Drug Discovery World

AUGUST 9, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T cell therapy.

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Drug Discovery World

OCTOBER 4, 2023

The US Food and Drug Administration (FDA) has accepted Rocket Pharmaceuticals’ Biologics License Application (BLA) and granted Priority Review for RP-L201 (marnetegragene autotemcel). As the Principal Investigator in the US, I oversaw treatment of six of the nine LAD-I patients in this trial. In my opinion, the results are remarkable.

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Drug Discovery World

AUGUST 8, 2023

Astellas Pharma will invest $50 million into Poseida Therapeutics to secure the rights to the company’s cancer CAR-T cell therapy for solid tumours, which is currently in Phase I trials. ” Astellas’ portfolio includes oncolytic viruses, bispecific immune cell engagers, small molecules, and cell therapy platforms.

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Drug Discovery World

MARCH 6, 2024

This second ODD allows research and development of a therapy for another form of the disease, Isolated Hypomyelination. Earlier last year the biotech successfully led a second round of investment, taking the total up to £13.2m ($16.7m), which will take it up to the start of in-human clinical trials later this year.

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Drug Discovery World

DECEMBER 2, 2022

The US Food and Drug Administration (FDA) has accepted Sarepta Therapeutics’ Biologics License Application (BLA) seeking accelerated approval of SRP-9001 (delandistrogene moxeparvovec) for the treatment of ambulant individuals with Duchenne muscular dystrophy. .

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Drug Discovery World

DECEMBER 20, 2022

The first gene therapy for haemophilia B could soon be available to patients in Europe following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). . 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

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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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. . Camaisa. .

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Drug Discovery World

MARCH 24, 2023

This synergy was demonstrated by the AIPAC Phase IIb trial’s encouraging efficacy and safety, including a over 2.9-month 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).

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Drug Discovery World

JULY 2, 2024

In a Phase I trial, patients with metastatic kidney cancer who took a live biotherapeutic product alongside immunotherapy and enzymatic tyrosine kinase inhibitors experienced improved health outcomes. Scientists from Osel and Miyarisan Pharmaceutical, the manufacturer of CBM588, collaborated on the study.

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Drug Discovery World

NOVEMBER 24, 2023

7,8 Results from the primary endpoint of the TOPAZ-1 Phase III trial showed that durvalumab, in combination with standard of care gemcitabine plus cisplatin (chemotherapy) demonstrated a clinically meaningful and durable overall survival (OS) benefit as a treatment for patients with advanced BTC.6 Innovative Licensing and Access Pathway.

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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

DECEMBER 14, 2023

However, 50% of responding patients will relapse either due to evolution of CD19 negative disease or early loss of CAR T-cells so that only around 40% of patients are cured by the currently licensed CAR T-cell therapies. Genetically modified CAR T-cells targeting CD19 have shown impressive outcomes in relapsed/refractory ALL.

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Drug Discovery World

JANUARY 3, 2024

It has been licensed by the National Medical Products Administration (NMPA) in cases where the infection is resistant to treatment with ganciclovir, valganciclovir, cidofovir or foscarnet. The post China’s NMPA okays maribavir for post-transplant cytomegalovirus appeared first on Drug Discovery World (DDW).

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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. Nothing is definitive yet, and these are complicated trials, but the world wants to move to safer alternatives that don’t impede daily life or cause further issues.

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Conversations in Drug Development Trends

OCTOBER 26, 2022

Bringing a psychedelic into a clinical trial setting is complex and requires a thorough operational approach to ensure the study’s success. Psychedelic trials need to be done with scientific rigor. Our team published recently in The Journal of Psychedelic Psychiatry exploring how we can bring more rigor to these trials.

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Drug Discovery World

SEPTEMBER 6, 2022

DDW Editor Reece Armstrong looks at the cell and gene therapy landscape, examining the challenges facing developers and the trends we can expect to see throughout the year. . There’s no doubt that cell and gene therapies present some of the most exciting opportunities for emerging drugs. billion, compared to $19.9 Cancer is king .

