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. The post European regulators begin rolling review of AZ’s COVID-19 vaccine appeared first on.

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Fierce Pharma

MAY 31, 2024

Just one week after Summit Therapeutics and Akeso’s bispecific antibody ivonescimab passed muster with Chinese regulators, the drug has pulled off another feat by staring down the PD-1 king Keytrud | In the phase 3 HARMONi-2 trial, solo ivonescimab delivered a statistically significant and clinically meaningful improvement in progression-free survival (..)

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STAT News

JANUARY 10, 2023

SAN FRANCISCO — For months, drugmakers have been pleading with regulators to lower the bar for authorizing antibody drugs for Covid. The virus, they noted, had evolved fast enough to render every previous antibody obsolete.

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BioPharma Reporter

JULY 19, 2021

Celltrion Group has reported that data from an in vivo efficacy study shows that its monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59), has a strong neutralizing effect against the rapidly spreading Delta variant.

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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. reported with placebo. Feature image courtesy of Rocky Mountain Laboratories/NIH.

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BioSpace

OCTOBER 19, 2023

Despite increasing antitrust scrutiny across the biopharma industry, the European Commission on Thursday said it found no competitive issues with Pfizer’s buyout of the antibody-drug conjugate company.

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Medical Xpress

JANUARY 5, 2023

Increased levels of the antibody immunoglobulin A (IgA) are correlated with the manifestation of several diseases as well as African ancestry, according to findings published in Nature Communications. The findings provide new insights into the genetic regulation of IgA levels and its potential role in human disease.

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BioPharma Reporter

JULY 11, 2024

Amid a period of clinical holds and legal tangles, the US antibody specialist CytoDyn has reached a settlement to resolve legal disputes with its former contract research organization (CRO) Amarex Clinical Research.

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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. The work is supported by the role of foralumab in dampening activated microglia cells, said to be an important component of the pathogenesis of this disease.

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BioPharma Reporter

MARCH 30, 2023

A T-cell engaging bispecific antibody developed by Roche has got its first green light in Canada for the treatment of relapsed or refractory forms of the blood cancer diffuse large B-cell lymphoma (DLBCL).

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BioPharma Reporter

APRIL 8, 2021

Moderna today highlighted the publication of antibody persistence data out to six months following the second dose of its COVID-19 vaccine in The New England Journal of Medicine.

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BioSpace

JULY 16, 2023

regulator Monday approved the Beyfortus single-dose monoclonal antibody, developed jointly by the two companies, for the pediatric prevention of respiratory syncytial virus.

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BioSpace

MARCH 24, 2024

The regulator has allowed for emergency use of Invivyd’s monoclonal antibody Pemgarda as a COVID-19 pre-exposure prophylaxis for moderately or severely immunocompromised patients.

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Pharmaceutical Technology

OCTOBER 25, 2022

Astellas chief strategy officer Naoki Okamura said: “Gene therapy is the cornerstone of Astellas’ Primary Focus, Genetic Regulation; our goal is to bring new transformative treatment options to patients living with serious genetic diseases and limited treatment options.

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BioPharma Reporter

NOVEMBER 10, 2020

Lilly's monoclonal antibody therapy, bamlanivimab (LY-CoV555), has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for the treatment of adults and children with recently diagnosed, mild to moderate COVID-19.

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BioPharma Reporter

NOVEMBER 18, 2021

This last week saw the EU Commission approve two monoclonal antibodies for the treatment of COVID-19.

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Pharmaceutical Technology

APRIL 19, 2023

However, the regulator has enforced temporary restrictions on those who have already received a single bivalent vaccine dose. Those with certain kinds of immunocompromise who have previously received a bivalent vaccine can receive an additional bivalent Covid-19 vaccine dose at least two months after a bivalent vaccine dose.

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BioSpace

OCTOBER 23, 2023

The regulator has approved the first-ever subcutaneous version of infliximab, an IgG1 monoclonal antibody, commonly sold by Johnson & Johnson under the brand name Remicade.

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XTalks

APRIL 15, 2021

The types of blood clotting events included vaccine-induced prothrombotic immune thrombocytopenia (VIPIT), a condition associated with the development of antibodies that activate platelets to stimulate the formation of clots and resulting in thrombocytopenia, as well as 18 cases of CVST as of March 17.

