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RSS FeedPosted by Michael Wonder on 04 Apr 2018
US FDA approves Bydureon for use with basal insulin in patients with type 2 diabetes with inadequate glycemic control
3 April 2018 - Duration-7 study results showed significant HbA1c reduction when Bydureon was added to insulin glargine therapy vs insulin ...
Posted by Michael Wonder on 04 Apr 2018
Motif Bio initiates NDA rolling submission for iclaprim
3 April 2018 - Motif Bio today announced the initiation of a rolling submission of a new drug application to ...
Posted by Michael Wonder on 04 Apr 2018
U.S. FDA grants fast track designation to Taris for TAR-200 (GemRIS) in muscle invasive bladder cancer
3 April 2018 - Designation for patients unfit for curative intent therapy. ...
Posted by Michael Wonder on 03 Apr 2018
US FDA accepts biologics license application for moxetumomab pasudotox in hairy cell leukaemia
3 April 2018 - Moxetumomab pasudotox application granted priority review. ...
Posted by Michael Wonder on 03 Apr 2018
FDA charts path forward for biosimilars — but drug makers aren’t all on board
30 March 2018 - In his recent public appearances, FDA Commissioner Scott Gottlieb has sounded a repeating note: drug prices ...
Posted by Michael Wonder on 03 Apr 2018
Eisai submits supplemental new drug application to FDA for Fycompa (perampanel) paediatric indications
31 March 2018 - First step to making Fycompa available for children, underscoring Eisai's commitment to epilepsy care for patients of ...
Posted by Michael Wonder on 03 Apr 2018
Alkermes receives refusal to file letter from FDA for ALKS 5461
2 April 2018 - Alkermes today announced that it received a refusal to file letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 30 Mar 2018
Sunovion submits new drug application to the FDA for apomorphine sublingual film (APL-130277) for the treatment of off episodes associated with Parkinson's disease
30 March 2018 - Submission is supported by Phase 3 clinical study data showing that the investigational medicine demonstrated superior efficacy ...
Posted by Michael Wonder on 30 Mar 2018
Statement from FDA Commissioner on FDA’s efforts to enhance the patient perspective and experience in drug development and review
30 March 2018 - Benefit-risk assessment is at the heart of what we do to ensure that Americans have access ...
Posted by Michael Wonder on 30 Mar 2018
Insmed submits new drug application to FDA for ALIS in NTM lung disease caused by MAC
29 March 2018 - ALIS previously designated as an orphan drug, breakthrough therapy and qualified infectious disease product. ...
Posted by Michael Wonder on 29 Mar 2018
FDA expands approval of Blincyto for treatment of a type of leukaemia in patients who have a certain risk factor for relapse
29 March 2018 - The U.S. FDA granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor ...
Posted by Michael Wonder on 29 Mar 2018
Mylan introduces Symfi triple combo once-daily HIV treatment in the U.S.
28 March 2018 - All ARV regimens are being offered at a significant discount to the price of competing products to ...
Posted by Michael Wonder on 28 Mar 2018
To make copycat drugs more competitive, the FDA is taking a harder look at the originals
28 March 2018 - The FDA wants to improve branded drugs to help bolster the biosimilars market. ...
Posted by Michael Wonder on 28 Mar 2018
FDA approves Toujeo Max SoloStar
27 March 2018 - Max SoloStar holds more insulin than any other long-acting insulin pen. ...
Posted by Michael Wonder on 27 Mar 2018
FDA authorises first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices
27 March 2018 - The U.S. FDA today permitted marketing of the Dexcom G6 integrated continuous glucose monitoring (iCGM) system for ...