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RSS FeedPosted by Michael Wonder on 18 May 2020
EU actions to support availability of medicines during COVID-19 pandemic – update #6
15 May 2020 - The EU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual ...
Posted by Michael Wonder on 18 May 2020
Seelos Therapeutics receives rare paediatric disease designation for SLS-005 (trehalose) in Sanfilippo syndrome
15 May 2020 - Seelos Therapeutics today announced it has been granted rare paediatric disease designation for SLS-005 in Sanfilippo ...
Posted by Michael Wonder on 17 May 2020
Less than a movie ticket or ‘impossible to overpay’? Experts name their price for remdesivir
15 May 2020 - Two weeks ago, the world learned that remdesivir, a treatment from Gilead Sciences, has a moderate ...
Posted by Michael Wonder on 17 May 2020
Blueprint Medicines receives complete response letter from FDA for avapritinib new drug application for the fourth-line treatment of gastro-intestinal stromal tumour
15 May 2020 - Blueprint Medicines today announced that the U.S. FDA has issued a complete response letter for the new ...
Posted by Michael Wonder on 15 May 2020
FDA approves first drug for fourth-line treatment of advanced gastro-intestinal stromal tumours
15 May 2020 - Today, the U.S. FDA approved Qinlock (ripretinib) tablets as the first new drug specifically approved as a ...
Posted by Michael Wonder on 15 May 2020
FDA grants accelerated approval to rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer
15 May 2020 - Today the FDA granted accelerated approval to rucaparib (Rubraca, Clovis Oncology) for patients with deleterious BRCA ...
Posted by Michael Wonder on 15 May 2020
A drug company wagers the U.S. won’t dare charge it with crimes
15 May 2020 - Teva, the world’s largest maker of generic drugs, recently pulled out of settlement talks with the Justice ...
Posted by Michael Wonder on 15 May 2020
U.S. FDA approves Opdivo (nivolumab) + Yervoy (ipilimumab) as first-line treatment of patients with metastatic non-small cell lung cancer whose tumours express PD-L1≥1%
15 May 2020 - Fifth indication for Opdivo + Yervoy, the first and only FDA-approved dual immunotherapy. ...
Posted by Michael Wonder on 15 May 2020
International coordination needed to encourage conduct of large, decision-relevant COVID-19 clinical trials
15 May 2020 - Regulators are highlighting the need for a comprehensive international coordination mechanism to allow the conduct of ...
Posted by Michael Wonder on 15 May 2020
U.S. Food and Drug Administration approves Bristol Myers Squibb’s Pomalyst (pomalidomide) for AIDS-related and HIV-negative Kaposi sarcoma
15 May 2020 - Pomalyst is the only oral and first new treatment option for Kaposi sarcoma in more than 20 ...
Posted by Michael Wonder on 15 May 2020
Seattle Genetics announces Adcetris (brentuximab vedotin) receives European Commission approval for treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma
14 May 2020 - Approval based on positive ECHELON-2 phase 3 trial results demonstrating superior progression-free survival and overall survival with ...
Posted by Michael Wonder on 15 May 2020
Neuraptive Therapeutics announces FDA has granted fast track designation to NTX-001 clinical development program for treatment of patients with peripheral nerve injuries
14 May 2020 - Neuraptive Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation ...
Posted by Michael Wonder on 14 May 2020
Emergency use authorisation of remdesivir: the need for a transparent distribution process
14 May 2020 - On 4 February 2020, the Secretary of the US Department of Health and Human Services (DHHS) determined ...
Posted by Michael Wonder on 14 May 2020
Coronavirus vaccine could be ready in a year: EU medicine agency
14 May 2020 - A vaccine to counter the new coronavirus could be approved in about a year in an ...
Posted by Michael Wonder on 14 May 2020
Sunovion discontinues dasotraline program
13 May 2020 - Sunovion Pharmaceuticals today announced that it has withdrawn the new drug applications for dasotraline, a novel ...