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pharmaphorum

JANUARY 29, 2024

The US regulator has started a priority review of the HER2-targeting antibody-drug conjugate (ADC) for the treatment of adults with unresectable or metastatic HER2-positive solid tumours who have been treated previously or have limited treatment options.

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BioSpace

OCTOBER 1, 2023

Eli Lilly’s Biologic License Application for its monoclonal antibody lebrikizumab was denied by the regulator after issues were found at a third-party contract manufacturing organization.

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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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Worldwide Clinical Trials

JUNE 21, 2024

This year, Matt Cooper, PhD , our Executive Director, Therapeutic Strategy Lead, Oncology, attended and found the presentations around antibody-drug conjugates (ADCs) and tumor-infiltrating lymphocytes (TILs) to be of great interest to the future of oncology therapeutics.

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Pharmaceutical Technology

APRIL 14, 2023

The regulator re-inspected the Reykjavik facility in March 2023 and again reported deficiencies. AVT02 is a monoclonal antibody approved as a biosimilar to Humira (adalimumab), a prescription drug used to treat rheumatoid arthritis and numerous other inflammatory diseases.

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BioPharma Reporter

JANUARY 5, 2023

AstraZeneca and Sanofi said their Biologics License Application (BLA) for nirsevimab has been accepted for review by the US Food and Drug Administration (FDA).

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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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BioPharma Reporter

NOVEMBER 13, 2023

Medix Biochemicals has acquired ViroStat in an effort to provide its customers with infectious disease antibodies and antigens for their IVD immunoassay test development.

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Pharmaceutical Technology

AUGUST 16, 2022

antibody, ADX-914 re-regulates adaptive immune function by hindering IL-7 and TSLP-facilitated signalling. On Horizon exercising the option, Q32 could be entitled to further receive up to another $645m in closing and milestone payments. Q32 will also receive tiered royalty payments on net sales. A fully human anti-IL-7R?

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pharmaphorum

DECEMBER 8, 2020

AbCellera Biologics has been in the spotlight since coming up with Eli Lilly’s COVID-19 antibody drug bamlanivimab, and looks set to capitalise on that exposure with a sizeable initial public offering. The drug is also being tested in other trials, including a phase 3 study looking at its role in prevention of SARS-CoV-2 infection.

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BioSpace

JUNE 14, 2023

Following cases of serious bleeding in patients, five of which were fatal, the regulator has put Mersana’s investigational antibody-drug conjugate UpRi on partial clinical hold in two ovarian cancer trials.

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BioPharma Reporter

APRIL 19, 2021

US pharma group, Lilly, has requested the US FDA revoke the Emergency Use Authorization (EUA) for bamlanivimab 700 mg alone due to the evolving variant landscape in the US.

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Camargo

DECEMBER 13, 2021

The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. CBER regulates products under a variety of regulatory authorities: INDs for CBER-regulated products. Section 351(a) is the traditional pathway for approving biologics under the PHS Act. BLA process (CBER).

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BioSpace

JUNE 28, 2023

Phase I/II data on AbbVie and Genmab’s recently approved bi-specific antibody in a second cancer indication positions them to talk to regulators about filings to challenge Roche’s Lunsumio.

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pharmaphorum

NOVEMBER 26, 2020

Danyelza (naxitamab) is an antibody that targets GD2, a protein found on the surface of some tumour cells, and it has been cleared by the US regulator for use alongside GM-CSF – a cytokine drug – as a second-line neuroblastoma treatment after a priority review. Both the antibodies stem from research carried out at the institution.

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XTalks

DECEMBER 28, 2023

HDFN is a condition where the mother’s antibodies attack the red blood cells (RBCs) of the fetus or newborn, leading to hemolysis, or rapid destruction of the baby’s RBCs. Nipocalimab is an investigational monoclonal antibody that targets the neonatal Fc receptor.

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BioSpace

AUGUST 10, 2023

overall response rate in a Phase II study, winning accelerated approval from the regulator. Despite being heavily pretreated, patients on J&J’s Talvey saw a 73.6%

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BioPharma Reporter

APRIL 26, 2021

The US Food and Drug Administration (FDA) has approved ADC Therapeuticsâ ZYNLONTA as a third-line therapy for patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).

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