Pharmaceutical Technology

NOVEMBER 22, 2023

Myricx Bio has signed a licence agreement for contract research, development and manufacturing organisation WuXi Biologics’ antibody.

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Pharmaceutical Technology

APRIL 4, 2024

Discover Xencor Inc's groundbreaking patent for novel GPC3 binding domains and bispecific antibodies targeting GPC3-associated cancers. Explore the innovative method for manufacturing these antibodies and their potential in cancer treatment.

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Pharmaceutical Technology

JANUARY 25, 2023

The Saudi Food & Drug Authority (SFDA) has approved the manufacturing and distribution of Alvotech and Bioventure’s AVT02 (adalimumab). The monoclonal antibody AVT02 is the approved biosimilar for AbbVie ’s Humira (adalimumab). Humira is commonly indicated to treat rheumatoid arthritis as well as many other inflammatory diseases.

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Bio Pharma Dive

OCTOBER 15, 2020

Lilly has asked the FDA for emergency clearance of the therapy, although a study safety review and an unrelated manufacturing inspection could complicate the request.

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Pharmaceutical Technology

NOVEMBER 21, 2022

Manufacturing woes have affected both cell and gene-modified cell therapies in oncology recently, disadvantaging patients with multiple myeloma (MM) and melanoma. ITIL-168 is an autologous TIL therapy, meaning that patients need to undergo apheresis and wait for the product to be manufactured and reinfused.

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Pharmaceutical Technology

NOVEMBER 30, 2022

However, efficiently manufacturing the drug represents another barrier to cross before realizing the full revenue potential then successfully. Each month, Pharmaceutical Technology takes a look at recent decisions taken by regulatory and reimbursement agencies and identifies the key manufacturing players that can be impacted by them.

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Pharmaceutical Technology

OCTOBER 12, 2022

Biotech start-up Toregem BioPharma has signed a memorandum of understanding (MoU) with WuXi Biologics to develop the monoclonal antibody, TRG035. Additionally, WuXi Biologics will help the company with the development of the anti-USAG-1 antibody for Investigational New Drug (IND) application.

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Fierce Pharma

SEPTEMBER 18, 2023

After inking and expanding a biosimilar production partnership with Pfizer this summer, Korea’s Samsung Biologics is boosting yet another Big Pharma manufacturing agreement. Samsung Biologics has inked a new deal with Bristol Myers Squibb for large-scale drug substance production on an unnamed commercial cancer antibody.

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pharmaphorum

SEPTEMBER 30, 2020

Regeneron’s antibody cocktail seems to reduce levels of coronavirus and improve symptoms in patients, according to early test results. REGN-COV2 is a combination of two monoclonal antibodies and was designed to block infectivity of SARS-CoV-2 , the virus that causes COVID-19. There were no deaths in the trial.

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Pharmaceutical Technology

MAY 17, 2023

WuXi Biologics and InflaRx have entered a manufacturing partnership for advancing Gohibic (vilobelimab) to treat certain critically ill Covid-19 patients. Under the collaboration, WuXi Biologics will be responsible for providing cGMP manufacturing of Gohibic.

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BioPharma Reporter

SEPTEMBER 2, 2021

Anti-CD25 antibodies have emerged as one of the most promising next-generation cancer therapeutics, says US plant-based manufacturer of therapeutics and vaccines, iBio, as it enters the field.

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BioPharma Reporter

DECEMBER 14, 2021

Samsung Biologics will manufacture AstraZenecaâs COVID-19 long-lasting antibody combination (AZD7442) and cancer immunotherapy product from next year under an expanded partnership.

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Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

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BioSpace

MAY 19, 2024

To support its growing antibody-drug conjugate portfolio, AstraZeneca on Monday said it is investing $1.5 billion in a Singapore production site that will include all steps of the ADC manufacturing process.

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BioPharma Reporter

JULY 20, 2021

Kineta says the partnership with Samsung Biologics will help it advance its novel anti-VISTA antibody as it aims to start clinical trials next year.

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Pharmaceutical Technology

JANUARY 20, 2023

However, scaling processes up to a manufacturing scale is far from straightforward. The challenges with scaling up mAbs therapy production When developing a mAb therapeutic, there has traditionally been inconsistency between early lab processes, pilot processes and commercial manufacturing.

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XTalks

NOVEMBER 12, 2024

Thus, to address drug-resistant infections, pharma and biotech companies are developing novel treatments such as bacteriophage therapies, immunomodulators and monoclonal antibodies. Monoclonal Antibody Therapies Monoclonal antibodies are gaining traction as targeted treatments for bacterial and viral infections.

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Pharmaceutical Technology

MAY 8, 2023

In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Immuno-oncology in Pharmaceuticals: Monoclonal antibody conjugates for cancer treatment.

