Drug Discovery World

MARCH 13, 2024

Johnson & Johnson has announced the first data from FRONTIER 2, the long-term extension of the Phase IIb FRONTIER 1 clinical trial evaluating JNJ-2113, the first and only investigational targeted oral peptide designed to block the IL-23 receptor. at 16 weeks and 76.2% at 52 weeks). .”

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Drug Discovery World

MARCH 24, 2023

Regulatory approval The company and the US Food and Drug Administration (FDA) agreed to the integrated Phase II/III trial design for AIPAC-003 that will help inform a Biologics License Application (BLA). month median overall survival (mOS) improvement, statistically significant mOS improvements between 4.2

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Drug Discovery World

AUGUST 2, 2022

Biotechnology company Calidi Biotherapeutics has announced that a Phase I US clinical trial will use the company’s licensed oncolytic virotherapy platform NeuroNova to deliver an oncolytic adenovirus selectively to tumor sites in patients with recurrent high-grade glioma. . Official comments . less than one year. Camaisa. .

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Drug Discovery World

NOVEMBER 16, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the world’s first gene therapy for sickle-cell disease (SCD) and transfusion-dependent β-thalassemia (TDT). Trial results for Casgevy The authorisation is based on positive clinical trial data.

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Drug Discovery World

JULY 12, 2024

The US Food and Drug Administration (FDA) has granted Fast Track Designation for Asklepios BioPharmaceutical’s (AskBio) AB-1005 which is being developed for moderate Parkinson’s disease. AB-1005 is an investigational adeno-associated virus 2 glial cell line-derived neurotrophic factor (AAV2-GDNF) neurorestorative gene therapy.

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The Pharma Data

OCTOBER 27, 2021

Small molecule candidate Anle138b targets disease modification for multiple system atrophy and other neurological disorders. NYSE and TASE: TEVA) and MODAG GmbH today announced a strategic collaboration on the exclusive worldwide licensing and development of MODAG’s lead compound anle138b and a related compound, sery433.

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Drug Discovery World

FEBRUARY 1, 2023

Big pharma is helping to shape the focus The good news is that clinical trials are on the increase and market education is upping pace. Meanwhile, the Pfizer purchase of Arena Pharmaceuticals, highlights cannabinoid-based bowel disease treatments as a promising area. The GW Pharmaceuticals purchase by Jazz for $6.7

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Drug Discovery World

OCTOBER 4, 2022

William Erhardt , President, Head of Development & Operations of biotech Oligomerix, tells Lu Rahman about the company’s differentiated approach to developing disease-modifying therapeutics for neurodegenerative diseases. . With its recent award of $3.35 Overcoming sector challenges .

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Drug Discovery World

AUGUST 24, 2022

The trial will see participants receive either a 14-day course of 600 mg tecovirimat twice daily or a matched placebo treatment. As a community-based trial, participants will take the treatment or placebo in their own homes. The trial looks to include at least 500 participants in the UK. .

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Drug Discovery World

JANUARY 3, 2024

Takeda’s Livtencity (maribavir) has been approved in China for the treatment of adult patients with post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) cytomegalovirus (CMV) infection/disease.

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The Pharma Data

AUGUST 5, 2020

. AstraZeneca has signed a licensing deal with UK-based biotech company Redx Pharma for its fibrotic disease candidate RXC006. Wnt ligands are known to drive fibrotic mechanisms and are highly expressed in a number of diseases, including idiopathic pulmonary fibrosis (IPF). Source link.

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Drug Discovery World

AUGUST 25, 2023

The headline news this week reflects the high level of interest and investment in neuroscience drug discovery, particularly neurodegenerative diseases like Alzheimer’s; including positive clinical trial results for new immunotherapy and biotherapeutic candidates, and hopes that existing medications could slow the progression of dementia.

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Drug Discovery World

JUNE 1, 2023

According to NCBI, most of the ADCs developed so far are for use in the treatment of cancer, but there is plenty of potential for using ADCs to treat other diseases 1. Under the terms of the licensing agreement, AstraZeneca will be granted an exclusive global license to research, develop, and commercialize LM-305.

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LifeSciVC

JULY 17, 2024

By Mike Cloonan, Chief Executive Officer of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC The drug development process in rare diseases is rife with challenges especially when companies target significant differentiation or first-in-class targets.

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Drug Discovery World

FEBRUARY 1, 2024

GSK’s Omjjara (momelotinib) has been granted marketing authorisation in Great Britain for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.

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Drug Discovery World

FEBRUARY 16, 2024

It is licensed for adults with active moderate to severe hidradenitis suppurativa (HS) (acne inversa) who have responded inadequately to conventional systemic HS therapy. New treatment options are needed to help the HS community find relief from the burden of this disease.”

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Drug Discovery World

JANUARY 8, 2024

The partners plan to take a MERS vaccine from early development through Phase II clinical trials. If the Phase II clinical trials are successful, an investigational ready reserve of 100,000 doses will be developed to quickly enter clinical trials in the event of a substantial outbreak.

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Drug Discovery World

DECEMBER 14, 2023

Dr Amrolia is Professor of Transplantation Immunology at the UCL Great Ormond Street Institute of Child Health and an international leader in CAR T-cell therapy for paediatric ALL, and ViroCell Biologics is a specialist viral vector CDMO for cell and gene therapy (CGT) clinical trials. The study is expected to initiate in Q2 2024.

