Blog
RSS FeedPosted by Michael Wonder on 16 Mar 2020
TGA cautions against over-buying medicines
16 March 2020 - In response to COVID-19, the TGA is aware that some pharmacists have been over-ordering medicines, while ...
Posted by Michael Wonder on 15 Mar 2020
FDA finalises guidance for industry on applications for drugs with inadequate generic competition
13 March 2020 - Today, the U.S. FDA finalised guidance for industry, “Competitive Generic Therapies” (CGTs), which describes the process that ...
Posted by Michael Wonder on 15 Mar 2020
For second time, FDA rejects Intarcia's diabetes implant
11 March 2020 - Boston-based Intarcia continues to run into a regulatory roadblock concerning its implanted diabetic pump ITCA 650. ...
Posted by Michael Wonder on 14 Mar 2020
Why test for proportional hazards?
13 March 2020 - The Cox proportional hazards model, introduced in 1972, has become the default approach for survival analysis in ...
Posted by Michael Wonder on 14 Mar 2020
GW Pharmaceuticals submits type II variation application to the EMA to expand the use of Epidyolex (cannabidiol) oral solution for the treatment of seizures associated with tuberous sclerosis complex
13 March 2020 - GW Pharmaceuticals today announces the submission of a Type II variation application to the EMA seeking approval ...
Posted by Michael Wonder on 14 Mar 2020
COVID-19: developers of medicines or vaccines to benefit from free scientific advice
13 March 2020 - EMA provides full fee waivers for scientific advice applications from developers of potential therapeutics (to treat ...
Posted by Michael Wonder on 13 Mar 2020
TGA response to coronavirus (COVID-19)
13 March 2020 - As part of the Department of Health, the Therapeutic Goods Administration is providing active support for monitoring ...
Posted by Michael Wonder on 13 Mar 2020
Agenus receives fast track designation for balstilimab & zalifrelimab in advanced cervical cancer
12 March 2020 - Agenus today announced that the U.S. FDA has granted Agenus fast track designation for investigation of balstilimab ...
Posted by Michael Wonder on 12 Mar 2020
Coronavirus spurs U.S. efforts to end China’s chokehold on drugs
11 March 2020 - The Trump administration says the U.S. is too dependent on China for vital drugs. But it’s unclear ...
Posted by Michael Wonder on 12 Mar 2020
Law makers pressure big pharma on drug supply chains amid coronavirus outbreak
11 March 2020 - Law makers have for years been concerned the U.S. is too reliant on foreign manufacturing of medicine. ...
Posted by Michael Wonder on 12 Mar 2020
Acacia Pharma announces brief extension of FDA review period for NDA for Byfavo, an ultra-short acting and reversible anesthetic for procedural sedation
12 March 2020 - Acacia Pharma announces that the US FDA has extended the review period for the new drug ...
Posted by Michael Wonder on 12 Mar 2020
AbbVie receives European Commission approval of Venclyxto combination regimen for patients with previously-untreated chronic lymphocytic leukaemia
12 March 2020 - Approval is based on data from the Phase 3 CLL14 trial, which showed that patients treated with ...
Posted by Michael Wonder on 12 Mar 2020
US FDA grants fast track designation to Jardiance for the treatment of chronic kidney disease
12 March 2020 - FDA fast track designation is for the investigation of potential new therapies that treat serious conditions and ...
Posted by Michael Wonder on 12 Mar 2020
RadioMedix and Curium Announce copper Cu 64 dotatate injection was granted priority review by the U.S. FDA
11 March 2020 - RadioMedix and its commercial partner Curium announced the U.S. FDA has granted copper Cu 64 dotatate injection ...
Posted by Michael Wonder on 12 Mar 2020
Therapeutic Goods Administration prepare to fast track coronavirus vaccines and treatment
11 March 2020 - The Therapeutic Goods Administration is gearing up to fast track the approval of any vaccines or treatments ...