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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Digital Pharmacist

NOVEMBER 21, 2022

Food and Drug Administration (FDA) announced its approval of the Boostrix vaccine, commonly known as Tdap (combination of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis) for immunization administration during the third trimester of pregnancy to prevent pertussis in infants younger than two months of age.

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The Checkup by Singlecare

SEPTEMBER 22, 2023

Here’s what you need to know about the new FDA-approved RSV vaccine. But young children, older adults, and individuals with weakened immune systems are at high risk of severe, potentially life-threatening RSV illness. The RSV vaccines are not mRNA immunizations, and “they are not live vaccines,” explains Blair Gingerich , Pharm.D.,

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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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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. Subsection 505(q) initially was added by Section 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub.

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pharmaphorum

JUNE 7, 2021

However results from that aren’t due to read out until 2023, according to the entry for the study in the clinicaltrials.gov database. It was filed for the adult ALL indication in the US in April, and has a priority review from the FDA, with a verdict due in October. Novartis eyes Yescarta challenge in follicular lymphoma.

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pharmaphorum

APRIL 29, 2021

Calliditas Therapeutics could have its first product on the market in the US this autumn, as the FDA has now started a priority review of Nefecon for rare disease primary IgA nephropathy (IgAN). . The post FDA sets September review date for Calliditas’ rare kidney disease drug appeared first on.

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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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Pharmaceutical Technology

APRIL 14, 2023

This will suppress the effector characteristics in multiple immune cell subsets. Tiziana Life Sciences chief medical officer Matthew Davis said: “We anticipate entering into a Phase 2a placebo-controlled clinical trial upon successful feedback from the FDA.

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The FDA Law Blog

MARCH 13, 2023

Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision about whether to participate in a clinical trial, and what kind of treatment effects would be most meaningful to them?

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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. Drug shortages have been a scourge for FDA , both as they negatively affect consumers and FDA’s reputation. By John W.M.

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The Checkup by Singlecare

MARCH 8, 2024

While nonbiologic drugs are made with chemicals and have a known structure, most biologics are complex mixtures and cannot be easily identified or characterized, according to the Food & Drug Administration (FDA). Continue reading to learn more about FDA approved Humira biosimilars, which are made by various drug companies.

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Pharmaceutical Technology

JANUARY 10, 2023

On November 17, 2022, the FDA approved Provention Bio’s Tzield (teplizumab) , making it the first and only treatment to delay the onset of type 1 diabetes (T1D). These therapies work by reprogramming the immune system, preventing it from attacking and eradicating insulin-producing cells in the pancreas. Equity in early-stage testing.

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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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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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Pharmaceutical Technology

APRIL 3, 2023

Tango Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for TNG260 to treat STK11-mutant cancers. It is in preclinical development to reverse immune evasion in STK11 mutated cancers.

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European Pharmaceutical Review

JUNE 30, 2023

Roctavian, an adeno-associated virus (AAV) vector-based gene therapy is the first to be approved by the US Food and Drug Administration (FDA) for adults with severe haemophilia A. The gene therapy is authorised for individuals without pre-existing antibodies to adeno-associated virus serotype 5 detected by an FDA-approved test.

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European Pharmaceutical Review

MAY 7, 2024

Injectable vaccines activate the immune system to help to prevent infectious conditions such as influenza. In 2023, North America accounted for the biggest market share due the region’s readiness to invest in innovative solutions such as injectable drug delivery systems.

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Pharmaceutical Technology

MAY 4, 2023

The US Food and Drug Administration (FDA) approved Kamada’s application to manufacture Cytogam (cytomegalovirus immune globulin intravenous [human]) at its facility located in Beit Kama, Israel. It is claimed to be the only immunoglobulin (IgG) product to receive FDA approval for this indication.

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European Pharmaceutical Review

JUNE 13, 2024

In April 2024, Ocugen received US Food and Drug Administration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa. In December 2023, the FDA granted OCU400 Regenerative Medicine Advanced Therapy (RMAT) designation.

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Pharmaceutical Technology

MARCH 27, 2023

Food and Drug Administration (FDA) for Lifileucel. Lifileucel is a tumour infiltrating lymphocyte (TIL) therapy for patients with advanced melanoma who do not respond to immune checkpoint inhibitors. Marc Hurlbert, CEO of the Melanoma Research Alliance (MRA) said he hopes for a quick FDA approval.

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European Pharmaceutical Review

MARCH 4, 2024

Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5 The emergency use approval from the FDA of lipid nanoparticle- (LNP-) based mRNA vaccines during the COVID-19 pandemic attested the significance of LNPs.

