Blog
RSS FeedPosted by Michael Wonder on 04 Oct 2024
Blue Shield of California slashes cost of world's best selling drug
1 October 2024 - Non-profit health plan collaborates with Fresenius Kabi and Evio Pharmacy Solutions to purchase FDA approved Humira biosimilar ...
Posted by Michael Wonder on 04 Dec 2024
Novartis Kisqali receives European Commission approval in a broad population of patients with HR positive/HER2 negative early breast cancer at high risk of recurrence
27 November 2024 - Approval is based on Phase 3 NATALEE data showing Kisqali (ribociclib) plus adjuvant endocrine therapy demonstrated clinically ...
Posted by Michael Wonder on 04 Dec 2024
Biden-Harris Administration announces Medicare Advantage and Medicare Part D prescription drug proposals that aim to improve care and access for enrollees
26 November 2024 - Today, the CMS is proposing actions in the Medicare Advantage and Medicare Part D prescription drug programs ...
Posted by Michael Wonder on 04 Dec 2024
Alnylam announces US FDA acceptance of supplemental new drug application for vutrisiran for the treatment of ATTR amyloidosis with cardiomyopathy
25 November 2024 - PDUFA date set for 23 March 2025. ...
Posted by Michael Wonder on 03 Dec 2024
Intellia Therapeutics announces FDA regenerative medicine advanced therapy designation granted to nexiguran ziclumeran for the treatment of hereditary transthyretin amyloidosis with polyneuropathy
25 November 2024 - Intellia Therapeutics today announced that the US FDA has granted regenerative medicine advanced therapy designation to nexiguran ...
Posted by Michael Wonder on 03 Dec 2024
HTA Policy and Methods Review update
3 December 2024 - The Minister for Health and Aged Care, the Hon Mark Butler MP has announced the Implementation Advisory ...
Posted by Michael Wonder on 03 Dec 2024
New Zealand Pharmaceutical Schedule - 1 December 2024
1 December 2024 - The December 2024 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 03 Dec 2024
Preferences for speed of access versus certainty of the survival benefit of new cancer drugs: a discrete choice experiment
18 November 2024 - The extent to which patients with cancer are willing to accept uncertainty about the clinical benefit of ...
Posted by Michael Wonder on 03 Dec 2024
The trade-off between accelerated cancer drug approvals and patient preferences
18 November 2024 - Cancer care stands at a critical juncture where the urgency of rapid drug approvals must be balanced ...
Posted by Michael Wonder on 03 Dec 2024
Shorla Oncology announces FDA approval of Imkeldi (imatinib) oral solution, an oral liquid for the treatment of certain forms of leukaemia and other cancers
25 November 2024 - Imkeldi marks Shorla Oncology’s fourth FDA Approval. ...
Posted by Michael Wonder on 02 Dec 2024
US FDA approves AOP Health’s Rapiblyk (landiolol) for atrial fibrillation and atrial flutter in the critical care setting
27 November 2024 - AOP Orphan Pharmaceuticals announced that the US FDA has granted regulatory approval for Rapiblyk (landiolol) in the ...
Posted by Michael Wonder on 02 Dec 2024
Blenrep combinations accepted for review by the US FDA for the treatment of relapsed/refractory multiple myeloma
25 November 2024 - Regulatory submission supported by Phase 3 head to head DREAMM-7 and DREAMM-8 trials showing statistically significant efficacy, ...
Posted by Michael Wonder on 02 Dec 2024
Gilead’s Trodelvy awaits re-deliberation for reimbursement in Korea following patient petitions, price cut proposal
25 November 2024 - The triple negative breast cancer treatment Trodelvy (sacituzumab govitecan), which drew 100,000 petitions from patients, will ...
Posted by Michael Wonder on 02 Dec 2024
‘We dodged a bullet’: biotech and pharma react to selection of Marty Makary for FDA commissioner
23 November 2024 - Many appear cautiously optimistic about Trump’s intended pick. ...
Posted by Michael Wonder on 01 Dec 2024
Update on the March 2025 meeting
28 November 2024 - As announced by the Minister on 6 November 2024, to process the unprecedented number of submissions for ...
Posted by Michael Wonder on 01 Dec 2024
Changes to the PBS listings for Opdualag and Vyxeos
1 December 2024 - As of 1 December 2024, combination chemotherapy medicines, Opdualag and Vyxeos, will be transitioned from the Highly ...