Blog
RSS FeedPosted by Michael Wonder on 07 May 2024
Clinical benefit and regulatory outcomes of cancer drugs receiving accelerated approval
7 May 2024 - In this cohort study of cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did ...
Posted by Michael Wonder on 22 Apr 2024
Carvykti (ciltacabtagene autoleucel) is the first BCMA targeted treatment approved by the European Commission for patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy
22 April 2024 - Approval is based on results from the Phase 3 CARTITUDE-4 study, in which treatment with ciltacabtagene autoleucel ...
Posted by Michael Wonder on 22 Apr 2024
EMA publishes agenda for 22-25 April 2024 CHMP meeting
22 April 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 22 Apr 2024
Alvotech signs US agreement to expand access for newly approved high concentration interchangeable biosimilar to Humira (adalimumab)
19 April 2024 - Alvotech, in agreement with Teva Pharmaceuticals, has signed an agreement with a strategic partner to bring to ...
Posted by Michael Wonder on 22 Apr 2024
Boost for pharmacists for flu season
20 April 2024 - The Albanese Government is protecting Australians in aged care and disability homes by funding pharmacists for the ...
Posted by Michael Wonder on 22 Apr 2024
Sandoz confirms European Commission approval of Pyzchiva (ustekinumab), further strengthening immunology offering
22 April 2024 - EC approval based on robust development program confirming match to reference medicine in terms of safety, ...
Posted by Michael Wonder on 22 Apr 2024
UCB receives European Commission approval for Bimzelx (bimekizumab) as the first IL-17A and IL-17F biologic for moderate to severe hidradenitis suppurativa
22 April 2024 - Approval is supported by data from two Phase 3 studies, BE HEARD I and BE HEARD ...
Posted by Michael Wonder on 21 Apr 2024
The myth of the free market for pharmaceuticals
20 April 2024 - Critics of US policy aiming to reduce spending on prescription drugs claim that the government is wrongfully ...
Posted by Michael Wonder on 20 Apr 2024
Nora Pharma receives Health Canada approval for Niopeg, a biosimilar of Neulasta
19 April 2024 - Nora Pharma, a wholly owned division of Sunshine Biopharma, has received approval from Health Canada for the ...
Posted by Michael Wonder on 20 Apr 2024
Health Canada approves Keytruda as a first-line treatment for adult patients with locally advanced unresectable or metastatic HER2 negative gastric or gastro-oesophageal junction adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy
19 April 2024 - Approval is based on the Phase 3 KEYNOTE-859 trial. ...
Posted by Michael Wonder on 19 Apr 2024
Medicare official says breakthrough device reimbursement rule coming in early summer
19 April 2024 - A federal rule aiming to make reimbursement for breakthrough devices easier is slated for early summer, ...
Posted by Michael Wonder on 19 Apr 2024
National pharmacare will reduce access to new medicines for 27 million privately insured Canadians
18 April 2024 - The federal Liberal-NDP coalition government recently announced it would work with the provinces to fund universal prescription ...
Posted by Michael Wonder on 19 Apr 2024
US FDA approves subcutaneous administration of Takeda’s Entyvio (vedolizumab) for maintenance therapy in moderately to severely active Crohn’s disease
19 April 2024 - Entyvio is now available in the US in both intravenous and subcutaneous administrations for maintenance treatment ...
Posted by Michael Wonder on 19 Apr 2024
Publication of Stage 1 and Stage 2 PBS Process Improvements metrics report for 2022-23
19 April 2024 - The 2022-23 Stage 1 and Stage 2 PBS process improvements metrics report is now available on ...
Posted by Michael Wonder on 18 Apr 2024
Lumicell’s cutting-edge imaging platform receives historic FDA approval to illuminate residual breast cancer
18 April 2024 - Lumisight and Lumicell DVS previously received FDA fast track and breakthrough device designations, respectively. ...
Posted by Michael Wonder on 18 Apr 2024
AskBio receives FDA fast track designation for AB-1002 investigational gene therapy program in congestive heart failure
18 April 2024 - AB-1002 is being studied for the treatment of adults with non-ischaemic cardiomyopathy and New York Heart Association ...