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RSS FeedPosted by Michael Wonder on 24 Apr 2018
Express Scripts targets Amgen, Lilly migraine drugs in pricing shift
24 April 2018 - The largest U.S. manager of prescription benefits is telling drug makers that the current pricing model is ...
Posted by Michael Wonder on 24 Apr 2018
Trump delays drug pricing speech, no set date yet
23 April 2018 - U.S. President Donald Trump has postponed a speech on lowering prescription drug prices previously scheduled for ...
Posted by Michael Wonder on 24 Apr 2018
FDA Advisory Committee recommends the approval of baricitinib 2 mg, but not 4 mg, for the treatment of moderately-to-severely active rheumatoid arthritis
23 April 2018 - Eli Lilly and Incyte Corporation announced today that the U.S. FDA Arthritis Advisory Committee recommended approval of ...
Posted by Michael Wonder on 23 Apr 2018
Abeona announces FDA grants RMAT designation to ABO-102 gene therapy in MPS IIIA
23 April 2018 - First gene therapy using AAV approach granted regenerative medicine advanced therapy designation. ...
Posted by Michael Wonder on 23 Apr 2018
Sage Therapeutics submits new drug application to U.S. FDA for intravenous brexanolone in the treatment of post-partum depression
23 April 2018 - Brexanolone IV submission is the company’s first new drug application. ...
Posted by Michael Wonder on 23 Apr 2018
MeiraGTx announces AAV-RPGR granted fast track designation by U.S. FDA for treatment of X-linked retinitis pigmentosa due to RPGR deficiency
23 April 2018 - MeiraGTx Limited today announced that the U.S. FDA has granted fast track designation for AAV-RPGR for the ...
Posted by Michael Wonder on 23 Apr 2018
Synthetic Biologics provides update on development of SYN-004 (ribaxamase), for the prevention of C. difficile infection
23 April 2018 - Synthetic Biologics today announced that it has preliminary agreement from the U.S. FDA on a proposed ...
Posted by Michael Wonder on 23 Apr 2018
Pfizer provides update on proposed trastuzumab biosimilar
23 April 2018 - Pfizer today announced that it received a complete response letter from the United States FDA in response ...
Posted by Michael Wonder on 23 Apr 2018
Pfizer granted FDA breakthrough therapy designation for Trumenba (meningococcal Group B vaccine) for the prevention of invasive meningococcal B disease in children aged 1 to 9 years
23 April 2018 - Pfizer today announced that Trumenba (meningococcal Group B vaccine) received breakthrough therapy designation from the U.S. FDA ...
Posted by Michael Wonder on 21 Apr 2018
U.S. FDA grants fast track designation for Polyphor's innovative immuno-oncology candidate balixafortide in combination with eribulin as third-line therapy for metastatic breast cancer
19 April 2018 - Polyphor announced today that the U.S. FDA has granted fast track designation for its novel immuno-oncology candidate ...
Posted by Michael Wonder on 21 Apr 2018
Pushing 'value,' Harvard Pilgrim tests outcomes deals
18 April 2018 - Harvard Pilgrim will pay less for AstraZeneca plc's asthma drug Symbicort if its members experience worsening symptoms ...
Posted by Michael Wonder on 21 Apr 2018
Three steps toward a more sustainable path for targeted cancer drugs
18 April 2018 - Spending on cancer drugs in the United States has increased substantially over the past 5 years, ...
Posted by Michael Wonder on 21 Apr 2018
Helsinn Group announces the FDA approval of the IV formulation of Akynzeo (fosnetupitant/palonosetron) in the United States
20 April 2018 - Helsinn today announces that the U.S. FDA has approved the intravenous formulation of Akynzeo (NEPA, a ...
Posted by Michael Wonder on 21 Apr 2018
FDA commissioner to drug middlemen: you're part of the problem
19 April 2018 - The FDA has approved nine biosimilars, generic versions of biologic medicines, but only three are available in ...
Posted by Michael Wonder on 19 Apr 2018
FDA staff raises safety concerns over Lilly/Incyte arthritis drug
19 April 2018 - An experimental rheumatoid arthritis drug developed by Eli Lilly and Incyte poses serious risks of deadly blood ...