Blog
RSS FeedPosted by Michael Wonder on 13 Dec 2018
Authorized generic for Evzio (naloxone hydrochloride injection) to be available at a reduced list price of $178
12 December 2018 - Product will be available in 2019. ...
Posted by Michael Wonder on 12 Dec 2018
Mallinckrodt's SpecGx receives FDA complete response letter for abuse-deterrent, immediate-release reformulation of Roxicodone (oxycodone hydrochloride)
12 December 2018 - SpecGx announced today that it has received a complete response letter from the U.S. FDA related ...
Posted by Michael Wonder on 12 Dec 2018
FDA takes aim at pharma’s biosimilar-delaying tactics
12 December 2018 - Ever-rising cost of insulins also to be targeted. ...
Posted by Michael Wonder on 12 Dec 2018
Metastasis-free survival in prostate cancer: faster drug approvals, better drugs?
12 December 2018 - On 13 February 2018, the US FDA granted marketing authorisation to apalutamide for treatment of non-metastatic castration-resistant ...
Posted by Michael Wonder on 12 Dec 2018
Bayesian hierarchical models
11 December 2018 - Treatment effects will differ from one study to another evaluating similar therapies, both because of random variation ...
Posted by Michael Wonder on 12 Dec 2018
Mayne Pharma receives FDA approval of Tolsura (SUBA-itraconazole capsules) for the treatment of certain fungal infections
11 December 2018 - Mayne Pharma is pleased to announce that the US FDA has approved the new drug application ...
Posted by Michael Wonder on 11 Dec 2018
Non-cystic fibrosis bronchiectasis FDA grants “fast-track” and “QIPD” to Zambon for colistimethate sodium powder for nebuliser solution delivered by the I-neb AAD system
11 December 2018 - Non–cystic fibrosis bronchiectasis is a, chronic, progressive and irreversible disease, prevalent in Europe and the US. ...
Posted by Michael Wonder on 11 Dec 2018
The drug industry is headed back to Congress to make its case. Will Democrats keep the door open?
10 December 2018 - With annual revenues of roughly $450 million and an army of some 160 lobbyists, PhRMA has ...
Posted by Michael Wonder on 11 Dec 2018
Intra-Cellular Therapies announces FDA acceptance of new drug application for lumateperone for the treatment of schizophrenia
11 December 2018 - Intra-Cellular Therapies today announced that the U.S. FDA has accepted for review its new drug application for ...
Posted by Michael Wonder on 11 Dec 2018
Statement from FDA Commissioner on new actions advancing the agency’s biosimilars policy framework
11 December 2018 - Our public health obligations touch on many aspects of how medical products are developed and used ...
Posted by Michael Wonder on 10 Dec 2018
Stealth BioTherapeutics granted fast track designation for elamipretide for the treatment of dry age-related macular degeneration with geographic atrophy
10 December 2018 - Stealth BioTherapeutics today announced that the U.S. FDA has granted fast track designation for its lead investigational ...
Posted by Michael Wonder on 10 Dec 2018
U.S. FDA grants fast track designation to Asana BioSciences’ oral dual JAK-SYK inhibitor, ASN002, for the treatment of atopic dermatitis
10 December 2018 - Asana BioSciences announced today that the U.S. FDA has granted fast track designation to Asana’s investigational oral ...
Posted by Michael Wonder on 10 Dec 2018
Pfenex submits new drug application to U.S. FDA seeking approval of PF708 for the treatment of osteoporosis
10 December 2018 - Submitted as a 505(b)(2) NDA with an expected ten month review. ...
Posted by Michael Wonder on 10 Dec 2018
Blue Earth Diagnostics announces U.S. FDA filing acceptance of supplemental new drug application for 18F-fluciclovine PET Imaging in Glioma
10 December 2018 - The application seeks to expand Axumin (fluciclovine F 18) label for use in detection and continuing ...
Posted by Michael Wonder on 10 Dec 2018
The rise of use of medical devices force FDA to change the rules
9 December 2018 - A disruptive market of $410 billion until 2023, changes dramatically with the entrance of small and medium ...