The Pharma Data

SEPTEMBER 14, 2020

Illustration of antibodies attacking the coronavirus. A new antibody treatment is to be trialled on Covid-19 patients in UK hospitals. Monoclonal antibodies, which are potent, laboratory-made antibodies, will be given to about 2,000 people to see if they are effective against coronavirus. What are monoclonal antibodies?

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Drug Discovery World

SEPTEMBER 15, 2023

Replicate Bioscience has dosed the first participant in a Phase I trial of its RBI-4000 vaccine for the prevention of rabies. Replicate’s srRNA technology offers the potential for more robust and durable immune responses, and improved tolerability at lower doses than existing mRNA approaches,” said Zelanna Goldberg, CMO of Replicate. “In

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pharmaphorum

JULY 6, 2021

A peptide vaccine developed by Australia’s Imugene has reduced tumour size in around half of patients with HER2-positive gastric or gastroesophageal junction (GEJ) cancer in a phase 2 trial. ” The anti-HER2 market is advancing rapidly however, with a new generation of drugs coming through the industry pipeline.

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NY Times

MAY 11, 2022

Antibody levels rose in the children who received it, suggesting the vaccine protects against infection. But the data were gathered before the arrival of Omicron.

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XTalks

JUNE 18, 2021

This is why Regeneron’s announcement of positive clinical trial results that show its antibody cocktail treatment can cut deaths among hospitalized patients is welcome news. It is the first trial to demonstrate that any antibody treatment could improve survival in patients hospitalized with COVID-19.

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pharmaphorum

JUNE 30, 2021

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. .

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Drug Discovery World

SEPTEMBER 25, 2023

Enrolment in a Phase I trial of a new investigational universal influenza vaccine candidate has begun at the National Institutes of Health’s Clinical Center in Bethesda, Maryland, US. With each new universal influenza vaccine candidate and clinical trial, we take another step closer to that goal,” said Acting NIAID Director Hugh Auchincloss.

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Pharmaceutical Technology

DECEMBER 16, 2022

The example of rituximab, originally a cancer drug, now used for lupus, has shown the potential of adopting cancer medications for lupus. Furthermore, drug-free remission was maintained during longer follow-up and even beyond the reappearance of B cells.

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Pharmaceutical Technology

APRIL 28, 2023

Therini Bio will use part of the funds to advance its potential first-in-class investigational antibody, THN391, into clinical trials. THN391 binds the inflammation-driving component of fibrin, known for activating the immune responses in neurodegenerative and ophthalmologic diseases.

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STAT News

DECEMBER 23, 2022

Food and Drug Administration approved a new treatment for patients with follicular lymphoma, a slow-growing type of blood cancer, said Genentech , its maker and a subsidiary of Roche. In a clinical trial, 60% of patients with follicular lymphoma treated with Lunsumio achieved a complete response. Happy holidays from all of us.

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Drug Discovery World

FEBRUARY 28, 2024

Lu Rahman selects some of the year’s interesting and noteworthy advances in cancer research drug discovery and development. As always, a year within cancer drug discovery and development brings with it significant breakthroughs, and 2023 has been no exception. Research into new cancer drugs remain strong. expressing cancers.

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Pharmaceutical Technology

AUGUST 18, 2022

The company sought expanded provisional approval for the booster shots based on findings from its Phase II clinical trial carried out in Australia, another Phase II trial in South Africa and the COV-BOOST trial sponsored by the UK. Furthermore, the occurrence of Grade 3 or higher events was found to be comparatively low.

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XTalks

MAY 4, 2023

A blood test can detect antibodies to gluten, but a definitive diagnosis requires a biopsy of the small intestine. As of now, the US Food and Drug Administration (FDA) has not approved any drugs for the treatment of celiac disease. How does Beyond Celiac spread awareness about research and clinical trials for celiac disease?

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pharmaphorum

JUNE 16, 2021

People who cannot generate an effective immune response against COVID-19 can be protected with an infusion of Regeneron’s antibody therapy REGN-COV, according to new data from the UK RECOVERY trial. 37% of the standard care group deteriorated to that point, compared to 30% of those on Regeneron’s drug.

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Drug Discovery World

APRIL 3, 2023

A team of researchers at the Keck School of Medicine of University of Southern California (USC) have found a drug with the potential for curbing painful hyperinflammation from osteoarthritis, according to results of an animal study.

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Pharmaceutical Technology

JUNE 5, 2023

According to GlobalData, Phase I drugs for Pediatric Diffuse Intrinsic Pontine Glioma does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Kid EDV LoA Report. Buy the report here.

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Drug Discovery World

MARCH 26, 2024

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to half-life extended monoclonal antibody (mAb) Pemgarda (pemivibart, or VYD222) for the pre-exposure prophylaxis (prevention) of Covid-19.

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Drug Discovery World

FEBRUARY 19, 2024

Replicate Bioscience has shared positive results from the Phase I trial of RBI-4000, its srRNA-based rabies vaccine. In this clinical trial, evaluating safety and immunogenicity of RBI-4000 , participants received one or two doses of srRNA vaccine at low doses (0.1mcg, 1mcg or 10mcg).

