Blog
RSS FeedPosted by Michael Wonder on 31 May 2020
Highlights from the May 25-28 CHMP meeting
29 May 2020 - Eight new medicines recommended for approval. ...
Posted by Michael Wonder on 24 May 2020
Zealand Pharma announces FDA acceptance of new drug application for the dasiglucagon HypoPal rescue pen for treatment of severe hypoglycemia
22 May 2020 - PDUFA target action date scheduled for 27 March 2021. ...
Posted by Michael Wonder on 23 May 2020
U.S. FDA approves Takeda’s Alunbrig (brigatinib) as a first-line treatment option for patients diagnosed with rare and serious form of lung cance
22 May 2020 - Long-term results from the Phase 3 ALTA 1L trial established Alunbrig as a superior first-line treatment compared ...
Posted by Michael Wonder on 23 May 2020
Intercept provides regulatory update
22 May 2020 - Intercept Pharmaceuticals today announced that based on discussions earlier this week, the U.S. FDA has notified Intercept ...
Posted by Michael Wonder on 23 May 2020
U.S. FDA approves Evofem Biosciences' Phexxi (lactic acid, citric acid and potassium bitartrate), the first and only non-hormonal prescription gel for the prevention of pregnancy
22 May 2020 - A new class of female-controlled birth control for use in-the-moment. ...
Posted by Michael Wonder on 23 May 2020
Orphazyme’s arimoclomol receives US fast track designation in amyotrophic lateral sclerosis
22 May 2020 - Orphazyme announces that the Company has received fast track designation from the US FDA for the development ...
Posted 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
Improved deal means new treatment for a type of advanced breast cancer can be recommended by NICE
22 May 2020 - Draft guidance published today by NICE recommends atezolizumab for treating people with a type of breast cancer, ...
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
CADTH posts final recommendation for Entyvio
21 May 2020 - CADTH has completed its consideration of subcutaneous vedolizumab for the treatment of adult patients with moderately to ...
Posted by Michael Wonder on 21 May 2020
Medicines with one seller and many buyers: strategies to increase the power of the payer
20 May 2020 - Andrew Rintoul and colleagues argue that collaboration and transparency increase the market power of buyers who ...
Posted by Michael Wonder on 21 May 2020
New rule makes it harder for patients to lower their out-of-pocket costs
20 May 2020 - In the midst of increased financial insecurity for Americans due to the COVID-19 pandemic, it is ...