Drug Discovery World

MARCH 8, 2023

Dosing has begun in a Phase I clinical study evaluating BAT8008, an antibody-drug conjugate (ADC) that targets Trop2. Key objectives of the study are to determine the maximum tolerated dose (MTD), recommended Phase II dose (RP2D), and to evaluate the pharmacokinetics and preliminary efficacy in patients with advanced solid tumours.

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Trials In-Vivo In-Vitro Antibody 52

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. . The post Altimmune ditches nasal COVID vaccine on weak trial data appeared first on.

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Vaccination Vaccine Trials Immune Response 98

pharmaphorum

JUNE 24, 2021

Just a few days after Biogen abandoned its tau-targeting Alzheimer’s disease candidate gosuranemab, Bristol-Myers Squibb has opted into a rival drug, paying $80 million for rights to Prothena’s PRX005 antibody in phase 1 testing. . The deal – which could be worth up to $2.2

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pharmaphorum

APRIL 12, 2022

Gilead Sciences can restart pivotal trials of its cancer antibody magrolimab – the centrepiece of its $4.9 Now, Gilead says the hold has been relaxed “after a review of the comprehensive safety data” from studies of the CD47-targeting antibody and azacitidine.

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pharmaphorum

JANUARY 5, 2022

A COVID-19 vaccine that could work against multiple variants of the coronavirus – developed by US biotech Gritstone bio – has generated encouraging immune response data in its first clinical trial. “With new variants – like Omicron and B.1.640.2

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Protein Vaccination Vaccine Immune Response 126

Drug Discovery World

MARCH 26, 2024

For example, progress made in developing gene mutant-specific inhibitors, antibody-drug conjugates (ADC), or cellular therapies. Results of that Phase I trial are expected to be presented later this year. OR: The presentations at ESMO TAT 2024 highlighted our advances in targeted and more personalised anti-tumour therapies.

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pharmaphorum

NOVEMBER 23, 2020

AstraZeneca is preparing to file its COVID-19 vaccine with regulators after phase 3 trial results showed it is up to 90% effective. AZ made the announcemen t as the UK regulator reportedly gears up to make a decision on the rival vaccine from Pfizer and BioNTech, ahead of counterparts in the US and Europe.

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XTalks

JUNE 28, 2023

The approval is restricted to ambulatory patients within this narrow age range due to uncertainty around its effectiveness in older children, which Sarepta hopes to clarify in a confirmatory trial. DMD is caused by the absence of dystrophin, a protein that helps maintain the integrity of muscle cells.

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The Pharma Data

MARCH 22, 2021

Investigational antibody cocktail of casirivimab and imdevimab also significantly shortened the duration of symptoms by four days. Companion dose-ranging phase II trial showed significant and comparable viral reductions for a range of doses of casirivimab and imdevimab.

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Antibody Trials Clinical Trials Clinical Trials 52

XTalks

JULY 10, 2023

Rystiggo received FDA approval under the Priority Review designation, specifically for the treatment of gMG in adult patients who have tested positive for anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies. The active ingredient in Rystiggo is rozanolixizumab, a humanized IgG4 monoclonal antibody.

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Drug Discovery World

JULY 19, 2023

Lilly will work with the FDA and other global regulators to achieve the fastest path to traditional approvals. Participants in TRAILBLAZER-ALZ 2 were stratified by their level of the brain protein tau, a predictive biomarker for Alzheimer’s disease progression.

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Trials Clinical Trials Clinical Trials Research 52

pharmaphorum

AUGUST 10, 2020

Biogen’s Alzheimer’s drug aducanumab could be on the market in the next few months after the FDA accepted a clinical trial dossier and granted a fast Priority Review. The FDA has set a decision date for March 27 next year, and Biogen said that the regulator could make a ruling before then.

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Drugs Clinical Trials Clinical Trials Trials 105

pharmaphorum

SEPTEMBER 7, 2020

A trial of Russia’s Sputnik V coronavirus vaccine has shown the jab produces an immune response, although the study was too small to produce conclusive findings, particularly on safety. In the phase 1 part of the trial, participants received one component of the two-part vaccine.

