Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 14 Sep 2021
EMA study reveals need for RWE framework, submission structure
14 September 2021 - The EMA has identified a need for more consistency in how real world evidence is submitted. ...
Posted by Michael Wonder on 14 Sep 2021
Moderate House Democrats threaten drug pricing bill in House panel
14 September 2021 - Three moderate House Democrats announced that they would vote against their party's legislation to lower drug ...
Posted by Michael Wonder on 14 Sep 2021
ISA Pharmaceuticals receives fast track designation for lead product ISA101b
14 September 2021 - Fast track designation for the treatment of recurrent and metastatic HPV16 positive oropharyngeal cancer to improve ...
Posted by Michael Wonder on 14 Sep 2021
Axsome Therapeutics announces FDA acceptance of new drug application for AXS-07 for the acute treatment of migraine
14 September 2021 - Axsome Therapeutics today announced that the U.S. FDA has accepted for filing the Company’s new drug application ...
Posted by Michael Wonder on 14 Sep 2021
New therapy to treat advanced small cell lung cancer approved for Australian patients
14 September 2021 - Zepzelca approval granted under a provisional regulatory pathway. ...
Posted by Michael Wonder on 14 Sep 2021
Nyxoah announces U.S. FDA breakthrough device designation granted for the Genio system for obstructive sleep apnea and complete concentric collapse
14 September 2021 - Nyxoah today announced that the U.S. FDA has granted the Genio bilateral hypoglossal nerve stimulation system breakthrough ...
Posted by Michael Wonder on 14 Sep 2021
MTAA supports call for future of private health summit
13 September 2021 - The Medical Technology Association of Australia (MTAA) today supported calls from AMA President, Dr Omar Khorshid, ...
Posted by Michael Wonder on 14 Sep 2021
Biden drug pricing plan seeks to balance access and innovation
13 September 2021 - On Thursday 9 September, Health and Human Services Secretary Xavier Becerra publicly released the Biden Administration’s ...
Posted by Michael Wonder on 14 Sep 2021
Branded price variation in the United States drug market, 2010 to 2019
13 September 2021 - Branded drug prices command considerable attention in the United States yet defining a drug’s price is not ...
Posted by Michael Wonder on 14 Sep 2021
Access Consortium: alignment with ICMRA consensus on immunobridging for authorising new COVID-19 vaccines
14 September 2021 - Placebo controlled disease outcome trial data are the gold standard for authorising vaccines. However, for COVID-19 ...
Posted by Michael Wonder on 14 Sep 2021
Limiting the impact on Kiwis as API leaves the NZ market
14 September 2021 - PHARMAC is working hard to limit the impact on over 1 million Kiwis who currently take ...
Posted by Michael Wonder on 14 Sep 2021
Alnylam submits marketing authorisation application to the European Medicines Agency for investigational vutrisiran for the treatment of hereditary ATTR amyloidosis with polyneuropathy
13 September 2021 - If approved, vutrisiran will provide a new, subcutaneously administered, once quarterly treatment option for patients with hATTR ...
Posted by Michael Wonder on 14 Sep 2021
Mirum Pharmaceuticals submits European marketing authorisation application for maralixibat in Alagille syndrome supported by new positive results from natural history study comparison
13 September 2021 - Natural history analysis shows significant improvement in event-free survival and transplant-free survival. ...
Posted by Michael Wonder on 14 Sep 2021
A court decision on “skinny labeling” another challenge for less expensive drugs
13 September 2021 - Brand name drugs, such as apixaban (Eliquis) and lenalidomide (Revlimid), account for approximately 80% of US drug ...
Posted by Michael Wonder on 13 Sep 2021
Reimagining pharmaceutical market exclusivities: should the duration of guaranteed monopoly periods be value based?
13 September 2021 - The amount of time in which brand pharmaceutical markets are protected does not correspond with the products’ ...