Regulatory

Proposals for changes to EU pharma legislation raise concerns for SMEs

1 May 2023

DDW’s Diana Spencer explores the European Commission’s proposed changes to EU pharmaceutical legislation, the reaction from industry and possible impact on smaller companies. The European Commission (EC) has proposed the largest reform to the EU’s pharmaceutical legislation in over 20 years. The EC says the revisions will make the system more agile, flexible, and adapted to the needs […]

Leukaemia

UK regulator approves ‘significant advance’ in CLL treatment

25 April 2023

The National Institute for Health and Care Excellence (NICE) has approved a combination of Imbruvica (ibrutinib) and venetoclax for all untreated chronic lymphocytic leukaemia (CLL) patients in England. The oral, fixed-duration combination treatment for adult CLL patients has been approved as first-line therapy and has been shown to be more effective than existing treatments. NICE’s […]

European Commission

EU approval for dual action prostate cancer therapy

25 April 2023

The European Commission (EC) has granted marketing authorisation for Akeega (niraparib and abiraterone acetate [AA]) for adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic). The drug is given in the form of a dual action tablet (DAT), with prednisone or prednisolone, and is approved in patients for whom chemotherapy is […]

Malaria vaccine

Ghana vaccine approval a ‘critical step’ in combatting malaria

13 April 2023

The R21/Matrix-M malaria vaccine has received regulatory clearance for use in Ghana by the country’s Food and Drugs Authority, making it the first country to approve the vaccine. R21/Matrix-M was developed by the University of Oxford and manufactured and scaled up by the Serum Institute of India (SIIPL), leveraging Novavax’s adjuvant technology. The vaccine has […]

Congestive heart failure

FDA reviews IND for congestive heart failure treatment

7 April 2023

Sequana Medical has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for its second-generation DSR product (DSR 2.0) for the treatment of congestive heart failure. Fluid accumulation in heart failure patients is caused by the retention of too much sodium. The DSR drug-based approach works in partnership with […]

Cancer research in laboratory

NICE approves olaparib for early-stage breast cancer and prostate cancer

6 April 2023

The UK’s National Institute for Health and Clinical Excellence (NICE) has recommended that Lynparza (olaparib) can be used for NHS patients with both early-stage breast cancer and prostate cancer. Olaparib is PARP inhibitor that targets cancers linked to faulty BRCA1 or BRCA2 genes and works across many different cancer types. The recommendation will grant patients in […]

FDA

The regulatory round-up: Eight key FDA decisions

4 April 2023

The Food and Drug Administration (FDA) in the US has made several key drug decisions over the last few weeks. Here’s a summary. Orserdu (elacestrant), Stemline Therapeutics The first and only treatment specifically indicated for patients with ESR1 mutations in ER+, HER2- advanced or metastatic breast cancer was approved in the US in February. The […]

Haematology

First gene therapy for haemophilia B approved in Great Britain

31 March 2023

CSL’s Hemgenix (etranacogene dezaparvovec) has been authorised as the first gene therapy for adults with severe and moderately severe haemophilia B (congenital Factor IX (FIX) deficiency) in Great Britain. It has been granted a marketing authorisation for patients without a history of FIX inhibitors by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The […]

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US FDA fast-tracks drug to prevent severe chemotherapy side effect

31 March 2023

The US Food and Drug Administration (FDA) has granted Fast Track Designation to RRx-001 for the prevention/attenuation of severe oral mucositis in chemotherapy and radiation-treated head and neck cancer patients. The FDA also accepted the company’s Investigational New Drug (IND) application to initiate a follow-on Phase IIb clinical trial, called KEVLARx, in the same head […]

European Commission vs Big Pharma, or profit vs access?  

29 March 2023

On January 31 2023, an internally circulated version of the European Commission’s overhaul of the EU’s pharma legislation was leaked, and published by Politico1. Politico published a summary of the key propositions outlined in the draft2, and DDW’s Multimedia Editor Megan Thomas investigates their intention, and observes how the industry has responded.   Key proposals   Approved […]

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