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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TransMedics receives IDE approval from FDA for OCS Heart trial
TransMedics Group has received full and unconditional investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) …
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Veradermics concludes enrolment in second Phase III VDPHL01 trial
Veradermics has completed enrolment in its second pivotal Phase III clinical trial of VDPHL01 for male pattern hair loss treatment. The …
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Takeda and Iambic announce $1.7bn deal to advance small molecule programmes
Takeda has entered a multi-year partnership to utilise Iambic’s AI drug discovery models for advancing small molecule programmes, in a …
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Abbott reports positive VERITAS study results for AFib
Abbott has reported positive early data from the VERITAS study, evaluating its investigational Amulet 360 left atrial appendage (LAA) occluder, …
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Genentech reports fenebrutinib Phase III results for PPMS
Roche’s Genentech has reported new data from the Phase III FENtrepid trial of fenebrutinib, an investigational Bruton’s tyrosine kinase inhibitor, …
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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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Novartis starts construction on new research facility in San Diego, US
Novartis has commenced construction on its new global biomedical research centre in San Diego, California, US, aimed at expanding its …
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FDA grants clearance for Eyas Medical Imaging’s neonatal MRI system
The US Food and Drug Administration (FDA) has granted 510(k) clearance for Eyas Medical Imaging’s Ascent³ᵀ neonatal magnetic resonance imaging …
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TransCode and Quantum Leap seek FDA approval for Phase IIa TTX-MC138 trial
A partnership comprising TransCode Therapeutics and Quantum Leap Healthcare Collaborative has submitted an investigational new drug (IND) application amendment seeking …
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Apotex and Grünenthal sign deal for Nebido Canadian distribution
Apotex and Grünenthal have finalised a licensing agreement granting Apotex exclusive Canadian rights to Nebido, a long-acting injectable testosterone undecanoate …
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Hologic’s Aptima assay secures FDA approval for HPV primary screening
Hologic has received the US Food and Drug Administration (FDA) approval for its Aptima HPV assay for use in clinician-collected …
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Affinia receives FDA approval for Phase I/II trial for dilated cardiomyopathy
Affinia Therapeutics has received approval from the US Food and Drug Administration (FDA) for an investigational new drug (IND) application …
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PrimeGen US and DT Cloud Star sign $1.5bn merger agreement
PrimeGen US and DT Cloud Star Acquisition have entered a definitive business combination agreement at an implied equity value of …
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Endospan reports one-year TRIOMPHE study results for NEXUS system
Endospan has announced positive one-year results from the TRIOMPHE study evaluating its NEXUS aortic arch stent-graft system. The multi-centre, three-arm, prospective …
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Biosion doses first patient in Phase Ia/Ib BSI-082 trial for solid tumours
Biosion has dosed the first patient in an investigator-initiated Phase Ia/Ib trial of BSI-082, a fully human anti-SIRPα monoclonal antibody, …
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CEPI and Samsung Biologics partner to boost global vaccine preparedness
The Coalition for Epidemic Preparedness Innovations (CEPI) and Samsung Biologics have partnered in an outbreak-ready vaccine manufacturing partnership to enhance …
