Blog
RSS FeedPosted by Michael Wonder on 15 Feb 2017
Amgen submits supplemental biologics license application for Blincyto (blinatumomab) in relapsed or refractory B-cell precursor acute lymphoblastic leukaemia
14 February 2017 - Application includes overall survival data from phase 3 TOWER study to support conversion from accelerated approval to ...
Posted by Michael Wonder on 08 Feb 2017
FDA grants fast track designation to Angionetics' Generx product candidate, a one-time gene therapy for coronary heart disease
7 February 2017 - Angionetics today reported that the FDA has granted fast track designation for the Phase 3 clinical ...
Posted by Michael Wonder on 08 Feb 2017
Flexion Therapeutics announces new drug application for Zilretta (FX006) accepted by U.S. Food and Drug Administration
7 February 2017 - FDA reviewing Zilretta as potential new treatment for osteoarthritis of the knee. ...
Posted by Michael Wonder on 07 Feb 2017
Perrigo confirms patent challenge for generic version of Onexton Gel
7 February 2017 - Perrigo announced that it has filed an abbreviated new drug application with the U.S. FDA for clindamycin, ...
Posted by Michael Wonder on 07 Feb 2017
Ablynx submits a marketing authorisation application to the EMA for caplacizumab, its anti-vWF nanobody, for the treatment of aTTP
6 February 2017 - Ablynx is on track to report results of the confirmatory Phase III HERCULES study in the second ...
Posted by Michael Wonder on 07 Feb 2017
Ariad announces submission of marketing authorisation application for brigatinib to the European Medicines Agency
6 February 2017 - Ariad Pharmaceuticals today announced the submission of a marketing authorisation application for its investigational oral anaplastic ...
Posted by Michael Wonder on 06 Feb 2017
Intarcia announces FDA filing acceptance of new drug application for ITCA 650 for the treatment of type 2 diabetes
3 February 2017 - Intarcia Therapeutics announced today that the U.S. FDA has accepted for active review its new drug ...
Posted by Michael Wonder on 04 Feb 2017
Intellipharmaceutics announces FDA acceptance for filing of NDA for Rexista (oxycodone hydrochloride extended release), an abuse deterrent opioid analgesic for the treatment of moderate to severe pain
2 February 2017 - Intellipharmaceutics International today announced that the U.S. FDA has accepted for filing the company's previously-announced new ...
Posted by Michael Wonder on 03 Feb 2017
FDA accepts two sBLAs for Merck’s Keytruda (pembrolizumab) for locally advanced or metastatic urothelial cancer in cisplatin-ineligible first-line and second-line post-platinum failure treatment settings
3 February 2017 - Keytruda also receives breakthrough therapy designation for second-line treatment based on KEYNOTE-045, which includes primary endpoints ...
Posted by Michael Wonder on 02 Feb 2017
Teva confirms generic Victoza patent challenge in the United States
2 February 2017 - Teva Pharmaceuticals today announced that it has filed an abbreviated new drug application with the U.S. ...
Posted by Michael Wonder on 02 Feb 2017
OptiNose announces FDA acceptance for filing of the new drug application for OPN-375
31 January 2017 - FDA sets user fee goal date in September 2017. ...
Posted by Michael Wonder on 31 Jan 2017
BioCryst announces the acceptance of peramivir MAA filing by the European Medicines Agency
30 January 2017 - BioCryst Pharmaceuticals announced today that the EMA has accepted the filing of its peramivir marketing authorisation ...
Posted by Michael Wonder on 25 Jan 2017
Atlantic Healthcare receives FDA agreement to initiate rolling submission of its new drug application for alicaforsen in the treatment of pouchitis
24 January 2017 - FDA to accept sections of the regulatory application ahead of final Phase 3 data expected in ...
Posted by Michael Wonder on 24 Jan 2017
EMA validates Gilead’s marketing authorisation application for investigational chronic hepatitis C therapy sofosbuvir/velpatasvir/voxilaprevir
20 January 2017 - Sofosbuvir with velpatasvir and voxilaprevir granted an accelerated assessment by the EMA. ...
Posted by Michael Wonder on 24 Jan 2017
European Medicines Agency grants accelerated assessment, validates marketing authorisation application for AbbVie's investigational regimen of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C in all major genotypes
24 January 2017 - Marketing authorisation application is supported by data from global registrational clinical development program across all major ...