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RSS FeedPosted by Michael Wonder on 17 Dec 2020
Decibel Therapeutics announces DB-020 has been granted fast track designation by the U.S. FDA
17 December 2020 - Decibel Therapeutics today announced that their clinical product candidate, DB-020, has been granted fast track designation ...
Posted by Michael Wonder on 17 Dec 2020
Most expensive medicines in Australia revealed
17 December 2020 - This second rate journalist thinks Zaltrap is listed on the PBS. ...
Posted by Michael Wonder on 17 Dec 2020
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) plus chemotherapy as first-line treatment for locally advanced unresectable or metastatic oesophageal and gastro-esophageal junction cancer
17 December 2020 - Application based on overall survival and progression-free survival data comparing Keytruda plus chemotherapy to chemotherapy alone from ...
Posted by Michael Wonder on 17 Dec 2020
FDA approves GSK’s Benlysta as the first medicine for adult patients with active lupus nephritis in the US
17 December 2020 - Approval builds on nearly 10 years of experience in lupus. ...
Posted by Michael Wonder on 17 Dec 2020
ICER publishes final evidence report and policy recommendations on new therapies for bladder cancer
17 December 2020 - Independent appraisal committee determines current evidence is adequate to demonstrate that nadofaragene firadenovec and oportuzumab monatox ...
Posted by Michael Wonder on 17 Dec 2020
Japan to lower drug prices to reduce medical costs
17 December 2020 - Japanese Finance Minister Taro Aso and health minister Norihisa Tamura agreed Thursday to reduce state-set prices ...
Posted by Michael Wonder on 17 Dec 2020
MacroGenics announces FDA approval of Margenza for patients with pretreated metastatic HER2 positive breast cancer
16 December 2020 - Product launch anticipated in March of 2021. ...
Posted by Michael Wonder on 17 Dec 2020
Amgen submits sotorasib new drug application to U.S. FDA for advanced or metastatic non-small cell lung cancer with KRAS G12C mutation
16 December 2020 - FDA granted breakthrough therapy designation for Sotorasib. ...
Posted by Michael Wonder on 17 Dec 2020
PBS Expenditure and Prescriptions Report 2019-20
17 December 2020 - The PBS Expenditure and Prescriptions Report 1 July 2019 to 30 June 2020 is now available. ...
Posted by Michael Wonder on 16 Dec 2020
Durect Corporation announces DUR-928 granted FDA fast track designation for treatment of alcoholic hepatitis
16 December 2020 - Durect Corporation today announced that the U.S. FDA has granted fast track designation to DUR-928 for ...
Posted by Michael Wonder on 16 Dec 2020
In a petition, Boehringer warns FDA its definition of ‘strength’ threatens biosimilar competition
10 December 2020 - Arguing the FDA is precluding competition for biosimilar manufacturers, Boehringer Ingelheim has petitioned the agency to ...
Posted by Michael Wonder on 16 Dec 2020
NICE recommends Novartis’ wet AMD drug Beovu
16 December 2020 - The UK’s NICE has recommended Novartis’ anti-VEGF treatment Beovu (brolucizumab) for routine NHS use in wet ...
Posted by Michael Wonder on 16 Dec 2020
Gilead and Galapagos announce new commercialisation and development agreement for Jyseleca (filgotinib)
15 December 2020 - Gilead will not advance Jyseleca for the treatment of rheumatoid arthritis in the U.S. following FDA Type ...
Posted by Michael Wonder on 16 Dec 2020
Year in review
16 December 2020 - PHARMAC claims it funded 14 new medicines, including six new cancer medicines, and widened access to ...
Posted by Michael Wonder on 16 Dec 2020
Fortress Biotech announces breakthrough therapy designation for CUTX-101, copper histidinate, for the treatment of Menkes disease
15 December 2020 - Rolling submission of new drug application to the FDA for CUTX-101 on track to begin in the ...