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RSS FeedPosted 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 ...
Posted by Michael Wonder on 10 Sep 2021
Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study
9 September 2021 - The researchers set out to investigate the regulatory handling of cancer drugs that were granted accelerated approval ...
Posted by Michael Wonder on 10 Sep 2021
Decibel Therapeutics receives orphan drug and rare paediatric disease designations for DB-OTO for the treatment of otoferlin related congenital hearing loss
9 September 2021 - Decibel Therapeutics today announced that the U.S. FDA has granted both orphan drug designation and rare paediatric ...
Posted by Michael Wonder on 10 Sep 2021
FDA grants breakthrough device designation to the NovoTTF-200T system for advanced liver cancer
9 September 2021 - Novocure today announced the United States FDA has granted breakthrough designation to the NovoTTF-200T System, a Tumour ...
Posted by Michael Wonder on 10 Sep 2021
VOR33 granted U.S. FDA fast track designation for AML
9 September 2021 - Vor Biopharma today announced that the U.S. FDA has granted fast track designation to VOR33, the ...
Posted by Michael Wonder on 09 Sep 2021
Eloxx Pharmaceuticals announces fast track designation for ELX-02 for the treatment of cystic fibrosis patients with nonsense mutations
9 September 2021 - Eloxx Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for ELX-02, a ...
Posted by Michael Wonder on 09 Sep 2021
Myovant Sciences and Pfizer announce FDA acceptance of supplemental new drug application for Myfembree for the management of moderate to severe pain associated with endometriosis
9 September 2021 - FDA PDUFA target action date is 6 May 2022. ...
Posted by Michael Wonder on 09 Sep 2021
FDA grants Jardiance breakthrough therapy designation for heart failure with preserved ejection fraction
9 September 2021 - Designation is based on results from the EMPEROR-Preserved Phase 3 trial, which established Jardiance as the first ...