Regulatory approval Archives

News and Trends 24 Nov 2022

Gene therapy approval “game changer” in hemophilia B treatment

The approval of CSL’s gene therapy Hemgenix has ushered in a new era for hemophilia B treatment. With the addition of other approvals like Rocktavian and Upstaza, 2022 could be a turning point for the broader gene therapy field. Earlier this week, etranacogene dezaparvovec (Hemgenix) made history as the first gene therapy approved by the […]

November 24, 2022 - 7 minutesmins - By Jonathan Smith

News and Trends 23 Nov 2022

FDA approves CSL gene therapy for hemophilia B

CSL has revealed that the U.S. Food and Drug Administration (FDA) has approved HEMGENIX (etranacogene dezaparvovec-drlb), the first and only one-time gene therapy for appropriate adults with hemophilia B. HEMGENIX is approved for the treatment of adults with hemophilia B who currently use factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage or […]

November 23, 2022 - 5 minutesmins - By Jim Cornall

News and Trends 18 Nov 2022

Novavax’ COVID-19 vaccine gets expanded authorization for booster in adults

Novavax, Inc., a U.S-based biotechnology company announced today (November 18) that Health Canada has granted expanded authorization for Covid-19 vaccine Nuvaxovid. The vaccine NVX-CoV2373 for active immunization to prevent the disease caused by severe acute respiratory syndrome (SARS-CoV-2) as a homologous booster in adults aged 18 and older. “Canadians now have access to our […]

November 18, 2022 - 2 minutesmins - By Liza Laws

News and Trends 14 Nov 2022

EpiEndo gets regulatory approval for first patient study of first non-antibiotic macrolide

EpiEndo Pharmaceuticals, a clinical-stage biopharma company developing therapeutics for chronic inflammatory diseases, has received regulatory approval to begin a phase 2a clinical trial. The trial will be with lead molecule EP395 in COPD (chronic obstructive pulmonary disease) patients, an orally available macrolide or ‘Barriolide,’ with reduced antimicrobial resistance potential. It aims to address the unmet […]

November 14, 2022 - 3 minutesmins - By Liza Laws

News and Trends 11 Nov 2022

Prurigo nodularis treatment recommended for EU approval

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Dupixent (dupilumab) in the European Union (EU) to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. Dupilumab is being jointly developed by Sanofi and Regeneron. The European Commission is expected […]

November 11, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 10 Nov 2022

Sanofi and GSK Covid-19 booster vaccine approved by European Commission

Sanofi and GSK’s Covid booster vaccine has been approved in Europe. After the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for VidPrevtyn Beta, the vaccine was approved by the European Commission, as a booster for the prevention of Covid-19 in adults 18 years of age and older. […]

November 10, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 26 Oct 2022

Singapore approves gas fermentation-powered protein

A food ingredient developed by the Finnish startup Solar Foods has earned its first market approval in Singapore. The product is brewed using microorganisms fed with carbon dioxide and electricity — a more sustainable alternative to conventional animal protein. Increasing numbers of fermentation-derived food products are reaching the market, including ingredients developed by Motif FoodWorks, […]

October 26, 2022 - 3 minutesmins - By Jonathan Smith

News and Trends 25 Oct 2022

Distributor of Curcugen and Ginfort receives dual natural product licenses

Two Health Canada natural product licenses have been achieved by DolCas Biotech LLC and have been found safe, effective and high quality. The products are its concentrated turmeric extract, Curcugen, and the other for Ginfort, a powerful ginger extract in powdered format. Produced by Olene Life Sciences, the two ingredient brands are research-backed for clinical […]

October 25, 2022 - 4 minutesmins - By Liza Laws

News and Trends 19 Oct 2022

Report says 20% of global cancer deaths could be avoided

A new study by members of the Bloomberg New Economy International Cancer Coalition says at least 1.5 million deaths from cancer could be avoided each year. This is 20% of the annual global deaths resulting from cancer. The study says this could happen if international regulations around patient trials were more standardized and people placed […]

October 19, 2022 - 6 minutesmins - By Jim Cornall

Caszyme crispr climate change Anastasiia Slynko

Interview 17 Oct 2022

CRISPR gene editing: a key tool for counteracting climate change

Monika Paulė, CEO and co-founder of the Lithuanian CRISPR developer Caszyme, explains how gene editing technology could fight climate change by boosting agriculture and biodiversity. The invention of CRISPR-Cas gene editing technology in the last decade sparked a revolution in biology, providing researchers a way to make selective and precise changes to an organism’s genetic […]

October 17, 2022 - 6 minutesmins - By Jonathan Smith

News and Trends 11 Oct 2022

Accelerated application for drug to help immunodeficiency submitted by Pharming

A marketing authorization application (MAA) has been submitted by Dutch company Pharming Group, to the European Medicines Agency (EMA) for a rare, primary immunodeficiency in adults and adolescents 12 years and older. Activated phosphonide 3-kinase delta syndrome (APDS), first discovered in 2013, is caused by genetic variants in either one of two identified genes known […]

October 11, 2022 - 4 minutesmins - By Liza Laws

News and Trends 3 Oct 2022

Poxel granted orphan drug designation for kidney disease treatment

French biopharma company Poxel SA says the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to PXL770 for the treatment of patients with autosomal-dominant polycystic kidney disease (ADPKD). PXL770 is a novel, first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator – and is also a phase 2 ready ADPKD asset, subject […]

October 3, 2022 - 2 minutesmins - By Jim Cornall

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Webinar: Organoids in cancer research - Paving the way for faster drug development across cancer indications

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Regulatory approval

Gene therapy approval “game changer” in hemophilia B treatment

FDA approves CSL gene therapy for hemophilia B

Novavax’ COVID-19 vaccine gets expanded authorization for booster in adults

EpiEndo gets regulatory approval for first patient study of first non-antibiotic macrolide

Prurigo nodularis treatment recommended for EU approval

Sanofi and GSK Covid-19 booster vaccine approved by European Commission

Singapore approves gas fermentation-powered protein

Distributor of Curcugen and Ginfort receives dual natural product licenses

Report says 20% of global cancer deaths could be avoided

CRISPR gene editing: a key tool for counteracting climate change

Accelerated application for drug to help immunodeficiency submitted by Pharming

Poxel granted orphan drug designation for kidney disease treatment

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Webinar: Organoids in cancer research - Paving the way for faster drug development across cancer indications

10 biotech companies leading the way in Denmark

Webinar: Advancements in antimalarial drug discovery and development

Six psychedelic drug companies aiming to revolutionize mental health treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

Webinar: Organoids in cancer research - Paving the way for faster drug development across cancer indications

10 biotech companies leading the way in Denmark

Webinar: Advancements in antimalarial drug discovery and development

Six psychedelic drug companies aiming to revolutionize mental health treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

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