Healthcare in 2022: what you need to know
With the Covid-19 pandemic sending shockwaves in the hospital sector, healthcare providers will continue looking for ways to slowly rebuild …
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First patient treated in Airiver Medical’s RESTORE-2 trial for CRS
Airiver Medical has treated the first patient in its RESTORE-2 pivotal clinical trial assessing the ESSpand Sinus drug-coated balloon (DCB) …
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Novo Nordisk identifies unauthorised data access from trials
Novo Nordisk has identified that certain patient information from some of its clinical trials was accessed and copied externally in …
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FDA grants priority review for Roche’s Tecentriq combo sBLA
Roche has received the US Food and Drug Administration (FDA) priority review for its supplemental biologics licence application (sBLA) for …
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Sibel Health’s ANNE One platform secures EU MDR CE mark
Sibel Health has received CE mark certification under the EU Medical Device Regulation (EU MDR 2017/745) for its ANNE One …
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CONNECTA Therapeutics begins Phase IIa trial of CTH120 for FXS
CONNECTA Therapeutics has commenced a Phase IIa trial to assess its lead programme, CTH120, a neuroplasticity modulator, in male adults …
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Healthcare in 2022: what you need to know
With the Covid-19 pandemic sending shockwaves in the hospital sector, healthcare providers will continue looking for ways to slowly rebuild …
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EMA validates Bayer’s asundexian application for ischaemic stroke
The European Medicines Agency (EMA) has validated Bayer's marketing authorisation application for asundexian, an oral Factor XIa inhibitor, to prevent …
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MHRA to roll out new AI sandbox for medicines development
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced plans to launch a new AI sandbox to expedite …
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Windward Bio doses first patients in Phase II SIRIUS COPD trial
Harbour BioMed’s partner Windward Bio has dosed the first patients in the Phase II SIRIUS trial with HBM9378/WIN378 (SKB378), a fully …
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Gore secures CE Mark for venous stent to treat inferior vena cava
W L Gore & Associates Medical Products (Gore) has secured CE Mark approval under the EU's Medical Device Regulation (MDR) for …
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Medtronic secures CE mark for Stealth AXiS system for ENT surgery
Medtronic has received the CE mark for its Stealth AXiS surgical system, clearing the way for its use in ear, …
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Coya Therapeutics begins extension phase of ALSTARS trial for COYA 302
Coya Therapeutics has initiated the blinded extension phase of the ALSTARS trial, evaluating the safety and efficacy of COYA 302 …
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Pfizer’s Hympavzi secures FDA expanded indications for haemophilia
Pfizer has received approval from the US Food and Drug Administration (FDA) for an expanded indication of Hympavzi (marstacimab-hncq) for …
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Insulet reports new data for Omnipod 6 and FCL systems
Insulet has reported results from two clinical studies, STRIVE and EVOLUTION 3, assessing its upcoming Omnipod 6 automated insulin delivery …
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Novo Nordisk reports Phase II data for zenagamtide in diabetes
Novo Nordisk has reported results from its Phase II study of zenagamtide, an investigational once-weekly subcutaneous treatment, showing statistically significant …
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EC grants marketing authorisation for IntraBio’s Aqneursa
The European Commission (EC) has granted marketing authorisation for IntraBio’s Aqneursa (levacetylleucine) to treat neurological symptoms of Niemann-Pick disease type …
