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. We are pleased with Biogen’s decision to license ATV: Aβ and we are hopeful this will foster the development of next-generation anti-Aβ therapeutics.”

Licensing 130

Licensing Licensing Antibody Clinical Trials 130

Worldwide Clinical Trials

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

Trials 200

Trials Clinical Trials Clinical Trials Regulation 200

Pharmaceutical Technology

JUNE 19, 2023

Bio-Thera Solutions and Biomm have entered a licensing and supply agreement for Bio-Thera’s BAT2206, a ustekinumab biosimilar. The therapy, which completed a Phase I trial, is now being assessed in an international Phase III clinical trial that includes participants from China and Eastern European countries.

Licensing 130

Licensing Licensing Clinical Trials Clinical Trials 130

Pharmaceutical Technology

APRIL 13, 2023

ImaginAb will be responsible for licensing and supplying the clinical doses of 89Zr crefmirlimab berdoxam, its investigational CD8 ImmunoPET tracer, to Leucid Bio. Biotechnology company ImaginAb has entered into a new non-exclusive licence and supply agreement with Leucid Bio for CD8 ImmunoPET technology.

Licensing 130

Licensing Licensing Gene Therapy Gene 130

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 20, 2023

Empowering of the Central Drugs Standard Control Organisation (CDSCO) through centralisation of drug licensing may not be the path to improve the quality of drugs manufactured in the country both for domestic and international markets, says SME Pharma Industries Confederation (SPIC), the apex organisation of small and medium pharma industries in the (..)

Licensing 156

Licensing Licensing Drugs Manufacturing 156

Pharmaceutical Technology

APRIL 25, 2023

German biotechnology firm 3B Pharmaceuticals (3BP) has entered into a licensing agreement with Novartis Innovative Therapies for its fibroblast activation protein (FAP)-targeting peptide technology. The therapy candidate is currently under evaluation in the Phase l LuMIERE clinical trial.

Licensing 130

Licensing Licensing Clinical Development Clinical Trials 130

Pharmaceutical Technology

JULY 28, 2022

According to the deal, Cidara will continue to oversee the international Phase III ReSPECT prophylaxis clinical trial underway. The post Melinta and Cidara sign licensing deal for rezafungin appeared first on Pharmaceutical Technology. At the time points mentioned in the deal, the NDA will be transferred to Melinta. “We

Licensing 147

Licensing Licensing Clinical Trials Clinical Trials 147

Pharmaceutical Technology

OCTOBER 4, 2022

In the Phase III portion of a Phase II/III clinical trial in Asia, ensitrelvir met the primary endpoint. The post Shionogi and MPP enter Covid-19 antiviral licensing deal appeared first on Pharmaceutical Technology.

Licensing 147

Licensing Licensing Manufacturing Medicine 147

Pharmaceutical Technology

MARCH 23, 2023

This year, Biohaven is expecting to advance the TYK2/JAK1 inhibitor into a Phase I trial. It showed high selectivity over JAK2, JAK3 and other kinases, and potentially improved safety over less selective or non-selective JAK inhibitors. BHV-8000’s mechanistic proof of concept was showed in several pre-clinical models.

Licensing 263

Licensing Licensing Clinical Development Development 263

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 29, 2024

Biodexa’s worldwide rights of eRapa come with a $17m grant from CPRIT to support the asset into Phase III clinical trials.

Licensing 130

Licensing Licensing Clinical Trials Clinical Trials 130

Pharmaceutical Technology

JANUARY 26, 2024

Renalys plans to start a registrational trial for sparsentan as a treatment for IgA nephropathy in Japan in Q2 2024.

Licensing 147

Licensing Licensing Trials 147

pharmaphorum

APRIL 22, 2021

Biosensor firm physIQ has licensed its technology to Johnson & Johnson’s Janssen pharma unit in a multi-year deal, to investigate use of wearable sensors in virtual clinical trials. The poll of 114 triallists by clinical data specialist ERT found 82% of them found organisations aery using “virtual trial” approaches.

Licensing 72

Licensing Licensing Trials Clinical Trials 72

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 147

Clinical Trials Clinical Trials Licensing Licensing 147

Bio Pharma Dive

OCTOBER 27, 2022

GSK said the drug, formerly a top prospect licensed from German biotech Morphosys, showed “limited efficacy” in a Phase 3 study of patients with rheumatoid arthritis.

Drugs 208

Drugs Licensing Licensing Trials 208

pharmaphorum

JANUARY 9, 2023

Swiss biotech Stalicla has continued to diversify its pipeline from a focus on autism therapies with a deal to license Novartis’ mavoglurant, in clinical trials for cocaine use disorder (CUD) as well as neurodevelopmental disorders (NDD). STP-2 was licensed from Evgen Pharma in October last year.

Licensing 59

Licensing Licensing Trials Clinical Trials 59

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 biotech said earlier it planned to seek FDA approval to start clinical trials towards the end of 2022.

Licensing 111

Licensing Licensing FDA Approval Clinical Trials 111

Pharmaceutical Commerce

FEBRUARY 20, 2024

The agency will make its final decision surrounding the locally advanced or metastatic nonsquamous NSCLC drug —based on results from the TROPION-Lung01 Phase III trial—by Q4 2024.

Licensing 101

Licensing Licensing Trials Drugs 101

Pharmaceutical Technology

JUNE 30, 2022

In the wake of Russia’s invasion of Ukraine, sponsors are increasingly evaluating other European countries to conduct their clinical trials. Among them, the Eastern European nation of Georgia has emerged as a key rescue country for multinational clinical trials that were put on hold due to the war. Logistics expertise.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Licensing 130

Bio Pharma Dive

DECEMBER 14, 2021

Fitusiran, which Sanofi licensed from Alnylam, could finally get to market after trial delays and safety concerns slowed its progress. But gene therapies and other new medicines might provide competition.

