pharmaphorum

JANUARY 15, 2021

South Korea’s Celltrion has announced encouraging top-line results for its potential antibody therapy for COVID-19, with the first part of a phase 2/3 trial showing it could cut recovery times and chances of progression from moderate to more severe disease. days shorter than placebo, the company said. reported with placebo.

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pharmaphorum

OCTOBER 2, 2020

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. In a separate announcement, AstraZeneca said that a trial of the vaccine has resumed in Japan after a safety scare in the UK.

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pharmaphorum

MARCH 30, 2021

Two antibodies targeting different parts of the COVID-19 virus spike protein, from Eli Lilly and GlaxoSmithKline/Vir Biotech, can cut viral load dramatically within a week. . GSK and Vir say they are discussing emergency use authorisation of VIR-7831 with the EMA and other regulators, including possible co-administration with bamlanivimab.

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The Pharma Data

JANUARY 27, 2021

COVID-19 Antibody Treatments Exceed Expectations in Early Trials. 27, 2021 — Promising new data on two antibody cocktails suggest these therapies can keep COVID-19 patients out of the hospital and even prevent illness altogether in some people. Professional. WEDNESDAY, Jan. At the same time, Regeneron Pharmaceuticals Inc.

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Pharmaceutical Technology

JUNE 20, 2023

SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. In a Phase III clinical trial, SKYCovione showed neutralising antibody responses against the SARS-CoV-2 parental strain.

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XTalks

JANUARY 17, 2024

Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense. They discussed the top new trends in oncology trial design that sponsors are either incorporating into clinical trials or need to start planning to include.

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BioPharma Reporter

OCTOBER 14, 2020

Enrollment is temporarily on hold in the ACTIV-3 clinical trial, which is evaluating Lilly's investigational neutralizing antibody bamlanivimab (LY-CoV555) as a treatment for COVID-19 in hospitalized patients. The pause was recommended by the study's independent Data and Safety Monitoring Board (DSMB).

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pharmaphorum

NOVEMBER 22, 2022

GSK confirmed this morning that the disappointing readout from the DREAMM-3 trial of multiple myeloma therapy Blenrep reported earlier this month means that it will take the drug off the US market. The post GSK will pull Blenrep from US market after failed trial appeared first on.

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Pharmaceutical Technology

APRIL 14, 2023

Foralumab is a fully human anti-CD3 monoclonal antibody, which works by binding to the T-cell receptor and regulating T-cell function to reduce pulmonary inflammation. Phase II trials of intranasal foralumab are anticipated to commence in the third quarter of 2023 in inactive secondary progressive multiple sclerosis (SPMS) patients.

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Pharmaceutical Technology

MAY 22, 2023

Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody that will be used to treat mild cognitive impairment caused due to AD and mild AD dementia in people with the confirmed presence of amyloid pathology in the brain. The regulator has also designated the therapy for the innovative licensing and access pathway (ILAP).

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BioPharma Reporter

MARCH 29, 2022

Prothena has announced FDA clearance of IND for PRX012, a subcutaneous anti-amyloid beta antibody under investigation for the treatment of Alzheimerâs disease (AD).

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pharmaphorum

MAY 19, 2021

In a rare move, the FDA has publicly accused US biotech CytoDyn of misrepresenting clinical trial results for leronlimab, an antibody being developed for COVID-19. . Leronlimab was also no better than placebo when it came to secondary endpoints including survival, time to symptom resolution, and time to return to normal activity.

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pharmaphorum

NOVEMBER 17, 2021

The US has made a sizeable order for GlaxoSmithKline and Vir Biotechnology’s antibody-based COVID-19 treatment sotrovimab said to be worth approximately $1 billion. Another phase 3 trial called COMET-STAR is assessing whether. The post US signs $1bn order for GSK, Vir’s COVID-19 antibody appeared first on.

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The Pharma Data

MARCH 25, 2021

today announced primary results from the Phase 2/3 RELATIVITY-047 (CA224-047) trial evaluating the fixed-dose combination of relatlimab, an anti-LAG-3 antibody, and Opdivo (nivolumab) versus Opdivo alone in patients with previously untreated metastatic or unresectable melanoma. About RELATIVITY-047 (CA224-047).

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pharmaphorum

MAY 10, 2021

The EMA has begun a rolling review of a COVID-19 antibody developed by GlaxoSmithKline and Vir BioTech which could become the fourth drug of its type cleared for early use in the EU. . At the moment the regulator is looking at the first batch of data from lab and animal studies as well as quality studies. Intramuscular injection.

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Pharmaceutical Technology

JANUARY 8, 2023

In 2023, the pharmaceutical industry will mark 20 years since Xolair, an anti-IgE antibody, became the first biologic approved to treat asthma. Since then, the US FDA, EMA, and other agencies have approved several biologic antibodies targeting the inflammatory cytokines IL-4, IL-13, IL-5, and others for asthma.