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Pharmaceutical Technology

DECEMBER 16, 2024

Manufacturing practices are evolving to advance antibody drug conjugates (ADCs) for cancer treatment through a targeted approach.

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pharmaphorum

MAY 18, 2022

Brand new UK startup RQ Biotechnology has been thrust into the spotlight after signing a $157 million licensing deal with AstraZeneca for monoclonal antibodies intended to protect vulnerable and immunosuppressed people from COVID-19. ” The post AstraZeneca buys into startup RQ Bio’s COVID antibodies appeared first on. .

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Pharmaceutical Technology

NOVEMBER 14, 2022

In a field dominated by antibodies and small molecules, two cell-therapy based approaches have come under the spotlight for showing early signs of efficacy in treating lupus. Apart from the monoclonal antibodies and small molecules, researchers have long held an interest in exploring cell therapies for autoimmune conditions.

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XTalks

NOVEMBER 21, 2024

The test, the first of its kind approved for over-the-counter (OTC) use in the US, detects antibodies for Treponema pallidum , the bacterium responsible for syphilis. NOWDiagnostics’ First To Know Syphilis Test circumvents these barriers with a convenient, in-home solution offering results in just 15 minutes. percent for positive cases.

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Fierce Pharma

FEBRUARY 20, 2024

After laying out plans to absorb a pair of production subsidiaries in October, Japan’s Daiichi Sankyo is doubling down on its quest to dominate the red-hot antibody-drug conjugate (ADC) field. Aiming to beef up development and manufacturing of antibody-drug conjugates, Daiichi Sankyo is plugging roughly €1 billion ($1.08

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pharmaphorum

SEPTEMBER 16, 2020

Regeneron’s COVID-19 antibody cocktail has been added to the UK’s RECOVERY trial, one of the largest of its kind in the world that is testing several potential coronavirus therapies at the same time. REGN-COV2 is a combination of two monoclonal antibodies, designed to block infections of SARS-CoV-2, the virus that causes COVID-19.

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BioPharma Reporter

MAY 20, 2021

Data management in antibody drug conjugate (ADC) manufacturing is challenging says ADC/Labs, which is trying to help scientists in the field get around such obstacles.

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Pharma Mirror

FEBRUARY 21, 2025

It is no secret that the complexities associated with biopharmaceuticals are ever increasing, particularly regarding the development of antibody therapeutics. Through its range of services, Creative Biolabs, in particular, speeds up the overall drug discovery process through antibody drug development.

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Pharmaceutical Commerce

MAY 20, 2024

The facility, company says, will be its first that covers end-to-end ADC production.

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pharmaphorum

DECEMBER 16, 2020

AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.

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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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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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XTalks

JANUARY 21, 2025

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Abbott Spinal Cord Stimulation (SCS) Systems Manufacturer/developer : Abbott Medical Date of FDA approval : May 30, 2024 Approved for : Chronic, hard-to-manage pain in the torso, arms and legs.

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Pharmaceutical Technology

JANUARY 31, 2024

Axplora has announced an €8m investment to expand antibody drug conjugate payload manufacturing capabilities at its Le Mans site in France.

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Fierce Pharma

JANUARY 9, 2024

But the Japanese company will have to clear up manufacturing issues first. The FDA has sent a complete response letter to Astellas, rejecting zolbetuximab because of unresolved deficiencies identified in a pre-license inspection of a third-party manufacturing facility.

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Fierce Pharma

MAY 20, 2024

Riding high on its Daiichi Sankyo-partnered antibody drug conjugate (ADC) Enhertu—and banking on an approval for its next ADC contender datopotamab durextecan this winter—AstraZeneca is placing a b | Riding high on its Daiichi Sankyo-partnered antibody drug conjugate (ADC) Enhertu—and banking on an approval for its next ADC contender datopotamab durextecan (..)

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Pharmaceutical Technology

MAY 21, 2024

AstraZeneca is set to invest $1.5bn in a new manufacturing facility in Singapore dedicated to the production of antibody drug conjugates.

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Pharmaceutical Technology

APRIL 6, 2023

A recent wave of monoclonal antibodies, including the FDA-approved Eisai / Biogen ’s Leqembi (lecanemab), is expected to shake up the space. The difficulty in finding a treatment for Alzheimer’s disease has plagued the drug industry for decades. If proven and approved, the rapid introduction of AD04 into the U.K.

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Pharmaceutical Technology

NOVEMBER 15, 2024

MSD has secured an exclusive worldwide license from LaNova Medicines for developing, manufacturing, and commercialising the latter’s new investigational programmed cell death 1 (PD-1)/vascular endothelial growth factor (VEGF) bispecific antibody, LM-299.

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