Approvals

chronic obstructive pulmonary disease
#Approvals #Chronic obstructive pulmonary disease (COPD) #Drug approvals #FDA #Verona Pharma

Verona Pharma submits COPD drug ensifentrine for US FDA approval 

Verona Pharma has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for approval of ensifentrine for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).  Ensifentrine is a selective dual inhibitor of the enzymes phosphodiesterase 3 and 4 combining… Read More

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#Approvals #Rare disease #Regulatory

Biotech Recursion granted EU approval for rare disease  

Biotechnology company Recursion has been granted an Orphan Drug Designation for its potential treatment of the rare disease familial adenomatous polyposis (FAP).   FAP is a rare tumour syndrome in which hundreds or thousands of precancerous colorectal polyps grow in the body. As it stands there are… Read More

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MHRA
#Approvals

Treatment for invasive candidiasis awarded PIM designation 

The Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has granted Mundipharma and Cidara Therapeutics’ rezafungin Promising Innovative Medicine (PIM) designation for the treatment of invasive candidiasis. Invasive candidiasis is a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues.  The criteria … Read More

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#Approvals #Drug approvals #epilepsy

Angelini Pharma’s anti-seizure medicine approved 

Angelini Pharma has announced that cenobamate, an oral anti-seizure medicine (ASM), is now available for use within NHS Scotland as a treatment for eligible adults with uncontrolled focal epilepsy. The Scottish Medicines Consortium (SMC) has accepted cenobamate for restricted use in adults with drug-resistant epilepsy as a second-line adjunctive… Read More

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#Approvals #Collaboration #Drug discovery #Public health #Research study

This week in drug discovery (14-18 February) 

News round-up by DDW’s Megan Thomas for 14-18 February, 2022  This week, DDW rounds up updates, approvals, research and trials which will enable scientists to make life-saving developments in the drug discovery industry.  1. Trial launched of HIV vaccine antigens delivered through mRNA technology… Read More

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Pills
#Approvals #Covid-19 #Marketing approval authorisation

NICE expands guidance for AstraZeneca’s hyperkalaemia drug

The National Institute for Health and Care Excellence (NICE) has updated Technology Appraisal Guidance (TAG) TA599 for AstraZeneca’s Lokelma (sodium zirconium cyclosilicate [SZC]) in the treatment of adult patients with hyperkalaemia in England, Wales, and Northern Ireland.   Context   This guidance update follows the removal of the previous commercial arrangement, meaning… Read More

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