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RSS FeedPosted by Michael Wonder on 29 Mar 2017
Novartis announces first CAR-T cell therapy BLA for paediatric and young adult patients with r/r B-cell ALL granted FDA Priority Review
29 March 2017 - Priority review for investigational CTL019 (tisagenlecleucel-T), a novel therapy that is manufactured for each individual patient using ...
Posted by Michael Wonder on 29 Mar 2017
Cempra withdraws solithromycin marketing authorisation application in Europe
28 March 2017 - Company plans to resubmit application with additional data, in alignment with FDA strategy. ...
Posted by Michael Wonder on 29 Mar 2017
AstraZeneca shares progress on Lynparza (olaparib) tablets in the US
28 March 2017 - FDA grants priority review for maintenance setting in ovarian cancer patients with PDUFA set for Q3 ...
Posted by Michael Wonder on 28 Mar 2017
Roche withdraws submission for Avastin
28 March 2017 - Roche was seeking a positive CADTH recommendation for the use of bevacizumab in combination with pemetrexed ...
Posted by Michael Wonder on 28 Mar 2017
FDA grants priority review for Eagle Pharmaceuticals’ Ryanodex NDA for the treatment of exertional heat stroke
27 March 2017 - Eagle Pharmaceuticals announced today that their 505(b)(2) new drug application for Ryanodex (dantrolene sodium) for the treatment ...
Posted by Michael Wonder on 25 Mar 2017
Symbiomix Therapeutics announces FDA’s acceptance of new drug application for Solosec with priority review status
23 March 2017 - Symbiomix today announced that the US FDA has accepted for filing the Company’s new drug application for ...
Posted by Michael Wonder on 25 Mar 2017
Almirall and Sun Pharma announce regulatory filing of tildrakizumab in Europe
24 March 2017 - Almirall and Sun Pharmaceutical Industries announced today the validation of the regulatory filing of tildrakizumab with ...
Posted by Michael Wonder on 24 Mar 2017
Lundbeck and Otsuka's brexpiprazole for adult patients with schizophrenia accepted for review by EMA
23 March 2017 - The EMA is expected to complete its review in second quarter of 2018. ...
Posted by Michael Wonder on 23 Mar 2017
Shire receives FDA fast track designation for recombinant ADAMTS13 (SHP655) for treatment of hereditary thrombotic thrombocytopenic purpura
22 March 2017 - Shire today announced that the United States FDA has granted fast track designation for recombinant ADAMTS13 (SHP655 ...
Posted by Michael Wonder on 22 Mar 2017
First anniversary of PRIME – experience so far
22 March 2017 - Registration opens for stakeholder meeting on 19 May 2017. ...
Posted by Michael Wonder on 22 Mar 2017
NICE terminates four single technology assessments
22 March 2017 - Appraisals terminated as a result of four sponsors deciding not to submit evidence. ...
Posted by Michael Wonder on 21 Mar 2017
Humacyte receives FDA regenerative medicine advanced therapy expedited review designation for Humacyl in vascular access for haemodialysis
20 March 2017 - Humacyte announced today that the U.S. FDA has granted Humacyl, its investigational human acellular vessel, the ...
Posted by Michael Wonder on 20 Mar 2017
Array BioPharma provides update on FDA submission for binimetinib
20 March 2017 - NRAS mutant melanoma NDA withdrawn based on thorough discussions with FDA and following late cycle review meeting. ...
Posted by Michael Wonder on 18 Mar 2017
AstraZeneca receives complete response letter from US FDA for ZS-9 (sodium zirconium cyclosilicate) for hyperkalaemia
17 March 2017 - AstraZeneca today announced that the US FDA has issued a complete response letter regarding the new ...
Posted by Michael Wonder on 16 Mar 2017
EMA publishes updated list of applications for new human medicines under evaluation by the CHMP
16 March 2017 - This document lists information on applications for centralised marketing authorisation for human medicines that the EMA ...