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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Alpha Cognition begins enrolment in RESOLVE Phase IV trial for Zunveyl
Alpha Cognition has started enrolling patients in its RESOLVE Phase IV post-marketing study, which is evaluating the tolerability and real-world …
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Altaris to acquire Simulations Plus in $375m all-cash deal
Simulations Plus has entered a definitive agreement to be purchased by affiliates of Altaris in an all-cash transaction valued at …
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Distalmotion secures second FDA gynaecology clearance for DEXTER system
Swiss medical device company Distalmotion has secured the US Food and Drug Administration (FDA) 510(k) clearance for its DEXTER robotic …
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Takeda reports pivotal data from FirstLight and RadiantLight trials
Takeda has reported pivotal results from its Phase III FirstLight and RadiantLight studies of oveporexton (TAK-861), an oral orexin receptor …
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FDA approves Bayer’s Ambelvist contrast agent
The US Food and Drug Administration (FDA) has approved Bayer’s Ambelvist (gadoquatrane), a macrocyclic gadolinium-based contrast agent (mGBCA), for use …
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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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Distalmotion secures second FDA gynaecology clearance for DEXTER system
Swiss medical device company Distalmotion has secured the US Food and Drug Administration (FDA) 510(k) clearance for its DEXTER robotic …
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Takeda reports pivotal data from FirstLight and RadiantLight trials
Takeda has reported pivotal results from its Phase III FirstLight and RadiantLight studies of oveporexton (TAK-861), an oral orexin receptor …
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FDA approves Bayer’s Ambelvist contrast agent
The US Food and Drug Administration (FDA) has approved Bayer’s Ambelvist (gadoquatrane), a macrocyclic gadolinium-based contrast agent (mGBCA), for use …
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ALK’s EURneffy secures MHRA approval for anaphylaxis treatment
ALK has received marketing authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for EURneffy 1mg, a needle-free …
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Lilly reports Phase III BRUIN CLL-322 trial results for Jaypirca combo
Eli Lilly and Company has reported results from the BRUIN CLL-322 Phase III trial, assessing Jaypirca (pirtobrutinib), a non-covalent bruton …
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FDA clears MSD’s Keytruda combo plus Welireg for ccRCC treatment
Merck & Co (MSD) has received approval from the US Food and Drug Administration (FDA) for both Keytruda (pembrolizumab) and …
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Fleming Initiative and Cepheid begin TRACE-CPE study on rapid CPE testing
The Fleming Initiative, a partnership between Imperial College London and Imperial College Healthcare National Health Service (NHS) Trust, and Cepheid, …
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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 …
