Blog
RSS FeedPosted by Michael Wonder on 23 Jun 2021
LEO Pharma announces European Commission approval of Adtralza (tralokinumab) as the first and only treatment specifically targeting IL-13 for adults with moderate-to-severe atopic dermatitis
22 June 2021 - The European Commission regulatory approval is primarily supported by data from the ECZTRA 1, 2 and ECZTRA ...
Posted by Michael Wonder on 23 Jun 2021
Orpathys approved in China for patients with lung cancer and MET gene alterations
23 June 2021 - First-in-class approval in China in this setting and first regulatory approval for the oral, potent and ...
Posted by Michael Wonder on 23 Jun 2021
PBS listings to support patients with mesothelioma
23 June 2021 - From July 1, thousands of Australians and their families suffering from rare cancers and genetic disorders are ...
Posted by Michael Wonder on 22 Jun 2021
FDA approved Biogen Alzheimer’s drug despite some staff concerns
22 June 2021 - The agency has faced criticism for approving the drug, Aduhelm, without clear proof it works. ...
Posted by Michael Wonder on 22 Jun 2021
Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium
22 June 2021 - The TGA is a member of the Access consortium along with Health Canada, Health Sciences Authority of ...
Posted by Michael Wonder on 22 Jun 2021
New drug could cost the Government as much as it spends on NASA
22 June 2021 - The Alzheimer’s treatment will cost $56,000 per patient, and millions may use it. The result: “crazy numbers” ...
Posted by Michael Wonder on 22 Jun 2021
Nib launches new product providing greater access to unfunded medicines
23 June 2021 - nib New Zealand has launched a new health insurance add-on which provides Kiwis with access to ...
Posted by Michael Wonder on 22 Jun 2021
Update of handbook for companies applying for a subsidy
18 June 2021 - The Swedish Dental and Pharmaceutical Benefits Agency, TLV, has updated parts of the handbook for companies ...
Posted by Michael Wonder on 22 Jun 2021
HIRA gives Leclaza benefits easily but delays decision on Tagrisso
22 June 2021 - Yuhan's Leclaza (lazertinib), a third-generation treatment for EGFR mutated non-small cell lung cancer, has won the ...
Posted by Michael Wonder on 22 Jun 2021
Fennec Pharmaceuticals announces FDA acceptance of new drug application resubmission for Pedmark
22 June 2021 - Prescription Drug User Fee Act target action date set for 27 November 2021. ...
Posted by Michael Wonder on 22 Jun 2021
Proposal for the supply of primidone and gabapentin
22 June 2021 - PHARMAC is seeking additional feedback on a proposal to change the funded brands of primidone tablets ...
Posted by Michael Wonder on 22 Jun 2021
Koselugo approved in the EU for children with neurofibromatosis type 1 and plexiform neurofibromas
22 June 2021 - First medicine approved in the EU to treat this rare and debilitating genetic condition. ...
Posted by Michael Wonder on 22 Jun 2021
Jardiance (empagliflozin) approved in Europe for the treatment of heart failure with reduced ejection fraction
21 June 2021 - This new indication is based on the EMPEROR Reduced trial, which showed a significant 25% reduction in ...
Posted by Michael Wonder on 22 Jun 2021
FDA 'may require' post-marketing studies to analyse long-term effects of breast cancer drugs
21 June 2021 - The US FDA "may require” or seek agreement from sponsors to conduct post-marketing studies to analyse ...
Posted by Michael Wonder on 22 Jun 2021
Bristol Myers Squibb receives European Commission approval for Onureg (azacitidine tablets) as frontline oral maintenance therapy for adults with acute myeloid leukaemia
18 June 2021 - Onureg is the first and only once daily, frontline oral maintenance therapy in the European Union for ...