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Immune Response Vaccination Vaccine Trials 107

XTalks

SEPTEMBER 17, 2020

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012.

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The Pharma Data

AUGUST 18, 2020

REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S. and around the world.

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Antibody Clinical Trials Clinical Trials Manufacturing 52

XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. Another method to isolate CTCs is by antibody targeting of white blood cells for removal, followed by collection of untagged CTCs.

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Clinical Trials Clinical Trials Trials FDA Approval 98

pharmaphorum

AUGUST 31, 2021

As a top vaccine maker, GlaxoSmithKline has been a laggard in the COVID-19 vaccine race, but has put on a late burst of speed with a start of phase 3 trials of a second candidate that will be compared directly to the AstraZeneca shot. 1.351) strain first identified in South Africa.

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Vaccination Vaccine Protein Immune Response 59

pharmaphorum

MARCH 30, 2022

CureVac and GlaxoSmithKline’s first attempt to develop a COVID-19 vaccine was a salutary reminder of the pitfalls in drug development, as the mRNA shot crashed and burned in a clinical trial last year, but they aren’t giving up. ” The post CureVac and GSK try again with COVID-19 vaccine appeared first on. .

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Vaccination Vaccine Protein Antibody 64

pharmaphorum

MARCH 9, 2022

Sanofi and Sobi’s haemophilia partnership has been under competitive pressure from new therapies like Roche’s antibody Hemlibra, so the two companies are hoping a new long-acting drug candidate can revitalise the franchise. The half life of the new drug – one of the main draws for Sanofi’s $11.6

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XTalks

NOVEMBER 26, 2020

In addition to innovative new antibody drugs and mRNA vaccines, researchers have found that the sleep-regulating hormone melatonin may also offer protection against COVID-19. Melatonin, which regulates the body’s circadian rhythm and sleep-wake cycle, is also available in pill form for use as a sleep aid.

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Research Hormones Protein Regulation 98

The Pharma Data

AUGUST 24, 2020

The National Medical Products Administration has granted approval to the West China Hospital of Sichuan University in Chengdu to begin a clinical trial. It is hoped that using insect cells to grow proteins for the vaccine could speed up large-scale production. These were primarily border officials and health workers. Conor Kavanagh.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

pharmaphorum

NOVEMBER 17, 2020

The vaccine developed in partnership with Germany’s BioNTech has been shown to be 90% effective in clinical trials. The company has picked four US states – Rhode Island, Texas, New Mexico and Tennessee, to trial a delivery programme that aims to overcome this challenge. Pfizer and BioNTech have a $1.95

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Vaccination Vaccine RNA Clinical Trials 77

XTalks

SEPTEMBER 2, 2021

The AlzoSure Predict prognostic biomarker Alzheimer’s blood test detects levels of an unfolded conformational variant of the p53 protein in the blood using a proprietary antibody called U-p53AZ. The Diadem AlzoSure Predict assay uses a proprietary antibody, U-p53AZ, to measure blood levels of the unfolded conformational p53 variant.

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Protein DNA Antibody Genome 105

The Pharma Data

JANUARY 17, 2021

The treatment is based on the Grifols immunoglobulin Gamunex®-C, and contains anti-SARS-COV-2 polyclonal antibodies from plasma donors who have recovered from COVID-19. It could also be given to immunocompromised patients for whom the vaccination isn’t indicated. BARCELONA, Spain , Jan.

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Clinical Trials Clinical Trials Trials Containment 52

pharmaphorum

APRIL 29, 2021

The Swedish biotech says the IUS regulator has set an action date of 15 September for its review of Nefecon, a novel formulation of the established corticosteroid drug budesonide that could become the first ever approved therapy for IgAN.

