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Potential blockbuster drugs to watch in 2023
Lecanemab for Alzheimer's and the first potential gene therapy primed for US launch for haemophilia A are two potential blockbuster Drugs to Watch™, says a 2023 report.
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Anti-Cancer Therapeutics
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FDA grants priority review of glofitamab for lymphoma
Glofitamab for relapsed or refractory large B-cell lymphoma has been granted priority review by the US Food and Drug Administration (FDA).
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GSK to pay $40 million to license multiple T cell engagers
A $40 million agreement will enable GSK to exclusively license up to four bi- and multi-specific T cell engaging antibodies.
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Could BioNTech’s new partnership accelerate personalised mRNA therapy trials?
The UK Government and BioNTech’s new partnership aims to accelerate clinical trials of personalised immunotherapies for cancer and infectious disease vaccines.
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First-in-class telomerase inhibitor aids transfusion independence in clinical trial
Telomerase inhibitor imetelstat benefitted both major subtypes of lower risk MDS in a Phase III trial for the first time.
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EMA validates Enhertu® Type II variation application for lung cancer
The Type II variation application for Enhertu® for adults with advanced non-small cell lung cancer has been validated by the EMA.
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Janssen submits marketing application for bispecific antibody
Approval for Janssen’s talquetamab to treat relapsed/refractory multiple myeloma has been submitted to the European Medicines Agency.
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First treatment approval for advanced ASPS
A Phase II trial has led to the FDA approval of atezolizumab for individuals over two years old with advanced alveolar soft part sarcoma.
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EC approves Zynlonta® for large B-cell lymphoma
Antibody drug conjugate Zynlonta® (loncastuximab tesirine) is approved in the European Union for treatment of relapsed or refractory diffuse large B-cell lymphoma.
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Kite to buy Tmunity, expanding its CAR T pipeline
The acquisition of Tmunity Therapeutics supports Kite’s plans to develop next generation CAR T-cell therapies for cancer.
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Lynparza combination approved in EU for advanced prostate cancer
Patients in the EU with an advanced prostate cancer will benefit from a newly approved Lynparza-based treatment combination for the first time.
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Sanofi licenses Innate Pharma’s NK cell platform with €25m upfront payment
Innate Pharma will receive a €25m upfront payment from Sanofi to license its B7H3 ANKETTM platform, which is creating a new class of molecules to induce synthetic cancer immunity.
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FDA approves first gene therapy for high-risk early bladder cancer
The first gene therapy for high-risk non-muscle-invasive bladder cancer has been approved by The US Food and Drug Administration (FDA).
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CHMP meeting highlights – December 2022
A total of five drugs were recommended for approval at the CHMP’s December meeting, including a gene therapy and two cancer drugs.
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mRNA vaccine plus KEYTRUDA® improve melanoma survival
An mRNA vaccine plus KEYTRUDA® significantly improved recurrence-free survival in a Phase II trial for advanced melanoma patients.
