Blog
RSS FeedPosted by Michael Wonder on 23 May 2018
Gene therapies that could transform diseases get easier FDA path
23 May 2018 - Haemophilia treatments could be first under proposed method. ...
Posted by Michael Wonder on 22 May 2018
Janssen questions literature review on biosimilar switching studies as authors defend it
22 May 2018 - Three employees of Johnson & Johnson’s Janssen Pharmaceuticals, which has not publicly disclosed that it is ...
Posted by Michael Wonder on 22 May 2018
Make drugs cheaper by encouraging generics
22 May 2018 - The FDA is pushing in that direction. Congress could do much more. ...
Posted by Michael Wonder on 22 May 2018
Lilly's Taltz (ixekizumab) receives the first U.S. FDA approval for label update to include data for psoriasis involving the genital area
22 May 2018 - The label update is effective immediately in the United States. ...
Posted by Michael Wonder on 22 May 2018
Utility receives qualified infectious disease product designation from the U.S. FDA
21 May 2018 – Utility Therapeutics today announced that the U.S. FDA has designated both mecillinam (injectable) and pivmecillinam (oral ...
Posted by Michael Wonder on 22 May 2018
GSK receives US approval of Arnuity Ellipta for use in children from 5 years old who suffer from asthma
21 May 2018 - GSK today announced it has received approval from the US FDA for the use of Arnuity Ellipta ...
Posted by Michael Wonder on 22 May 2018
Harmony Biosciences receives breakthrough therapy and fast track designations for pitolisant
21 May 2018 - Expanded access program for pitolisant is open and patients are being enrolled. ...
Posted by Michael Wonder on 21 May 2018
Immunomedics submits biologics license application for sacituzumab govitecan to the U.S. Food and Drug Administration
21 May 2018 - First-in-class antibody-drug conjugate had received prior breakthrough therapy designation from the FDA for the treatment of metastatic ...
Posted by Michael Wonder on 21 May 2018
Glenmark Pharmaceuticals announces the company's first new drug application for Ryaltris for patients with seasonal allergic rhinitis
21 May 2018 - Glenmark Pharmaceuticals today announced that the company has submitted a new drug application to the U.S. FDA ...
Posted by Michael Wonder on 21 May 2018
FDA approves new drug for patients with chronic liver disease who have low blood platelets and are undergoing a medical procedure
21 May 2018 - The U.S. FDA today approved Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in adults ...
Posted by Michael Wonder on 20 May 2018
Requiring prices in drug ads: would it do any good? Is it even legal?
19 May 2018 - A commercial for Neulasta, a drug that reduces the risk of infections after chemotherapy. If President Trump ...
Posted by Michael Wonder on 19 May 2018
Lokelma approved in the US for the treatment of adults with hyperkalaemia
18 May 2018 - Lokelma provides a rapid and sustained treatment for hyperkalaemia, a condition with high unmet need. ...
Posted by Michael Wonder on 19 May 2018
FDA accepts new drug application submission for Cosmo Pharmaceuticals' rifamycin SV MMX and sets PDUFA date
18 May 2018 - Cosmo Pharmaceuticals today announced that it has been notified by the U.S. FDA that the agency ...
Posted by Michael Wonder on 18 May 2018
FDA looking at ways to include price info in drug ads, Gottlieb says, as questions loom
18 May 2018 - The commissioner of the FDA, Scott Gottlieb, said a proposal to have pharmaceutical companies include drug ...
Posted by Michael Wonder on 18 May 2018
How a migraine drug is easing the headache of high prices
19 May 2018 - Amgen and Novartis got it right this time by not charging as much as they could. Their ...