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RSS FeedPosted by Michael Wonder on 14 Sep 2021
Trodelvy approved by the TGA
14 September 2021 - Sacituzumab govitecan is a new treatment option for adult patients with unresectable locally advanced or metastatic triple negative ...
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
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
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
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’ ...
Posted by Michael Wonder on 13 Sep 2021
EMA publishes agenda for 13-16 September CHMP meeting
13 September 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 13 Sep 2021
Joint statement of support for an Australian Patent Box
13 September 2021 - Australia’s health innovators support the introduction of a Patent Box, and we welcome this initiative by the ...
Posted by Michael Wonder on 13 Sep 2021
BeiGene announces U.S. FDA acceptance of biologics license application for tislelizumab in oesophageal squamous cell carcinoma
13 September 2021 - This marks the first ex-China regulatory filing for tislelizumab, following approval in five indications in China. ...
Posted by Michael Wonder on 13 Sep 2021
Trodelvy approved following heroic efforts of breast cancer sufferer Alison Day
12 September 2021 - A dying woman’s selfless campaign will give Australian women battling a rare aggressive form of breast cancer ...