Pharmaceutical Technology

JANUARY 9, 2023

Eisai and Biogen have received approval for their antibody Leqembi (lecanemab-irmb) , 100mg/mL injection for intravenous use, from the US Food and Drug Administration (FDA) under the Accelerated Approval Pathway to treat Alzheimer’s disease (AD). The regulatory approval is based on the data obtained from the Phase II trial.

FDA Approval 246

FDA Approval Antibody Clinical Trials Clinical Trials 246

Pharma Mirror

APRIL 18, 2023

The license allows Sterling to manufacture antibody-drug conjugates (ADCs) for clinical use in its current Good Manufacturing Practices (cGMP) compliant manufacturing facility in Deeside, UK.

Licensing 130

Licensing Licensing Manufacturing Antibody 130

Pharmaceutical Technology

OCTOBER 17, 2023

LegoChem Biosciences has entered an exclusive worldwide licensing agreement with Glycotope to develop an antibody-drug conjugate (ADC).

Antibody 130

Antibody Development Drugs Licensing 130

Fierce Pharma

NOVEMBER 8, 2024

A subcutaneous version of Daiichi Sankyo’s AstraZeneca-partnered blockbuster antibody-drug conjugate (ADC) Enhertu could be in the works from Korea’s Alteogen following a licensing deal worth up to | Alteogen will use its human hyaluronidase hybridization platform to develop a subcutaneous formulation of the blockbuster antibody-drug conjugate.

Licensing 137

Licensing Licensing Antibody Drugs 137

Pharmaceutical Technology

OCTOBER 13, 2023

MediLink will receive $70m upfront and will be eligible for up to $1bn in additional milestone-based payments from BioNTech.

Licensing 147

Licensing Licensing Antibody Drugs 147

Pharmaceutical Technology

DECEMBER 26, 2022

LegoChem Biosciences and Amgen have signed a multi-target research collaboration and license agreement to develop antibody-drug conjugates (ADC). Till date, the company has signed a total of 12 ADC licensing deals, worth more than $5bn.

Antibody 130

Antibody Development Drugs Licensing 130

Pharmaceutical Technology

OCTOBER 5, 2023

Antibody-drug conjugates (ADCs) saw a 400% growth in total licensing agreement deal value from 2017 to 2022 and reached a peak of $16.6bn.

Licensing 130

Licensing Licensing Antibody Drugs 130

Bio Pharma Dive

JUNE 21, 2024

Elsewhere, Vanda rejected two takeover bids and Ashibio emerged from stealth with an antibody licensed from Gilead. A medicine Jazz acquired in 2019 missed the goal of a Phase 2 study.

Licensing 167

Licensing Licensing Development Antibody 167

pharmaphorum

JANUARY 10, 2023

Astellas has licensed rights to a drug developed by Selecta Biosciences that could make more patients eligible for treatment with its gene therapy for inherited neuromuscular disorder Pompe disease. The post Astellas licenses companion drug for Pompe gene therapy appeared first on.

Gene Therapy 119

Gene Therapy Gene Licensing Licensing 119

Pharmaceutical Technology

APRIL 13, 2023

Biogen has exercised an option to license Denali Therapeutics ’ (Denali) programme to develop immunotherapies for the treatment of Alzheimer’s disease. ATV: Aβ uses Denali’s ATV technology to cross the blood-brain barrier (BBB) and increase brain exposure to antibodies.

Licensing 130

Licensing Licensing Antibody Clinical Trials 130

Pharmaceutical Technology

JANUARY 15, 2025

AbbVie and Simcere Zaiming have announced an option-to-license agreement for the development of an investigational drug candidate, SIM0500.

Development 147

Development Antibody Licensing Licensing 147

Bio Pharma Dive

JUNE 14, 2024

Following Roche, Merck and others into a hot field, the Humira maker will pay $150 million to license a preclinical TL1A antibody for IBD.

Licensing 157

Licensing Licensing Antibody Drugs 157

pharmaphorum

OCTOBER 10, 2024

Ono Pharma and Boehringer Ingelheim both added to their cancer pipelines, licensing drugs from LigaChem Bio and Circle Pharma, respectively.Ono's deal with South Korean antibody-drug conjugate (ADC) specialist LigaChem is worth up to $700 million and covers a license to a preclinical-stage candidate for solid tumours, as well as an R&D collaboration (..)

Licensing 103

Licensing Licensing Antibody Drugs 103

pharmaphorum

APRIL 2, 2024

Ipsen has expanded its oncology pipeline by licensing rights to an antibody-drug conjugate (ADC) for solid tumours from Sutro Biopharma, its first drug in the category.

Licensing 105

Licensing Licensing Antibody Drugs 105

Bio Pharma Dive

OCTOBER 20, 2023

The deal is worth up to $22 billion in total, making it one of the largest pharmaceutical licensing agreements by value.

Antibody 157

Antibody Licensing Licensing Drugs 157

BioPharma Reporter

NOVEMBER 7, 2023

The German mRNA giant BioNTech has sealed a pact worth up to $1 billion with Biotheus to develop the Chinese biotech companyâs bispecific antibody cancer drug PM8002 in all territories except for Greater China.