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The Pharma Data

JANUARY 13, 2021

The patent application is titled “Anti-CD154 Antibodies and Uses Thereof” and published under International Publication No. TNX-1500 is a third generation anti-CD40-ligand mAb that has been designed by protein engineering to decrease Fc?RII antagonist receptor fusion protein. WO 2021/001458 A1. International Immunol. (11):1583

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Antibody Development Protein Vaccination 52

pharmaphorum

DECEMBER 1, 2020

Pfizer and BioNTech have filed their COVID-19 vaccine with the European medicines regulator, paving the way for a potential approval before the end of the year. The companies initially filed the nonclinical data and other technical data, followed by emerging clinical trial results.

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Vaccination Vaccine RNA Clinical Trials 88

XTalks

JANUARY 8, 2024

The FDA’s endorsement stems from results obtained from the company’s Phase III NefIgArd clinical trial. This accumulation triggers inflammation and damages kidney tissues, leading to the leakage of blood and protein into the urine. There, it specifically targets the mucosal B cells in the ileum to inhibit antibody formation.

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FDA Approval Clinical Trials Clinical Trials Nurses 64

pharmaphorum

DECEMBER 18, 2020

The US regulator has cleared both intravenous and subcutaneous formulations of Benlysta (belimumab) for the new indication, extending the use of the drug beyond its earlier label covering the treatment of active systemic lupus erythematosus (SLE) in combination with other medicines.

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FDA Approval Contract Manufacturing Sales Trials 99

pharmaphorum

OCTOBER 6, 2020

The announcement comes just days after the regulator said its CHMP scientific committee had begun to look at the first batch of data from AZ’s rival. In the case of a rolling review, the EMA evaluates trial data as they become available before a complete filing is submitted.

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Vaccination Vaccine RNA Immune Response 59

pharmaphorum

NOVEMBER 9, 2020

The companies said they will be ready to file the vaccine with the FDA in the third week of November once they have enough safety data to meet the regulator’s requirements. Top-line results come from a phase 3 trial of the candidate known as BNT162b2 and an evaluation of 94 cases from the trial of 43,538 patients.

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Vaccination Vaccine Clinical Trials Clinical Trials 98

XTalks

JULY 2, 2021

This is because the processes that maintain the uterine lining, including the placenta, during pregnancy are different than those that regulate the normal menstrual cycle. However, the similarity between the two proteins is not great enough for anti-spike antibodies to cross-react with placental syncytin-1.

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Vaccination Vaccine Protein Immune Response 105

pharmaphorum

SEPTEMBER 25, 2020

Leap Therapeutics will get a swift FDA review for its lead drug DKN-01 for a form of gastric and gastroesophageal junction (G/GEJ) cancer after being awarded fast-track status by the regulator. In animal models, neutralising DKK1 has been shown to activate an innate immune response against malignant cells.

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Immune Response Trials Drugs Containment 72

pharmaphorum

MAY 18, 2021

Canadian biotech Medicago has the data it was hoping for from a phase 2 trial of its COVID-19 vaccine, partnered with GlaxoSmithKline, and is now hoping to have phase 3 data available “by early summer.” The purified vaccine is administered alongside GSK’s pandemic adjuvant to boost the immune response.

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Immune Response Vaccination Vaccine Gene Sequencing 64

pharmaphorum

MARCH 21, 2022

The US regulator cleared BMS’ LAG-3 drug relatlimab as a fixed-dose combination with its PD-1 inhibitor Opdivo (nivolumab) – under the Opdualag brand name – in patients aged 12 or over with unresectable or metastatic melanoma. months, versus 4.6 months for Opdivo alone.

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FDA Approval Regulation Drugs Trials 52

pharmaphorum

JANUARY 14, 2021

When Eli Lilly reported results for donanemab in Alzheimer’s disease earlier this week it was hailed as a rare win for the amyloid hypothesis, although there’s no shortage of candidates that have failed despite positive mid-stage trial results.

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Drugs Protein Antibody Regulation 85

The Pharma Data

JANUARY 10, 2021

PLANEGG / MUNICH, GERMANY / ACCESSWIRE / January 11, 2021 / MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR), a commercial-stage biopharmaceutical company and a leader in antibody, protein and peptide technologies, announced today that Jean-Paul Kress, M.D., In July 2020, the U.S.

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