BioPharma Reporter

APRIL 2, 2024

Ipsen is expanding its oncology pipeline by securing the global licensing rights to an antibody-drug conjugate (ADC) for solid tumors from Sutro Biopharma, its first drug in the category.

Licensing 52

Licensing Licensing Antibody Drugs 52

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 59

Licensing Licensing Antibody Drugs 59

Pharmaceutical Technology

MAY 24, 2023

Y-mAbs Therapeutics has received marketing authorisation for Danyelza (naxitamab-gqgk) 40mg/10mL injection from the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária, to treat high-risk neuroblastoma. The therapy is given three times a week and repeated every four weeks.

Marketing 130

Marketing Licensing Licensing Antibody 130

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 52

Licensing Licensing Antibody Research 52

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

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 52

Licensing Licensing Antibody Development 52

Pharmaceutical Technology

MAY 8, 2023

Reddy’s Laboratories have partnered for the development and commercialisation of the anti-PD-1 monoclonal antibody, toripalimab, in 21 countries. The company may also choose to expand the scope to license toripalimab in New Zealand, Australia, and in nine other countries.

Development 130

Development Marketing Licensing Licensing 130

pharmaphorum

SEPTEMBER 27, 2022

While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. The post Lava fires up a $700m cancer licensing deal with Seagen appeared first on.

Licensing 111

Licensing Licensing FDA Approval Clinical Trials 111

The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

Antibody 52

Antibody Licensing Licensing Development 52

The Pharma Data

JUNE 2, 2022

Boehringer Ingelheim and the Agency for Science, Technology and Research (A*STAR) today announced a global licensing agreement under which Boehringer Ingelheim will obtain exclusive worldwide rights to research, develop and commercialize products based on a panel of innovative, tumor-specific antibodies from A*STAR.

Antibody 52

Antibody Licensing Licensing Development 52

Roots Analysis

JANUARY 21, 2024

With fourteen approved drugs and several drug candidates being evaluated under different stages of development, antibody drug conjugates (ADCs) are now recognized as a potent class of targeted therapeutics. In this context, the role of the linker molecule and the conjugation technology used is pivotal.

Antibody 40

Antibody Recombinant DNA Technology Drugs Marketing 40

Pharmaceutical Technology

JANUARY 19, 2023

Acute myeloid leukemia (AML) is part of a market of blood malignancies that commercial cell therapies have not managed to penetrate yet. However, it is possible to target CD33 in the clinic, as evidenced by the FDA approval of Pfizer’s anti-CD33 antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) in 2000.

Marketing 130

Marketing Gene Editing Production Sales 130

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 105

Antibody Licensing Licensing Drugs 105

pharmaphorum

APRIL 9, 2021

The FDA says it has uncovered “deficiencies” in the marketing application for Provention Bio’s much-anticipated drug teplizumab for the prevention of type 1 diabetes (T1D) that could delay its review. The post Provention faces delay in FDA review of diabetes prevention antibody appeared first on.

Antibody 98

Antibody Insulin Trials Production 98

pharmaphorum

JULY 8, 2022

Swedish rare disease specialist Sobi is paying $55 million upfront to license rights to ADC Therapeutics’ lymphoma therapy Zynlonta – approved in the US last year – in Europe and other international markets. The post Sobi bolsters blood division via $435m ADC licensing deal appeared first on.

Licensing 52

Licensing Licensing Sales Marketing 52

Pharmaceutical Technology

SEPTEMBER 13, 2022

Gilead’s Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2 directed antibody-drug conjugate (ADC), with a potent topoisomerase I inhibitor payload. As Trodelvy will have the first-in-class advantage in the HER2-negative setting, dato-DXd would have to demonstrate superior efficacy to dominate this market.

HR 162

HR Marketing Hormones FDA Approval 162

Pharmaceutical Technology

MAY 12, 2023

On 8 May 2023, China-based Bliss Biopharmaceutical (BlissBio) announced a clinical trial collaboration with Eisai to develop BB-1701, an antibody-drug conjugate (ADC) for multiple cancer types. Seagen has three marketed ADCs as well as two novel ones, one of which, disitamab vedotin, is HER2-directed.

Clinical Trials 162

Clinical Trials Clinical Trials Licensing Licensing 162

pharmaphorum

JANUARY 4, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), seeking approval of talquetamab for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). This reduces the timeframe for the MAA to be reviewed.

Marketing 98

Marketing Antibody Medicine FDA Approval 98

pharmaphorum

APRIL 14, 2022

Epcoritamab is a bispecific antibody which targets CD3 on white blood cells and CD20 on tumour cells, and is designed to encourage an immune response against the cancer. The post AbbVie preps filings for lymphoma bispecific licensed from Genmab appeared first on. billion product at peak. billion product at peak.

Licensing 64

Licensing Licensing Immune Response Antibody 64

pharmaphorum

OCTOBER 18, 2022

Gilead Sciences has made yet another rush into the oncology category, licensing a bispecific antibody from MacroGenics in development as a treatment for CD123-positive blood cancers, including acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS). Along with the signing fee, there is another $1.7

Antibody 52

Antibody Sales Clinical Trials Clinical Trials 52

Pharmaceutical Technology

DECEMBER 19, 2022

With the latest development, Sanofi will licence a NK cell engager programme that acts on B7H3 from the antibody-based NK cell engager therapeutics (ANKET) platform of Innate. On choosing the candidate, the company will oversee the complete development, production and marketing.

