Blog
RSS FeedPosted by Michael Wonder on 09 Mar 2020
U.S. FDA accepts biologics license application for Mylan and Biocon's proposed biosimilar bevacizumab for review
9 March 2020 - Biocon and Mylan today announced that the U.S. FDA has accepted Mylan’s biologics license application for ...
Posted by Michael Wonder on 09 Mar 2020
Regulating medicines in a globalised world with increased recognition and reliance among regulators
5 March 2020 - Research and development of pharmaceuticals are now complex global endeavours, with drug companies operating worldwide using global ...
Posted by Michael Wonder on 09 Mar 2020
Celltrion applies for European approval of Humira biosimilar
9 March 2020 - Celltrion said Monday that it applied for the European Medicine Agency’s commercialization approval of CT-P17, a ...
Posted by Michael Wonder on 09 Mar 2020
Reformatting Product Information: frequently asked questions
6 March 2020 - A new product information form was approved on 8 November 2017, with a commencement date of ...
Posted by Michael Wonder on 08 Mar 2020
Five years on, biosimilars need support from all health care players
6 March 2020 - Today marks a milestone for the U.S. biosimilar market: the FDA approved our first biosimilar, Sandoz’s ...
Posted 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 05 Mar 2020
Janssen submits European marketing authorisation application for ponesimod for treatment of adults with relapsing multiple sclerosis
4 March 2020 - Janssen announced today the submission of a marketing authorisation application to the European Medicines Agency seeking ...
Posted by Michael Wonder on 04 Mar 2020
International work-sharing initiative - baloxavir marboxil (Xofluza)
5 March 2020 - The Therapeutic Goods Administration (TGA) has approved a new medicine for the treatment of influenza (flu) as ...
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 ...