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 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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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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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 …
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Moonlight begins SURVEYOR Phase I trial for peanut allergy
Moonlight Therapeutics has begun the SURVEYOR Phase I clinical trial to assess MOON101, an investigational immunotherapy for peanut allergy. The ascending-dose, …
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Roche’s giredestrant secures FDA priority review for breast cancer
The US Food and Drug Administration (FDA) has accepted priority review of the new drug application (NDA) for Roche’s investigational …
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Philips secures FDA clearance for Elevate Plus AI ultrasound upgrade
Philips has received the US Food and Drug Administration (FDA) 510(k) clearance for Elevate Plus, an upgrade that adds new …
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Jade reports interim Phase I results of JADE101 for IgAN
Jade Biosciences has reported positive interim data from its Phase I trial studying JADE101, an investigational anti-A proliferation-inducing ligand (APRIL) …
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MicroPort launches LBBOT Solution commercially in Europe and Australia
MicroPort CardioFlow has commercially launched its LBBOT Solution in Europe and Australia after obtaining the required regulatory approvals. The LBBOT Solution …
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Servier to acquire Edgewise’s muscular dystrophy business for $2.65bn
Servier has signed an agreement to acquire Edgewise Therapeutics’ muscular dystrophy business in a deal valued at up to $2.65bn. The …
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SKIA secures FDA 510(k) clearance for AR surgical platform
South Korean medical technology company SKIA has received the US Food and Drug Administration (FDA) 510(k) clearance for SKIA HEAD, …
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FDA approves AstraZeneca’s Imfinzi-BCG combination for NMIBC therapy
AstraZeneca has received approval from the US Food and Drug Administration (FDA) for Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin …
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Labcorp announces partnership for colorectal cancer trials
Labcorp has collaborated with the Alliance for Clinical Trials in Oncology on a new study that seeks to expand access …
