Regulatory approval Archives

News and Trends 15 Dec 2022

EMA gives Myrtelle’s Canavan disease gene therapy candidate OD designation

Myrtelle Inc., a clinical stage gene therapy company, has announced that the European Medicines Agency (EMA) has granted orphan drug (OD) designation for rAAV-Olig001-ASPA, the company’s lead gene therapy product candidate for the treatment of Canavan disease (CD). EMA OD designation’s aim is to encourage the development of treatments for life-threatening rare conditions by providing […]

December 15, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 9 Dec 2022

Visiox Pharma announces FDA acceptance of glaucoma new drug application

Visiox Pharma, LLC has received notification from the U.S. Food and Drug Administration (FDA) that the agency has completed its filing review and accepted for filing the New Drug Application (NDA) for PDP-716 (0.35% brimonidine tartrate) for the treatment of glaucoma. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date […]

December 9, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 29 Nov 2022

Biocomposites antibiotic carrier, STIMULAN, receives approval for use in Mexico

UK-based medical devices company, Biocomposites Ltd., has announced that antibiotic carrier STIMULAN has received a new broad-based approval for use in bone and soft tissue in Mexico. The approval, granted by COFEPRIS, the Mexican Regulatory Authority, authorizes the use of STIMULAN as a carrier of substances such as antibiotics that are chosen by the surgeon […]

November 29, 2022 - 2 minutesmins - By Liza Laws

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

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