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The Pharma Data

AUGUST 20, 2020

Poor regulation of antibodies tests – that could indicate if someone has had coronavirus – could be putting the public at risk, doctors have warned. It is still not known whether having antibodies will protect people from a second infection. Coronavirus infection triggers the immune system to produce antibodies.

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Pharmaceutical Technology

APRIL 5, 2023

It is a first-in-class monoclonal anti-human complement factor C5a antibody. The regulator granted the EUA based on data obtained from the multicentre Phase III PANAMO trial, which was conducted in Covid-19 patients who are invasively mechanically ventilated in intensive care units.

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Pharma in Brief

DECEMBER 17, 2023

On December 4, 2023, the Federal Court held that a patent claiming a formulation of adalimumab, a monoclonal antibody used to treat autoimmune diseases, is valid and is being infringed by a biosimilar product. The Federal Court upheld the Minister’s decision; AbbVie’s appeal of the Federal Court’s decision is pending (Court File No.

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pharmaphorum

OCTOBER 24, 2022

Novartis has chalked up another clinical trial win for its targeted factor B inhibitor iptacopan as it strives to position the drug as a patient-friendly, oral alternative to big-selling injectable rivals. The post Novartis’ oral drug iptacopan tops injectables in head-to-head PNH trial appeared first on.

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STAT News

NOVEMBER 28, 2022

The clinical trial death, described in an unpublished case report obtained by the news site, is the second thought to be associated with the Eisai and Biogen antibody drug, called lecanemab. The woman suffered a stroke and a type of swelling and bleeding previously seen with such antibodies.

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The Pharma Data

DECEMBER 20, 2020

Oxford University released new trial data last week that raises further questions about the most effective dosing regimen for Oxford’s COVID-19 vaccine candidate, AZD1222, that is being co-developed with AstraZeneca and how it came to pass that two different dosing regimens were pursued. Efficacy was not measured in the phase 1/2 trials.

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Pharmaceutical Technology

AUGUST 16, 2022

According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. Under the agreement, Horizon will hold an option for the acquisition of the ADX-914 programme, which is exercisable through a period after concluding the Phase II trials. A fully human anti-IL-7R?

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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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XTalks

OCTOBER 27, 2022

Patients are eligible for the drug if they have previously received four or more lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody — this can include a combination of the different drugs.

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pharmaphorum

JANUARY 27, 2021

Regeneron is considering an emergency filing for its antibody cocktail REGEN-COV to protect people against COVID-19 after early trial results showed it conferred 100% protection against symptomatic infection. The post Regeneron and Lilly post new data backing COVID antibody cocktails appeared first on.

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The Pharma Data

JANUARY 21, 2021

Eli Lilly reported yesterday that its monoclonal antibody bamlanivimab (LY-CoV555) significantly lessened the risk of contracting COVID-19 among nursing home residents and staff, according to findings from a phase 3 trial. James Miessler. Source link.

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The Pharma Data

JANUARY 26, 2021

In what looks like a breakthrough for COVID-19 treatments, Regeneron’s monoclonal antibody cocktail REGEN-COV (casirivimab and imdevimab) cut infection rates in half and provided full protection against symptomatic COVID-19, according to interim results from a phase 3 trial evaluating the treatment as a passive vaccine.

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pharmaphorum

APRIL 14, 2021

A phase 3 trial of Romark’s antiviral drug NT-300 has missed the main objective in a phase 3 trial in mild to moderate COVID-19 patients, but could still have a shot at emergency use authorisation (EUA), according to the US company. . Severe disease was seen in 0.5% of the NT-300 group (one patient), compared to 3.5%

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

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Pharmaceutical Technology

JANUARY 18, 2023

The monoclonal antibody selectively attaches to calcitonin gene-related peptide (CGRP). The regulator also granted approval for Galcanezumab to treat episodic cluster headaches in adults in June 2019. In September 2018, the US Food and Drug Administration (FDA) approved Galcanezumab as the preventive treatment of migraine in adults.

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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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Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?

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pharmaphorum

AUGUST 19, 2022

Australia’s CSL has said its one-monthly treatment for hereditary angioedema has shown it is safe and effective in a phase 3 trial, and will be filed for approval in its current financial year which ends on 30 June next year. The post CSL preps filings for once-monthly antibody for HAE appeared first on.

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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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Pharmaceutical Technology

OCTOBER 25, 2022

TSHA-102 is the first gene therapy in the clinical development stage for Rett syndrome currently while TSHA-120 is being analysed in a Phase I/II clinical trial for treating GAN. Astellas will also receive specific rights linked to any possible change of Taysha’s control.

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pharmaphorum

MAY 24, 2022

Eli Lilly has the results it was looking for in a second, confirmatory trial of its anti-IL-23p19 antibody mirikizumab in ulcerative colitis as it waits for the outcome of regulatory reviews in the US and EU. The post Second trial opens door for Lilly’s mirikizumab in ulcerative colitis appeared first on.

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