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Drug Discovery World

JUNE 1, 2023

6 Also in May 2023, Shanghai-native LaNova Medicines entered into an exclusive license agreement with AstraZeneca for LM-305, a pre-clinical stage ADC targeting G protein-coupled receptor, class C, group 5, member D (GPRC5D).

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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. Following the out licensing agreement, AZ will take RXC006 into clinical development, and will focus on evaluating the asset in a number of fibrotic disease including IPF. Source link.

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Drug Target Review

FEBRUARY 1, 2024

This can present challenges when attempting to recruit an enriched patient population for clinical trials. Historically, what has limited investor interest in funding neurological and psychiatric therapies in development? We were able to license a molecule from a multi-national pharmaceutical company.

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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Drug Discovery World

JANUARY 25, 2024

This follows another BIA report in January 2024, which showed that the UK is a global leader in cell and gene therapy (CGT), with significant investment and the highest number of clinical trials in Europe. Major licensing and M&A deals demonstrate the ongoing quality and attractiveness of UK science.

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The Pharma Data

JANUARY 6, 2021

CAMBRIDGE, England & WETHERBY, England–( BUSINESS WIRE )– Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer ® and pre|CISION platforms, is pleased to announce that it has entered into a license agreement with POINT Biopharma Inc.

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Drug Discovery World

JULY 26, 2023

A Cancer Research UK-funded clinical trial has shown, for the first time, that a new class of antibody could benefit cancer patients whose existing treatments have stopped working. The drug, MOv18 IgE, was developed by researchers at King’s College London.

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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.

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Drug Discovery World

AUGUST 1, 2023

Partnerships Earlier this year cell-engineering company MaxCyte signed a strategic platform license (SPL) with biotechnology company Catamaran Bio. In return MaxCyte will receive platform licensing fees and program-related revenue.

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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. The approval by the SMC is based on robust results from two trials in the largest Phase III programme in HS to date, SUNSHINE and SUNRISE11-13.

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Drug Discovery World

FEBRUARY 6, 2023

Mesoblast has resubmitted its biologics license application (BLA) to the US Food and Drug Administration (FDA) for approval of remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).

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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 Discovery World

SEPTEMBER 27, 2023

The therapy is now recommended within an NHS setting for the treatment of adults with newly diagnosed MM where an autologous stem cell transplant (ASCT) is unsuitable. Seven years of trial data DLd is licensed and has been available for use in Europe since 2019.

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Drug Discovery World

JULY 11, 2023

There is a significant unmet medical need for therapies that slow down or reverse disease progression in the field of neurodegenerative diseases. The partnership has already been successful in generating a pipeline of discovery and pre-clinical-stage programmes.

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The Pharma Data

OCTOBER 27, 2021

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. Small molecule candidate Anle138b targets disease modification for multiple system atrophy and other neurological disorders. About Teva.

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Drug Discovery World

OCTOBER 21, 2022

Under an exclusive agreement, Jazz Pharmaceuticals will acquire development and commercialisation rights to Zymeworks’ zanidatamab across all indications and all territories except for those Asia/Pacific territories previously licensed by Zymeworks. billion, plus royalties on net sales.

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The Pharma Data

MARCH 30, 2021

Novartis Oncology continues to reimagine cancer care through development of robust radioligand therapy portfolio. We continue to invest in radioligand therapy as one of the four unique platforms of Novartis Oncology. Broad expression of FAP demonstrated in tumors or in tumor stroma across many solid tumors 1 ,2 ,3.

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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. About ImaginAb.

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Drug Discovery World

JANUARY 15, 2024

Chiesi and Oak Hill Bio intend to continue a Phase IIb clinical trial in 2024 in the United States, Europe, and Japan. Babies born at less than 28 weeks gestational age have low levels of IGF-1 and face high risk of severe bronchopulmonary dysplasia (BPD), which may lead to chronic lung disease. of Perspective’s shares for up to $33 million.

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The Pharma Data

DECEMBER 13, 2020

Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that the company conducted a Type B Meeting for omidubicel with the U.S. BOSTON–( BUSINESS WIRE )– Gamida Cell Ltd. Food and Drug Administration (FDA) on Friday, December 11, 2020.

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