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.

Antibody 130

Antibody Manufacturing 130

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.

Manufacturing 147

Manufacturing Antibody Marketing Licensing 147

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.

Antibody 180

Antibody Manufacturing Drugs 180

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.

Antibody 130

Antibody Development Bioassay Manufacturing 130

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.

Antibody 82

Antibody Manufacturing Production Drugs 82

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.

Manufacturing 130

Manufacturing Immune Response Protein Antibody 130

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.

Manufacturing 98

Manufacturing Antibody Production 98

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.

Manufacturing 93

Manufacturing Antibody Production Drugs 93

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.

Antibody 98

Antibody Manufacturing Clinical Trials Clinical Trials 98

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.

Manufacturing 130

Manufacturing Production Development Engineer 130

BioPharma Reporter

AUGUST 20, 2020

Roche agrees to distribute Regeneronâs COVID-19 antibody combination outside the US, more than tripling manufacturing capacity.

Antibody 98

Antibody Manufacturing 98

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.

Antibody 130

Antibody Drugs Development Medicine 130

Pharmaceutical Technology

JANUARY 15, 2023

In order to get a therapy to the market, pharma companies often outsource the drug manufacturing to specialist contract manufacturing organizations (CMOs). While Catalent Inc and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API. EMA and NICE news.

Manufacturing 130

Manufacturing Packaging Packaging Contract Manufacturing 130

Pharmaceutical Technology

DECEMBER 16, 2024

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

Antibody 147

Antibody Manufacturing Drugs 147

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.

Antibody 362

Antibody Gene Therapy Manufacturing Trials 362

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.

Bacterium 104

Bacterium Antibody Manufacturing Pharmacy 104

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

Antibody 99

Antibody Production Drugs Manufacturing 99

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.

Antibody 98

Antibody Trials Manufacturing Protein 98

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.

Manufacturing 95

Manufacturing Antibody Scientist Drugs 95

Pharmaceutical Commerce

MAY 20, 2024

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

Antibody 106

Antibody Manufacturing Production Drugs 106

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.

Antibody 130

Antibody Development Drugs Manufacturing 130

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.

Antibody 98

Antibody Trials Licensing Licensing 98

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.

Antibody 98

Antibody Clinical Trials Clinical Trials Regulation 98

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.

Manufacturing 91

Manufacturing Contract Manufacturing Licensing Licensing 91

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.

FDA Approval 105

FDA Approval Manufacturing Development RNA 105

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.

Antibody 147

Antibody Manufacturing Drugs 147

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.

Manufacturing 88

Manufacturing Antibody Licensing Licensing 88

Pharmaceutical Technology

MARCH 9, 2023

Global biopharmaceutical firm UCB and Cancer Research UK have entered a multi-project partnership to advance two of the former’s oncology antibody candidates through clinical trials. The clinical development partnership will focus on the development of UCB6114 and UCB4594 investigational antibody candidates.

Antibody 130

Antibody Research Clinical Trials Clinical Trials 130

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 (..)

Manufacturing 82

Manufacturing Antibody Drugs 82

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.

Production 130

Production Antibody Manufacturing Drugs 130

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.

FDA Approval 264

FDA Approval Licensing Licensing Antibody 264

BioTech 365

JUNE 17, 2022

The global antibodies contract manufacturing market is expected to reach from USD 13.4 Rise in demand for the production of therapeutic antibodies … Continue reading → billion in 2022 to USD 35.9 billion by 2030, registering a CAGR of 13.1% from 2022 to 2030.

Contract Manufacturing 52

Contract Manufacturing Antibody Manufacturing Marketing 52

pharmaphorum

APRIL 9, 2021

The issues are holding up discussions between the agency and company about labeling and post-marketing requirements for teplizumab, and are concentrated around the pharmacokinetics data for the antibody, and whether it is comparable to the drug that its original developer Eli Lilly entered into clinical trials.

Antibody 98

Antibody Insulin Trials Production 98

Pharmaceutical Technology

NOVEMBER 22, 2022

The iPSC-based allogeneic cell therapy platform of Umoja leverages its synthetic receptor enabled differentiation (ShRED) manufacturing process to guide iCIL differentiation and development with robust anti-tumour activity. In the initial stage, the partnership will focus on acute myeloid leukaemia (AML) to boost accessibility to patients.

Development 276

Development In-Vivo Engineer Clinical Trials 276

BioPharma Reporter

JANUARY 9, 2023

Lonza and Context Therapeutics are collaborating on the manufacture of a bispecific antibody-based therapy.

Antibody 52

Antibody Manufacturing Drugs 52

pharmaphorum

AUGUST 25, 2020

The first patients have been dosed in a trial of two AstraZeneca antibodies, collectively known as AZD7442, that are being developed to both treat and prevent coronavirus infections. AZD7442 is a combination of antibodies derived from convalescent plasma, taken from patients who have been infected with SARS-CoV-2 but have recovered.

Antibody 84

Antibody Trials Trial Funding Licensing 84

Fierce Pharma

AUGUST 19, 2024

Genmab is revamping its executive team as the Danish antibody specialist expands its commercialization efforts and looks to evolve into “a fully integrated biotech innovation powerhouse.” | Genmab is revamping its executive team as the Danish antibody specialist expands its commercialization efforts and looks to evolve into “a fully integrated biotech (..)

Manufacturing 89

Manufacturing Antibody 89