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RSS FeedPosted by Michael Wonder on 26 Dec 2017
Cancer drug price rises 1,400% with no generic to challenge it
25 December 2017 - Lomustine among 319 drugs with expired patents but no copies; FDA trying to boost competition. ...
Posted by Michael Wonder on 26 Dec 2017
Six health stories to watch in 2018
24 December 2017 - A new year could bring new treatments for migraines and breast cancer, greater access to a powerful ...
Posted by Michael Wonder on 23 Dec 2017
Many FDA approved cancer drugs might lack clinical benefit
21 December 2017 - New research shows that less than half of the randomised controlled trials that support the approval of ...
Posted by Michael Wonder on 23 Dec 2017
Agile Therapeutics receives a complete response letter from the FDA for Twirla (AG200-15) for the prevention of pregnancy
22 December 2017 - Agile Therapeutics today announced that the U.S. FDA issued a complete response letter in response to ...
Posted by Michael Wonder on 23 Dec 2017
BioMarin receives anticipated notification of PDUFA extension for pegvaliase biologics license application to 28 May 2018
22 December 2017 - Regulatory review process proceeding in-line with company's expectations. ...
Posted by Michael Wonder on 23 Dec 2017
Santen receives complete response letter from U.S. FDA for intravitreal sirolimus (DE-109)
21 December 2017 - Santen Pharmaceutical today announced that the U.S. FDA has issued a complete response letter for the ...
Posted by Michael Wonder on 22 Dec 2017
FDA updates the label of Tasigna to reflect that certain patients with a type of leukaemia may be eligible to stop treatment after sustained response
22 December 2017 - Discontinuation in treatment marks a first in chronic myeloid leukaemia. ...
Posted by Michael Wonder on 22 Dec 2017
Novartis' combination therapy Tafinlar and Mekinist granted FDA priority review for the adjuvant treatment of stage III BRAF V600 mutation-positive melanoma
22 December 2017 - Priority review designation based on Phase III study showing 53% reduction in risk of recurrence or death ...
Posted by Michael Wonder on 22 Dec 2017
Mesoblast receives FDA regenerative medicine advanced therapy designation for its cell therapy in heart failure patients with left ventricular assist devices
21 December 2017 - Mesoblast today announced that the United States FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation for ...
Posted by Michael Wonder on 22 Dec 2017
Basilea reports that ceftobiprole received QIDP designation from U.S. FDA for the treatment of Staphylococcus aureus bacteremia
21 December 2017 - Basilea Pharmaceutica announced today that the U.S. FDA designated its investigational drug ceftobiprole as a Qualified ...
Posted by Michael Wonder on 22 Dec 2017
U.S. FDA grants priority review to Janssen for apalutamide as a treatment for non-metastatic castration-resistant prostate cancer
21 December 2017 - Apalutamide is the first agent submitted for approval to treat earlier stage castration-resistant prostate cancer at high ...
Posted by Michael Wonder on 22 Dec 2017
FDA approves drug to treat dangerously low blood pressure
21 December 2017 - The U.S. FDA today approved Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in ...
Posted by Michael Wonder on 21 Dec 2017
Diabetes is officially the messiest drug market
22 December 2017 - A crowded space gets more so as the FDA approves Pfizer/Merck's Steglujan. ...
Posted by Michael Wonder on 21 Dec 2017
FDA grants breakthrough therapy designation for alevumab in combination with Inlyta in advanced renal cell carcinoma
21 December 2017 - Second breakthrough therapy desgnation for avelumab in hard to treat cancer. ...
Posted by Michael Wonder on 21 Dec 2017
Samsung Bioepis’ SB3 trastuzumab biosimilar candidate accepted for review by the US FDA
20 December 2017 - Samsung Bioepis today announced that the US FDA has accepted for review the company’s biologics license application ...