Drug Discovery World

APRIL 11, 2024

The Scottish Medicines Consortium (SMC) has accepted GSK’s dostarlimab as a treatment for adult patients with endometrial cancer when used in combination with platinum-containing chemotherapy. This means that dostarlimab is the first immunotherapy treatment to be accepted for use within NHS Scotland for this group of eligible patients.

Therapies 130

Therapies Licensing Licensing Treatment 130

Drug Discovery World

AUGUST 16, 2024

The chosen news highlights this week all feature advances in drug development in oncology indications and reflect the breadth of therapeutic approaches to cancer treatment. First claudin 18.2 monoclonal antibody. First claudin 18.2 monoclonal antibody.

Licensing 148

Licensing Licensing Drugs Clinical Trials 148

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). All of these children have been in good health with no significant LAD-I-related infections or inflammatory skin lesions since treatment.

FDA 130

FDA Therapies Pharmaceuticals Licensing 130

Drug Discovery World

MARCH 6, 2024

This second ODD allows research and development of a therapy for another form of the disease, Isolated Hypomyelination. The technology has been proven in the treatment of other dystrophies, including Duchenne muscular dystrophy, and is quick and cost-effective to develop.

Disease 130

Disease FDA Therapies Drugs 130

Drug Discovery World

FEBRUARY 22, 2024

Astellas-owned Xyphos Biosciences and Kelonia Therapeutics have entered into a research collaboration and license agreement to develop novel immuno-oncology therapeutics. The post Companies agree $800m deal for off-the-shelf in vivo CAR-T cell therapy appeared first on Drug Discovery World (DDW).

Therapies 130

Therapies Licensing Licensing Research 130

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. months, compared to 14.9

Marketing 130

Marketing Treatment Therapies Disease 130

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. .

FDA 130

FDA Therapies Clinical Trials Licensing 130

Drug Discovery World

SEPTEMBER 6, 2023

A new licensing agreement between Vita Therapeutics and MilliporeSigma (the US and Canada Life Science business of Merck) will see Vita leverage MilliporeSigma’s foundational CRISPR patents to advance its preclinical asset VTA-100 for limb-girdle muscular dystrophy (LGMD2A).

Therapies 130

Therapies Licensing Licensing Science 130

Drug Discovery World

MAY 23, 2023

The US Food and Drug Administration (FDA) Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) have voted eight to six in favour of a new gene therapy for Duchenne muscular dystrophy. The Biologics License Application (BLA) for SRP-9001 is currently under priority review by the FDA.

FDA 130

FDA Therapies Licensing Licensing 130

Drug Discovery World

OCTOBER 7, 2022

The MHRA has granted marketing authorisation for Eli Lilly’s baricitinib (Olumiant), the first licensed JAK inhibitor for the treatment of severe alopecia areata in adult patients. . This is an important authorisation for patients as previously there has never been a licensed oral therapy for adults with severe alopecia areata.” .

Therapies 130

Therapies Licensing Licensing Treatment 130

Drug Discovery World

NOVEMBER 14, 2022

Minoryx and Neuraxpharm have agreed a strategic alliance to provide a new therapy for rare CNS disease patients in Europe. . The companies have entered into a license agreement for the European rights to leriglitazone, currently under European Medicines Agency (EMA) review for the orphan indication X-linked Adrenoleukodystrophy (X-ALD). .

Therapies 130

Therapies Disease Licensing Licensing 130

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. . A one-time treatment with etranacogene dezaparvovec costs US$3.5

Therapies 130

Therapies Clinical Trials Licensing Licensing 130

Drug Discovery World

MARCH 24, 2023

Other patients, some of whom are already in late stages of the disease, are awaiting treatment. The researchers estimate that there are dozens to hundreds of people that could benefit from the effective life-saving treatment.

Disease 130

Disease Treatment Research Licensing 130

Drug Discovery World

NOVEMBER 1, 2022

Complement Therapeutics’ lead asset CTx001, an AAV-based gene therapy for the treatment of geographic atrophy (GA), has been awarded an Innovation Passport by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). . The post Green light for potential AAV gene therapy appeared first on Drug Discovery World (DDW).

Therapies 130

Therapies Licensing Licensing Production 130

Drug Discovery World

AUGUST 29, 2024

The benefits of Alzheimer’s drug lecanemab (Leqembi) are too small to justify the cost of providing the treatment to NHS patients, the UK regulator has ruled. However, the reality is that the benefits this first treatment provides are just too small to justify the significant cost to the NHS.

Regulations 148

Regulations Hospitals Licensing Licensing 148

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).

Therapies 130

Therapies Licensing Licensing Treatment 130

Drug Discovery World

NOVEMBER 21, 2022

The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for anti-CD3-directed antibody TZIELD (teplizumab-mzwv), the first immunomodulatory treatment for type 1 diabetes (T1D). . The company also offers financial assistance options to eligible patients for out-of-pocket costs. . .