Gene Therapy 329

Gene Therapy Licensing Licensing Gene 329

Bio Pharma Dive

FEBRUARY 10, 2022

The agency criticized Eli Lilly for using a trial run in China to seek approval of an immunotherapy it licensed from Innovent Biologics. Outside advisers agreed in a decisive vote that could have repercussions for several other drugmakers.

Licensing 341

Licensing Licensing Drugs Trials 341

Pharma Times

DECEMBER 21, 2021

The DETERMINE trial aims to discover whether existing ‘licensed’ drugs could also benefit patients with rare cancer types that the drug is not currently licensed for.

Trials 123

Trials Licensing Licensing Drugs 123

BioTech 365

JANUARY 10, 2022

Cellectis’ Licensed Partner, Allogene Therapeutics, Announces Removal of FDA Clinical Hold on their Clinical Trials Cellectis’ Licensed Partner, Allogene Therapeutics, Announces Removal of FDA Clinical Hold on their Clinical Trials • Allogene reported that Chromosomal Abnormality Was Not the Result of TALEN® … Continue reading →

Clinical Trials 40

Clinical Trials Clinical Trials Licensing Licensing 40

Pharmaceutical Technology

MAY 18, 2023

The trial, a six-week study, will assess the change in the Hamilton Depression Rating Scale score, says Houghtaling. The trial will take place at US clinical sites, adds Houghtaling. Gate Neuroscience has already identified the CRO for the trial alongside some initial trial sites, he says. Rob Houghtaling, Sr.

Trials 130

Trials Licensing Licensing Development 130

Pharmaceutical Technology

MAY 16, 2024

Uniquity is planning Phase II trials in COPD and asthma with TSLP-targeting drug solrikitug that it licensed from MSD

Licensing 130

Licensing Licensing Trials Drugs 130

Worldwide Clinical Trials

OCTOBER 19, 2022

Vice President of Scientific Solutions, Neuroscience, at Worldwide Clinical Trials. Of note, these programs differ significantly from conventional psychiatry trials. In a nonpsychedelic trial, sites should remain neutral with patients to remove non-specific treatment effects. Managing the ethics of psychedelic trials.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Production 130

Cloudbyz

MARCH 31, 2024

The landscape of clinical trial management is undergoing a significant transformation, driven by the complex demands of modern medical research. As we delve into the challenges posed by point systems, it becomes clear that a platform approach is not just beneficial but essential for the future of clinical trials.

Clinical Trials 103

Clinical Trials Clinical Trials Trials Compliance 103

BioTech 365

JANUARY 19, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Ex-Gilead execs bag $80M to trial drug licensed from Merck KGaA.Ex-Gilead Gilead execs bag $80M to trial drug licensed from Merck KGaA ntaylor Tue, 01/19/2021 – 08:16 from … Continue reading →

Licensing 40

Licensing Licensing Trials Drugs 40

Pharmaceutical Technology

APRIL 19, 2023

Neuronascent plans to start a potential Phase II trial of its neurorestorative agent NNI-362 in Parkinson’s disease in H1 2024, said CEO Judith Kelleher-Andersson in an interview with P harmaceutical Technology. The potential Phase II trial in Parkinson’s disease will recruit between 75 and 100 patients, said Kelleher-Andersson.

Trials 130

Trials Drugs Licensing Licensing 130

BioSpace

MAY 10, 2024

With its $525 million investment, Royalty Pharma will acquire the royalties and milestones for ImmuNext’s anti-CD40 therapy frexalimab, which is currently in Phase III trials for multiple sclerosis.

Licensing 87

Licensing Licensing Trials 87

CTTI (Clinical Trials Transformation Initiative)

DECEMBER 3, 2024

Through this project, CTTI will clarify the needs and expectations of clinical trial partner groups and facilitate unified, action-focused engagement to support the development and execution of trials that recruit, retain, and enroll a diverse, representative patient population.

45

45

BioTech 365

JANUARY 27, 2022

Systemic Hypertension Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing and Acquisitions, and Drug-specific Revenue Forecasts – ResearchAndMarkets.com Systemic Hypertension Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing (..)

Clinical Trials 40

Clinical Trials Clinical Trials Licensing Licensing 40

BioTech 365

JANUARY 27, 2022

Glioblastoma (GBM) Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing and Acquisitions, and Drug-specific Revenue Forecasts – ResearchAndMarkets.com Glioblastoma (GBM) Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing and (..)

Clinical Trials 40

Clinical Trials Clinical Trials Licensing Licensing 40

BioTech 365

JANUARY 27, 2022

Atrial Fibrillation (AF) Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing and Acquisitions, and Drug-Specific Revenue Forecasts – ResearchAndMarkets.com Atrial Fibrillation (AF) Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, (..)

Clinical Trials 40

Clinical Trials Clinical Trials Licensing Licensing 40

BioTech 365

JANUARY 27, 2022

Systemic Lupus Erythematosus (SLE)Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, Regulatory Events, Licensing and Acquisitions, and Drug-specific Revenue Forecasts – ResearchAndMarkets.com Systemic Lupus Erythematosus (SLE)Market Spotlight Report 2021: 10-Year Disease Prevalence Forecast, Clinical Trials, (..)

Clinical Trials 40

Clinical Trials Clinical Trials Licensing Licensing 40

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

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. The post Oral COVID-19 vaccine beckons, as ImmunityBio licenses iosBio tech appeared first on. Symvivo also has an oral candidate in a phase 1 study which started last November.

Licensing 119

Licensing Licensing Vaccination Vaccine 119