Blog
RSS FeedPosted by Michael Wonder on 18 Dec 2018
Establishing the effectiveness of procedural interventions: the limited role of randomised trials
18 December 2018 - Procedural interventions comprise a large and growing component of medical care. Patients, physicians, health care organisations, and ...
Posted by Michael Wonder on 18 Dec 2018
Warren unveils bill to lower drug prices by letting government manufacture them
18 December 2018 - Senator Elizabeth Warren has unveiled a bill aimed at lowering drug prices by allowing the government ...
Posted by Michael Wonder on 18 Dec 2018
Our door is open: FDA puts patients first
18 December 2018 - We believe patients are experts when it comes to their health conditions. ...
Posted by Michael Wonder on 18 Dec 2018
Statement from FDA Commissioner and Director of the Center for Devices and Radiological Health on new steps to promote innovations in medical devices that help advance patient safety
18 December 2018 - Spurring innovation of medical products so that patients can have access to safe, effective treatments that ...
Posted by Michael Wonder on 18 Dec 2018
UroGen Pharma initiates rolling submission of new drug application for UGN-101 for the treatment of low-grade upper tract urothelial cancer
17 December 2018 - Company expects to complete submission by mid-2019, with potential approval in 2019. ...
Posted by Michael Wonder on 18 Dec 2018
FDA approves Shire’s Motegrity (prucalopride), the only serotonin-4 receptor agonist for adults with chronic idiopathic constipation
17 December 2018 - Unlike other prescription chronic idiopathic constipation treatments, Motegrity works differently by enhancing natural movements of the colon ...
Posted by Michael Wonder on 18 Dec 2018
Alkermes and Biogen announce submission of a new drug application to U.S. FDA for diroximel fumarate in multiple sclerosis
17 December 2018 - Alkermes and Biogen today announced that Alkermes has submitted a new drug application to the U.S. ...
Posted by Michael Wonder on 17 Dec 2018
Eiger announces breakthrough therapy designation granted by FDA for lonafarnib for treatment of hepatitis delta virus infection
17 December 2018 - Phase 3 HDV “D-LIVR” international study initiating. ...
Posted by Michael Wonder on 17 Dec 2018
Amgen submits biologics license application for ABP 710 (biosimilar infliximab) to US Food And Drug Administration
17 December 2018 - Filing for ABP 710, a biosimilar candidate to infliximab, supported by Phase 3 study in patients with ...
Posted by Michael Wonder on 16 Dec 2018
A drug that was once inexpensive gets a new price tag: $375,000
13 December 2018 - An old, formerly inexpensive drug called Firdapse was just slapped with a steep new price tag: ...
Posted by Michael Wonder on 15 Dec 2018
Supernus announces FDA approval of sNDA to expand Oxtellar XR label to include monotherapy
14 December 2018 - Supernus Pharmaceuticals announced today that the United States FDA has approved the Company’s supplemental new drug ...
Posted by Michael Wonder on 15 Dec 2018
Celltrion and Teva announce FDA approval of Herzuma (trastuzumab-pkrb), a biosimilar to Herceptin, for the treatment of HER2-over-expressing breast cancer for certain indications
15 December 2018 - Celltrion and Teva Pharmaceutical Industries today announced that the U.S. FDA has approved Herzuma (trastuzumab-pkrb), a ...
Posted by Michael Wonder on 15 Dec 2018
FDA approves Nplate (romiplostim) for use in paediatric patients with immune thrombocytopenia
14 December 2018 - Application granted priority review designation. ...
Posted by Michael Wonder on 13 Dec 2018
A method for approximating future entry of generic drugs
13 December 2018 - The paper by Beall and colleagues relates to the development and testing of a method for approximating ...
Posted by Michael Wonder on 13 Dec 2018
Statement from FDA Commissioner and Director of FDA’s Center for Drug Evaluation and Research on efforts to modernise generic drug labels while maintaining the efficiency of generic development
13 December 2018 - Protecting patient safety is at the core of the FDA’s mission. All FDA-approved drugs have benefits and ...