Pharmaceutical Technology

JUNE 10, 2025

Enflonsia is a long-acting monoclonal antibody developed to offer speedy, direct and durable protection throughout a typical five-month RSV season with a consistent 105mg dose regardless of bodyweight. Can pharma tariffs “Make America Manufacture Again”? Credit: MargJohnsonVA/Shutterstock. Sign up for our daily news round-up!

FDA Approval

Pharmaceutical Technology

JUNE 23, 2025

This collaboration underscores the strength of Harbour BioMed’s proprietary Harbour Mice and HBICE technology platforms, which enable the rapid development of fully human bispecific antibodies with optimised safety and efficacy profiles. Can pharma tariffs “Make America Manufacture Again”?

Gene Therapy

Pharmaceutical Technology

JUNE 23, 2025

This is the second approval for the therapy in Europe and the first cleared for the treatment of generalised myasthenia gravis (gMG) in individuals positive for anti-acetylcholine receptor (AChR) antibodies. Can pharma tariffs “Make America Manufacture Again”? Sign up for our daily news round-up!

Manufacturing

Pharmaceutical Technology

JUNE 18, 2025

Orion Corporation has broadened its partnership with Glykos, focusing on the development of antibody-drug conjugates (ADCs). Under the research partnership and licensing agreement, Orion will obtain access to Glykos’ ADC technologies for probable expansion into three new programmes beyond those specified in the original agreement.

Clinical Trials

Pharmaceutical Technology

JUNE 17, 2025

NextCure has entered a strategic partnership with Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group, to develop SIM0505, a new antibody-drug conjugate (ADC) targeting cadherin-6 or K-cadherin (CDH6) for treating solid tumours. Can pharma tariffs “Make America Manufacture Again”?

Development

pharmaphorum

JUNE 26, 2025

Image Phil Taylor 26 June, 2025 atopic dermatitis Bookmark this News Vor Bio revives, thanks to $4bn+ licensing deal with RemeGen After winding up its stem cell therapy operations last month, Vor Bio has reinvented itself as an autoimmune disease-focused biotech.

Trials

pharmaphorum

JUNE 30, 2025

Today, the company revealed that its mRNA-based investigational seasonal influenza vaccine, mRNA-1010 , showed greater protective efficacy than a licensed flu jab in the phase 3 P304 trial involving adults aged 50 and over. Moderna said that the result – which showed its shot was around 26.6%

Vaccination

Pharmaceutical Technology

JULY 9, 2025

Ross Law July 9, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The panel discussed topics around regulation changes in oncology research. These ‘anchoring aspects’ provide the strength and conviction necessary to talk in depth with our regulators about what we need to do to ensure our trial designs are appropriate.”

Clinical Trials

Pharmaceutical Technology

JUNE 23, 2025

As per biosimilar regulation, the CHMP nod for AVT06 covers the same indications. Bayer has also had to contend with fierce competition from Roche’s bispecific antibody Vabysmo. Can pharma tariffs “Make America Manufacture Again”? Thank you for subscribing View all newsletters from across the GlobalData Media network.

Marketing

Pharmaceutical Technology

JUNE 13, 2025

June 13, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook AbYlink’s adaptability has been validated across different antibody isotypes and associated payloads. The broad-ranging adaptability of AbYlink has been validated across different antibody isotypes and associated payloads. Credit: Piyaset /Shutterstock.

Development

pharmaphorum

JUNE 30, 2025

Last week, our round-up of recent biotech financings was headed by a $140 million Series D for GRIN Therapeutics, which also scored a $570 million licensing deal with Angelini Pharma. In the brain, NMDA receptors help regulate various physiological functions, including learning and memory.

Sales

Pharmaceutical Technology

JULY 10, 2025

This is particularly evident in the rise of antibody-drug conjugates (ADCs), which combine the specificity of antibodies and the potency of cytotoxic drugs. Indena’s current focus is the payload-linker – the warhead bearing the chemical bridge to link the payload to the antibody. The ADCs market growth is considerable.

Manufacturing

Pharmaceutical Technology

JUNE 16, 2025

This is intended for adults whose tumours express PD-L1 with a combined positive score [CPS] ≥1 as measured by a test approved by the US regulator. This humanised monoclonal antibody prevents PD-1 from interacting with its ligands, PD-L1 and PD-L2, leading to the activation of T lymphocytes, impacting both tumour and healthy cells.

FDA Approval

Pharmaceutical Technology

JULY 1, 2025

Piramal Pharma Solutions has announced an investment of $90m to expand its two US facilities, enhancing manufacturing capabilities for sterile injectables and antibody-drug conjugate (ADC) therapies. ADC therapies are witnessing high interest due to their efficacy and wider acceptance among healthcare regulators.

Manufacturing

Pfizer

MAY 27, 2025

Its diversified portfolio of oncology product candidates aiming to address the full continuum of cancer includes mRNA cancer immunotherapies, next-generation immunomodulators and targeted therapies such as antibody-drug conjugates (ADCs) and innovative chimeric antigen receptor (CAR) T cell therapies.