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Pharmaceutical Technology

JUNE 16, 2023

Avenge Bio has obtained orphan drug designation from the US Food and Drug Administration (FDA) for its AVB-001 to treat mesothelioma patients. In March 2023, the FDA provided positive feedback on Avenge Bio’s preclinical and clinical development initiatives for pleural malignant mesothelioma.

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pharmaphorum

DECEMBER 8, 2022

The FDA has started its review of Pfizer’s respiratory syncytial virus (RSV) vaccine for older adults, fast-tracking the biologics license application (BLA) with a decision due in May 2023. The post RSV vaccine race in balance as FDA sets May date for Pfizer decision appeared first on.

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The Checkup by Singlecare

DECEMBER 31, 2024

Prednisone is an FDA-approved prescription medication to treat a range of common conditions characterized by inflammation caused by the immune system. Like other steroids, prednisone reduces swelling, redness, and other symptoms caused by immune system reactions.

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Pharmaceutical Technology

MAY 26, 2023

After earning multimillion dollar revenues while being an authorised preferred treatment for Covid-19, the US Food and Drug Administration (FDA) has granted a full approval to Pfizer’s oral antiviral Paxlovid (nirmatrelvir + ritonavir).

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Pharmaceutical Technology

FEBRUARY 26, 2023

While the French MaaT Pharma has submitted further information to the FDA, its trial remains on hold. In January 2023, Finch announced plans to scrap the PRISM4 trial altogether. In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI. with placebo.

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European Pharmaceutical Review

APRIL 10, 2024

The recent FDA approvals of two microbiome products in the US, in November 2022 and April 2023, 1-2 represent a significant milestone, maturing the industry and paving the way for advancement and regulatory clearance of additional microbiome products in broader indications. Internet] Pharmaceutical Technology. cited 2024Feb].

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pharmaphorum

JUNE 9, 2021

Pfizer has the FDA approval it was seeking for Prevnar 20, the latest update to its blockbuster pneumococcal vaccination franchise, keeping it one step ahead of a competing shot from Merck & Co. In two phase 3 trials in adults reported last year, V114 stimulated immune responses to all serotypes in the shot.

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European Pharmaceutical Review

JUNE 27, 2023

difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. Notably, gut microbiome was found to linked to cancer CAR T therapy response, based data from the largest prospective study of its kind, published in Nature Medicine in March 2023.

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PharmaShots

MARCH 29, 2023

PharmaShots has prepared a list of the top 20 drugs with patent expiry in 2023 Company: Eisai Generic Name: Rufinamide First Approval Date: Nov 17, 2008 Patent Expiration: Apr 2023 2022 Sales: $52M Indication: Lennox-Gastaut syndrome (LGS) Banzel is a prescription add-on drug for the treatment of seizures linked with LGS.

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European Pharmaceutical Review

APRIL 25, 2023

The R21/Matrix-M malaria vaccine, developed by the University of Oxford , has been approved for use in Ghana (13 April 2023) and was authorised for use in Nigeria on 17 April. Granted full national licensure by the country’s Food and Drugs Authority (FDA Ghana), it is authorised for children aged 5 to 36 months.

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pharmaphorum

JULY 19, 2021

The FDA has approved a new pneumococcal vaccine from Merck & Co, just over a month after Pfizer got a green light for a new version of its market leading Prevnar shot. Also in the running is Vaxcyte, which has a 24-valent shot in early development and hopes to have initial clinical data from that programme in late 2022/early 2023.

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Hospital Pharmacy Europe

AUGUST 24, 2023

The the first and only treatment indicated to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, budesonide was approved by the FDA in 2021 under the accelerated approval scheme. IgA nephropathy is a chronic immune-mediated kidney disease characterised by IgA deposition in the glomeruli.

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European Pharmaceutical Review

AUGUST 29, 2023

Research published in Annals of Oncology in May 2023 showed comparable levels of Tecentriq in the blood when administered subcutaneously. Inhibition of PD-L1 means Tecentriq may enable the activation of T-cells, which support the body’s immune system. The safety and efficacy profile was consistent with the IV formulation.

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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. If the results are positive, Concert could be ready to file for approval in 2023. All three drugs have breakthrough designations from the FDA for this indication.

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pharmaphorum

NOVEMBER 18, 2022

At its second attempt, Provention Bio has secured FDA approval for teplizumab, as a treatment to delay late-stage type 1 diabetes (T1D) in at-risk individuals – becoming the first disease-modifying therapy for these patients. It is now in line for a $35 million equity investment by Sanofi following FDA approval.

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