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RSS FeedPosted by Michael Wonder on 22 May 2020
Passage Bio receives rare paediatric disease designation for PBGM01 for patients with GM1 gangliosidosis
21 May 2020 - PBGM01 to enter the clinic in fourth quarter of 2020. ...
Posted by Michael Wonder on 22 May 2020
Sunovion announces U.S. FDA approval of Kynmobi (apomorphine hydrochloride) sublingual film for the treatment of Parkinson’s disease OFF episodes
21 May 2020 - First and only sublingual therapy approved for the on-demand treatment of Parkinson’s disease OFF episodes. ...
Posted by Michael Wonder on 22 May 2020
EMA validates Bristol Myers Squibb’s applications for idecabtagene vicleucel and CC-486
22 May 2020 - Applications based on positive results from pivotal KarMMa study in relapsed and refractory multiple myeloma and QUAZAR-AML-001 ...
Posted by Michael Wonder on 22 May 2020
European Medicines Agency accepts Astellas’ marketing authorisation application for roxadustat
21 May 2020 - Submission for the treatment of anaemia in adult patients with chronic kidney disease. ...
Posted by Michael Wonder on 21 May 2020
Incyte and MorphoSys announce the validation of the European marketing authorisation application for tafasitamab
20 May 2020 - The application seeks approval of tafasitamab in combination with lenalidomide for the treatment of adult patients with ...
Posted by Michael Wonder on 21 May 2020
EMA extends virtual-only meeting policy through August
20 May 2020 - The EMA has announced it is extending its decision to hold all upcoming meetings virtually through ...
Posted by Michael Wonder on 21 May 2020
Drug innovation is back in fashion
21 May 2020 - Big pharma is no longer the villain. ...
Posted by Michael Wonder on 21 May 2020
What to expect when a coronavirus vaccine finally arrives
20 May 2020 - Sobering lessons from the history of the polio vaccine. ...
Posted by Michael Wonder on 21 May 2020
Coronavirus revives debate over drug pricing
21 May 2020 - Lure of profits laid groundwork for some COVID-19 treatments, though may not determine who finds a cure. ...
Posted by Michael Wonder on 21 May 2020
Chiesi Group receives FDA approval for Ferriprox (deferiprone) twice-a-day tablets
21 May 2020 - Chiesi Global Rare Diseases today announced that the U.S. FDA has approved Ferriprox (deferiprone) twice-a-day tablets for ...
Posted by Michael Wonder on 21 May 2020
Cipla receives final approval for generic version of Migranal (dihydroergotamine mesylate 4 mg/mL nasal spray) with a competitive generic therapy designation
21 May 2020 - Cipla today announced that it has received final approval for its abbreviated new drug application for ...
Posted by Michael Wonder on 21 May 2020
Mithra and Searchlight Pharma announce filing of new drug submission for Estelle in Canada
20 May 2020 - Searchlight Pharma's new drug submission for a novel combined oral contraceptive accepted for review by Health Canada. ...
Posted by Michael Wonder on 21 May 2020
AstraZeneca secures orders for virus vaccine under testing
21 May 2020 - Drug maker AstraZeneca has secured the first agreements Thursday for 400 million doses of a COVID-19 vaccine ...
Posted by Michael Wonder on 21 May 2020
Health Canada grants market authorisation to Rozlytrek (entrectinib) for ROS1-positive, locally advanced or metastatic non-small cell lung cancer patients, not previously treated with crizotinib
20 May 2020 - Data show responses in 73% of patients who were treated with Rozlytrek. ...
Posted by Michael Wonder on 20 May 2020
A new entry in the race for a coronavirus vaccine: hope
20 May 2020 - Scientists are increasingly optimistic that a vaccine can be produced in record time. But getting it manufactured ...