Blog
RSS FeedPosted by Michael Wonder on 18 May 2020
Beware of underpriced drugs for COVID-19 treatments
18 May 2020 - It has become painfully obvious that the only path back to normalcy involves either an effective ...
Posted by Michael Wonder on 18 May 2020
Adamis Pharmaceuticals resubmits Zimhi new drug application to FDA
18 May 2020 - Adamis Pharmaceuticals Corporation today announced the resubmission of the Company’s new drug application to the U.S. ...
Posted by Michael Wonder on 18 May 2020
Blueprint pays the price of Ayvakit phase 3 miss as FDA rejects drug
18 May 2020 - The FDA has turned down Blueprint Medicines’ Ayvakit for more general use in gastro-intestinal stromal tumour ...
Posted by Michael Wonder on 18 May 2020
Enhertu granted breakthrough therapy designation in the U.S. for HER2 mutant metastatic non-small cell lung cancer
18 May 2020 - Designation based on phase 2 DESTINY-Lung01. ...
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
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
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
Sunovion discontinues dasotraline program
13 May 2020 - Sunovion Pharmaceuticals today announced that it has withdrawn the new drug applications for dasotraline, a novel ...