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RSS FeedPosted by Michael Wonder on 17 Feb 2021
Immortal time bias in observational studies
16 February 2021 - Observational studies are commonly used to evaluate the association between a risk factor or “exposure” and the ...
Posted by Michael Wonder on 17 Feb 2021
FDA grants sotorasib priority review designation for the treatment of patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer
16 February 2021 - FDA target action date is 16 August 2021 ...
Posted by Michael Wonder on 17 Feb 2021
Sandoz Canada completes its fifth biosimilar launch with new biosimilar Hyrimoz (adalimumab)
16 February 2021 - Hyrimoz for use in nine indications covered by the reference medicine in the fields of rheumatology, gastro-enterology ...
Posted by Michael Wonder on 17 Feb 2021
Health Canada approves Reblozyl (luspatercept), new class of treatment for adult patients living with myelodysplastic syndromes
16 February 2021 - Reblozyl, an erythroid maturation agent, is the first and only of its kind approved for use in ...
Posted by Michael Wonder on 17 Feb 2021
Reflections on a record year for novel device innovation despite COVID-19 challenges
16 February 2021 - As we look ahead this year, it is important to pause and reflect on the important milestones ...
Posted by Michael Wonder on 16 Feb 2021
Medicines Australia statement on TGA’s provisional approval of AstraZeneca’s COVID-19 vaccine
16 February 2021 - Medicines Australia welcomes the TGA’s decision granting provisional approval of the AstraZeneca/Oxford University COVID-19 vaccine, marking ...
Posted by Michael Wonder on 16 Feb 2021
Jazz Pharmaceuticals completes submission of supplemental new drug application for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for idiopathic hypersomnia
16 February 2021 - Jazz Pharmaceuticals today announced the completion of the rolling submission for the supplemental new drug application to ...
Posted by Michael Wonder on 16 Feb 2021
Forge Biologics receives FDA fast track, orphan drug, and rare paediatric disease designations for FBX-101 gene therapy for patients with Krabbe disease
16 February 2021 - FBX-101 is a first-in-human gene therapy utilising an adeno-associated virus to deliver a functioning copy of the ...
Posted by Michael Wonder on 16 Feb 2021
After a controversial Alzheimer’s drug review, FDA’s Woodcock rejects proposal to ‘firewall’ agency and drug companies
16 February 2021 - In response to criticism, a top FDA official maintained that creating a firewall between agency staff ...
Posted by Michael Wonder on 16 Feb 2021
Sesen Bio announces FDA acceptance and priority review of its biologics license application for Vicineum
16 February 2021 - FDA stated it is not currently planning to hold an advisory committee meeting. ...
Posted by Michael Wonder on 16 Feb 2021
Novartis Entresto granted expanded indication in chronic heart failure by FDA
16 February 2021 - Entresto is the first and only therapy approved in the US to treat patients diagnosed with guideline-defined ...
Posted by Michael Wonder on 16 Feb 2021
EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen
16 February 2021 - EMA has received an application for conditional marketing authorisation for a COVID-19 vaccine developed by Janssen-Cilag. ...
Posted by Michael Wonder on 16 Feb 2021
Celltrion Healthcare receives European Commission approval for the first high concentration, low-volume and citrate-free biosimilar adalimumab, Yuflyma (CT-P17)
15 February 2021 - Yuflyma is approved in all intended indications for the treatment of multiple chronic inflammatory diseases. ...
Posted by Michael Wonder on 16 Feb 2021
TGA provisionally approves AstraZeneca's COVID-19 vaccine
16 February 2021 - The Therapeutic Goods Administration has granted provisional approval to AstraZeneca for its COVID-19 vaccine, making it ...
Posted by Michael Wonder on 16 Feb 2021
The US regulatory system and COVID-19 vaccines: the importance of a strong and capable FDA
15 February 2021 - For many in public health and medicine, the coronavirus disease 2019 (COVID-19) pandemic in the US has ...