Regulatory

Part 1: What impact has Brexit had on UK drug discovery?

27 July 2023

On 31 January 2020, the United Kingdom (UK) withdrew from the European Union (EU). Alongside a number of repercussions, the most impactful to the drug discovery sector arguably relates to regulatory affairs on account of adjusting from the European Medicines Agency (EMA) to the Medicines and Healthcare products Regulatory Agency (MHRA). DDW’s Megan Thomas evaluates […]

Part 2: What impact has Brexit had on UK drug discovery?

27 July 2023

On 31 January 2020, the United Kingdom (UK) withdrew from the European Union (EU). Alongside a number of repercussions, the most impactful to the drug discovery sector arguably relates to regulatory affairs on account of adjusting from the European Medicines Agency (EMA) to the Medicines and Healthcare products Regulatory Agency (MHRA). This is the second […]

Paediatric medicine concept

What recent paediatric guidelines mean for drug developers 

25 July 2023

Justin Hay, Senior Director, Amy Cheung Senior Director of Integrated Drug Development, and Patrick Loebs Director, at Certara, examine recent changes in paediatric guidelines and how they affect drug development projects.   It has been a very busy period recently for paediatric drug development with the release of many guidance documents from two notable regulatory agencies. […]

FDA

FDA approves quizartinib for acute myeloid leukaemia

25 July 2023

The US Food and Drug Administration (FDA) has approved Daiichi Sankyo’s quizartinib (Vanflyta) for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3 internal tandem duplication (ITD)-positive. It is approved with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy. The FDA also […]

Leukaemia

EU positive opinion for acute lymphoblastic leukaemia drug

24 July 2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorisation of JZP458 (a recombinant Erwinia asparaginase or crisantaspase). It has been recommended for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma […]

Bispecific antibodies

Bispecific antibody a “promising treatment option” for DLBCL

24 July 2023

The EU Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of conditional marketing authorisation for epcoritamab (Tepkinly) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. The final European Commission decision on this […]

Multiple myeloma

CHMP recommendation for bispecific antibody talquetamab

24 July 2023

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended conditional marketing authorisation for Janssen’s Talvey (talquetamab). The drug has received a positive opinion for use as a monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three […]

Ginkgo Bioworks awarded DARPA contract for therapeutic proteins 

24 July 2023

The Defense Advanced Research Projects Agency (DARPA) has announced that Ginkgo Bioworks, which is building a platform for cell programming and biosecurity, has been awarded a four-year contract worth up to $18 million to reimagine how to manufacture complex therapeutic proteins.   As a performer on DARPA’s Reimagining Protein Manufacturing (RPM) project, Ginkgo aims to […]

Stamp of approval

The CHMP recommends 14 new medicines for approval

24 July 2023

The EU’s Committee for Medicinal Products for Human Use (CHMP) recommended granting a marketing authorisation for 14 new medicines in its July meeting. The following novel medicines and biosimilars each received a positive opinion: Abrysvo (bivalent, recombinant), a vaccine to protect small infants and older people against lower respiratory tract disease caused by respiratory syncytial […]

Non-alcoholic fatty liver disease

First drug for NASH with liver fibrosis submitted to FDA

21 July 2023

Madrigal Pharmaceuticals has submitted an application for resmetirom, a drug for nonalcoholic steatohepatitis (NASH) with liver fibrosis, to the US Food and Drug Administration (FDA) and has requested a priority review. Resmetirom is a once daily, oral, thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH in the liver. The […]

FDA

The regulatory round-up: Five important FDA approvals

20 July 2023

The US Food and Drug Administration (FDA) has granted marketing authorisations to several new therapeutics over the last month that will have a significant impact on areas of unmet need and the evolution of future treatments. Elevidys, Sarepta Therapeutics Elevidys became the first gene therapy for Duchenne muscular dystrophy (DMD) to gain marketing authorisation in […]

AI brain

EMA urges “human-centric approach” to AI in drug discovery

20 July 2023

The European Medicines Association (EMA) has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of medicines. The paper, which is now open for public consultation, reflects on principles relevant to the application of AI and machine learning […]

Baby on a respirator - RSV

Monoclonal antibody to prevent RSV in babies approved in US

19 July 2023

The US Food and Drug Administration (FDA) has approved AstraZeneca’s Beyfortus (nirsevimab-alip) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season. The drug is also approved in children up to 24 months of age who remain vulnerable to severe RSV […]

ESG cloud icon green earth concept for environment

Exclusive insight from ICON Cares 2022 ESG Report 

18 July 2023

ICON, a healthcare intelligence and clinical research organisation, recently released its ICON Cares 2022 Environmental, Social and Governance (ESG) Report. Diarmaid Cunningham, Chief Administrative Officer at ICON, shares insight with DDW.  At ICON, we engage with our key stakeholders through a variety of methods and the environmental, social and governance (ESG) report is a key […]

Monoclonal antibodies

EMA reviews monoclonal antibody for gastric cancer

18 July 2023

The European Medicines Agency (EMA) has accepted for regulatory review Astellas Pharma’s marketing authorisation application (MAA) for zolbetuximab, an investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody. The application is for authorisation as a first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are CLDN18.2-positive. Gastric cancer […]

Doctor writing a prescription

Unlicensed and off-label drugs: What do we know?

13 July 2023

Following the death of a cancer patient after they were given an unlicensed drug, Diana Spencer unpacks the practice of prescribing unlicensed and off-label medicines. This month, a cancer patient died and three others were hospitalised in the UK after they were administered an unlicensed version of the chemotherapy drug cabazitaxel. In a statement, the […]

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