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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BioPharma Reporter

SEPTEMBER 17, 2024

The original concerns of the US regulatory agency over the manufacturing of Eli Lillyâs Ebglyss seem to have been resolved, as the FDA greenlit the antibody drug on Friday.

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pharmaphorum

AUGUST 4, 2021

The withdrawals – while voluntary – come as the FDA has been taking a closer look at accelerated approvals of cancer drugs, focusing mainly on checkpoint inhibitors that have seen new uses added to their labels at breakneck speed since being launched onto the market.

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XTalks

OCTOBER 27, 2022

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the US Food and Drug Administration (FDA) approved Tecvayli (teclistamab-cqyv) for the treatment of relapsed or refractory multiple myeloma. Tecvayli is a first-in-class, bispecific T-cell engager antibody administered as a subcutaneous treatment.

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XTalks

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. BTK plays an important role in the immune system by regulating B cell receptor signaling through its effects on the development and maturation of B cells.

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BioPharma Reporter

JUNE 20, 2024

Biotest, a subsidiary of Grifols, has received FDA approval for Yimmugo, a treatment for primary antibody deficiency syndromes (PID)

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Pharmaceutical Technology

JANUARY 18, 2023

Under the latest agreement, AffaMed Therapeutics will get exclusive rights for importing, marketing, promoting, distributing, and detailing Galcanezumab after receiving approval in Mainland China. The monoclonal antibody selectively attaches to calcitonin gene-related peptide (CGRP).

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XTalks

OCTOBER 6, 2020

The US Food and Drug Administration (FDA) has given approval to Janssen Pharmaceutical for Simponi Aria (golimumab) in the treatment of patients two years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA). FDA approval for the treatment was based on results from the Phase III GO-VIVA clinical trial.

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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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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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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.

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Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act. BLA process (CBER).

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pharmaphorum

NOVEMBER 26, 2020

Y-mAbs Therapeutics has claimed its first product approval, getting a green light from the FDA for Danyelza for the rare cancer neuroblastoma. Both the antibodies stem from research carried out at the institution. Danyelza has been granted accelerated approval by the FDA on the strength of two open-label phase 2 studies.

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The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. Approval supported by one of the largest clinical trial programmes undertaken for this rare disease. Basel, 17 August 2020.

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XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

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XTalks

NOVEMBER 1, 2022

Rinvoq received its sixth FDA approval, this time it is for treating adults with non-radiographic axial spondyloarthritis, a form of inflammatory arthritis that affects the spine. JAK inhibitors block cell signaling that cause inflammation, providing patients an alternative method to regulating an overactive immune system.

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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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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. NEW YORK, Nov.

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Pharmaceutical Technology

NOVEMBER 30, 2022

In late September, the European Commission approved the rare disease therapy Ultomiris (ravulizumab), developed by Alexion, a division of AstraZeneca to treat generalized myasthenia gravis. The monoclonal antibody (mAb) is already approved for treating paroxysmal nocturnal haemoglobinuria in children and adolescents.

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XTalks

JULY 11, 2024

Susvimo, a refillable eye implant, received US Food and Drug Administration (FDA) approval in 2021, but its initial rollout faced challenges due to septum dislodgement cases that prompted Roche to issue a voluntary market recall in October 2022. In October 2023, the bispecific antibody got a label expansion to retinal vein occlusion.

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pharmaphorum

SEPTEMBER 2, 2022

German drugmaker Boehringer Ingelheim has its first regulatory approval for spesolimab, its antibody therapy for rare and life-threatening skin disorder generalised pustular psoriasis (GPP), in the US. It is also under review by regulators in Europe, with a decision expected before the end of the year.

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pharmaphorum

DECEMBER 21, 2021

The Swiss pharma group is paying BeiGene $300 million upfront for an option on ociperlimab, a TIGIT antibody in phase 3 testing for non-small cell lung cancer (NSCLC), with another $700 million on offer if that option is exercised before 2023. Anti-TIGIT antibodies are separated into groups, depending on the status of the Fc portion.

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pharmaphorum

DECEMBER 18, 2020

GlaxoSmithKline’s Benlysta has been on the market for almost a decade, but it still has some tricks up its sleeve – it’s just become the first and only FDA-approved treatment for lupus nephritis.

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XTalks

OCTOBER 27, 2021

Ranibizumab is an anti-angiogenic monoclonal antibody fragment that targets vascular endothelial growth factor A (VEGF A). It received FDA approval in 2018. It became the first ophthalmology biosimilar approved in the US. Ranibizumab was developed by Genentech and is sold under the brand name Lucentis.

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pharmaphorum

DECEMBER 23, 2021

At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. It will be launched in the US in January, said Novartis.

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pharmaphorum

AUGUST 19, 2022

Pharming attempted to extend the use of its C1 esterase inhibitor product Ruconest (conestat alfa) into the prevention setting, having won FDA approval for acute treatment of attacks in 2014, but was knocked back by the regulator. The post CSL preps filings for once-monthly antibody for HAE appeared first on.

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BioPharma Reporter

FEBRUARY 22, 2023

An experimental antibody drug developed by Regeneron Pharmaceuticals called pozelimab could become the first approved treatment of the hereditary immune disease CHAPLE, with a US Food and Drug Administration (FDA) approval decision expected by August 2023.

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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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Pharmaceutical Technology

APRIL 24, 2023

Covid-19 vaccines from Moderna and Pfizer /BioNTech, which use lipid nanoparticles, became the only two FDA-approved vaccines for almost all ages. However, after a period of slow movement in the field, the FDA approved the first nanodrug, Doxil, for Kaposi sarcoma in 1995.

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The Pharma Data

FEBRUARY 13, 2022

Food and Drug Administration issued an emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant. director of the FDA’s Center for Drug Evaluation and Research. The issuance of an EUA is different than an FDA approval. Today, the U.S.

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XTalks

JUNE 28, 2023

The FDA approval came after several delays and a narrow advisory committee vote of eight to six in favor of the gene therapy’s risk-benefit profile. It has taken Sarepta six years to develop Elevidys with several roadblocks in its journey, including two clinical holds due to safety concerns.

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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Haematologica.

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pharmaphorum

FEBRUARY 11, 2021

The accelerated development assumes that regulators are prepared to accept immunogenicity data from smaller trials, Pangalos said in the briefing to announce the firm’s quarterly results. While the vaccine is approved in Europe, the UK and several other countries, FDA approval hangs on a study in the US.

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XTalks

NOVEMBER 20, 2023

PI3K/AKT is a key intracellular signaling pathway that regulates cell survival and proliferation. Truqap was reviewed under the FDA’s Project Orbis, which offers a framework for the concurrent submission and review of oncology drugs among international regulators. It was also given FDA priority review. billion to $1.28

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Delveinsight

OCTOBER 1, 2021

This disease is associated with antibodies directed against the acetylcholine receptor, muscle-specific kinase (MUSK), lipoprotein-related protein 4 (LRP4), or agrin in the postsynaptic membrane at the neuromuscular junction. Myasthenia Gravis Approved Therapies. Some of the approved drugs are: Prograf (Tacrolimus).

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FDA Law Blog

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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