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Drug Discovery World

MARCH 27, 2024

The vaccines currently in late-stage development hold promise in tackling the disease burden of tuberculosis (TB), says data and analytics company GlobalData on World Tuberculosis Day 2024. The day aims to raise awareness about the devastating health, social, and economic consequences of the disease.

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Drug Discovery World

JULY 11, 2023

Evotec and BMS aim to identify disease-modifying treatments for a broad range of neurodegenerative diseases. There is a significant unmet medical need for therapies that slow down or reverse disease progression in the field of neurodegenerative diseases.

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Drug Discovery World

OCTOBER 27, 2023

A Phase I clinical trial to evaluate the safety and tolerability of HB‑400 in humans is ongoing. It is one of two independent development programs in HOOKIPA’s collaboration and license agreement with Gilead Sciences. The alternating two-vector approach is designed to optimise and focus the immune response against the target antigens.

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Drug Target Review

JUNE 3, 2024

How does COUR Pharmaceuticals’ immune-modifying nanoparticle platform differ from traditional approaches to treating immune-mediated diseases? Essentially, our CNPs reprogramme the immune system by restoring balance and returning the body to a homeostatic state, offering a precise approach to treating immune-mediated diseases.

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Drug Discovery World

JANUARY 3, 2023

A monoclonal antibody to prevent Covid-19 in vulnerable patients, AZD3152, has entered clinical trials less than 12 months after discovery. . The commencement of the trial triggers a $5 million milestone payment to RQ Bio and will enable the company to execute its four scientific programmes focused on viral diseases. .

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The Pharma Data

MARCH 31, 2023

AstraZeneca has completed an exclusive global license agreement with KYM Biosciences Inc. CMG901 is currently being evaluated in a Phase I trial for the treatment of Claudin 18.2-positive CMG901 is currently being evaluated in a Phase I trial for the treatment of Claudin 18.2-positive million deaths.

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Drug Discovery World

JANUARY 15, 2024

The NVIDIA DGX SuperPOD will be installed at Amgen’s deCODE genetics’ headquarters in Reykjavik, Iceland and will be used to build a human diversity atlas for drug target and disease-specific biomarker discovery. Chiesi and Oak Hill Bio intend to continue a Phase IIb clinical trial in 2024 in the United States, Europe, and Japan.

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Drug Discovery World

OCTOBER 3, 2023

Phase III trial data The WHO recommendation was based on pre-clinical and clinical trial data which showed good safety and high efficacy in four countries, making it the world’s second-ever WHO recommended vaccine for preventing malaria in children.

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Drug Discovery World

MARCH 7, 2024

A combined pipeline of therapeutic candidates Akari’s nomacopan is a bispecific recombinant inhibitor of complement C5 and leukotriene B4 (LTB4) being evaluated in a Phase III clinical trial for paediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA).

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FDA Law Blog: Drug Discovery

MARCH 13, 2023

Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision about whether to participate in a clinical trial, and what kind of treatment effects would be most meaningful to them?

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Drug Discovery World

SEPTEMBER 16, 2022

A biologic therapy for very young children with moderate to severe eczema (or atopic dermatitis) has been shown to be safe and effective in an international trial. The therapy is already licensed in the UK for adults and children aged six to 18, and was approved by the FDA in June 2022 for use in younger children.

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The Pharma Data

JANUARY 6, 2021

a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. Under the terms of the agreement, ImaginAb will supply clinical doses of 89Zr CD8 Immuno-PET agent to Pfizer for use in select oncology clinical trials. LOS ANGELES , Jan.

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Drug Discovery World

OCTOBER 4, 2023

Findings from the RESMAIN study of 4SC’s resminostat (Kinselby) treatment show that the therapy can postpone disease progression in advanced CTCL. The RESMAIN study is one of the largest randomised controlled clinical trials in advanced CTCL, involving more than 50 clinical centres in Europe and Japan, alongside 201 patients.

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Drug Discovery World

JANUARY 17, 2023

Leqembi’s prospects in the Alzheimer’s disease market remain uncertain despite its advantages over Aduhelm, says analytics company GlobalData. . Although Leqembi is a clear improvement on Aduhelm in terms of efficacy, the 27% reduction in clinical decline in its Phase III Clarity AD trial is still modest.

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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Pfizer Inc. About BioNTech.

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Drug Discovery World

AUGUST 21, 2023

Medications containing semaglutide such as Ozempic, licensed for diabetes, and Wegovy, for weight loss, are being studied to see if they can treat a range of different conditions, including addiction and dementia. However, these trials won’t be complete until 2026 at the earliest. It’s an exciting area,” he told The Guardian.

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Drug Discovery World

NOVEMBER 8, 2022

Merck has exercised its option to jointly develop and commercialise personalised cancer vaccine (PCV) mRNA-4157/V940 pursuant to the terms of its existing collaboration and license agreement with Moderna. . KEYNOTE-942 is an ongoing randomised, open-label Phase II trial that enrolled 157 patients with high-risk melanoma.

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Drug Discovery World

DECEMBER 20, 2022

The CHMP has recommended conditional marketing authorisation of CSL’s (etranacogene dezaparvovec), a one-time gene therapy for the treatment of appropriate adults with the disease. . The therapy was also recently approved by the FDA for patients in the US. . World’s most expensive drug.

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Drug Discovery World

JANUARY 4, 2023

Celltrion USA has submitted a Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act for CT-P13 SC for the treatment of inflammatory bowel disease (IBD). To read this content in full, you need to login.

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