2023 a new team is aiming to beat that amount as well as widen our scope to include Schwannomatosis more generally. The post Walk For NF2 Two Fundraiser 2023 appeared first on NF2 BioSolutions. So, we go again. And this time there are 3 of us.

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Immunization 52

PQA

SEPTEMBER 12, 2023

The Pharmacy Quality Alliance (PQA) seeks interested pharmacy and payer partners to participate in proof-of-concept pilots to implement and test high priority immunization pharmacy measure concepts. PQA has issued a request for interest (RFI) to gauge interest and willingness to participate in these pilots.

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Immunization Patient Care 40

PharmaShots

JANUARY 27, 2023

Magenta Therapeutics Pauses the P-I/II Study in AML Patients Date: Jan 27, 2023 | Tags: Magenta Therapeutics, MGTA-117, AML, Clinical Trial, P-I/II Ipsen Receives CHMP Negative Opinion for Palovarotene to Treat Fibrodysplasia Ossificans Progressiva Date: Jan 27, 2023 | Tags: Ipsen, Palovarotene, Fibrodysplasia Ossificans Progressiva, Regulatory, CHMP, (..)

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FDA Immunization 40

Hospital Pharmacy Europe

JANUARY 25, 2023

The Joint Committee on Vaccination and Immunisation (JCVI) has advised offering Covid booster vaccinations in spring and autumn 2023 for patients deemed to be at high risk. A first vaccination will no longer be available to adults under 50 years not in an at-risk group with the offer being phased out over the course of 2023, the JCVI said.

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Vaccines Immunization Hospitals 98

The FDA Law Blog

APRIL 8, 2024

Claud — CDER’s Office of Pharmaceutical Quality (OPQ) issued its 2023 Annual Report last week, and it’s an upbeat assessment of the Office’s policy and outreach efforts. This strikes us as another signal that FDA sees the policies of cGMP as evergreen, and largely immune to even seismic technology shifts. By John W.M.

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FDA Immunization 59

PharmaShots

MAY 12, 2023

Sanofi Reports P-IIIb Trial (HARMONIE) Results of Nirsevimab for the Prevention of Hospitalizations due to RSV-Related LRTD Date: May 12, 2023 | Tags: Sanofi, Nirsevimab, RSV-Related LRTD, Clinical Trial, P-IIIb, HARMONIE Trial G1 Therapeutics Presents Preliminary Results from P-II Trial of Trilaciclib for Triple-Negative Breast Cancer at ESMO 2023 (..)

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FDA Chemotherapy Immunization Hospitals 40

PharmaShots

MARCH 24, 2023

PTC Therapeutics’ Upstaza (eladocagene exuparvovec) Receives NICE Recommendation for the Treatment of AADC Deficiency Date: Mar 24, 2023 | Tags: PTC Therapeutics, Upstaza, eladocagene exuparvovec, AADC Deficiency, Regulatory, NICE Onconova Therapeutics Entered into a Research Collaboration with Pangea Biomed to Identify Biomarkers for Cancer (..)

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FDA Immunization 40

The Checkup by Singlecare

NOVEMBER 6, 2023

According to the FDA announcement, the most serious side effect of Wezlana is infection because the prescription affects your immune response. Department of Health and Human Services (2023) Stelara and Enbrel chosen for IRA price negotiation , AJMC (2023) STELARA® (ustekinumab) approved by the U.S.

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FDA Immunization 110

The FDA Law Blog

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.

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pharmaphorum

MAY 10, 2021

billion doses through 2023. 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. On Saturday, the bloc extended its contract with the companies to provide up to 1.8 — Ursula von der Leyen (@vonderleyen) May 8, 2021.

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Vaccines Labelling Immunization 122