Antibody 98

Antibody Licensing Licensing Drugs 98

Pharmaceutical Technology

OCTOBER 19, 2022

Syncromune and Biocytogen Pharmaceuticals’ wholly owned subsidiary Eucure Biopharma have entered an exclusive global licence agreement for OX40 antibody YH002 and two other active ingredients. . Eucure will oversee the production and delivery of the drug, while Syncromune will handle the clinical development and marketing.

Antibody 130

Antibody Licensing Licensing Containment 130

Pharmaceutical Technology

NOVEMBER 27, 2022

Biocytogen Pharmaceuticals and ADC Therapeutics have signed an assessment and option agreement for evaluating antibodies against three tumour targets. Under the deal, ADC Therapeutics will receive a licence from Biocytogen to evaluate the latter’s antibodies against the targets.

Antibody 130

Antibody Licensing Licensing Development 130

pharmaphorum

AUGUST 20, 2024

Danish biotech Adcendo has accelerated its progression to a clinical-stage biotech by licensing an antibody-drug conjugate (ADC) from China's Multitude Therapeutics with potential in various forms of cancer.Copenhagen-based Adcendo is paying what is rumours to be tens of millions of dollars in upfront fees for rights to Multitude's anti-tissue factor (..)

Licensing 105

Licensing Licensing Antibody Drugs 105

Pharmaceutical Technology

JANUARY 6, 2023

Danish biotech company Adcendo has entered into a licence agreement with Duality Biologics on the next-generation antibody-drug conjugates (ADC) platform. The post Adcendo and Duality Biologics sign license deal for ADC platform appeared first on Pharmaceutical Technology.

Licensing 130

Licensing Licensing Antibody Development 130

Pharmaceutical Technology

SEPTEMBER 16, 2022

The US Food and Drug Administration (FDA) has granted fast track designation to Jasper Therapeutics’ antibody, JSP191, for the treatment of severe combined immunodeficiency (SCID) patients who undergo allogeneic hematopoietic stem cell transplant. .

Antibody 130

Antibody Clinical Trials Clinical Trials Licensing 130

Pharmaceutical Technology

OCTOBER 7, 2022

Provention Bio and Sanofi US have signed a co-promotion agreement to launch the former’s lead investigational drug candidate, teplizumab for the delay in the onset of clinical type 1 diabetes (T1D). The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk.

FDA Approval 299

FDA Approval Licensing Licensing Antibody 299

Bio Pharma Dive

AUGUST 20, 2024

In addition to new stock offerings, this week saw Merck license an antibody drug conjugate and BARDA further work trying to innovate remote clinical trials.

Clinical Trials 144

Clinical Trials Clinical Trials Licensing Licensing 144

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

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

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. .

Antibody 98

Antibody Licensing Licensing Medicine 98

Pharmaceutical Technology

APRIL 5, 2023

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to InflaRx’s Gohibic (vilobelimab) to treat critically ill hospitalised Covid-19 adult patients. It is a first-in-class monoclonal anti-human complement factor C5a antibody.

Licensing 246

Licensing Licensing Antibody Regulation 246

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

pharmaphorum

JUNE 17, 2021

Biogen has four other Alzheimer’s candidates in its clinical pipeline behind recently-approved Aduhelm, but one of them – anti-tau antibody gosuranemab – has just been canned. The drug also proved ineffective in an earlier trial in patients with progressive supranuclear palsy (PSP), another neurodegenerative disorder.

Antibody 98

Antibody Protein Licensing Licensing 98

Pharmaceutical Technology

MARCH 23, 2023

The US Food and Drug Administration (FDA) has approved Incyte ’s Zynyz (retifanlimab-dlwr) to treat metastatic or recurrent locally advanced merkel cell carcinoma (MCC) in adult patients. Zynyz (retifanlimab-dlwr) is a humanised monoclonal antibody targeting programmed death receptor-1 (PD-1).

FDA Approval 245

FDA Approval Licensing Licensing Antibody 245

pharmaphorum

JANUARY 12, 2021

ImmunityBio has licensed technology underpinning a COVID-19 vaccine that could be administered orally rather than by injection from UK biotech iosBio. ImmunityBio’s vaccine design drives both antibody and T-cells to the spike (S) protein and nucleocapsid (N) protein.

Licensing 119

Licensing Licensing Vaccination Vaccine 119

Pharmaceutical Technology

AUGUST 8, 2022

AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer.

FDA Approval 264

FDA Approval HR Clinical Trials Clinical Trials 264

BioSpace

DECEMBER 21, 2022

Merck entered into a license and collaboration agreement with Chinese company Kelun-Biotech to develop seven antibody-drug conjugates candidates against oncology targets.

Licensing 74

Licensing Licensing Antibody Development 74

Pharmaceutical Technology

JULY 29, 2022

The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease.

Trials 264

Trials Clinical Trials Clinical Trials Licensing 264

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

BioSpace

AUGUST 11, 2020

Celleron Therapeutics signed a licensing agreement with Roche for the worldwide rights to cancer drug emactuzumab, a monoclonal antibody directed against colony-stimulating factor 1 (CSF-1R) expressed on macrophages.

Drugs 96

Drugs Licensing Licensing Antibody 96

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 study was a key element of the FDA filing, and the first ever evidence that a drug therapy could delay the onset of T1D.

Antibody 98

Antibody Insulin Trials Production 98