Vaccination

Bio Pharma Dive

JUNE 9, 2025

Originally designed to regulate blood sugar in type 2 diabetes, GLP-1 receptor agonists have evolved into groundbreaking treatments for obesity, cardiovascular disease and even neurodegenerative conditions. Enhertu, Datroway and other antibody-drug conjugates developed by Daiichi Sankyo have made the company a leader in a competitive field.

Medicine

Pharmaceutical Technology

JUNE 11, 2025

Go deeper with GlobalData Reports LOA and PTSR Model - Monoclonal Antibody Conjugate 3 To Target Egfr. Boehringer Ingelheim holds global responsibility for the development and commercialisation of Survodutide after licensing it from Zealand Pharma. Can pharma tariffs “Make America Manufacture Again”?

Clinical Trials

Pharmaceutical Technology

JUNE 11, 2025

June 11, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The decision marks the therapy as the first and only licensed bevacizumab’s ophthalmic formulation for wet AMD treatment for adults in the UK. Lytenava is the first and only licensed bevacizumab ophthalmic formulation for wet AMD in adults in the UK.

Clinical Trials

Pharmaceutical Technology

JULY 1, 2025

Go deeper with GlobalData Reports LOA and PTSR Model - Efgartigimod Alfa in Antibody-Mediated Rejecti. Nominate Now Share Copy Link Share on X Share on Linkedin Share on Facebook Go deeper with GlobalData Reports LOA and PTSR Model - Efgartigimod Alfa in Antibody-Mediated Rejecti. How will RFK Jr’s American dream for vaccines play out?

FDA Approval

Pharmaceutical Technology

JUNE 16, 2025

By GlobalData Learn more about Strategic Intelligence Surovatamig is Fc-engineered [using the modification of the crystallisable fragment (Fc) region of an antibody to enhance its therapeutic properties] for extended half-life and optimised CD3 binding, enabling intermittent dosing and controlled T-cell activation.

Clinical Trials

Pfizer

JUNE 13, 2025

TALZENNA is the first and only PARP inhibitor licensed in the European Union for use with XTANDI for patients with mCRPC, with or without gene mutations. The combination was also approved by the European Commission in January 2024 for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated.

Gene

Bio Pharma Dive

JUNE 27, 2025

Published June 27, 2025 Ned Pagliarulo Lead Editor post share post print email license Bristol Myers Squibb sells two CAR-T cell therapies for cancer. Alongside removal of the REMS, the regulator also reduced its requirement that patients remain nearby the facility they received treatment from one month to two weeks.

Gene Therapy

Pharmaceutical Technology

JULY 1, 2025

Zilovertamab, a clinical-stage monoclonal antibody, was being evaluated in the treatment of several blood cancer types via inhibition of receptor tyrosine kinase-like orphan Receptor 1 (ROR1), a protein that plays a role in tumour growth. How will RFK Jr’s American dream for vaccines play out?

Clinical Trials

Pharmaceutical Technology

JUNE 13, 2025

There is also a seronegative MG population with no detectable antibodies, potentially involving unknown antibodies or different mechanisms. No curative therapies yet exist Four main categories of treatment are currently used in MG: corticosteroids, immunosuppressants, acetylcholinesterase inhibitors and monoclonal antibodies.

Marketing

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.

Gene Therapy

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

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).

Antibody

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).

Marketing

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).

Licensing

Camargo

DECEMBER 13, 2021

A biologics license application (BLA) is required for biological products subject to licensure under the PHS Act, and FDA approval to market a biologic is granted by issuance of a biologics license. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

Development

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?

Development

BioPharma Reporter

OCTOBER 26, 2023

The biopharmaceutical industry witnessed a 400% growth in total deal value of antibody-drug conjugate (ADC) licensing agreements from 2017-2022 and reached a peak of $16.6 billion in 2022, reveals data and analytics company GlobalData.

Licensing

pharmaphorum

APRIL 14, 2022

billion alliance with Genmab to find new cancer therapies, AbbVie has said it is ready to start talking to regulators about filing for approval of the lead drug in the partnership – epcoritamab for large B-cell lymphoma (LBCL). The post AbbVie preps filings for lymphoma bispecific licensed from Genmab appeared first on.

Licensing

BioPharma Reporter

SEPTEMBER 8, 2020

AbbVie has boosted its immunotherapy pipeline in a global licensing deal with Chinese biotech, I-Mab, for its anti-CD47 monoclonal antibody, lemzoparlimab.

Licensing

BioPharma Reporter

JANUARY 6, 2023

Synaffix, a Netherlands based company providing clinical-stage platform technology for the development of antibody-drug conjugates (ADCs), has signed off on two new licensing deals this week.

Licensing

Pharmaceutical Technology

JANUARY 19, 2023

Nuvaxovid demonstrated a significant antibody response when given as a booster dose after primary vaccination with other authorised Covid-19 doses in the COV-BOOST trial. The regulator approved Nuvaxovid for use as a primary series in adolescents aged 12 to 17 years in August last year.

Vaccination

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.

Drugs