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RSS FeedPosted by Michael Wonder on 21 Jun 2021
Notice of Compliance with Conditions granted for Retevmo (selpercatinib), the first therapy in Canada specifically for patients with advanced RET driven lung and thyroid cancers
21 June 2021 - Conditional marketing authorisation based on data from LIBRETTO-001 Phase 1/2, the largest trial ever reported in patients ...
Posted by Michael Wonder on 21 Jun 2021
Bayer submits regulatory applications for oncology treatment combination of copanlisib and rituximab in the U.S. and EU
21 June 2021 - Bayer today announced the submission of a supplemental new drug application to the U.S. FDA and a ...
Posted by Michael Wonder on 21 Jun 2021
FDA approves first oral blood thinning medication for children
21 June 2021 - Today, the U.S. FDA approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less ...
Posted by Michael Wonder on 21 Jun 2021
Agios submits new drug application to FDA for mitapivat for treatment of adults with pyruvate kinase deficiency
21 June 2021 - Agios Pharmaceuticals today announced that it has submitted a new drug application for mitapivat to the U.S. ...
Posted by Michael Wonder on 21 Jun 2021
Novartis’ Cosentyx wins NICE backing for non-radiographic axial spondyloarthritis
18 June 2021 - Novartis’ Cosentyx has been recommended by NICE for the treatment of adults with non-radiographic axial spondyloarthritis. ...
Posted by Michael Wonder on 21 Jun 2021
Are drugs priced in accordance with value? A comparison of value based and net prices using Institute for Clinical and Economic Review reports
19 June 2021 - The Institute for Clinical and Economic Review is an independent organisation that reviews drugs and devices with ...
Posted by Michael Wonder on 21 Jun 2021
BeiGene announces China NMPA approval of Brukinsa (zanubrutinib) for the treatment of patients with relapsed or refractory Waldenström’s macroglobulinaemia
18 June 2021 - Third approval for Brukinsa in China and second approval in Waldenström’s macroglobulinaemia worldwide. ...
Posted by Michael Wonder on 21 Jun 2021
Cystic fibrosis life-altering drug nearing patient access across the country: Health Canada
20 June 2021 - For the cystic fibrosis community, persistence and constant belief are paying off. ...
Posted by Michael Wonder on 20 Jun 2021
Expensive brain cancer drug no longer an option under Medicare
19 June 2021 - Brain tumour experts and patient advocates are among those decrying a decision by the seller of ...
Posted by Michael Wonder on 20 Jun 2021
United States to spend $4.2 billion on anti-viral pills and other treatments for COVID-19
18 June 2021 - The United States is devoting $US3.2 billion ($4.2 billion) to speed development of antiviral pills to treat ...
Posted by Michael Wonder on 19 Jun 2021
HutchMed announces NMPA approval of surufatinib (Sulanda in China) for advanced pancreatic neuroendocrine tumours
18 June 2021 - Second new drug application approved for Sulanda in China. ...
Posted by Michael Wonder on 18 Jun 2021
Manchin wants Biden to oust FDA Chief over controversial Alzheimer’s drug approval
17 June 2021 - After some of the FDA’s outside advisors quit in outrage after the agency approved a controversial new ...
Posted by Michael Wonder on 18 Jun 2021
Health Canada grants marketing authorisation for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in people ages 12 and older who have at least one F508del mutation
18 June 2021 - Approximately 1,100 F/MF patients now eligible for a CFTR modulator to treat the underlying cause of their ...
Posted by Michael Wonder on 18 Jun 2021
European Commission approves Aubagio (teriflunomide) as the first oral MS therapy for first-line treatment of children and adolescents living with relapsing-remitting multiple sclerosis
18 June 2021 - The European Commission has approved Aubagio (teriflunomide) for the treatment of paediatric patients 10 to 17 years ...
Posted by Michael Wonder on 18 Jun 2021
Orphazyme provides regulatory update from FDA on arimoclomol for Niemann-Pick disease type C
18 June 2021 - Orphazyme today announced it has received a complete response letter from the U.S. FDA following its ...