Development 264

Development Engineer Clinical Trials Clinical Trials 264

Pharmaceutical Technology

APRIL 6, 2023

The designation, under the regulator’s Innovative Licensing and Access Pathway (ILAP), will fast-track a potential route to market for AD04 by providing collaborative opportunities with UK institutes like the National Institute for Health and Care Excellence (NICE).

FDA Approval 264

FDA Approval Licensing Licensing Antibody 264

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.

Antibody 78

Antibody Hormones Medicine Licensing 78

pharmaphorum

FEBRUARY 8, 2022

The FDA has dropped a bomb on Eli Lilly’s marketing application for cancer immunotherapy sintilimab ahead of an advisory committee meeting due to take place on Thursday. Lilly has a long history of developing oncology products, but missed the boat when the market started to shift towards cancer immunotherapies a few years back.

Antibody 52

Antibody Licensing Licensing FDA Approval 52

Pharmaceutical Technology

OCTOBER 7, 2022

A decision on the approval of the Biologics License Application (BLA) is anticipated on 17 November. Additionally, the company granted Sanofi an exclusive right of first negotiation (ROFN) to attain international rights to market teplizumab for T1D indications for a one-time payment of $20m.

FDA Approval 299

FDA Approval Licensing Licensing Antibody 299

pharmaphorum

JUNE 24, 2021

Armed with a positive mid-stage trial readout in lung cancer, Arcus Biosciences will expand a phase 3 programme for domvanalimab, its anti-TIGIT antibody. Zimberelimab “showed activity similar to that of marketed anti-PD-1 antibodies studied in this setting,” said Arcus’ chief medical officer Bill Grossman.

Antibody 84

Antibody Trials Licensing Licensing 84

pharmaphorum

NOVEMBER 10, 2021

It is competing in the US with rival oral CGRPs, namely AbbVie’s Qulipta (atogepant) which was approved for episodic migraine prevention in September and AbbVie’s Ubrelvy (ubrogepant) in the acute treatment category, as well as several CGRP-targeting antibodies delivered by injection or infusion from Amgen, Eli Lilly, Teva and Lundbeck.

Licensing 52

Licensing Licensing Drugs Sales 52

Roots Analysis

FEBRUARY 27, 2024

Currently, product licensing agreements, technology licensing agreements, research and development agreements and clinical trial agreements are the common types of partnerships inked by developers that are currently focused on the development of ADCs pipeline. In nature, they are made by a group of bacteria known as actinomycetes.

Antibody 52

Antibody Licensing Licensing Contract Manufacturing 52

BioPharma Reporter

DECEMBER 15, 2022

The French National Agency for the Safety of Health Products (ANSM) has granted a pharmaceutical establishment license to Axploraâs Le Mans site.

Antibody 52

Antibody Licensing Licensing Drugs 52

Pharmaceutical Technology

OCTOBER 31, 2022

The European Medicines Agency (EMA) has validated AbbVie ’s marketing authorization application (MAA) for epcoritamab (DuoBody-CD3xCD20) to treat relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adult patients following two or more lines of systemic therapy.

Antibody 130

Antibody Licensing Licensing Trials 130

Pharmaceutical Technology

JUNE 2, 2023

Switzerland-based company Lonza has boosted its antibody-drug conjugates (ADCs) offering with the acquisition of Dutch biotechnology company Synaffix for a total consideration of $172m (€160m). The deal includes $107.17m (€100m) of initial financial consideration in cash and an additional $64.3m (€60m) in performance-based consideration.

Licensing 130

Licensing Licensing Gene Therapy Clinical Trials 130

pharmaphorum

MAY 13, 2021

The UK government has got cold feet over plans to buy a million doses of AstraZeneca’s antibody treatment for coronavirus, according to a press report. Bloomberg quoted two sources close to the matter saying that the government is rethinking the plans as AZ prepares to announce late-stage data for the antibody called AZD7442.

Antibody 52

Antibody Vaccination Vaccine Licensing 52

BioPharma Reporter

AUGUST 1, 2023

Renaissance Pharma, a company focused on the development of life changing therapies in pediatric rare disease, has entered into an exclusive license agreement with St. Jude Childrenâs Research Hospital for Hu14.18, a humanised antibody in development by the hospital for the treatment of newly diagnosed high-risk neuroblastoma.

Research 87

Research Licensing Licensing Antibody 87

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.

Antibody 52

Antibody Regulation Doctors Doctor 52

Pharmaceutical Technology

AUGUST 25, 2022

The European Commission (EC) has granted conditional marketing authorisation (CMA) for BioMarin Pharmaceutical ’s gene therapy, Roctavian (valoctocogene roxaparvovec), to treat adults with severe haemophilia A (congenital Factor VIII deficiency).

Gene Therapy 264

Gene Therapy Gene Clinical Trials Clinical Trials 264

Delveinsight

DECEMBER 8, 2020

KaliVir, Astellas Pharma forms a licensing deal for VET2-L2 oncolytic virus. KaliVir Immunotherapeutics and Astellas Pharma entered into a worldwide exclusive licensing agreement for the development, research, and commercialization of VET2-L2 to widen the horizon of therapeutic approaches available in the Immuno-Oncology market.

Licensing 52

Licensing Licensing Gene Therapy Antibody 52

XTalks

OCTOBER 22, 2024

Vyloy is a first-in-class monoclonal antibody that targets the CLDN18.2 The FDA had rejected Vyloy in January due to “unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility” for the drug. targeting antibody-drug conjugate. Astellas acquired Vyloy through its $1.4

FDA Approval 89

FDA Approval Drugs Licensing Licensing 89