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Home » Topics » Regulatory » EMA

EMA
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Endocrine/Metabolic

GC Biopharma’s ERT GC-1130A designated orphan drug in EU for MPS IIIA

Jan. 23, 2024
The EMA has awarded orphan drug designation to GC Biopharma Corp.’s intracerebroventricular enzyme replacement therapy (ERT) candidate, GC-1130A, for mucopolysaccharidosis type IIIA (MPS IIIA, Sanfilippo syndrome type A), developed in collaboration with Novel Pharma Inc.
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Neurology/Psychiatric

Endocannabinoid reuptake inhibitor SYT-510 granted EU IND

Jan. 19, 2024
Synendos Therapeutics AG has received approval from the European Medicines Agency (EMA) to initiate a first-in-human trial of its lead asset, SYT-510, a first-in-class inhibitor that modulates a newly identified drug target in the endocannabinoid system (ECS) to restore healthy brain physiology.
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EMA logo on mobile screen, vials, syringes

EMA grants 77 approvals in 2023, outpaces FDA in biosimilars

Jan. 16, 2024
By Nuala Moran
The EMA has once again come in behind the U.S. FDA, granting market access to 77 new products in 2023, fewer than half the 157 approvals the FDA processed in the 11 months from January through December 2023.
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CAR T cell attacking cancer cells

EMA reviewing CAR T safety over malignancy risks

Jan. 12, 2024
By Nuala Moran
Six weeks after the U.S. FDA issued an alert, the EMA is following suit and starting a review of the safety of six approved CAR T-cell cancer therapies, following 23 reports of patients developing secondary cancers. The EMA said such malignancies were considered “an important potential risk” at the time of approval and are included in the risk management plan. Close monitoring is in place, with companies required to conduct long-term safety and efficacy follow-up studies and to file safety update reports.
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Top Trends Therapeutics, pill, syringe

Psychedelic-assisted therapy: The state of play in Europe

Dec. 21, 2023
By Nuala Moran
Following the decision of Australia’s Therapeutic Drugs Administration to allow prescribing of MDMA for post-traumatic stress disorder and psilocybin in treatment-resistant depression from July 2023, and with U.S. FDA approval of MDMA for treating PTSD expected in 2024, the EMA is under increasing pressure to set out a path to approval for psychedelics.
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EMA, FDA offer help with challenges of expedited drug programs

Dec. 20, 2023
By Mari Serebrov
Given the challenges of generating chemistry, manufacturing and control information on the compressed timelines used in the EMA’s Priority Medicines scheme and the U.S. FDA’s breakthrough therapy designation program, the two regulators published a joint question-and-answer document discussing quality and good manufacturing practice aspects of applications for both programs, which are aimed at speeding development of innovative products to address unmet medical needs.
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AI microchip illustration

EMA lays out workplan to maximize AI benefits, manage risks

Dec. 19, 2023
By Mari Serebrov
With the use of artificial intelligence (AI) increasing in both biopharma R&D and the regulatory science used to evaluate new drug candidates in member states, the EMA and Heads of Medicines Agencies have laid out a five-year workplan to ensure that the European medicines regulatory network remains at the forefront in benefiting from AI in medicines regulation.
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Zymfentra

Biosimilar maker strides into ‘biobetter’ territory

Oct. 24, 2023
By Mari Serebrov
Biologics innovators typically take a lifecycle approach to developing new indications and formulations of their prescription drugs, especially when biosimilar competition is on the horizon.
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Injection syringes

Limited semaglutide supply keeps window open for counterfeits

Oct. 19, 2023
By Mari Serebrov
Fake versions of Novo Nordisk A/S’ 1-mg Ozempic prefilled pens are sounding alarms in Europe amid an ongoing shortage of the company’s semaglutide products resulting from demand in the weight-management space.
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Endocrine/Metabolic

Bloomsbury’s BGT-NPC awarded orphan drug designations for Niemann-Pick disease type C

Oct. 18, 2023
Bloomsbury Genetic Therapies Ltd. has announced U.S. and E.U. orphan drug designations for BGT-NPC, an investigational gene therapy for the treatment of Niemann-Pick disease type C (NPC). BGT-NPC is an investigational AAV9 gene therapy designed to provide a potentially curative solution to NPC patients following a one-time injection in the cerebrospinal fluid.
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