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RSS FeedPosted by Michael Wonder on 16 Apr 2019
FDA agrees to rolling review of Mesoblast's biologic licence application for its cell therapy in children with steroid-refractory acute graft versus host disease
16 April 2019 - Mesoblast announced today that the FDA has agreed that Mesoblast can submit on a rolling basis ...
Posted by Michael Wonder on 16 Apr 2019
FDA to launch new website next week
16 April 2019 - In his first “all hands” speech at the US FDA White Oak campus on Tuesday, Acting ...
Posted by Michael Wonder on 16 Apr 2019
Evenity (romosozumab-aqqg) now available in the United States for the treatment of osteoporosis in post-menopausal women at high risk for fracture
15 April 2019 - New therapy to cost one-third less than other bone-building agents over full course of therapy. ...
Posted by Michael Wonder on 15 Apr 2019
FDA approves PureTech’s obesity device Plenity
15 April 2019 - The FDA has approved PureTech Health’s ‘space occupying’ device Plenity as a new prescription treatment for ...
Posted by Michael Wonder on 15 Apr 2019
Novartis announces FDA filing acceptance and priority review of brolucizumab (RTH258) for patients with wet AMD
15 April 2019 - Filing is based on Phase III data from the HAWK and HARRIER trials for brolucizumab. ...
Posted by Michael Wonder on 14 Apr 2019
Medicare aims to expand coverage of cancer care. But is it enough?
13 April 2019 - In a major test case, Medicare is poised to cover a promising but expensive new type ...
Posted by Michael Wonder on 14 Apr 2019
Biopharma CEOs explain problems with biosimilars to Congress
12 April 2019 - Following their Senate Finance Committee hearing in February, all seven biopharmaceutical CEOs have now offered hundreds ...
Posted by Michael Wonder on 13 Apr 2019
How are gene therapies going to get paid for?
12 April 2019 - Ideally, gene therapies address the root causes of disease with a single curative dose. ...
Posted by Michael Wonder on 13 Apr 2019
Polyphor's antibiotic murepavadin receives US FDA qualified infectious disease product designation in four new indications
12 April 2019 - Polyphor's antibiotic murepavadin receives US FDA qualified infectious disease product designation in four new indications. ...
Posted by Michael Wonder on 13 Apr 2019
Missing from the PBM hearings: value based drug reimbursement
11 April 2019 - This week, committees in both the Senate and House of Representatives used their power to shine ...
Posted by Michael Wonder on 13 Apr 2019
FDA approves first targeted therapy for metastatic bladder cancer
12 April 2019 - The U.S. FDA today granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally ...
Posted by Michael Wonder on 12 Apr 2019
FDA approves expanded monotherapy label for Merck’s Keytruda (pembrolizumab)
11 April 2019 - Keytruda now approved for first-line treatment of patients with Stage III NSCLC who are not candidates for ...
Posted by Michael Wonder on 11 Apr 2019
The perils of value based pricing for prescription drugs
11 April 2019 - How do you determine the value, and the price, of life-saving medication? ...
Posted by Michael Wonder on 11 Apr 2019
Institute for Clinical and Economic Review posts draft scoping document for the assessment of treatments for rheumatoid arthritis
11 April 2019 - Document open to public comment until 1 May 2019. ...
Posted by Michael Wonder on 11 Apr 2019
Institute for Clinical and Economic Review to assess treatments for type 2 diabetes mellitus
11 April 2019 - Report will be subject of New England CEPAC meeting in November 2019; open Input now being ...