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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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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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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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 …
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First patient dosed in Onchilles’ Phase I/II trial of N17350
Onchilles Pharma has dosed the first patient in its Phase I/II clinical trial of N17350, the lead tumour-directed therapeutic candidate, …
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FDA approves GE HealthCare’s MIM Contour ProtégéAI+ 2.0 software
GE HealthCare has received 510(k) clearance from the US Food and Drug Administration (FDA) for its medical imaging management (MIM) …
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Biogen’s salanersen gains FDA breakthrough therapy designation for SMA
Biogen has received the breakthrough therapy designation from the US Food and Drug Administration (FDA) for salanersen (BIIB115), an investigational …
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Insulet launches algorithm improvements for Omnipod 5 AID system in US
Insulet has begun distributing an updated version of its Omnipod 5 automated insulin delivery (AID) system across the US, following …
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J&J’s nipocalimab meets primary endpoint in Phase II JASMINE study
Johnson & Johnson (J&J) has reported that its monoclonal antibody, nipocalimab, met the primary endpoint in the Phase II JASMINE …
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Regeneron and CytomX extend cancer therapy partnership to $4bn deal
Regeneron Pharmaceuticals and CytomX have expanded their research and licensing partnership to develop conditionally activated bispecific antibody cancer therapies, with …