FDA Approval 130

FDA Approval FDA Therapies Disease 130

Drug Discovery World

JANUARY 5, 2023

CANbridge Pharmaceuticals has exercised its option to secure the exclusive global rights to develop, manufacture and commercialise a novel gene therapy to treat spinal muscular atrophy (SMA) from UMass Chan Medical School. . The benchmark therapy uses a vector similar to that used in the only gene therapy approved for SMA.

Therapies 130

Therapies Medical Schools Clinical Development Pharmaceuticals 130

Drug Discovery World

FEBRUARY 23, 2024

In a breakthrough for advanced therapies, this week saw the FDA approve the first ever cell therapy for solid tumour cancers, but there were other significant developments in the cell and gene therapy space. News round-up for 19-23 February by DDW Digital Content Editor Diana Spencer.

FDA Approval 130

FDA Approval Therapies Licensing Licensing 130

The Pharma Data

MARCH 9, 2022

Novartis today announced a license option agreement with Voyager Therapeutics, a gene therapy company focused on next-generation adeno-associated virus (AAV) technologies, for three capsids to use in potential gene therapies for neurological diseases, with options to access capsids for two other targets.

Licensing 52

Licensing Licensing Therapies Disease 52

Drug Discovery World

JULY 2, 2024

If the positive results observed in this small trial and a previous trial with nivolumab and ipilimumab are confirmed, CBM588 could become a valuable supplement in the treatment of various cancers, particularly for patients treated with immune checkpoint inhibitors.”

Trials 148

Trials Treatment Clinical Trials Licensing 148

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. million price point per dose.

Therapies 130

Therapies Clinical Trials Vaccine Disease 130

BioPharma Drive: Drug Pricing

JULY 10, 2023

The pharma company will pay $30 million upfront to gain rights to an experimental therapy meant to enhance the anti-tumor effect of radiation.

Licensing 57

Licensing Licensing Pharma Companies Treatment 57

Drug Target Review

SEPTEMBER 7, 2023

The first clinical candidate, BSB-1001, aims to transform leukemia treatment by targeting minor histocompatibility antigen-1. This two-part therapy aligns with allogeneic hematopoietic stem cell transplantation to enhance patient outcomes. TCX-102 complements this effort by focusing on TCRs against NPM1 gene mutations.

Treatment 98

Treatment Licensing Licensing Disease 98

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. The post China’s NMPA okays maribavir for post-transplant cytomegalovirus appeared first on Drug Discovery World (DDW).

Licensing 130

Licensing Licensing Trials Therapies 130

The Pharma Data

JUNE 2, 2022

Boehringer Ingelheim and the Agency for Science, Technology and Research (A*STAR) today announced a global licensing agreement under which Boehringer Ingelheim will obtain exclusive worldwide rights to research, develop and commercialize products based on a panel of innovative, tumor-specific antibodies from A*STAR.

Licensing 52

Licensing Licensing Therapies Science 52

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.”

Licensing 163

Licensing Licensing Treatment Disease 163

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.

Licensing 130

Licensing Licensing Drugs Engineering 130

BioPharma Drive: Drug Pricing

AUGUST 3, 2023

A treatment licensed from the NIH and in clinical testing for lupus is the startup’s lead program, while its founding “Treg” cell therapy research matures, according to CEO Peter Maag.

Therapies 52

Therapies Licensing Licensing Treatment 52

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.

Therapies 119

Therapies FDA FDA Approval Treatment 119

Drug Discovery World

NOVEMBER 25, 2022

Gene therapies have made the headlines over the last few days, with treatments for rare AADC deficiency, lung cancer and haemophilia B given the go ahead from regulators. Gene therapy could ‘transform prognosis’ for AADC deficiency patients . FDA approves first disease-modifying therapy for T1D . The top stories: .

FDA Approval 130

FDA Approval FDA Drugs Therapies 130

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.

Licensing 52

Licensing Licensing Therapies Pharmaceutical Companies 52

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).

FDA 130

FDA FDA Approval Therapies Licensing 130

Drug Discovery World

FEBRUARY 19, 2024

However, despite these challenges, there are some positive developments; for instance, potential signs of improvement in the financial situation were flagged in late 2023 with AstraZeneca’s acquisition of cell therapy company Gracell for $1.2bn. antibody-drug conjugate [ADC] pipelines in some oncology settings).

Drug Development 148

Drug Development Small Molecule Drugs Therapies 148

Drug Discovery World

MAY 5, 2023

The acquisition will provide Eterna with a pipeline of allogeneic immuno-oncology products under development for the treatment of haematologic and solid tumours. Eterna plans to use Exacis’ platform to develop engineered cell therapies containing genomic edits designed to enhance their performance.

Engineering 130

Engineering DNA Therapies Licensing 130

Drug Target Review

FEBRUARY 1, 2024

What challenges has the industry faced in developing and commercialising treatments for neurological diseases, including rare diseases? 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.

Therapies 104

Therapies Drug Development Disease Clinical Development 104

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.

Marketing 245

Marketing FDA Approval Licensing Licensing 245