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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Ray Therapeutics receives EMA PRIME status for gene therapy
Ray Therapeutics has received priority medicines (PRIME) designation from the European Medicines Agency (EMA) for its RTx-015 gene therapy to …
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enVVeno Medical secures FDA IDE approval for venous valve study
enVVeno Medical has received the investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for a …
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Precision begins patient enrolment for FUNCTION-DMD trial
Precision BioSciences has activated Arkansas Children’s Hospital as the first site and initiated patient enrolment for its Phase I/II FUNCTION-DMD …
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Abbott secures FDA approval for Ultreon 3.0 imaging platform
Abbott has received the US Food and Drug Administration (FDA) approval and CE Mark for its Ultreon 3.0 AI-powered coronary …
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Massive Bio partners with OpenAI to broaden clinical trial access
Massive Bio has entered a partnership with OpenAI to expand global access to clinical studies through AI-driven parameterisation of protocols …
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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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Rocket to sell PRV for $180m to advance gene therapy pipeline
Rocket Pharmaceuticals has signed an agreement to sell its rare paediatric disease priority review voucher (PRV) for $180m to advance …
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Nervonik closes $52.5m Series B funding to advance PNS system
US-based medical device company Nervonik has secured $52.5m in Series B financing aimed at advancing its peripheral nerve stimulation (PNS) …
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Oruka reports positive data from Phase IIa trial for plaque psoriasis
Oruka Therapeutics has reported positive interim data from the ongoing EVERLAST-A Phase IIa trial evaluating ORKA-001 in patients with moderate-to-severe …
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FDA approves AstraZeneca’s Saphnelo for SLE
AstraZeneca has received approval from the US Food and Drug Administration (FDA) for the subcutaneous self-administration of Saphnelo (anifrolumab-fnia) using …
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Sun Pharma to acquire Organon for $11.75bn
Sun Pharmaceutical Industries has signed a definitive agreement to acquire Organon in a transaction with an enterprise valuation of $11.75bn in cash, …
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BrioHealth secures FDA approval to launch BrioVAD system trial
BrioHealth Solutions has secured conditional approval from the US Food and Drug Administration (FDA) to initiate a clinical trial of …
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Kyowa Kirin and Kura initiate Phase II trial of ziftomenib for AML
Kyowa Kirin and Kura Oncology have started a Japanese Phase II registrational study of oral menin inhibitor ziftomenib in adult …
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First patient dosed in GE HealthCare’s Phase II/III LUMINA clinical trial
GE HealthCare has dosed the first patient in its international, multi-centre Phase II/III LUMINA clinical trial for the investigational manganese-based …
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CatalYm doses first patient in Phase II/III VINCIT trial
CatalYm has commenced dosing the first subject in its Phase II/III VINCIT trial, assessing the safety and efficacy of its …
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Cumberland to sell drug portfolio to Apotex for $100m
Cumberland Pharmaceuticals has agreed to sell its branded commercial drug portfolio to Canadian pharmaceutical company Apotex for $100m in cash. Under …
