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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pharmaphorum

AUGUST 8, 2022

As we reported this morning, the deal gives Pfizer already-approved SCD therapy Oxbryta (voxelator) – which industry watchers reckon could see a dramatic uptick in sales with Pfizer’s marketing muscle – plus a phase 3 antibody candidate, a phase 1 follow-up to Oxbryta that could offer improved dosing.

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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. Background In January 2022, JAMP Pharma Corporation ( JAMP ) was approved to market SIMLANDI, a biosimilar of HUMIRA (adalimumab).

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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

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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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

MARCH 29, 2021

The EU looks set to approve emergency use of a third antibody therapy for COVID-19 after its human medicines committee backed use of Celltrion’s regdanvimab at its March meeting. . The EU’s medicines regulator is also reviewing COVID-19 antibodies from AstraZeneca , GlaxoSmithKline/Vir Biotechnology, and Brii Biosciences.

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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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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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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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BioPharma Reporter

JULY 17, 2023

Crossbow Therapeutics, a biotech company developing a novel class of potent and precise antibody therapies to treat a broad range of cancers, has announced a $80 million Series A funding round.

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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. The post US signs $1bn order for GSK, Vir’s COVID-19 antibody appeared first on. Another phase 3 trial called COMET-STAR is assessing whether.

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BioPharma Reporter

MARCH 16, 2023

South Korean players, Celltrion and Genuv, are teaming up on the discovery and development of therapeutic antibodies using Genuv's mouse platform.

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Delveinsight

JANUARY 22, 2021

The launch of a novel drug in the market is not less than a celebration in the pharmaceutical and healthcare market; however, it also brings the real challenge of sustenance in the market. Similar is the picture of the Thrombocytopenia Drugs Market. At present, there stands no treatment option that can cure the disease.

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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

NOVEMBER 10, 2022

Corbus says new data shows its monoclonal antibody demonstrates robust pre-clinical anti-tumor activity alone and in combination with anti-PD-1 therapy.

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BioPharma Reporter

MARCH 31, 2022

Sanofi and IGM announce partnership to develop IgM antibody agonists against oncology and immunology/inflammation targets.

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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. The current Myasthenia Gravis therapeutics market has many FDA-approved drugs for the treatment of Myasthenia Gravis.

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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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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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BioPharma Reporter

MARCH 11, 2021

GSK and its partner, Vir Biotechnology, report that their jointly developed monoclonal antibody, VIR-7831, reduces hospitalization and risk of death in early treatment of adults with COVID-19.

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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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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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Pharmaceutical Technology

MARCH 10, 2023

Pharmaceutical and biotechnology industries widely use freeze-drying systems to protect vaccines, antibodies, antibiotics such as penicillin, blood plasma, proteins, enzymes, hormones, viruses, and bacteria from heat and minimise their biological activity. The process eliminates the disadvantages of conventional drying methods or freezing.

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Pharmaceutical Technology

OCTOBER 25, 2022

There are options in the future to possibly apply the worldwide research and development (R&D), manufacturing and marketing expertise of Astellas in gene therapy to AAV gene therapy development programmes of Taysha for genetic ailments of the central nervous system (CNS).

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pharmaphorum

AUGUST 19, 2022

Also vying for market share is BioCryst Pharma’s Orladeyo (berotralstat), which is given orally once a day and is being targeted towards HAE patients with fewer attacks as well as those with difficult venous access and needle phobia. The post CSL preps filings for once-monthly antibody for HAE appeared first on.

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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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BioPharma Reporter

DECEMBER 16, 2020

Sterling Pharma Solutions, a global contract development and manufacturing organization (CDMO), has announced a new strategic partnership with ADC Biotechnology, a UK based company specializing in antibody-drug conjugates (ADCs).

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The Pharma Data

JANUARY 12, 2021

LONDON, UK / ACCESSWIRE / January 13, 2021 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company (“GlobalCo”).

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BioPharma Reporter

AUGUST 30, 2022

AstraZeneca's long-acting antibody combination Evusheld has been approved in Japan for both prevention (pre-exposure prophylaxis) and treatment of symptomatic disease caused by SARS-CoV-2 infection: marking the first global marketing approval of Evusheld as a treatment for COVID-19.

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The Pharma Data

SEPTEMBER 17, 2020

17, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly ‘s potential COVID-19 therapies. INDIANAPOLIS and THOUSAND OAKS, Calif. Reese , M.D.,

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pharmaphorum

DECEMBER 2, 2021

The UK medicines regulator has approved GlaxoSmithKline and Vir Biotech’s antibody for COVID-19, Xevudy, which has been shown to be effective against the new Omicron strain of SARS-CoV-2 in lab testing. The antibody was found to reduce the risk of hospitalisation and death by 79% in this patient group in a clinical trial.

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pharmaphorum

JULY 26, 2021

The test – originally developed by US manufacturer Chembio Diagnostics – has been introduced into the UK and Irish markets by Guilford-based Luas Diagnostics and tests for the presence of SARS-CoV-2-targeting antibodies in the blood.

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BioPharma Reporter

JUNE 1, 2021

Corbus Pharmaceuticals announced the expansion of its portfolio into immuno-oncology through licensing deals with the University of California San Francisco and Panorama Research Inc for two new monoclonal antibodies (mAbs).

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BioPharma Reporter

FEBRUARY 12, 2024

Just â Evotec Biologics has expanded its relationship with Advanced BioScience Laboratories (ABL), a global CDMO serving the US Government and biopharmaceutical industry.

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Drug Discovery World

FEBRUARY 19, 2024

This has been a real cause for concern for the industry, which is also facing growing competition in the investment market from big tech and AI. antibody-drug conjugate [ADC] pipelines in some oncology settings). Whilst AI has clear benefits, it must be applied carefully and without compromising patient safety.

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