Blog
RSS FeedPosted by Michael Wonder on 08 Mar 2020
Acacia Pharmaceuticals and Neuren Pharmaceuticals announce rare paediatric disease designation for trofinetide for the treatment of Rett syndrome
3 March 2020 - With no approved treatments in Rett syndrome, FDA decision highlights significant unmet need. ...
Posted by Michael Wonder on 07 Mar 2020
FDA approves new treatment for adults with Cushing’s disease
6 March 2020 - The U.S. FDA today approved Isturisa (osilodrostat) oral tablets for adults with Cushing’s disease who either cannot ...
Posted by Michael Wonder on 05 Mar 2020
Urovant Sciences announces U.S. FDA acceptance of new drug application for vibegron for the treatment of overactive bladder
5 March 2020 - Urovant Sciences today announced that the U.S. FDA has accepted for review the company’s new drug ...
Posted by Michael Wonder on 05 Mar 2020
Allergan receives FDA approval for Durysta (bimatoprost implant) the first and only intracameral biodegradable sustained-release implant to lower intra-ocular pressure in open-angle glaucoma or ocular hypertension patients
5 March 2020 - Durysta lowered intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension by approximately 30% from baseline ...
Posted by Michael Wonder on 05 Mar 2020
Trevena announces FDA has set PDUFA date of 7 August 2020 for oliceridine
5 March 2020 - FDA considers NDA resubmission a complete Class 2 response. ...
Posted by Michael Wonder on 05 Mar 2020
FDA track: PDUFA Performance
5 March 2020 - The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User ...
Posted by Michael Wonder on 04 Mar 2020
Emerald Health Pharmaceuticals receives fast track designation from US FDA for EHP-101 in the treatment of systemic sclerosis
3 March 2020 - First-in-class product candidate in Phase 2 clinical development now has fast track and orphan designations. ...
Posted by Michael Wonder on 04 Mar 2020
Zosano Pharma announces FDA acceptance of 505(b)(2) new drug application for Qtrypta for the acute treatment of migraine
4 March 2020 - Zosano Pharma today announced that the U.S. FDA has accepted the company’s new drug application for ...
Posted by Michael Wonder on 04 Mar 2020
When a drug study abruptly ends, volunteers are left to cope
3 March 2020 - A participant might commit months or years to a drug trial, only to see it vanish overnight. ...
Posted by Michael Wonder on 04 Mar 2020
Expanding access and reducing prices for drugs to prevent HIV. Should Government enforce its patent rights against the pharmaceutical industry?
3 March 2020 - On November 6, 2019, the Department of Health and Human Services (HHS) filed a lawsuit against Gilead ...
Posted by Michael Wonder on 04 Mar 2020
Drug shortages in the United States. Are some prices too low?
3 March 2020 - The US public identified lowering prescription drug prices as the top health priority for Congress in 2019. ...
Posted by Michael Wonder on 04 Mar 2020
Estimated research and development investment needed to bring a new medicine to market, 2009-2018
3 March 2020 - In this study, which included 63 of 355 new therapeutic drugs and biologic agents approved by the ...
Posted by Michael Wonder on 03 Mar 2020
Ayala Pharmaceuticals granted U.S. FDA fast track designation for AL101 for the treatment of recurrent or metastatic adenoid cystic carcinoma
3 March 2020 - Ayala Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to AL101 for ...
Posted by Michael Wonder on 03 Mar 2020
FDA grants rare paediatric disease designation to Stealth BioTherapeutics for elamipretide for the treatment of Barth syndrome
3 March 2020 - Stealth BioTherapeutics today announced that the U.S. FDA has granted rare paediatric disease designation for elamipretide ...
Posted by Michael Wonder on 03 Mar 2020
The coronavirus could help pharma reset its reputation in Washington
3 March 2020 - The coronavirus outbreak could be the pharmaceutical industry’s ticket to saving its reputation in Washington. ...