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

Biotech company 4SC has announced positive new data for its treatment for patients with advanced-stage cutaneous T-cell lymphoma (CTCL). Findings from the RESMAIN study of 4SC’s resminostat (Kinselby) treatment show that the therapy can postpone disease progression in advanced CTCL.

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Drug Discovery World

AUGUST 23, 2022

The European Medicines Agency (EMA) has granted a Marketing Authorisation Application (MAA) for a combination treatment targeting adults with acute myeloid leukaemia (AML) who are not candidates for standard induction chemotherapy. . Poster presented at EHA Annual Meeting, Vienna, Austria June 9 – 12, 2022. Abstract P573.

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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. Participants’ gut microbiome were analysed via stool samples in the beginning for a baseline and then again 13 weeks into treatment.

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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

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. .

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Drug Discovery World

NOVEMBER 16, 2023

Casgevy (exagamglogene autotemcel, or exa-cel) is the first medicine to be licensed that uses gene editing tool CRISPR, for which its inventors were awarded the Nobel Prize in 2020. To date, a bone marrow transplant – which must come from a closely matched donor and carries a risk of rejection – has been the only permanent treatment option.

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Drug Discovery World

FEBRUARY 9, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation to AstraZeneca for Imfinzi (durvalumab) in combination with gemcitabine and cisplatin in Great Britain for use as a first-line treatment of adults with locally advanced, unresectable or metastatic biliary tract cancer (BTC). versus 11.5%).

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Conversations in Drug Development Trends

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.

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Drug Discovery World

SEPTEMBER 21, 2022

Otsuka Pharmaceutical’s Lupkynis (voclosporin) is the first oral treatment to be approved in Europe for the treatment of active lupus nephritis (LN) in adult patients. The combination treatment for this indication was approved by the US Food and Drug Administration in 2021 and gained a positive opinion from the CHMP earlier this year.

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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.

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Drug Discovery World

JULY 12, 2024

AB-1005 has also been awarded the innovative medicine designation, the Innovation Passport by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of Parkinson’s disease.

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Drug Discovery World

AUGUST 24, 2022

A new study investigating a potential treatment for people who have been diagnosed with monkeypox has been launched by the same team who helped develop Covid-19 treatments. . The trial will see participants receive either a 14-day course of 600 mg tecovirimat twice daily or a matched placebo treatment.

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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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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

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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Drug Discovery World

AUGUST 21, 2024

Adcendo and Multitude Therapeutics have signed a licensing agreement for the development of a novel, highly differentiated antibody-drug conjugate (ADC) targeting Tissue Factor (TF) with the development code ADCE-T02.

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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. Currently, all antibodies approved for the treatment of cancer belong to a class known as IgG.

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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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Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

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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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Conversations in Drug Development Trends

NOVEMBER 27, 2023

Casgevy, the commercial product formerly known as exa-cel, is administered by taking stem cells out of a patient’s bone marrow and editing a gene in the cells in a laboratory, with the modified cells then infused back into the patient after conditioning treatment to prepare the bone marrow.

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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

SEPTEMBER 6, 2022

Biopharmaceutical company Sosei Group received both Licensing Deal of the Year and Executive of the Year at the first Informa Pharma Intelligence Awards Japan. Licensing Deal of the Year recognises deals that were closed during 2021. The winning deal.

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Drug Discovery World

JULY 11, 2023

We are confident that the strong collaboration of the experienced teams at Evotec and BMS will make novel innovative treatment options available to patients living with a broad range of neurodegenerative conditions.” Evotec and BMS aim to identify disease-modifying treatments for a broad range of neurodegenerative diseases.

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Drug Discovery World

NOVEMBER 24, 2023

AstraZeneca has announced that the National Institute for Health and Care Excellence (NICE) has recommended Imfinzi (durvalumab) in combination with gemcitabine and cisplatin (chemotherapy) for NHS use in England and Wales for the first-line treatment of adults with locally advanced, unresectable, or metastatic biliary tract cancer (BTC).

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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. billion, plus royalties on net sales.

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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 including gastric cancers.

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Drug Discovery World

FEBRUARY 28, 2024

According to the American Association of Cancer Research (AACR) 2 , research-driven advances in treatments have resulted in the decline in death rates for melanoma, leukaemia, and kidney cancer. Currently, all antibodies approved for the treatment of cancer belong to a class known as IgG. Research into new cancer drugs remain strong.

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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. . A one-time treatment with etranacogene dezaparvovec costs US$3.5 The therapy was also recently approved by the FDA for patients in the US. .

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Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

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Drug Discovery World

JULY 28, 2023

The top stories: Partnership could enhance antibody discovery for cancer research Cancer Research Horizons has signed a collaboration agreement to license the entire Twist Biopharma Solutions Library of Libraries. New eBook: Breakthroughs accelerating therapeutic antibodies The latest eBook by DDW is out now.

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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. The drugs are currently approved as treatments for type 2 diabetes and weight loss.

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Drug Discovery World

FEBRUARY 27, 2023

Destiny Pharma is obliged to continue its current plan to complete the ongoing manufacture of all clinical trial supplies needed to undertake the required clinical studies. NTCD-M3 acts as a safe ‘ground cover’, preventing toxic strains of C difficile proliferating in the colon after antibiotic treatment.

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Drug Discovery World

NOVEMBER 14, 2023

Additionally, interim results from an ongoing Phase I/II trial for Aulos Bioscience’s monoclonal antibody AU-007 were positive, showing that AU-007 is well tolerated in patients with unresectable locally advanced or metastatic cancer and there are early signs of anti-tumour activity. billion in 2022 to $53.81

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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

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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