Regulatory approval Archives

Galapagos Gilead filgotinib rheumatoid arthritis

News and Trends 29 Mar 2019

Galapagos Nears First Drug Approval with Phase III Success in Rheumatoid Arthritis

Galapagos has released positive data from two phase III trials testing its flagship drug candidate, filgotinib, that will let the company and its partner Gilead apply for marketing approval. 20 years after its foundation, Galapagos is finally approaching the finish line. Yesterday, the company has shared positive data from two clinical trials that together enrolled […]

March 29, 2019 - 3 minutesmins - By Clara Rodríguez Fernández

News and Trends 1 Mar 2019

Update: Hansa Biopharma Applies for EMA Market Approval for Kidney Transplant Drug

Update (01/03/2019): Hansa Biopharma (previously named Hansa Medical) has filed an application for marketing authorization for imlifidase with the EMA also for use in patients undergoing kidney transplants. Update (18/10/2018): Imlifidase has just been given Fast Track Designation by the FDA for application in transplantation. The designation should accelerate the treatment through the FDA’s regulatory process, with […]

March 1, 2019 - 3 minutesmins - By Jonathan Smith

News and Trends 13 Feb 2018

Watch Out Eli Lilly: Novo’s Diabetes Drug Ozempic Gets European Approval

Update (13/02/2018): The European Commission has given Novo Nordisk a market authorization for Ozempic (semaglutide), bringing the competition for Eli Lilly’s Trulicity over to Europe. Eli Lilly executives have said that they are not worried by Novo’s competition, and keep confident on the performance of Trulicity, which now tops 40% of the market share of diabetes drugs belonging […]

February 13, 2018 - 2 minutesmins - By Clara Rodríguez Fernández

News and Trends 20 Dec 2017

How to Deal with Regulations to Get Approval for CAR-T Cells

The biotech industry is diving into the field of highly individualized gene and cell therapy products. The first CAR-T therapy has just been approved in the US and other breakthrough technologies like mRNA and CRISPR have a foot in the door. But getting to the market is not straightforward, not only for developers but also for […]

December 20, 2017 - 8 minutesmins - By Timothé Cynober

News and Trends 18 Dec 2017

Belgian Biotech’s Crohn’s Disease Cell Therapy Gets Recommended for Approval

An EMA committee has supported an allogeneic stem cell therapy for the first time, as TiGenix’s Crohn’s disease candidate is backed for approval. TiGenix and its Japanese partner, Takeda, are developing a stem cell therapy for Crohn’s disease – an autoimmune disease affecting the gastrointestinal tract. This morning, the companies have revealed that their candidate, Cx601, has received the backing […]

December 18, 2017 - 3 minutesmins - By Alex Dale

News and Trends 15 Dec 2016

Curing Cancer with Safer Transplants: UK Approval to start Clinical Trials

Kiadis Pharma has received approval to test in the UK an immune therapy to address the big challenges of bone marrow transplants, currently the only cure for blood cancers. Kiadis Pharma, based in Amsterdam, is working on therapies to improve the outcome of hematopoietic stem cell transplantation (HSCT), a common treatment for multiple types of […]

December 15, 2016 - 2 minutesmins - By Clara Rodríguez Fernández

News and Trends 1 Jun 2016

Novel Bionic Vision device gains approval for clinical trials in Renowned UK Hospital

Pixium Vision will be testing its new IRIS II bionic vision system in a clinical trial. The device can mimic eye function in people affected by Retinitis pigmentosa and Macular degeneration. Based in Paris (France), Pixium Vision is developing an alternative for people who have lost their sight – a bionic vision restoration system (VRS). One […]

June 1, 2016 - 2 minutesmins - By Denise Neves Gameiro

News and Trends 18 Mar 2015

Novartis’ Jakavi receives European Commission approval

Novartis received the approval from the European Commission for Jakavi (ruxolitinib) for the treatment of adult patients with Polycythemia Vera (PV) who are resistant to or intolerant of hydroxyurea. Jakavi is the first targeted treatment approved by the European Commission for these patients. PV is a rare and incurable blood cancer associated with an overproduction […]

March 18, 2015 - 2 minutesmins - By Lourdes Riquelme

News and Trends 4 Mar 2015

Boehringer Ingelheim submits applications for approval of Idarucizumab, an anti-anticoagulant

Boehringer Ingelheim submitted idarucizumab for approval of marketing authorization to the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA) and Health Canada. The submission is directed to patients who require rapid reversal of the anticoagulant effect of dabigatran, the active ingredient in Boehringer Ingelheim’s Pradaxa. Pradaxa, a direct thrombin inhibitor (DTI), was the first […]

March 4, 2015 - 2 minutesmins - By Lourdes Riquelme

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Regulatory approval

Galapagos Nears First Drug Approval with Phase III Success in Rheumatoid Arthritis

Update: Hansa Biopharma Applies for EMA Market Approval for Kidney Transplant Drug

Watch Out Eli Lilly: Novo’s Diabetes Drug Ozempic Gets European Approval

How to Deal with Regulations to Get Approval for CAR-T Cells

Belgian Biotech’s Crohn’s Disease Cell Therapy Gets Recommended for Approval

Curing Cancer with Safer Transplants: UK Approval to start Clinical Trials

Novel Bionic Vision device gains approval for clinical trials in Renowned UK Hospital

Novartis’ Jakavi receives European Commission approval

Boehringer Ingelheim submits applications for approval of Idarucizumab, an anti-anticoagulant

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10 biotech companies to watch in 2025

Biotech in 2024: A retrospective

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Five biosimilar companies you should know about

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10 biotech companies to watch in 2025

Biotech in 2024: A retrospective

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Five biosimilar companies you should know about

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