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XTalks

AUGUST 14, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that its bispecific antibody Talvey (talquetamab-tgvs) received US Food and Drug Administration (FDA) approval as a fifth-line treatment for adult patients with heavily pretreated multiple myeloma. Results were similar at the higher 0.8

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pharmaphorum

NOVEMBER 25, 2021

The first patients are now being treated as part of a first-in-human trial of a vaccine, administered as a nasal spray, that aims to slow down the progression of Alzheimer’s disease (AD). The post Trial of intranasal Alzheimer’s vaccine gets underway in US appeared first on.

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XTalks

NOVEMBER 22, 2022

Provention Bio’s Tzield (teplizumab) has won US Food and Drug Administration (FDA) approval to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years of age and older who have stage 2 type 1 diabetes. In clinical trials, the treatment delayed stage 3 disease onset for about two years compared with the placebo.

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pharmaphorum

SEPTEMBER 15, 2020

Humanigen is hoping for emergency use authorisation in the US for an antibody to treat severe COVID-19 before the end of 2020, and has teamed up with Swiss contract manufacturer Lonza to make sure it can meet demand. They looked at safety as well as carrying out a futility analysis to gauge whether the drug was working as expected.

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pharmaphorum

OCTOBER 11, 2022

An intranasal formulation of AstraZeneca’s widely-used COVID-19 vaccine Vaxzevria has failed at the first hurdle, after results from a phase 1 trial found it was unable to stimulate a strong immune response to the virus.

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Drug Discovery World

JUNE 28, 2023

MinervaX, a Danish biotechnology company developing a novel, prophylactic vaccine against Group B Streptococcus (GBS), has completed enrolment and initial dosing in its Phase I clinical vaccine trial in older adults. The trial is taking place at CEVAC (Centre for Vaccinology), Ghent University, Belgium.

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The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Regeneron Pharmaceuticals, Inc. futility analysis). log 10 copies/mL for combined doses).

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XTalks

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

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pharmaphorum

JANUARY 26, 2022

The FDA has placed a partial clinical fold on clinical trials of Gilead Sciences’ magrolimab, the centre piece of its $4.9 Gilead has been forced to pause recruitment into trials involving the combination while the safety signal is investigated, but subjects already enrolled can continue to be treated, according to a company statement.

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pharmaphorum

DECEMBER 17, 2020

UK-based EUSA Pharma has begun a late-stage trial of its antibody siltuximab in COVID-19, hoping that the IL-6 inhibitor will succeed where class rivals from Roche and Sanofi/Regeneron have failed. EUSA Pharma bought global rights to the drug from Janssen in $115 million.

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Drug Discovery World

APRIL 11, 2024

We have noted that cancer patients can develop powerful anti-tumour immune responses that can result in complete cure of the disease and we call these patients ‘elite responders’. By understanding what triggers the adaptive immune response in “elite responders” we have identified new targets and therapeutic antibodies.

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Drug Discovery World

MARCH 27, 2023

The first subjects have been dosed in a Phase I clinical trial of VXX-401, an investigational vaccine designed to lower low-density lipoprotein (LDL) cholesterol, a known factor in heart disease. The drug works by targeting proprotein convertase subtilisin/kexin type 9 serine protease (PCSK9).

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XTalks

AUGUST 8, 2022

MiroBio is a private biotech company based in the UK that focuses on developing checkpoint agonist antibodies, which are a new class of therapies that work to restore immune balance in patients with autoimmune and inflammatory diseases. PD-1 is a potent immune inhibitory receptor. MiroBio’s Research Pursuits.

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The Pharma Data

APRIL 15, 2022

Food and Drug Administration in the coming days with additional submissions to other regulatory agencies worldwide to follow. About the Phase 1/2/3 Trial in Children. Additional children have been enrolled in all age groups following study amendments and the trial currently includes more than 10,000 children. Pfizer Inc.

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pharmaphorum

DECEMBER 12, 2022

Johnson & Johnson is in pole position to bring a drug targeting GPRC5D to market as a new therapeutic approach to multiple myeloma, and told delegates at ASH yesterday why its talquetamab candidate should be viewed as an important new option for the blood cancer. mg/kg dose and 73% at a 0.8 mg/kg dose and 73% at a 0.8

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Pharmaceutical Technology

MAY 24, 2023

Morphogenesis’s technologies include Immune Fx (IFx) personalised cancer vaccines and tumour microenvironment (TME) modulators. IFx has been designed to activate an innate immune response against tumour antigens that are patient-specific. Morphogenesis’ lead personalised cancer vaccine, IFx-Hu2.0,

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XTalks

MAY 7, 2021

As Novavax awaits emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its protein-based COVID-19 vaccine NVX-CoV2373, the company shared new data this week on the vaccine’s efficacy against the South African B.1.351 These results came from data from Novavax’s Phase III UK trial where B.1.117

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The Pharma Data

SEPTEMBER 17, 2020

The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. The test targets antibodies against the spike protein. Food and Drug Administration (FDA). This is the focus of vaccines in development and convalescent plasma therapy.

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Drug Discovery World

OCTOBER 27, 2023

HB-400, a novel arenaviral therapeutic vaccine developed by HOOKIPA Pharma and Gilead Sciences, has been shown to generate robust T cell responses specific to hepatitis B virus with high antibody levels in a preclinical setting. A Phase I clinical trial to evaluate the safety and tolerability of HB‑400 in humans is ongoing.

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